Emblem MAPD 2018 Part D Prior Authorization Criteria
User Manual: Part-D-Prior-Authorization-Criteria
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GuildNet Gold HMO SNP 2018 Prior Authorization (PA) Criteria Certain drugs require prior authorization from GuildNet Gold Medicare Plan. This means that your doctor must contact us to get approval before prescribing the drug to you. If your doctor does not get prior approval, the drug may not be covered. This list also includes drugs that may be covered under Medicare Part B or Part D depending on how the drugs are used or administered. If your drug is on this list, your doctor should call us and to provide information describing the use and administration of the drug so we can advise on whether the drug will be covered. To see if your drug is on the list, refer to the index located at the end of this document for the medication you are looking for. H6864_GN263_PA Criteria_Accepted 1 ACTHAR Products Affected • Acthar H.P. PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Use in patients with multiple sclerosis (MS) as pulse therapy on a monthly basis. Use as maintenance therapy in patients with psoriatic arthritis, rheumatoid arthritis, or ankylosing spondylitis. Treatment of proteinuria in diabetic nephropathy. Required Medical Information MS exacerbation, rheumatic disorder exacerbation, history of corticosteroid use, concomitant use of disease-modifying antirheumatic drugs (DMARDs). Age Restrictions N/A Prescriber Restrictions Infantile spasms, prescribed by or in consultation with a neurologist or an epileptologist. MS exacerbation, prescribed by or in consultation with a neurologist or physician that specializes in the treatment of MS. Rheumatic disorder exacerbation, prescribed by or in consultation with a rheumatologist. Coverage Duration One month Other Criteria For MS exacerbation and rheumatic disorder exacerbation, approve if the patient cannot use high-dose IV corticosteroids because IV access is not possible or if the patient has tried high-dose corticosteroids administered IV for an acute exacerbation and has experienced a severe or limiting adverse effect. 2 ACTIMMUNE Products Affected • Actimmune PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 3 ADCIRCA Products Affected • Adcirca PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Nitrate therapy Required Medical Information PAH been confirmed by right heart catheterization. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 4 ADEMPAS Products Affected • Adempas PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions PAH and CTEPH- must be prescribed by or in consultation with a cardiologist or a pulmonologist. Coverage Duration Plan Year Other Criteria For PAH - must have PAH (WHO Group 1) and had a right heart catheterization to confirm the diagnosis of PAH (WHO Group 1). Right heart catheterization is not required in pts who are currently receiving Adempas or another agent indicated for WHO group 1. 5 AFINITOR Products Affected • • Afinitor Afinitor Disperz PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Oncologist Coverage Duration Plan Year Other Criteria N/A 6 ALECENSA Products Affected • Alecensa PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Patients already started on Alecensa for a covered use Exclusion Criteria Xalkori (Crizotinib) treatment naive patients Required Medical Information Confirmed ALK-positive NSCLC as detected by an FDA-approved test and prior therapies tried Age Restrictions 18 years and older Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC): The patient has metastatic ALK-positive NSCLC as detected by an FDA-approved test AND The patient has progressed on or are intolerant to Xalkori (crizotinib) 7 ALOSETRON Products Affected • alosetron PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D coverage Exclusion Criteria Patient has a history of any of the following conditions: Chronic or severe constipation or sequelae from constipation. Intestinal obstruction, stricture, toxic megacolon, gastrointestinal perforation, and/or adhesions. Ischemic colitis. Impaired intestinal circulation, thrombophlebitis or hypercoagulable state. Crohn's disease or ulcerative colitis. Diverticulitis. Severe hepatic impairment. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For diagnosis of severe diarrhea-predominant irritable bowel syndrome (IBS) alosetron is being prescribed for a woman AND chronic IBS symptoms have lasted at least 6 months AND gastrointestinal tract abnormalities have been ruled out AND the patient has had inadequate response to conventional therapy. 8 ALUNBRIG Products Affected • Alunbrig PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Concurrent use with other chemotherapy, patients with ALK-negative NSCLC, pediatric patients less than 18 years of age Required Medical Information Diagnosis, prior therapies, ALK-positive NSCLC confirmed by an FDAapproved test Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with an oncologist Coverage Duration Plan Year Other Criteria For NSCLC, patient has metastatic or recurrent disease that is ALKpositive as detected by an FDA-approved test AND Alunbrig is being used as a single agent AND patient has progressed on Xalkori (crizotinib) 9 AMPYRA Products Affected • Ampyra PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on dalfampridine extended-release for Multiple Sclerosis (MS). Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions MS. If prescribed by, or in consultation with, a neurologist or MS specialist. Coverage Duration Plan Year Other Criteria N/A 10 ANADROL Products Affected • Anadrol-50 PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 11 ANTICONVULSANTS Products Affected • • topiramate oral capsule, sprinkle topiramate oral capsule,sprinkle,ER 24hr • • topiramate oral tablet zonisamide PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 12 APOKYN Products Affected • APOKYN PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 13 APTIOM Products Affected • Aptiom PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 14 ARCALYST Products Affected • Arcalyst PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on rilonacept for Muckle Wells Syndrome (MWS) or Familial Cold Autoinflammatory Syndrome (FCAS). Exclusion Criteria Rilonacept should not be given in combination with biologic therapy (e.g. tumor necrosis factor (TNF) blocking agents (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), anakinra, or canakinumab). Required Medical Information N/A Age Restrictions Initial tx CAPS-Greater than or equal to 12 years of age. Prescriber Restrictions Initial tx CAPS-prescribed by, or in consultation with, a rheumatologist, geneticist, dermatologist or immunologist. Coverage Duration Plan Year Other Criteria CAPS renewal - approve if they have had a response and are continuing therapy to maintain response/remission. 15 AUBAGIO Products Affected • Aubagio PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Concurrent use of Aubagio with other disease-modifying agents used for multiple sclerosis (MS) Required Medical Information MS, patient must have a relapsing form of MS (RRMS, SPMS with relapses, or PRMS). MS, previous MS therapies tried. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, a neurologist or physician who specializes in the treatment of MS. Coverage Duration Plan Year Other Criteria N/A 16 AVONEX Products Affected • • Avonex (with albumin) Avonex intramuscular pen injector kit • Avonex intramuscular syringe kit PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Concurrent use of other disease-modifying agents used for multiple sclerosis (MS) Required Medical Information Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, a neurologist or physician who specializes in the treatment of MS. Coverage Duration Plan Year Other Criteria N/A 17 BANZEL Products Affected • Banzel oral tablet PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 18 BAVENCIO Products Affected • Bavencio PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria For urothelial carcinoma, treatment naive patients Required Medical Information For urothelial carcinoma, previous treatment with platinum-containing chemotherapy Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an oncologist Coverage Duration Plan Year Other Criteria For Locally Advanced or Metastatic Urothelial Carcinoma patient must have disease progression during or after platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant treatment with platinumcontaining chemotherapy 19 BOSULIF Products Affected • Bosulif PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Bosulif for a Covered Use. Exclusion Criteria N/A Required Medical Information Diagnosis for which Bosulif is being used. For chronic myelogenous leukemia (CML), the Philadelphia chromosome (Ph) status of the leukemia must be reported. For CML, prior therapies tried must be reported to confirm resistance or intolerance. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For CML, patient must have Ph-positive CML and must have resistance or intolerance to any one prior therapy for approval. 20 BRIVIACT Products Affected • Briviact PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 21 CABOMETYX Products Affected • Cabometyx PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, medication history, histology, RET gene rearrangement status Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Advance Renal Cell Carcinoma-Patients must meet both 1 AND 2-1. Patient has RCC with predominant clear-cell histology 2. Patient has tried one tyrosine kinase inhibitor therapy (e.g., Sutent [sunitinib malate capsules], Votrient [pazopanib tablets], Inlyta [axitinib tablets], Nexavar [sorafenib tosylate tablets]). 22 CHOLBAM Products Affected • Cholbam PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information baseline liver function tests Age Restrictions N/A Prescriber Restrictions Prescribed by or in consultation with hepatologist, metabolic specialist, or GI Coverage Duration Initial approval for 3 months, continuation approval for plan year Other Criteria For continuation of therapy to be approved patient must meet 2 of the 3 following lab criteria or meet 1 of the 3 follow lab criteria and have body weight increased by 10% or stable at greater than the 50th percentile. Lab criteria: (1) patient alanine aminotransferase (ALT) or aspartate aminotransferase (AST) less than 50 U/L or the baseline levels reduced by 80%, (2) patient total bilirubin level must be reduced to less than or equal to 1 mg/dL, (3) patient must not have evidence of cholestasis on liver biopsy. 23 CHORIONIC GONADOTROPINS (HCG) Products Affected • • chorionic gonadotropin, human Novarel intramuscular recon soln 10,000 unit • Pregnyl PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 24 CIALIS Products Affected • Cialis oral tablet 2.5 mg, 5 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Indication for which tadalafil is being prescribed. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Benign prostatic hyperplasia (BPH), after confirmation that tadalafil is being prescribed to treat the signs and symptoms of BPH and not for the treatment of erectile dysfunction (ED) and after a trial of an alpha-1 blocker (eg, doxazosin [Cardura XL], terazosin, tamsulosin [Flomax], alfuzosin extended-release [UroXatral]) or 5 alpha reductase inhibitor (eg, finasteride, dutasteride [Avodart]). 25 CINRYZE Products Affected • Cinryze PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Must be prescribed by, or in consultation with, an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders. Coverage Duration Plan Year Other Criteria N/A 26 COMETRIQ Products Affected • Cometriq PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Cometriq for a Covered Use. Exclusion Criteria N/A Required Medical Information Diagnosis of progressive, metastatic medullary thyroid cancer. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 27 CORLANOR Products Affected • Corlanor PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Previous use of a Beta-blocker, LVEF, sinus rhythm, and resting HR Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration 12 months Other Criteria HF in pts not currently receiving Corlanor - must all of the following 1. have LVEF of less than or equal 35 percent, 2. have sinus rhythm and a resting HR of greater than or equal to 70 BPM, AND 3. tried or is currently receiving a Beta-blocker for HF (e.g., metoprolol succinate sustained-release, carvedilol, bisoprolol, carvedilol ER) unless the patient has a contraindication to the use of beta blocker therapy (e.g., bronchospastic disease such as COPD and asthma, severe hypotension or bradycardia). HF in pts currently receiving Corlanor - had a LVEF of less than or equal to 35 percent prior to initiation of Corlanor therapy AND has tried or is currently receiving a Beta-blocker for HF unless the patient has a contraindication to the use of beta blocker therapy. 28 COTELLIC Products Affected • Cotellic PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Previous therapies tried, presence of BRAF V600E or V600K mutation confirmed by an FDA approved test Age Restrictions 18 years and older Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Melanoma - being prescribed in combination with vemurafenib 29 CRINONE Products Affected • Crinone PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Use in patients to supplement or replace progesterone in the management of infertility. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Secondary amenorrhea, 12 months. Support of an established pregnancy, 9 months. Other Criteria N/A 30 CYRAMZA Products Affected • Cyramza PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Previous therapies tried Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For gastric cancer or malignant neoplasm of cardio-esophageal junction of stomach, prior therapy with fluoropyrimidine- or platinum-containing therapy. For metastatic colorectal cancer, in combination with 5fluorouracil, leucovorin, irinotecan (FOLFIRI) and prior therapy with Avastin (bevacizumab), oxaliplatin, and a fluoropyrimidine. For metastatic NSCLC, in combination with docetaxel and prior therapy with platinumbased chemotherapy. Part B versus D determination per CMS guidance. 31 DARAPRIM Products Affected • Daraprim PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D coverage Exclusion Criteria hypersensitivity to pyrimethamine, documented megaloblastic anemia due to folate deficiency Required Medical Information Medication history, patient's immune status Age Restrictions N/A Prescriber Restrictions Toxoplasma gondii Encephalitis, Chronic Maintenance and Prophylaxis (Primary)-prescribed by or in consultation with an infectious diseases specialist. Toxoplasmosis Treatment-prescribed by or in consultation with an infectious diseases specialist, a maternal-fetal medicine specialist, or an ophthalmologist. Coverage Duration Plan Year Other Criteria Malaria Prophylaxis, approve if the patient has tried at least two other antimalarials (eg, atovaquone-proguanil, chloroquine phosphate, hydroxychloroquine sulfate, doxycycline, mefloquine, and primaquine). Malaria Treatment, approve if the patient has tried at least two other antimalarials (eg, Coartem [artemether-lumefantrine tablets], quinine sulfate or quinidine gluconate in combination with doxycycline, tetracycline, or clindamycin, quinine sulfate in combination with primaquine and either doxycycline or tetracycline, or the following medications as monotherapy or in combination with primaquine: atovaquone-proguanil, mefloquine, chloroquine phosphate, and hydroxychloroquine). Toxoplasma gondii Encephalitis, Chronic Maintenance, approve if the patient is immunosuppressed. Toxoplasma gondii Encephalitis Prophylaxis (Primary), approve if the patient is immunosuppressed and the patient has tried one other recommended therapy, unless contraindicated (eg, trimethoprim-sulfamethoxazole [TMPSMX], atovaquone). 32 DARZALEX Products Affected • Darzalex PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Treatment-naive patients Required Medical Information History of previous treatments Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For the treatment of Multiple myeloma as monotherapy, patients must have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or are double-refractory to a PI and an immunomodulatory agent. For the treatment of Multiple myeloma in combination with pomalidomide and dexamethasone, patients must have received at least two prior therapies including lenalidomide and a proteasome inhibitor. For the treatment of Multiple myeloma, In combination with lenalidomide plus dexamethasone or bortezomib plus dexamethasone patients must have received at least one prior therapy. 33 DEMSER Products Affected • Demser PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 34 DICLOFENAC GEL Products Affected • diclofenac sodium topical gel 3 % PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 35 DIGOXIN Products Affected • • Digitek digoxin injection solution • • digoxin oral solution 50 mcg/mL digoxin oral tablet PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D coverage Exclusion Criteria N/A Required Medical Information The physician has documented the indication for the continued use of the HRM (high risk medication) with an explanation of the specific benefit established with the medication and how that benefit outweighs the potential risk, AND the physician will continue to monitor for side effects, AND the physician has documented that the patient has tried and failed digoxin 0.125mg daily or provided clinical rationale as to why the lower dose is not appropriate for the patient. Age Restrictions This prior authorization only applies to members 65 years of age or older to ensure safe use of a potentially high risk medication in the elderly population. Members under 65 years of age are not subject to the prior authorization requirements. Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 36 EGRIFTA Products Affected • Egrifta subcutaneous recon soln 1 mg PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Diagnosis. Age Restrictions Adults Prescriber Restrictions Prescribed by or in consultation with an endocrinologist or a physician specializing in the treatment of HIV (eg, infectious disease, oncology). Coverage Duration Plan Year Other Criteria HIV-infected adult patients (18 years of age or older) with lipodystrophy AND Egrifta is being used to reduce excessive abdominal fat 37 EMPLICITI Products Affected • Empliciti PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Treatment-naive patients Required Medical Information History of previous treatments Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For the treatment of multiple myeloma, patient must have received at least one prior therapy. Part B versus Part D determination will be made at time of prior authorization review per CMS guidance. 38 EPCLUSA Products Affected • Epclusa PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Combination use with other direct acting antivirals, excluding ribavirin. Required Medical Information Documentation from the medical record of diagnosis including genotype, HCV RNA viral levels prior to treatment, history of previous HCV therapies, and presence/absence of cirrhosis. For patients with cirrhosis, cirrhosis must be documented by FibroScan, FibroTest ActiTest, liver biopsy, or radiological imaging. Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician. Coverage Duration 12 weeks, based on indication and current AASLD/IDSA guidance. Other Criteria Criteria will be applied consistent with current AASLD/IDSA guidance 39 ERIVEDGE Products Affected • Erivedge PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus, patient already started on Erivedge for a covered use. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Locally advanced basal cell carcinoma (LABCC), approve if the patients BCC has recurred following surgery or the patient is not a candidate for surgery or radiation therapy. 40 ERWINAZE Products Affected • Erwinaze PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Documentation of hypersensitivity to Escherichia coli derived asparaginase as a component of a multi-agent chemotherapeutic regimen. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist or Hematologist Coverage Duration Plan Year Other Criteria N/A 41 ESBRIET Products Affected • Esbriet PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Combination use with Nintedanib Required Medical Information N/A Age Restrictions 18 years of age and older Prescriber Restrictions Prescribed by or in combination with a pulmonologist Coverage Duration Plan Year Other Criteria IPF baseline - must have FVC greater than or equal to 50 percent of the predicted value AND IPF must be diagnosed with either findings on highresolution computed tomography (HRCT) indicating usual interstitial pneumonia (UIP) or surgical lung biopsy demonstrating UIP. 42 EXTAVIA Products Affected • Extavia subcutaneous kit PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Concurrent use of any of the following medications: Interferon-beta therapy (Avonex, Betaseron, Extavia, or Rebif), mitoxantrone, fingolimod, teriflunomide, or dimethyl fumarate. Required Medical Information Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, a neurologist or physician who specializes in the treatment of MS. Coverage Duration Plan Year Other Criteria Patients with previous use (12 or more months) of Extavia must demonstrate one of the following clinical responses: decrease in the frequency of relapses, slowing of disease progression, MRI lesions have diminished with therapy, OR patient is stable on therapy. 43 FABRAZYME Products Affected • Fabrazyme intravenous recon soln 35 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 44 FARYDAK Products Affected • Farydak PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist or Hematologist Coverage Duration Plan Year Other Criteria Must be used in combination with Velcade and dexamethasone AND previously tried Velcade and one immunomodulatory drug (i.e., Thalomid, Revlimid, or Pomalyst). 45 FERRIPROX Products Affected • Ferriprox oral tablet PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 46 FIRAZYR Products Affected • Firazyr PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders. Coverage Duration Plan Year Other Criteria N/A 47 FYCOMPA Products Affected • Fycompa oral suspension • Fycompa oral tablet PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, a Neurologist Coverage Duration Plan Year Other Criteria N/A 48 GATTEX Products Affected • Gattex 30-Vial PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 49 GILOTRIF Products Affected • Gilotrif PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information For metastatic non-small cell lung cancer (NSCLC) documentation of epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test. For metastatic squamous NSCLC, documentation of prior platinum-based chemotherapy. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 50 GLATOPA/COPAXONE Products Affected • Glatopa PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Concurrent use of any of the following medications: Interferon-beta therapy (Avonex, Betaseron, Extavia, or Rebif), mitoxantrone, fingolimod, teriflunomide, or dimethyl fumarate. Required Medical Information Previous therapies tried. Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, a neurologist or physician who specializes in the treatment of MS. Coverage Duration Plan year Other Criteria Patients with previous use (12 or more months) of Glatopa must demonstrate one of the following clinical responses: decrease in the frequency of relapses, slowing of disease progression, diminished MRI lesions, OR patient is stable on therapy. 51 GROWTH HORMONE Products Affected • Norditropin FlexPro PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information For pediatric GHD in neonate with hypoglycemia: patient has a randomly assessed GH level less than 20 ng/mL, other causes of hypoglycemia have been ruled out, and other treatments have been ineffective. For all pediatric patients: patients have short stature or slow growth velocity and have been evaluated for other causes of growth failure. For pediatric GHD, patient has delayed bone age. For pediatric GHD without pituitary disease, patient failed 2 stimulation tests. For pediatric GHD with a pituitary or CNS disorder, patient has clinical evidence of GHD and low IGF-1/IGFBP3. For TS and SHOX patients: diagnosis confirmed by genetic testing. For CRI patients: metabolic, endocrine and nutritional abnormalities have been treated or stabilized and patient has not had a kidney transplant. For SGA: patient has a low birth weight or length for gestational age. For ISS: pediatric GHD has been ruled out with one stimulation test. For adult GHD, patient was assessed for other causes of GHD-like symptoms. For adult GHD without pituitary disease, patient failed 2 stimulation tests. For adult GHD with at least 3 pituitary hormone deficiencies (PHD) or panhypopituitarism: have a low IGF-1. For adult GHD with less than 3 PHD, low IGF-1 and failed one stimulation test. For renewal: patient has seen clinical improvement. Age Restrictions For Turner syndrome and SGA, 2 years of age and older. For Noonan syndrome and SHOX, 3 years of age and older. Prescriber Restrictions Endocrinologist, Pediatric Nephrologist, Gastroenterologist, Nutritional Support Specialist, Infectious Disease Specialist Coverage Duration Plan Year Other Criteria N/A 52 HARVONI Products Affected • Harvoni PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Combination use with other direct acting antivirals, excluding ribavirin. Required Medical Information Documentation from the medical record of diagnosis including genotype, HCV RNA viral levels prior to treatment, history of previous HCV therapies, and presence/absence of cirrhosis. For patients with cirrhosis, cirrhosis must be documented by FibroScan, FibroTest ActiTest, liver biopsy, or radiological imaging. Age Restrictions 12 years of age and older Prescriber Restrictions Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician. Coverage Duration 12 to 24 weeks, based on indication and current AASLD/IDSA guidance. Other Criteria Criteria will be applied consistent with current AASLD/IDSA guidance 53 HETLIOZ Products Affected • Hetlioz PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For the indication of Non-24-Hour Sleep-Wake Disorder (Non-24), approval will only be granted for patients who are totally blind. 54 HRM Products Affected • • • • • • benztropine oral butalbital-acetaminop-caf-cod butalbital-acetaminophen-caff oral capsule 50-325-40 mg butalbital-aspirin-caffeine oral capsule clemastine oral tablet 2.68 mg cyclobenzaprine oral tablet • • • • • • • cyproheptadine ergoloid meprobamate metaxalone methyldopa-hydrochlorothiazide promethazine oral tablet trihexyphenidyl PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Approve when the provider has assessed the risk versus benefit in using this High Risk Medication (HRM) in the patient and has confirmed that they would still like to initiate or continue therapy 55 HRM - BENZODIAZEPINES Products Affected • • alprazolam oral tablet extended release 24 hr 1 mg, 2 mg, 3 mg Lorazepam Intensol • • • lorazepam oral tablet oxazepam temazepam PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Prescriber Restrictions N/A Coverage Duration Procedure-related sedation = 1mo. All other conditions = Plan Year. Other Criteria All medically accepted indications other than insomnia, authorize use. Insomnia, approve lorazepam, oxazepam, or temazepam if the patient has had a trial with two of the following: ramelteon, trazodone, doxepin 3mg or 6 mg, eszopiclone, zolpidem, or zaleplon. 56 HRM BENZODIAZEPINES/ANTICONVULSANTS Products Affected • • • clonazepam oral tablet,disintegrating clorazepate dipotassium Diazepam Intensol • • diazepam oral solution 5 mg/5 mL (1 mg/mL) diazepam oral tablet PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Approve when the provider has assessed the risk versus benefit in using this High Risk Medication (HRM) in the patient and has confirmed that they would still like to initiate or continue therapy 57 HRM PD Products Affected • • • • • • • • • • amitriptyline clomipramine doxepin oral estradiol oral imipramine HCl imipramine pamoate megestrol oral tablet perphenazine-amitriptyline phenobarbital trimipramine PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Approve when the provider has assessed the risk versus benefit in using this High Risk Medication (HRM) in the patient and has confirmed that they would still like to initiate or continue therapy 58 HYDROXYPROGESTERONE Products Affected • hydroxyprogesterone caproate PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 59 IBRANCE Products Affected • Ibrance PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 60 ICLUSIG Products Affected • Iclusig PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis the Philadelphia chromosome (Ph) status of the leukemia must be reported. T315I status Age Restrictions CML/ALL - Adults Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria CML Ph+, T315I-positive or has tried TWO other TKIs indicated for use in Philadelphia chromosome positive CML (e.g., Gleevec, Sprycel, Tasigna). ALL Ph+, T315I-posistive or has tried TWO other TKIs indicated for use in Ph+ ALL (e.g. Gleevec, Sprycel.) 61 ILARIS Products Affected • Ilaris (PF) subcutaneous recon soln PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria When used in combination with concurrent biologic therapy (e.g.TNF antagonists, etanercept, adalimumab, certolizumab pegol, golimumab, infliximab), anakinra, or rilonacept. Required Medical Information N/A Age Restrictions CAPS-4 years of age and older. SJIA-2 years of age and older. Prescriber Restrictions CAPS/MWS/FCAS initial- Prescribed by or in consultation with a rheumatologist, geneticist, immunologist or dermatologist. SJIA initialprescribed by or in consultation with a rheumatologist Coverage Duration Plan Year Other Criteria For renewal of CAPS/MWS/FCAS - after pt had been started on Ilaris, approve if the pt had a response to therapy as determined by prescribing physician and the pt is continuing therapy to maintain a response/remission. For treatment of SJIA, initial therapy approve if the pt meets one of the following 1. has tried at least 2 other biologics for SJIA (tocilizumab, abatacet, TNF antagonists (e.g. etanercept, adalimumab, infliximab) OR 2. pt has features of poor prognosis (e.g. arthritis of the hip, radiographic damage, 6-month duration of significant active systemic disease, defined by fever, elevated inflammatory markers, or requirement for treatment with systemic glucocorticoids AND tried Actemra or Kineret. SJIA renewal approve if it patient was already started on Ilaris and the pt had a response (e.g. resolution of fever, improvement in limitations of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue, improved function or ADLs, reduced dosage of CS) and the pt is continuing therapy to maintain response/remission. 62 IMATINIB/GLEEVEC Products Affected • imatinib oral tablet 100 mg, 400 mg PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Chronic myeloid leukemia (CML) and acute lymphoblastic leukemia (ALL) must be positive for the Philadelphia chromosome or BCR-ABL gene. For CML, patient meets one of the following: 1) newly diagnosed, 2) resistance or intolerance to prior therapy, or 3) recurrence after stem cell transplant. For ALL, patient meets one of the following: 1) newly diagnosed and imatinib is used in combination with chemotherapy, or 2) ALL is relapsed or refractory. For GIST, patient meets one of the following: 1) unresectable, recurrent, or metastatic disease, or 2) use of imatinib for adjuvant therapy following resection, or 3) use of imatinib for pre-operative therapy and patient is at risk for significant surgical morbidity. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 63 IMBRUVICA Products Affected • Imbruvica PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information For patients with mantle cell lymphoma (MCL)-history of prior treatment. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 64 IMFINZI Products Affected • Imfinzi PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Treatment naive patients, pregnancy Required Medical Information Diagnosis, prior treatment with platinum-based chemotherapy Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with an oncologist Coverage Duration Plan Year Other Criteria For locally advanced or metastatic urothelial carcinoma, patient had disease progression during or following platinum-containing chemotherapy or patient had disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy 65 INLYTA Products Affected • Inlyta PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Inlyta for a Covered Use. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Advanced renal cell carcinoma, approve the patient has failed at least one prior systemic therapy (eg, Torisel, Avastin, Sutent, IFN-alpha, IL-2, Votrient, Nexavar). 66 IRESSA Products Affected • Iressa PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Metastatic NSCLC - The patient has epidermal growth factor receptor (EGFR) exon 19 deletions OR has exon 21 (L858R) substitution mutations as detected by an FDA-approved test. 67 IVIG Products Affected • Gammagard Liquid • Gamunex-C injection solution 1 gram/10 mL (10 %) PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Authorization will be for Plan Year. Other Criteria Part B versus D determination per CMS guidance to establish if drug used for PID in pts home. 68 JAKAFI Products Affected • Jakafi oral tablet 10 mg, 15 mg, 20 mg, 25 mg, 5 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Jakafi for a Covered Use. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist or Hematologist Coverage Duration Plan Year Other Criteria For polycythemia vera patients must have tried hydroxyurea 69 JUXTAPID Products Affected • Juxtapid PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 70 KADCYLA Products Affected • Kadcyla intravenous recon soln 100 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information HER2 overexpression status. Prior therapies tried. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 71 KALYDECO Products Affected • Kalydeco PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Patients with cystic fibrosis who are homozygous for the F508del mutation in the CFTR gene. Required Medical Information CF mutation test documenting a G551D, G1244E, G1349D, G178R, G551S, R117H, S1251N, S1255P, S549N, or S549R mutation in the CFTR gene. Age Restrictions 2 years of age and older for packets. 6 years of age and older for tablets. Prescriber Restrictions Prescribed by or inconsultation with a pulmonologist or a physician who specializes in CF Coverage Duration Plan Year Other Criteria N/A 72 KEVEYIS Products Affected • Keveyis PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Patient with history of hypersensitivity to diclorphenamide or other sulfonamides, Patient on high dose aspirin, Patient with severe pulmonary disease, Patient with hepatic insufficiency Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Initial therapy - 2 months, Continuing therapy - plan year Other Criteria Hyperkalemic Periodic Paralysis (HyperPP) and Related Variants: Patient has a confirmed diagnosis of primary hyperkalemic periodic paralysis by meeting at least ONE of the following criteria: Patient has had an increase from baseline in serum potassium concentration of greater than or equal to 1.5 mEq/L during a paralytic attack OR Patient has had a serum potassium concentration during a paralytic attack of greater than 5.0 mEq/L OR Patient has a family history of the condition OR Patient has a genetically confirmed skeletal muscle sodium channel mutation AND The prescribing physician has excluded other reasons for acquired hyperkalemia (e.g., drug abuse, renal and adrenal dysfunction) For Continuation of treatment a patient has decrease in the frequency or severity of paralytic attacks with treatment as determined by the prescribing physician. For Hypokalemic Periodic Paralysis (HypoPP) and Related Variants for Initiation of treatment: Patient has a confirmed diagnosis of primary hypokalemic periodic paralysis by meeting at least ONE of the following: Patient has had a serum potassium concentration of less than 3.5 mEq/L during a paralytic attack OR Patient has a family history of the condition OR Patient has a genetically confirmed skeletal muscle calcium or sodium channel mutation AND Patient has had improvements in paralysis attack symptoms with potassium intake. For Continuation of treatment: Patient has decrease 73 PA Criteria Criteria Details in the frequency or severity of paralytic attacks with treatment as determined by the prescribing physician 74 KEYTRUDA Products Affected • Keytruda PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information For NSCLC, PD-L1 status and prior therapies tried. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria N/A 75 KISQALI Products Affected • Kisqali Femara Co-Pack oral tablet 200 mg/day(200 mg x 1)-2.5 mg, 400 mg/day(200 mg x 2)-2.5 mg, 600 mg/day(200 mg x 3)-2.5 mg • Kisqali oral tablet 200 mg/day (200 mg x 1), 400 mg/day (200 mg x 2), 600 mg/day (200 mg x 3) PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Use as monotherapy, pregnancy Required Medical Information Estrogen receptor (ER) status, human epidermal growth factor receptor 2 (HER2) status, menopause status, previous therapies tried Age Restrictions 18 years or older Prescriber Restrictions Prescribed by, or in consultation with, an oncologist Coverage Duration Plan Year Other Criteria For advanced (metastatic) breast cancer, patient has estrogen receptorpositive, human epidermal growth factor receptor 2-negative (ER-positive, HER2-negative) breast cancer and patient is postmenopausal and, for patients who have not previously received endocrine therapy for advanced disease, Kisqali must be used in combination with an aromatase inhibitor (anastrozole, exemestane, letrozole) 76 KORLYM Products Affected • Korlym PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Pregnancy. Patients taking simvastatin, lovastatin, and CYP3A substrates with narrow therapeutic ranges, such as cyclosporine, dihydroergotamine, ergotamine, fentanyl, pimozide, quinidine, sirolimus, and tacrolimus. Concomitant treatment with systemic corticosteroids for serious medical conditions or illnesses. Women with a history of unexplained vaginal bleeding. Women with endometrial hyperplasia with atypia or endometrial carcinoma. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 77 KUVAN Products Affected • Kuvan oral tablet,soluble PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Blood phenylalanine (Phe) levels. Pretreatment blood phenylalanine (Phe) levels greater than 10mg/dL if the patient is older than 12 years of age or greater than 6mg/dL if less than or equal to 12 years of age. Response to a therapeutic trial (greater than or equal to a 30% reduction in blood Phe levels) is required for long-term authorization. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration 2 months initial, plan year on renewal Other Criteria Blood Phe levels should be checked after 1 week of therapy and periodically up to one month during a therapeutic trial. 78 KYNAMRO Products Affected • Kynamro PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Current LDL-C (within the past 30 days), prior therapies tried Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For HoFH approve after trial of Repatha. 79 KYPROLIS Products Affected • Kyprolis PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, prior therapies Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with Oncologist or hematologist Coverage Duration Plan Year Other Criteria For Relapsed or Refractory Multiple Myeloma, patient has tried at least one prior therapy. 80 LARTRUVO Products Affected • Lartruvo PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, prior therapies Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with Oncologist Coverage Duration Plan Year Other Criteria For the treatment of adult patients with soft tissue sarcoma (STS) must be used in combination with doxorubicin. 81 LENVIMA Products Affected • Lenvima PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria DTC - must be locally recurrent or metastatic, progressive refractory to radioactive iodine treatment for approval 82 LETAIRIS Products Affected • Letairis PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Pregnancy, idiopathic pulmonary fibrosis, including idiopathic pulmonary fibrosis patients with pulmonary hypertension (WHO group 3). Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by or in consultation with a cardiologist or pulmonologist Coverage Duration Plan Year Other Criteria UD or two appropriate contraceptive methods will be used for women of childbearing potential. 83 LEUKINE Products Affected • Leukine injection recon soln PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Administration within 24 hours preceding or following chemotherapy or radiotherapy, hypersensitivity to yeast-derived products. For prophylaxis of febrile neutropenia: use to increase the chemotherapy dose intensity or dose schedule above established regimens. For treatment of febrile neutropenia, when patient receives Neulasta during the current chemotherapy cycle. For AML only, excessive (greater than or equal to 10%) leukemic myeloid blasts in the bone marrow or peripheral blood. Required Medical Information For patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy: Leukine may be used for the prevention of chemotherapyinduced febrile neutropenia if the patient experienced febrile neutropenia with a prior chemotherapy cycle OR the patient is at risk of developing febrile neutropenia. Leukine is allowable for the treatment of febrile neutropenia in patients who have received prophylaxis with Leukine (or Neupogen) OR in patients at risk for infection-related complications. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration 6 months Other Criteria N/A 84 LEUPROLIDE Products Affected • • • • • • Eligard Eligard (3 month) Eligard (4 month) Eligard (6 month) leuprolide subcutaneous kit Lupron Depot • • • • Lupron Depot (3 month) Lupron Depot (4 month) Lupron Depot (6 Month) Lupron Depot-Ped intramuscular kit 11.25 mg, 15 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D but specific to the following drugs as follows: Prostate cancer (Lupron Depot [7.5 mg-1mo, 22.5 mg-3-mo, 30 mg-4-mo, 45 mg-6-mo] OR Eligard [7.5 mg-1-mo, 22.5mg-3-mo, 30 mg-4-mo, 45 mg-6-mo]), Endometriosis (Lupron Depot [3.75 mg-1-mo, 11.25 mg-3-mo]), Uterine leiomyomata (Lupron Depot [3.75 mg-1-mo, 11.25 mg-3-mo]), Treatment of central precocious puberty (Lupron Depot Ped [11.25 mg-1-mo, 15 mg-1-mo]). Ovarian cancer (Lupron Depot [7.5 mg-1-mo]). Breast cancer (Lupron Depot [3.75 mg-1-mo, 11.25 mg-3-mo]). Prophylaxis or treatment of uterine bleeding in premenopausal women with hematologic malignancy or prior to bone marrow/stem cell transplantation (BMT/SCT) (Lupron Depot [3.75 mg-1-mo, 7.5 mg-1-mo]). Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration For abnrml uterine bleeding, uterine leiomyomata,endometriosis-6 mo.All other=Plan Year Other Criteria N/A 85 LIDOCAINE PATCH Products Affected • lidocaine topical adhesive patch,medicated PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus diabetic neuropathic pain. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For diabetic neuropathic pain: the patient must have previous use and inadequate response or intolerance to any ONE medication that is FDAlabeled for diabetic peripheral neuropathy, including (but not limited to) duloxetine and Lyrica. 86 LINEZOLID Products Affected • linezolid PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Culture and sensitivity and CBC within normal limits Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration 28 days Other Criteria N/A 87 LONSURF Products Affected • Lonsurf PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria Treatment-naive patients Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan year Other Criteria For Metastatic colorectal cancer, patient must have previously been treated with a fluoropyrimidine (e.g., capecitabine, 5-FU) AND oxaliplatin AND irinotecan AND an anti-VEGF therapy And if RAS wild type, anantiEGFR therapy. 88 LYNPARZA Products Affected • Lynparza oral capsule PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information A deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer as detected by an FDA-approved test. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria A documented diagnosis of advanced ovarian cancer which has been treated with at least three prior lines of chemotherapy. 89 MEGESTROL Products Affected • megestrol oral suspension 400 mg/10 mL (40 mg/mL), 625 mg/5 mL PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 90 MEKINIST Products Affected • Mekinist PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Documentation of the detected BRAFV600E or BRAFV600K mutation Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 91 METHAMPHETAMINE Products Affected • methamphetamine PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 92 NAMENDA Products Affected • • memantine oral solution memantine oral tablet • • memantine oral tablets,dose pack Namenda XR PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 93 NATPARA Products Affected • Natpara PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Hypoparathyroidism caused by calcium-sensing receptor mutations. Patients with acute post-surgical hypoparathyroidism. Required Medical Information Serum calcium level Age Restrictions 18 years of age and older Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria For diagnosis of hypocalcemia in patients with hypoparathyroidism, documentation required to show hypocalcemia is not corrected by calcium supplements and active forms of vitamin D alone. 94 NEUPOGEN Products Affected • Neupogen PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Administration within 24 hours preceding or following chemotherapy or radiotherapy, E coli hypersensitivity. For prophylaxis of febrile neutropenia: use to increase the chemotherapy dose intensity or dose schedule beyond established regimen. For treatment of febrile neutropenia, when patient receives Neulasta during the current chemotherapy cycle. Required Medical Information For patients with nonmyeloid malignancies receiving myelosuppressive chemotherapy: Neupogen may be used for the prevention of chemotherapyinduced febrile neutropenia if the patient experienced febrile neutropenia with a prior chemotherapy cycle OR the patient is at risk of developing febrile neutropenia. Neupogen is allowable for the treatment of febrile neutropenia in patients who have received prophylaxis with Neupogen (or Leukine) OR in patients at risk for infection-related complications. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration 6 months Other Criteria N/A 95 NEUPRO Products Affected • Neupro PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria N/A 96 NEXAVAR Products Affected • Nexavar PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Combination with carboplatin and paclitaxel in patients with squamous cell lung cancer Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Oncologist Coverage Duration Plan Year Other Criteria N/A 97 NINLARO Products Affected • Ninlaro PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Previous therapies tried and failed, baseline CBC Age Restrictions 18 years and older Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For multiple myeloma, patient has received at least one prior therapy AND will be used in combination with lenalidomide and dexamethasone. 98 NORTHERA Products Affected • Northera PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Documentation from the medical record of diagnosis and prior medication history Age Restrictions N/A Prescriber Restrictions Prescribed by or in consultation with a cardiologist or a neurologist Coverage Duration Initial 4 weeks, renewal 6 months Other Criteria NOH, approve if the patient meets ALL of the following criteria: a) Patient has been diagnosed with symptomatic NOH due to primary autonomic failure (Parkinsons disease, multiple system atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency, or non-diabetic autonomic neuropathy, AND b) Patient has tried midodrine 99 NUPLAZID Products Affected • Nuplazid PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 100 NUVIGIL/PROVIGIL Products Affected • modafinil PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions Patients must be greater than or equal to 17 years of age. Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria Excessive sleepiness due to SWSD if the patient is working at least 5 overnight shifts per month. 101 OCTREOTIDE Products Affected • octreotide acetate injection solution PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 102 ODOMZO Products Affected • Odomzo PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan year Other Criteria For locally advanced basal cell carcinoma (BCC) has recurred following surgery or radiation therapy or if the patient is not a candidate for surgery and the patient is not a candidate for radiation therapy, according to the prescribing physician. 103 OFEV Products Affected • Ofev PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Combination use with pirfenidone Required Medical Information N/A Age Restrictions 18 years of age and older Prescriber Restrictions Prescribed by or in combination with a pulmonologist Coverage Duration Plan Year Other Criteria IPF baseline - must have FVC greater than or equal to 50 percent of the predicted value AND IPF must be diagnosed with either findings on highresolution computed tomography (HRCT) indicating usual interstitial pneumonia (UIP) or surgical lung biopsy demonstrating UIP. 104 ONFI Products Affected • Onfi oral suspension • Onfi oral tablet 10 mg, 20 mg PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information The patient will receive Onfi for the treatment of seizures associated with Lennox-Gastaut syndrome. Age Restrictions 2 years of age and older Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 105 OPDIVO Products Affected • Opdivo intravenous solution 40 mg/4 mL PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information For NSCLC, EGFR or ALK status. Prior therapies tried Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For NSCLC, patient must have prior platinum-based chemotherapy or FDA-approved therapy for EGFR or ALK aberrations. For RCC, patient must have prior antiangiogenic therapy. 106 OPSUMIT Products Affected • Opsumit PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information PAH WHO group, right heart catheterization Age Restrictions N/A Prescriber Restrictions PAH - must be prescribed by or in consultation with a cardiologist or a pulmonologist. Coverage Duration Plan Year Other Criteria Pulmonary arterial hypertension (PAH) WHO Group 1 patients not currently on Opsumit or another agent indicated for WHO Group 1 PAH are required to have had a right-heart catheterization to confirm the diagnosis of PAH to ensure appropriate medical assessment. PAH WHO Group 1 patients currently on Opsumit or another agent indicated for WHO Group 1 PAH may continue therapy without confirmation of a right-heart catheterization. For patients not currently on Opsumit with confirmed diagnosis of PAH, approval will be given after a trial of Letairis, unless contraindicated. 107 ORKAMBI Products Affected • Orkambi PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Combination use with Kalydeco Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria CF - homozygous for the Phe508del (F508del) mutation in the CFTR gene (meaning the patient has two copies of the Phe508del mutation) 108 PEGASYS Products Affected • Pegasys subcutaneous solution • Pegasys subcutaneous syringe PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 109 PENICILLAMINE Products Affected • Depen Titratabs PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria N/A 110 PERJETA Products Affected • Perjeta PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information HER2 overexpression status. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For breast cancer and metastatic breast cancer, must be used in combination with trastuzumab and docetaxel. 111 PHENOXYBENZAMINE Products Affected • phenoxybenzamine PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 112 POMALYST Products Affected • Pomalyst PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Pregnancy Required Medical Information For active myeloma, patient meets the following: 1) Pomalyst is used after at least two prior therapies or as salvage therapy. 2) Pomalyst may be used with dexamethasone. For female patients of childbearing potential, pregnancy is excluded by 2 negative serum or urine pregnancy tests. For all patients, complete blood counts are monitored for hematologic toxicity while receiving Pomalyst. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist or Hematologist Coverage Duration Plan Year Other Criteria Male and female patients of child-bearing potential should be instructed on the importance of proper utilization of appropriate contraceptive methods for Pomalyst use. Patients should be monitored for signs and symptoms of thromboembolism. 113 PRALUENT Products Affected • Praluent Pen subcutaneous pen injector 150 mg/mL, 75 mg/mL PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Concurrent use of Praluent with Repatha, Juxtapid or Kynamro. Required Medical Information Current LDL-C (within the past 30 days), prior therapies tried, medication adverse event history Age Restrictions 18 years of age and older. Prescriber Restrictions Prescribed by, or in consultation with, a cardiologist, endocrinologist, or a physician who focuses in the treatment of CV risk management and/or lipid disorders Coverage Duration Plan Year Other Criteria Hyperlipidemia in pts w/ (ASCVD) apprv if the pt has a curr LDL-C lvl of grtr or eq to 70 mg/dL w/in the past 30 ds (after tx with antihyperlipidemic agnts but prior to PCSK9 inh tx such as Praluent or Repatha) AND the pt has had one of the following conds or dxs: prev MI,OR has a hx of an acute coronary syndrome, OR The pt has a dx of angina (stable or unstable) ,OR The pt has a past hx of stroke or TIA, OR The pt has PAD, The pt has undergone a coronary or other arterial revascularization procedure AND The pt has tried 1 high-intensity statin tx (i.e., atorvastatin 80 mg daily or Crestor 40 mg daily) for equal or more than 12 cont wks AND the LDL-C lvl remains equal or more than70 mg/dL unless pt experienced statinrelated rhabdomyolysis, OR the pt experienced skeletal-related muscle symptoms while receiving separate trials of atorvastatin and Crestor and during both trials the skeletal-related symptoms resolved during d/c. AND If pt able to tolerate statins cont to rec. the max tolerated dose of a statin while rec. Praluent tx. Heterozygous Familial Hypercholesterolemia apprve if the pt has a curnt LDL-C lvl eq or more than 100 mg/dL w/in the past 30 days, AND the pts dx of HeFH is def as probable or definite by WHO/Dutch Lipid grp criteria OR definite by Simon-Broome Criteria OR genetic testing, AND The pt has tried 1 high-intensity statin txs (i.e., 114 PA Criteria Criteria Details atorvastatin 80 mg daily or Crestor 40 mg daily) for equal or more than 12 cont wks, AND the LDL-C lvl remains eq or more than 100 mg/dL, unless pt experienced statin-related rhabdomyolysis, OR the pt experienced skeletal-related muscle symptoms while receiving separate trials of atorvastatin and Crestor and during both trials the skeletal-related symptoms resolved during d/c. AND If pt able to tolerate statins cont to rec. the max tolerated dose of a statin while rec. Praluent tx. 115 PROCRIT Products Affected • Procrit injection solution 10,000 unit/mL, 2,000 unit/mL, 20,000 unit/mL, 3,000 unit/mL, 4,000 unit/mL, 40,000 unit/mL PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia, . Plus anemia in patients with HIV who are receiving zidovudine. Anemic patients (Hb of 13.0 g/dL or less) at high risk for perioperative transfusions (secondary to significant, anticipated blood loss and are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions). Additional off-label coverage is provided for Anemia due to myelodysplastic syndrome (MDS), Anemia associated with use of ribavirin therapy for hepatitis C, and Anemia in HIV-infected patients. Exclusion Criteria N/A Required Medical Information CRF anemia in patients on and not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dL to start. Hb less than or equal to 10 g/dL for adults (CKD, not on dialysis), 11 g/dL (CKD on dialysis) or 12 g/dL or less for pediatric CKD. Anemia w/myelosuppressive chemotx.pt must be currently receiving myelosuppressive chemo and Hb less than or equal to 10.0 g/dL. MDS, approve if Hb is 10 g/dL or less. Surgical pts to reduce RBC transfusions pt is unwilling or unable to donate autologous blood prior to surgery Age Restrictions MDS anemia/HepC anemia = 18 years of age and older Prescriber Restrictions MDS anemia, prescribed by or in consultation with, a hematologist or oncologist. Hep C anemia, prescribed by or in consultation with hepatologist, gastroenterologist, hematologist or infectious disease physician who specializes in the management of hepatitis C. Coverage Duration Anemia w/myelosuppress = 4 mos.Transfus=1 mo.Other= 6mo. HIV + zidovudine = 4 mo 116 PA Criteria Criteria Details Other Criteria Part B versus Part D determination will be made at time of prior authorization review per CMS guidance to establish if the drug prescribed is to be used for an end-stage renal disease (ESRD)-related condition. 117 PROLIA Products Affected • Prolia PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Concomitant use with other medications for osteoporosis (eg, denosumab [Prolia], bisphosphonates, raloxifene, calcitonin nasal spray [Miacalcin, Fortical]), except calcium and Vitamin D. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Treatment of postmenopausal osteoporosis/Treatment of osteoporosis in men (to increase bone mass), approve if the patient meets one of the following: 1. has had inadequate response after 12 months of therapy with an oral bisphosphonate, had osteoporotic fracture while receiving an oral bisphosphonate, or intolerability to an oral bisphospohate, OR 2. the patient cannot take an oral bisphosphonate because they cannot swallow or have difficulty swallowing, they cannot remain in an upright position, or they have a pre-existing GI medical condition, OR 3. pt has tried an IV bisphosphonate (ibandronate or zoledronic acid), OR 4. the patient has severe renal impairment (eg, creatinine clearance less than 35 mL/min) or chronic kidney disease, or if the patient has multiple osteoporotic fractures. Treatment of bone loss in men at high risk for fracture receiving ADT for nonmetastatic prostate cancer, approve if the patient has prostate cancer that is not metastatic to the bone and the patient is receiving ADT (eg, leuprolide, triptorelin, goserelin) or the patient has undergone a bilateral orchiectomy. Treatment of bone loss (to increase bone mass) in patients at high risk for fracture receiving adjuvant AI therapy for breast cancer, approve if the patient has breast cancer that is not metastatic to the bone and is receiving concurrent AI therapy (eg, anastrozole, letrozole, exemestane). 118 119 PROMACTA Products Affected • Promacta PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Thrombocytopenia due to hepatitis C virus (HCV)-related cirrhosis. Exclusion Criteria Use in the management of thrombocytopenia in myelodysplastic syndrome (MDS). Use in combination with Nplate for treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia purpura. Required Medical Information Cause of thrombocytopenia. Age Restrictions N/A Prescriber Restrictions Treatment of thrombocytopenia due to chronic immune (idiopathic) thrombocytopenic purpura (ITP), approve if prescribed by, or after consultation with, a hematologist. Treatment of thrombocytopenia due to HCV-related cirrhosis, approve if prescribed by, or after consultation with, either a hematologist, gastroenterologist, a hepatologist, or a physician who specializes in infectious disease. Coverage Duration Plan Year Other Criteria Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia purpura, approve if the patient has tried corticosteroids or IVIG or has undergone a splenectomy. Treatment of thrombocytopenia due to HCV-related cirrhosis, approve to allow for initiation of antiviral therapy if the patient has low platelet counts (eg, less than 75,000 mm3) and the patient has chronic HCV infection and is a candidate for hepatitis C therapy . 120 QUININE Products Affected • quinine sulfate PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria N/A 121 RAVICTI Products Affected • Ravicti PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 122 REBIF Products Affected • • Rebif (with albumin) Rebif Rebidose subcutaneous pen injector 22 mcg/0.5 mL, 44 mcg/0.5 mL, 8.8mcg/0.2mL-22 mcg/0.5mL (6) • Rebif Titration Pack PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 123 REMICADE Products Affected • Remicade PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Active infection (including TB), concurrent use with other biologics, unstable moderate to severe HF (NYHA Functional Class III/IV). Required Medical Information Screening for latent TB infection and assessment for Hep B risk. For positive latent TB, patient must have completed treatment or is currently receiving treatment for LTBI. HBV infection ruled out or treatment initiated for positive infection. Rheumatoid arthritis - An inadequate response or intolerance to Enbrel or Humira and one of the following: 1) inadequate response to methotrexate (MTX), 2) inadequate response to another nonbiologic DMARD (e.g., leflunomide, hydroxychloroquine, sulfasalazine) if contraindicated or intolerant to MTX, 3) intolerance or contraindication to 2 nonbiologic DMARDs. Psoriatic arthritis with predominantly peripheral symptoms - Must meet both of the following: 1) have an inadequate response or intolerance to either Enbrel or Humira, and 2) have an inadequate response to at least an 8-week maximum tolerated dose trial of at least 1 nonbiologic DMARD unless contraindicated or intolerant to such therapy. For plaque psoriasis - More than 10% BSA affected or has crucial body areas (e.g., feet, hands, face) affected. An inadequate response to at least a 60-day trial of 2 conventional therapies (e.g., phototherapy, calcipotriene, MTX, acitretin) unless contraindicated or intolerant to such therapies. Crohn's disease - Must meet both of the following: 1) have an inadequate response to at least a 60-day trial of 1 conventional therapy (e.g., corticosteroids, sulfasalazine, azathioprine, mesalamine) unless contraindicated or intolerant to such therapy, and 2) have an inadequate response or intolerance to either Humira or Cimzia. Ulcerative colitis - An inadequate response to at least a 60-day trial of 2 conventional therapies (e.g., corticosteroids, mesalamine) unless contraindicated or intolerant to such therapies. Age Restrictions For plaque psoriasis, patient must be 18 years of age and older. Prescriber Restrictions Adult with RA (initial course). Prescribed by a rheumatologist or in consultation with a rheumatologist. 124 PA Criteria Criteria Details Coverage Duration Initial: 3 months for Crohn's disease and UC, plan year for all others. Renewal: plan year Other Criteria For continuation of therapy, patient's condition must have improved or stabilized. 125 REPATHA Products Affected • • Repatha Pushtronex Repatha SureClick • Repatha Syringe PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Concurrent use of Repatha with Praluent, Juxtapid or Kynamro Required Medical Information Current LDL-C (within the past 30 days), prior therapies tried, medication adverse event history Age Restrictions ASCVD/HeFH - 18 yo and older, HoFH 13 yo and older. Prescriber Restrictions Prescribed by, or in consultation with, a cardiologist, endocrinologist, or a physician who focuses in the treatment of CV risk management and/or lipid disorders Coverage Duration Plan Year Other Criteria Hyperlipidemia in pts w/ (ASCVD) apprv if the pt has a curr LDL-C lvl of grtr or eq to 70 mg/dL w/in the past 30 ds (after tx with antihyperlipidemic agnts but prior to PCSK9 inh tx such as Praluent or Repatha) AND the pt has had one of the following conds or dxs: prev MI,OR has a hx of an acute coronary syndrome, OR The pt has a dx of angina (stable or unstable) ,OR The pt has a past hx of stroke or TIA, OR The pt has PAD, The pt has undergone a coronary or other arterial revascularization procedure AND The pt has tried 1 high-intensity statin tx (i.e., atorvastatin 80 mg daily or Crestor 40 mg daily) for equal or more than 12 cont wks AND the LDL-C lvl remains equal or more than70 mg/dL unless pt experienced statinrelated rhabdomyolysis, OR the pt experienced skeletal-related muscle symptoms while receiving separate trials of atorvastatin and Crestor and during both trials the skeletal-related symptoms resolved during d/c. AND If pt able to tolerate statins cont to rec. the max tolerated dose of a statin while rec. Repatha tx. Heterozygous Familial Hypercholesterolemia apprve if the pt has a curnt LDL-C lvl eq or more than 100 mg/dL w/in the past 30 days, AND the pts dx of HeFH is def as probable or definite by WHO/Dutch Lipid grp criteria OR definite by Simon-Broome Criteria OR genetic testing, AND The pt has tried 1 high-intensity statin txs (i.e., atorvastatin 80 mg daily or Crestor 40 mg daily) for equal or more than 12 126 PA Criteria Criteria Details cont wks, AND the LDL-C lvl remains eq or more than 100 mg/dL, unless pt experienced statin-related rhabdomyolysis, OR the pt experienced skeletal-related muscle symptoms while receiving separate trials of atorvastatin and Crestor and during both trials the skeletal-related symptoms resolved during d/c. AND If pt able to tolerate statins cont to rec. the max tolerated dose of a statin while rec. Repatha tx. HoFH approve if meets all of the following has one of the following genetic confirmation of two mutant alleles at the LDLR, APOB, PCSK9, or LDLRAP1 gene locus AND LDL-C lvl grtr or eq to 100 mg/dL within the past 30 ds AND tried 1 high-intensity statin therapystatin tx (i.e., atorvastatin 80 mg daily or Crestor 40 mg daily) for equal or more than 12 cont wks AND the LDL-C lvl remains equal or more than 100 mg/dL unless pt experienced statin-related rhabdomyolysis, OR the pt experienced skeletal-related muscle symptoms while receiving separate trials of atorvastatin and Crestor and during both trials the skeletal-related symptoms resolved during d/c. AND If pt able to tolerate statins cont to rec. the max tolerated dose of a statin while rec. Repatha tx. 127 REVATIO Products Affected • sildenafil (antihypertensive) oral PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Nitrate therapy Required Medical Information Diagnosis of pulmonary arterial hypertension (PAH), (WHO Group 1). PAH been confirmed by right heart catheterization. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 128 REVLIMID Products Affected • Revlimid PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D Exclusion Criteria Pregnancy Required Medical Information For active myeloma patient meets one of the following: 1) Revlimid is used in combination with dexamethasone. 2) Revlimid is used as maintenance monotherapy following response to either stem cell transplant or primary induction therapy. For mantle cell lymphoma (MCL): Revlimid is used after 2 prior therapies, 1 of which is bortezomib. For Low or Intermediate-1 Risk myelodysplastic syndrome (MDS): for those with 5q deletion, patients should have transfusion-dependent anemia or symptomatic anemia with clinically significant cytopenias. For those with non-5q deletion MDS and symptomatic anemia, patients should have failed to respond to epoetin alfa or darbepoetin or have a pretreatment serum erythropoietin levels greater than 500 mU/mL and a low probability of response to immunosuppressive therapy. For female patients of childbearing potential, pregnancy is excluded by 2 negative serum or urine pregnancy tests. For all patients, complete blood counts are monitored for hematologic toxicity while receiving Revlimid. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Male and female patients of child-bearing potential should be instructed on the importance of proper utilization of appropriate contraceptive methods for Revlimid use. Patients should be monitored for signs and symptoms of thromboembolism. 129 RIBAVIRIN Products Affected • ribavirin oral capsule • ribavirin oral tablet 200 mg PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Hemoglobinopathy. History of pre-existing heart disease. Creatinine clearance less than 50 mL/minute and unwilling to use modified dose of ribavirin. Pregnancy (self or partner).Unwilling to use effective contraception. Coadministration with didanosine in HIV coinfected patients. Required Medical Information Prior to initiating therapy, detectable levels of HCV RNA in the serum. Must use in combination with Harvoni, interferon, Viekira, Daklinza, Technivie, Zepatier or Sovaldi. Cirrhosis documented by FibroScan, liver biopsy, or radiological imaging. genotype Age Restrictions N/A Prescriber Restrictions ID specialist, gastroenterologist, or oncologist Coverage Duration 12 wks, 24 wks, or 48 wks as specified in Other Criteria. Other Criteria Criteria will be applied consistent with current AASLD-IDSA guidance 130 RITUXAN Products Affected • Rituxan PA Criteria Criteria Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Patients already started on Rituxan for a Covered Use. Exclusion Criteria Concurrent use with a biologic agent (TNF alpha antagonists (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), or anakinra, abatacept, tocilizumab or tofacitinib. Required Medical Information N/A Age Restrictions RA, adults. Prescriber Restrictions Adult with RA (initial course). Prescribed by a rheumatologist or in consultation with a rheumatologist. Coverage Duration RA,3 mo. Othr= Plan Year. Other Criteria Adult with RA (initial course), approve if Rituxan is prescribed in combination with methotrexate or another traditional DMARD (eg, leflunomide or sulfasalazine) unless the patient has been shown to be intolerant or has a contraindication to one or more traditional DMARDs AND the patient has tried one of certolizumab pegol, etanercept, adalimumab, infliximab, golimumab (ie, a TNF antagonist) OR if the patient has not yet tried a TNF antagonist, the patient must have a trial with etanercept or adalimumab. 131 RUBRACA Products Affected • Rubraca oral tablet 200 mg, 300 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, Prior therapies, documentation of the presence of a deleterious BRCA mutation (germline and/or somatic) Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with Oncologist Coverage Duration Plan Year Other Criteria Patient selection must be based on an FDA-approved companion diagnostic. Patient must have been treated with two or more chemotherapies prior to Rubraca. Rubraca must be used as monotherapy. 132 RYDAPT Products Affected • Rydapt PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria For AML, use as monotherapy and patients with FLT3-mutation negative disease, Pediatric patients Required Medical Information Diagnosis, for AML, patients must have the FLT3-mutation, as detected by an FDA approved test Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with an oncologist Coverage Duration For AML - 6 months, for Systemic Mast Cell Disease - Plan Year Other Criteria For AML, patient is newly diagnosed, AND Rydapt will be used in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation therapy AND the patient has FLT3-mutation positive AML as detected by an FDA approved test AND patient is receiving Rydapt on days 8-21 of each cycle of induction with cytarabine and daunorubicin and on days 8-21 of each cycle of consolidation with high-dose cytarabine 133 SABRIL Products Affected • Sabril PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Patients with or at high risk of vision loss (except patients who have blindness). Patients using other medications associated with serious adverse ophthalmic effects such as retinopathy or glaucoma. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Infantile spasms: initial 4 wks, reauth 6 mths. CPS: initial 3 mths, reauth to plan year Other Criteria N/A 134 SAMSCA Products Affected • Samsca oral tablet 15 mg, 30 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Up to 30 days Other Criteria N/A 135 SIGNIFOR Products Affected • Signifor PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Diagnosis for which Signifor is being used. Age Restrictions Cushing's, 18 years of age and older. Prescriber Restrictions Initial course, prescribed by or in consultation with an endocrinologist. Coverage Duration Initial therapy, approve for 3 months. Continuation therapy, approve for the plan year. Other Criteria Cushing's disease, approve if according to the prescribing physician the patient is not a candidate for surgery or surgery has not been curative. Patients who have already been started on Signifor for Cushing's disease will be approved if the patient has had a response, as determined by the prescribing physician and the patient is continuing therapy to maintain response. 136 SOVALDI Products Affected • Sovaldi PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Combination use with other direct acting antivirals, excluding ribavirin, daclatasvir, and simeprevir. Required Medical Information Documentation from the medical record of diagnosis including genotype, HCV RNA viral levels prior to treatment, history of previous HCV therapies, and presence/absence of cirrhosis. For patients with cirrhosis, cirrhosis must be documented by FibroScan, FibroTest ActiTest, liver biopsy, or radiological imaging. Age Restrictions 12 years of age and older Prescriber Restrictions Prescribed by or in consultation with a gastroenterologist, hepatologist, infectious diseases physician, or a liver transplant physician. Coverage Duration 12 to 48 weeks, based on indication and current AASLD/IDSA guidance. Other Criteria Must be used with other concurrent therapy based on indication and established treatment guidelines. Criteria will be applied consistent with current AASLD/IDSA guidance. 137 SPRYCEL Products Affected • Sprycel oral tablet 100 mg, 140 mg, 20 mg, 50 mg, 70 mg, 80 mg PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Acute lymphoblastic leukemia (ALL) and newly diagnosed chronic myeloid leukemia (CML) must be positive for the Philadelphia chromosome or BCR-ABL gene. For CML, patient meets one of the following: 1) newly diagnosed in chronic phase, 2) resistance or intolerance to imatinib, or 3) relapse after stem cell transplant. For ALL, resistance or intolerance to prior therapy. Age Restrictions 18 years of age and older Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 138 STIVARGA Products Affected • Stivarga PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Stivarga for a Covered Use. Exclusion Criteria N/A Required Medical Information Diagnosis for which Stivarga is being used. For metastatic colorectal cancer (CRC)and gastrointestinal stromal tumors (GIST), prior therapies tried. For metastatic CRC, KRAS mutation status. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For metastatic CRC with KRAS mutation, patient must have previously been treated with each of the following for approval: a fluoropyrimidine (eg, Xeloda, 5-FU), oxaliplatin, irinotecan, anti-VEGF therapy (eg, Avastin, Zaltrap). For metastatic CRC with no detected KRAS mutations (ie, KRAS wild-type), patient must have previously been treated with each of the following for approval: a fluoropyrimidine (eg, Xeloda, 5-FU), oxaliplatin, irinotecan, anti-VEGF therapy (eg, Avastin, Zaltrap), antiEGFR therapy (eg, Eribitux, Vectibix). For GIST, patient must have previously been treated with imatinib (Gleevec) and sunitinib (Sutent). 139 SUTENT Products Affected • Sutent PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Clinical manifestations of congestive heart failure. Required Medical Information For gastrointestinal stromal tumor (GIST), disease progression while on an at least 30-day regimen of Gleevec or intolerance to Gleevec is required. LFT monitoring at initiation of therapy and throughout treatment. Age Restrictions N/A Prescriber Restrictions Oncologist Coverage Duration Plan Year Other Criteria Therapy will be interrupted for serious hepatic adverse events and discontinued if serious hepatic adverse events do not resolve. 140 SYLATRON Products Affected • Sylatron PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 141 SYNAGIS Products Affected • Synagis intramuscular solution 50 mg/0.5 mL PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Prophylaxis of Respiratory Syncytial Virus (RSV): One of the following: (criteria 1) all of the following: Infant is less than 24 months of age, infant has chronic lung disease (CLD), infant required medical therapy (supplemental oxygen, bronchodilator, diuretic or corticosteroid therapy) within 6 months prior to the start of RSV season, (criteria 2) all of the following: infant was born at 28 weeks of gestation or earlier, infant does not have chronic lung disease (CLD), and infant was less than 12 months of age at the start of RSV season, (criteria 3) all of the following: infant was born at 29 to 32 weeks of gestation (ie, 31 weeks, 6 days or less), infant does not have chronic lung disease (CLD), and infant was less than 6 months of age at the start of RSV season. (criteria 4): infant was born at 32 to less than 35 weeks of gestation (ie, between 32 weeks, 0 days through 34 weeks, 6 days), infant does not have CLD, infant was less than 3 months of age at the start of the RSV season, and infant has one of the following risk factors: (1) Child care attendance defined as a home or facility in which care is provided for any number of infants or toddlers OR (2) Infant has a sibling younger than 5 years of age, (criteria 5) both of the following: Infants and children 24 months of age and younger, or Infant or child has one of the following: (1) Congenital abnormalities of the airways, or (2) Neuromuscular condition that compromises handling of respiratory secretions, (criteria 6) both of the following: Infants and children 24 months of age or younger, or infant or child has hemodynamically significant cyanotic or acyanotic congenital heart disease (CHD) (eg, receiving medication to control congestive heart failure, moderate to severe pulmonary hypertension), (criteria 7) both of the following: Infants and children 24 months of age and younger, infant or child has severe immunodeficiency (eg, severe combined immunodeficiency or advanced AIDS) (off label). Age Restrictions N/A 142 PA Criteria Criteria Details Prescriber Restrictions N/A Coverage Duration 5 months Other Criteria Synagis will not be approved for the following conditions unless one of the required criteria is met: 1) Infants and children with hemodynamically insignificant heart disease (eg, secundum atrial septal defect, small ventricular septal defect, pulmonic stenosis, uncomplicated aortic stenosis, mild coarctation of the aorta, and patent ductus arteriosus), 2) Infants with lesions adequately corrected by surgery, unless they continue to require medication for congestive heart failure, 3) Infants with mild cardiomyopathy who are not receiving medical therapy for the condition. 143 TAFINLAR Products Affected • Tafinlar PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Documentation of the detected BRAF V600E or V600K mutations Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 144 TAGRISSO Products Affected • Tagrisso PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Tagrisso for a covered use. Exclusion Criteria EGFR tyrosine kinase inhibitor treatment naive patients Required Medical Information Confirmed T790M mutation-positive NSCLC as detected by an FDA approved test and Prior therapies tried Age Restrictions 18 years or older Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria The patient has metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive NSCLC as detected by an FDA approved test AND The patient has progressed on or after one of Tarceva (erlotinib tablets), Iressa (gefitinib tablets), or Gilotrif (afatinib tablets) therapy. 145 TARCEVA Products Affected • Tarceva oral tablet 100 mg, 150 mg, 25 mg PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information For 1st line therapy of locally advanced or metastatic NSCLC, patient should have a known active EGFR exon 19 deletions or exon 21 substitution mutation or amplification of the EGFR gene. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 146 TARGRETIN Products Affected • bexarotene PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D Exclusion Criteria Pregnancy Required Medical Information For capsules, patient meets one of the following: 1) cutaneous T cell lymphoma (includes mycosis fungoides [MF] and Sezary syndrome [SS]) refractory to prior systemic therapy, 2) advanced-stage MF/Sezary syndrome, 3) early-stage MF refractory/progressive to skin-directed therapy, or 4) early-stage MF with blood involvement or folliculotropic/large cell transformation. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Patient has been instructed on the importance of and proper utilization of contraception. 147 TASIGNA Products Affected • Tasigna PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Long QT syndrome, uncorrected electrolyte disorders (hypokalemia, hypomagnesemia). Required Medical Information ECG obtained at baseline, 7-10 days after initiation of therapy and periodically throughout therapy. Newly diagnosed chronic myeloid leukemia (CML) must be positive for the Philadelphia chromosome or BCR-ABL gene. For CML, patient meets one of the following: 1) newly diagnosed in chronic phase, 2) resistance to imatinib, 3) intolerance/toxicity to imatinib or dasatinib, or 4) relapse after stem cell transplant. Age Restrictions 18 years of age and older Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria Patient has been instructed to avoid eating food 2 hours before and 1 hour after taking Tasigna. Concomitant use of drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided. 148 TECENTRIQ Products Affected • Tecentriq PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria N/A 149 TETRABENAZINE Products Affected • tetrabenazine PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Tardive dyskinesia (TD). Tourette syndrome and related tic disorders. Hyperkinetic dystonia. Hemiballism. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions For treatment of chorea associated with Huntington's disease, Tourette syndrome or related tic disorders, hyperkinetic dystonia, or hemiballism, must be prescribed by or after consultation with a neurologist. For TD, must be prescribed by or after consultation with a neurologist or psychiatrist. Coverage Duration Plan Year Other Criteria N/A 150 THALOMID Products Affected • Thalomid PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Pregnancy Required Medical Information For active myeloma, patient meets one of the following: 1) Thalomid is used as salvage or palliative therapy. 2) Thalomid is used for newly diagnosed disease or as primary induction therapy in combination with dexamethasone or in combination with melphalan and prednisone in nontransplant candidates. 3) Thalomid is used as maintenance monotherapy following response to either stem cell transplant or primary induction therapy. For female patients of childbearing potential, pregnancy is excluded by a negative pregnancy test. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Patients are monitored for signs and symptoms of thromboembolism. Male and female patients of child-bearing potential are instructed on the importance of proper utilization of appropriate contraceptive methods. 151 THIORIDAZINE Products Affected • thioridazine PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 152 THIOTEPA Products Affected • thiotepa PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 153 TIRF MEDICATIONS Products Affected • fentanyl citrate buccal lozenge on a handle 1,200 mcg, 1,600 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For breakthrough pain in patients with cancer if patient is unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting OR patient is unable to take 2 other short-acting narcotics (eg, oxycodone, morphine sulfate, hydromorphone, etc) secondary to allergy or severe adverse events AND patient is on or will be on a longacting narcotic (eg, Duragesic), or the patient is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics (eg, morphine sulfate, hydromorphone, fentanyl citrate). 154 TRETINOIN Products Affected • • • adapalene topical cream adapalene topical gel tretinoin microspheres topical gel • • tretinoin topical topical cream 0.025 %, 0.05 %, 0.1 % tretinoin topical topical gel 0.01 %, 0.025 % PA Criteria Criteria Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Exclusion Criteria Coverage is not provided for cosmetic use. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 155 TYKERB Products Affected • Tykerb PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Liver function tests must be monitored at baseline and every four to six weeks during therapy and as clinically indicated. In patients with severe hepatic impairment, Tykerb is used at a reduced dose. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 156 TYSABRI Products Affected • Tysabri PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Tysabri for a Covered Use. Exclusion Criteria Concurrent use of another immunomodulator (eg, Rebif, Betaseron, Extavia, Copaxone or Avonex or Aubagio), Tecfidera, or fingolimod (Gilenya) or an immunosuppressant such as mitoxantrone, cyclophosphamide, rituximab (Rituxan), alemtuzumab (Campath), azathioprine, MTX, or mycophenolate mofetilin in multiple sclerosis (MS) patients. Concurrent use with immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or tumor necrosis factor (TNF) alfa inhibitors (eg, infliximab, adalimumab, certolizumab pegol) in Crohn's disease (CD) patients. Per warning and precautions, coverage is not provided for immune compromised patients with MS or CD. Required Medical Information Adults with MS. Patient has a relapsing form of MS (relapsing forms of MS are relapsing remitting [RRMS], secondary progressive [SPMS] with relapses, and progressive relapsing [PRMS]). Adults with CD. Patient has moderately to severely active CD with evidence of inflammation (eg, elevated C-reactive protein). Age Restrictions Adults Prescriber Restrictions MS. Prescribed by, or in consultation with , a neurologist or physician who specializes in the treatment of MS.CD. Prescribed by or in consultation with a gastroenterologist. Coverage Duration Plan Year Other Criteria Adults with a relapsing form of MS. Patient has had an inadequate response to, or is unable to tolerate, therapy with at least one of the following MS medications: interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), glatiramer acetate (Copaxone), fingolimod (Gilenya), Tecfidera, or Aubagio OR the patient has highly active or aggressive disease according to the prescribing physician. Adults with CD. Patient has moderately to severely active CD with evidence of inflammation (eg, elevated C-reactive protein) and patient has tried two TNF antagonists for CD for at least 2 months each, adalimumab, 157 PA Criteria Criteria Details certolizumab pegol, or infliximab, and had an inadequate response or was intolerant to the TNF antagonists. 158 UPTRAVI Products Affected • Uptravi oral tablet • Uptravi oral tablets,dose pack PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Breast feeding mother, severe hepatic impairment (Child-Pugh Class C) Required Medical Information prior treatments Age Restrictions 18 years of age or older Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Must have PAH (WHO Group 1) and had a right heart catheterization to confirm the diagnosis of PAH (WHO Group 1). Right heart catheterization is NOT required in pts who are currently receiving Uptravi or another agent indicated for PAH (WHO group 1). Patient must have previously tried or is currently taking at least one other agent indicated for PAH treatment (eg, sildenafil, Adcirca, Revatio, Tracleer, Letairis Opsumit, Adempas, Orenitram, Tyvaso, Ventavis, Remodulin, or epoprostenol injection). 159 VENCLEXTA Products Affected • • Venclexta Venclexta Starting Pack PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, prior therapy, 17p deletion status Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria CLL - approve if the patient has 17p deletion and has tried one prior therapy. 160 VIMPAT Products Affected • • Vimpat intravenous Vimpat oral solution • Vimpat oral tablet PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions 17 years of age and older Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 161 VOTRIENT Products Affected • Votrient PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Alanine transaminase (ALT) greater than 3 times the upper limit of normal (ULN) and bilirubin greater than 2 times the ULN. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions Oncologist Coverage Duration Plan Year Other Criteria N/A 162 XALKORI Products Affected • Xalkori PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus, patients with non-small cell lung cancer (NSCLC) already started on crizotinib. Exclusion Criteria N/A Required Medical Information For the FDA-approved indication of NSCLC for patients new to therapy, ALK status required. ROS1 Status Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria NSCLC, patient new to therapy must be ALK-positive for approval. 163 XERMELO Products Affected • Xermelo PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Treatment naive patients, use as a monotherapy Required Medical Information Diagnosis, previous therapies tried with dates of treatment, chart notes documenting number of bowel movements per day Age Restrictions 18 years or older Prescriber Restrictions Prescribed by, or in consultation with, an oncologist or gastroenterologist Coverage Duration Initiation - 12 weeks, Continuation - Plan year Other Criteria For initiation for carcinoid sydrome diarrhea, the patient has been on a long-acting somatostatin analog (SSA) therapy (e.g. Somatuline Depot [lanreotide for injection], Sandostatin LAR Depot [octreotide for injection], octreotide injection) for at least 3 consecutive months and while on longacting somatostatin analog therapy (prior to starting Xermelo) the patient continues to have at least four bowel movements per day and iii. Xermelo will be used in combination with a long-acting somatostatin analog therapy. For continuation for carcinoid sydrome diarrhea, the patient has experienced a decrease in the number of bowel movements per day and the patient continues to take Xermelo in combination with a long-acting somatostatin analog therapy. 164 XOLAIR Products Affected • Xolair PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Body weight greater than 150 kg. Required Medical Information For IgE-mediated allergic asthma: pre-treatment serum IgE level greater than or equal to 30 IU/mL to less than or equal to 700 IU/mL and patient's body weight. For CIU - must have urticaria for more than 6 weeks, with symptoms present more than 3 days per week despite daily non-sedating H1-antihistamine therapy (e.g., cetirizine, desloratadine, fexofenadine, levocetirizine, loratadine) AND must have tried therapy with a leukotriene modifier (e.g., montelukast) with a daily non-sedating H1 antihistamine. Age Restrictions 6 years of age and older Prescriber Restrictions Moderate to severe persistent asthma if prescribed by, or in consultation with an allergist, immunologist, or pulmonologist. CIU if prescribed by or in consultation with an allergist, immunologist, or dermatologist. Coverage Duration Plan Year Other Criteria Moderate to severe persistent asthma must meet all criteria patient's asthma symptoms have not been adequately controlled by concomitant use of at least 3 months of inhaled corticosteroid and a long-acting beta-agonist (LABA) or LABA alternative, if LABA contraindicated or patient has intolerance then alternatives include sustained-release theophylline or a leukotriene modifier (eg, montelukast), AND inadequate control demonstrated by hospitalization for asthma, requirement for systemic corticosteroids to control asthma exacerbation(s), or increasing need (eg, more than 4 times a day) for short-acting inhaled beta2 agonists for symptoms (excluding preventative use for exercise-induced asthma). 165 XTANDI Products Affected • Xtandi PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Xtandi for a Covered Use. Exclusion Criteria Pregnancy Required Medical Information Documentation from medical records of diagnosis. For metastatic castration-resistant prostate cancer, prior therapies tried. Age Restrictions N/A Prescriber Restrictions Prescribed by, or in consultation with, an Oncologist Coverage Duration Plan Year Other Criteria For prostate cancer, patient must have metastatic, castration-resistant prostate cancer for approval. The patient must have a history of failure, intolerance or contraindication to Zytiga before Xtandi is authorized. 166 YERVOY Products Affected • Yervoy intravenous solution 50 mg/10 mL (5 mg/mL) PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 167 YONDELIS Products Affected • Yondelis PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, Prior therapies Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation with Oncologist Coverage Duration Plan Year Other Criteria For unresectable or metastatic liposarcoma or leiomyosarcoma patient must have received a prior anthracycline containing regimen. 168 ZALTRAP Products Affected • Zaltrap intravenous solution 100 mg/4 mL (25 mg/mL) PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Prior therapies tried. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For metastatic colorectal cancer, must be used in combination with 5fluorouracil, leucovorin, irinotecan (FOLFIRI). 169 ZEJULA Products Affected • Zejula PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Diagnosis, confirmed complete or partial response to platinum-based chemotherapy Age Restrictions N/A Prescriber Restrictions Prescribed by or in consultation with an oncologist Coverage Duration Plan Year Other Criteria For ovarian cancer, patient has had a complete or partial response to platinum-based chemotherapy AND Zejula therapy is to begin within 8 weeks after the most recent platinum-containing regimen 170 ZELBORAF Products Affected • Zelboraf PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus, patients with melanoma already started on vemurafenib. Exclusion Criteria N/A Required Medical Information For the FDA-approved indication of melanoma, for patients new to therapy, BRAFV600E status required. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria Melanoma, patient new to therapy must have BRAFV600E mutation for approval. 171 ZOLEDRONIC ACID Products Affected • zoledronic acid-mannitol-water PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D and patients already started on zoledronic acid for a covered use. Exclusion Criteria Concurrent Use with Other Medications for Osteoporosis (e.g., other bisphosphonates, Prolia, Forteo, Evista, calcitonin nasal spray), except calcium and Vitamin D. Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Paget's 1 month. Others 12 months. Other Criteria Treatment of osteoporosis in post menopausal women or osteoporosis in men, must meet ONE of the following patient had an inadequate response after a trial duration of 12 months (eg, ongoing and significant loss of BMD, lack of BMD increase) or patient had an osteoporotic fracture while receiving therapy or patient experienced intolerability (eg, severe GIrelated adverse effects, severe musculoskeletal-related side effects, a femoral fracture), OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a preexisting GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]). Prevention or treatment of glucocorticoid induced osteoporosis (GIO), approve if: pt is initiating or continuing therapy with systemic glucocorticoids, AND has had an inadequate response after a trial duration of 12 months (eg, ongoing and significant loss of BMD, lack of BMD increase) or patient had an osteoporotic fracture while receiving therapy or patient experienced intolerability (eg, severe GIrelated adverse effects, severe musculoskeletal-related side effects, a femoral fracture), OR pt cannot take an oral bisphosphonate because the pt 172 PA Criteria Criteria Details cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a preexisting GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]). Treatment of Paget's disease, approve if patient has elevations in serum alkaline phosphatase of two times higher than the upper limit of the age-specific normal reference range, OR patient is symptomatic (eg, bone pain, hearing loss, osteoarthritis), OR patient is at risk for complications from their disease (eg, immobilization, bone deformity, fractures, nerve compression syndrome). Preventions of PMO meets one of the following had an inadequate response after a trial duration of 12 months (eg, ongoing and significant loss of BMD, lack of BMD increase) or patient had an osteoporotic fracture while receiving therapy or patient experienced intolerability (eg, severe GI-related adverse effects, severe musculoskeletal-related side effects, a femoral fracture), OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]). Part B versus Part D determination will be made at time of prior authorization review per CMS guidance. 173 ZYDELIG Products Affected • Zydelig PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Documentation of AST/ALT less than 20 x ULN and Bilirubin less than 10 x ULN. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A 174 ZYKADIA Products Affected • Zykadia PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For metastatic non-small cell lung cancer that is anaplastic lymphoma kinase positive, patient must have progressed or be intolerant to crizotinib for approval. 175 PART B VERSUS PART D Products Affected • • • • • • • • • • • • • • • • • • • • • • • • Abelcet intravenous suspension ABILIFY MAINTENA INTRAMUSCULAR SUSPENSION,EXTENDED RELEASE RECON 300 MG Abraxane intravenous suspension for reconstitution acetylcysteine solution Actemra intravenous solution acyclovir sodium intravenous solution Adagen intramuscular solution Adriamycin intravenous solution 20 mg/10 mL Adrucil intravenous solution 500 mg/10 mL albuterol sulfate inhalation solution for nebulization 0.63 mg/3 mL, 1.25 mg/3 mL, 2.5 mg /3 mL (0.083 %), 5 mg/mL Aldurazyme intravenous solution Alimta intravenous recon soln 500 mg allopurinol sodium intravenous recon soln AmBisome intravenous suspension for reconstitution amikacin injection solution 500 mg/2 mL amino acids 15 % intravenous parenteral solution Aminosyn 8.5 %-electrolytes intravenous parenteral solution Aminosyn II 10 % intravenous parenteral solution Aminosyn II 15 % intravenous parenteral solution Aminosyn II 7 % intravenous parenteral solution Aminosyn II 8.5 % intravenous parenteral solution Aminosyn II 8.5 %-electrolytes intravenous parenteral solution Aminosyn-HBC 7% intravenous parenteral solution Aminosyn-PF 10 % intravenous parenteral solution • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 176 Aminosyn-PF 7 % Sulfite Free intravenous parenteral solution Aminosyn-RF 5.2 % intravenous parenteral solution amiodarone intravenous solution amphotericin B injection recon soln ampicillin sodium injection recon soln 1 gram, 10 gram, 125 mg ampicillin-sulbactam injection recon soln aprepitant oral capsule aprepitant oral capsule,dose pack Aralast NP intravenous recon soln 500 mg Astagraf XL oral capsule,extended release 24hr Avastin intravenous solution Avelox in NaCl (iso-osm) intravenous piggyback Azasan oral tablet azathioprine oral tablet azathioprine sodium injection recon soln azithromycin intravenous recon soln BCG vaccine, live (PF) percutaneous suspension for reconstitution Beleodaq intravenous recon soln Benlysta intravenous recon soln benztropine injection solution BiCNU intravenous recon soln bleomycin injection recon soln 30 unit budesonide inhalation suspension for nebulization 0.25 mg/2 mL, 0.5 mg/2 mL, 1 mg/2 mL buprenorphine HCl injection solution buprenorphine HCl injection syringe Busulfex intravenous solution calcitriol intravenous solution 1 mcg/mL calcitriol oral capsule calcitriol oral solution Cancidas intravenous recon soln Capastat injection recon soln carboplatin intravenous solution cefazolin injection recon soln 1 gram, 10 gram, 500 mg cefepime injection recon soln • • • • • • • • • • • • • • • • • • • • • • • • • • • cefoxitin intravenous recon soln ceftriaxone injection recon soln 10 gram, 250 mg, 500 mg ceftriaxone intravenous recon soln cefuroxime sodium injection recon soln 750 mg cefuroxime sodium intravenous recon soln CELLCEPT INTRAVENOUS RECON SOLN CellCept oral suspension for reconstitution Cerezyme intravenous recon soln 400 unit chloramphenicol sod succinate intravenous recon soln cidofovir intravenous solution Cimzia Powder for Reconst subcutaneous kit ciprofloxacin lactate intravenous solution 400 mg/40 mL cisplatin intravenous solution cladribine intravenous solution clindamycin phosphate injection solution clindamycin phosphate intravenous solution 600 mg/4 mL CLINIMIX 5%/D15W SULFITE FREE INTRAVENOUS PARENTERAL SOLUTION Clinimix 5%/D25W sulfite free intravenous parenteral solution Clinimix 2.75%/D5W Sulfite Free intravenous parenteral solution Clinimix 4.25%/D10W Sulfite Free intravenous parenteral solution Clinimix 4.25%/D5W Sulfite Free intravenous parenteral solution Clinimix 4.25%-D20W Sulfite Free intravenous parenteral solution Clinimix 4.25%-D25W Sulfite Free intravenous parenteral solution Clinimix 5%-D20W Sulfite Free intravenous parenteral solution Clinimix E 2.75%/D10W Sulfite Free intravenous parenteral solution Clinimix E 2.75%/D5W Sulfite Free intravenous parenteral solution Clinimix E 4.25%/D10W Sulfite Free intravenous parenteral solution • • • • • • • • • • • • • • • • • • • • • • • • • • • • 177 Clinimix E 4.25%/D25W Sulfite Free intravenous parenteral solution Clinimix E 4.25%/D5W Sulfite Free intravenous parenteral solution Clinimix E 5%/D15W Sulfite Free intravenous parenteral solution Clinimix E 5%/D20W Sulfite Free intravenous parenteral solution Clinimix E 5%/D25W Sulfite Free intravenous parenteral solution clofarabine intravenous solution colistin (colistimethate Na) injection recon soln cromolyn inhalation solution for nebulization cyclophosphamide oral capsule cyclosporine intravenous solution cyclosporine modified oral capsule cyclosporine modified oral solution cyclosporine oral capsule cytarabine injection solution D2.5 %-0.45 % sodium chloride intravenous parenteral solution D5 % and 0.9 % sodium chloride intravenous parenteral solution D5 %-0.45 % sodium chloride intravenous parenteral solution dacarbazine intravenous recon soln 200 mg daunorubicin intravenous solution decitabine intravenous recon soln Depo-Provera intramuscular solution dexamethasone sodium phosphate injection solution dexrazoxane HCl intravenous recon soln 250 mg dextrose 10 % and 0.2 % NaCl intravenous parenteral solution dextrose 10 % in water (D10W) intravenous parenteral solution dextrose 5 % in water (D5W) intravenous parenteral solution dextrose 5 %-lactated ringers intravenous parenteral solution dextrose 5%-0.2 % sod chloride intravenous parenteral solution • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • dextrose 5%-0.3 % sod.chloride intravenous parenteral solution Dextrose With Sodium Chloride intravenous parenteral solution diltiazem HCl intravenous recon soln diltiazem HCl intravenous solution diphenhydramine HCl injection solution 50 mg/mL doxorubicin intravenous solution 50 mg/25 mL doxorubicin, peg-liposomal intravenous suspension dronabinol oral capsule Duramorph (PF) injection solution 0.5 mg/mL, 1 mg/mL Elaprase intravenous solution Elelyso intravenous recon soln Elitek intravenous recon soln Emend oral suspension for reconstitution Engerix-B (PF) intramuscular syringe Engerix-B Pediatric (PF) intramuscular suspension Engerix-B Pediatric (PF) intramuscular syringe Envarsus XR oral tablet extended release 24 hr epirubicin intravenous solution 200 mg/100 mL Erythrocin intravenous recon soln 500 mg esomeprazole sodium intravenous recon soln etoposide intravenous solution famotidine (PF) intravenous solution famotidine (PF)-NaCl (iso-osm) intravenous piggyback Faslodex intramuscular syringe fluconazole in NaCl (iso-osm) intravenous piggyback 200 mg/100 mL, 400 mg/200 mL fludarabine intravenous recon soln fluorouracil intravenous solution 2.5 gram/50 mL fluphenazine decanoate injection solution fluphenazine HCl injection solution fomepizole intravenous solution • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 178 fosphenytoin injection solution 100 mg PE/2 mL furosemide injection syringe Gammagard S-D (IgA < 1 mcg/mL) intravenous recon soln ganciclovir sodium intravenous recon soln gemcitabine intravenous recon soln 1 gram Gengraf oral capsule Gengraf oral solution gentamicin injection solution 40 mg/mL Geodon intramuscular recon soln granisetron (PF) intravenous solution 100 mcg/mL granisetron HCl intravenous solution granisetron HCl oral tablet haloperidol decanoate intramuscular solution haloperidol lactate injection solution heparin (porcine) in 5 % dex intravenous parenteral solution 20,000 unit/500 mL (40 unit/mL), 25,000 unit/250 mL(100 unit/mL), 25,000 unit/500 mL (50 unit/mL) heparin (porcine) injection solution Hepatamine 8% intravenous parenteral solution Herceptin intravenous recon soln 440 mg hydralazine injection solution hydromorphone (PF) injection solution hydroxyzine HCl intramuscular solution idarubicin intravenous solution ifosfamide intravenous recon soln 1 gram imipenem-cilastatin intravenous recon soln Increlex subcutaneous solution Intralipid intravenous emulsion 20 % Intralipid intravenous emulsion 30 % Intron A injection recon soln Intron A injection solution 6 million unit/mL ipratropium bromide inhalation solution ipratropium-albuterol inhalation solution for nebulization irinotecan intravenous solution 100 mg/5 mL • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Istodax intravenous recon soln labetalol intravenous solution leucovorin calcium injection recon soln 100 mg, 350 mg levalbuterol HCl inhalation solution for nebulization 0.31 mg/3 mL, 0.63 mg/3 mL, 1.25 mg/0.5 mL, 1.25 mg/3 mL levetiracetam intravenous solution levocarnitine (with sugar) oral solution levocarnitine oral tablet levofloxacin intravenous solution levoleucovorin intravenous solution lidocaine (PF) injection solution 10 mg/mL (1 %), 5 mg/mL (0.5 %) lidocaine HCl injection solution 20 mg/mL (2 %) magnesium sulfate injection solution magnesium sulfate injection syringe melphalan HCl intravenous recon soln meropenem intravenous recon soln 500 mg mesna intravenous solution methadone injection solution methotrexate sodium (PF) injection recon soln methotrexate sodium (PF) injection solution methotrexate sodium oral tablet methylprednisolone acetate injection suspension methylprednisolone sodium succ injection recon soln 125 mg, 40 mg methylprednisolone sodium succ intravenous recon soln metoclopramide HCl injection solution metoprolol tartrate intravenous solution metoprolol tartrate intravenous syringe Miacalcin injection solution mitomycin intravenous recon soln mitoxantrone intravenous concentrate morphine intravenous syringe 10 mg/mL, 8 mg/mL Mozobil subcutaneous solution Mustargen injection recon soln mycophenolate mofetil HCl intravenous recon soln • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 179 mycophenolate mofetil oral capsule mycophenolate mofetil oral suspension for reconstitution mycophenolate mofetil oral tablet mycophenolate sodium oral tablet,delayed release (DR/EC) nafcillin injection recon soln 1 gram, 10 gram Naglazyme intravenous solution nalbuphine injection solution 10 mg/mL, 20 mg/mL Nebupent inhalation recon soln Neoral oral capsule Neoral oral solution Nephramine 5.4 % intravenous parenteral solution nitroglycerin intravenous solution Normosol-M in 5 % dextrose intravenous parenteral solution Normosol-R in 5 % dextrose intravenous parenteral solution Normosol-R pH 7.4 intravenous parenteral solution Nulojix intravenous recon soln ondansetron HCl (PF) injection solution ondansetron HCl (PF) injection syringe ondansetron HCl oral solution ondansetron HCl oral tablet ondansetron oral tablet,disintegrating oxaliplatin intravenous solution 100 mg/20 mL paclitaxel intravenous concentrate pamidronate intravenous solution paricalcitol oral capsule penicillin G potassium injection recon soln 5 million unit penicillin G sodium injection recon soln Pentam injection recon soln Perforomist inhalation solution for nebulization phenytoin sodium intravenous solution piperacillin-tazobactam intravenous recon soln 3.375 gram, 4.5 gram, 40.5 gram Plasma-Lyte 148 intravenous parenteral solution • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • Plasma-Lyte A intravenous parenteral solution potassium chlorid-D5-0.45%NaCl intravenous parenteral solution potassium chloride in 0.9%NaCl intravenous parenteral solution 20 mEq/L, 40 mEq/L potassium chloride in 5 % dex intravenous parenteral solution 20 mEq/L, 40 mEq/L potassium chloride in LR-D5 intravenous parenteral solution 20 mEq/L potassium chloride-D5-0.2%NaCl intravenous parenteral solution 20 mEq/L potassium chloride-D5-0.3%NaCl intravenous parenteral solution 20 mEq/L potassium chloride-D5-0.9%NaCl intravenous parenteral solution Premarin injection recon soln Premasol 10 % intravenous parenteral solution Premasol 6 % intravenous parenteral solution Procalamine 3% intravenous parenteral solution Proleukin intravenous recon soln propranolol intravenous solution Prosol 20 % intravenous parenteral solution Pulmozyme inhalation solution Rapamune oral solution Rapamune oral tablet Recombivax HB (PF) intramuscular suspension 10 mcg/mL, 40 mcg/mL Recombivax HB (PF) intramuscular syringe Remodulin injection solution rifampin intravenous recon soln Ringer's intravenous parenteral solution Risperdal Consta intramuscular syringe Sancuso transdermal patch weekly Sandimmune oral capsule Sandimmune oral solution Sensipar oral tablet 30 mg, 60 mg, 90 mg Simulect intravenous recon soln 20 mg sirolimus oral tablet • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • • 180 Solu-Cortef (PF) injection recon soln 100 mg/2 mL, 250 mg/2 mL Somatuline Depot subcutaneous syringe Somavert subcutaneous recon soln streptomycin intramuscular recon soln sulfamethoxazole-trimethoprim intravenous solution Synercid intravenous recon soln Synribo subcutaneous recon soln tacrolimus oral capsule Teflaro intravenous recon soln testosterone cypionate intramuscular oil testosterone enanthate intramuscular oil tetanus-diphtheria toxoids-Td intramuscular suspension tobramycin in 0.225 % NaCl inhalation solution for nebulization tobramycin sulfate injection solution Toposar intravenous solution topotecan intravenous recon soln tranexamic acid intravenous solution Travasol 10 % intravenous parenteral solution Treanda intravenous recon soln 100 mg Trelstar intramuscular syringe Trisenox intravenous solution TrophAmine 10 % intravenous parenteral solution Trophamine 6% intravenous parenteral solution Twinrix (PF) intramuscular suspension valproate sodium intravenous solution vancomycin intravenous recon soln 1,000 mg, 10 gram, 500 mg Varubi oral tablet Velcade injection recon soln verapamil intravenous solution vinblastine intravenous solution Vincasar PFS intravenous solution 1 mg/mL vincristine intravenous solution 1 mg/mL vinorelbine intravenous solution 50 mg/5 mL voriconazole intravenous solution VPRIV intravenous recon soln Xgeva subcutaneous solution • • • Zemplar intravenous solution zoledronic acid intravenous solution Zometa intravenous piggyback • • Zortress oral tablet Zyprexa Relprevv intramuscular suspension for reconstitution 210 mg Details This drug may be covered under Medicare Part B or D depending upon the circumstances. Information may need to be submitted describing the use and setting of the drug to make the determination. 181 Index Aminosyn 8.5 %-electrolytes intravenous parenteral solution ............................... 175 Aminosyn II 10 % intravenous parenteral solution................................................ 175 Aminosyn II 15 % intravenous parenteral solution................................................ 175 Aminosyn II 7 % intravenous parenteral solution................................................ 175 Aminosyn II 8.5 % intravenous parenteral solution................................................ 175 Aminosyn II 8.5 %-electrolytes intravenous parenteral solution ............................... 175 Aminosyn-HBC 7% intravenous parenteral solution................................................ 175 Aminosyn-PF 10 % intravenous parenteral solution................................................ 175 Aminosyn-PF 7 % Sulfite Free intravenous parenteral solution ............................... 175 Aminosyn-RF 5.2 % intravenous parenteral solution................................................ 175 amiodarone intravenous solution ............ 175 amitriptyline .............................................. 57 amphotericin B injection recon soln ....... 175 ampicillin sodium injection recon soln 1 gram, 10 gram, 125 mg ....................... 175 ampicillin-sulbactam injection recon soln ............................................................. 175 Ampyra ....................................................... 9 Anadrol-50 ................................................ 10 APOKYN .................................................. 12 aprepitant oral capsule ............................ 175 aprepitant oral capsule,dose pack ........... 175 Aptiom ...................................................... 13 Aralast NP intravenous recon soln 500 mg ............................................................. 175 Arcalyst ..................................................... 14 Astagraf XL oral capsule,extended release 24hr ..................................................... 175 Aubagio ..................................................... 15 Avastin intravenous solution................... 175 Avelox in NaCl (iso-osm) intravenous piggyback ............................................ 175 Avonex (with albumin) ............................. 16 Avonex intramuscular pen injector kit ...... 16 A Abelcet intravenous suspension .............. 175 ABILIFY MAINTENA INTRAMUSCULAR SUSPENSION,EXTENDED RELEASE RECON 300 MG................................. 175 Abraxane intravenous suspension for reconstitution....................................... 175 acetylcysteine solution ............................ 175 Actemra intravenous solution ................. 175 Acthar H.P................................................... 1 Actimmune.................................................. 2 acyclovir sodium intravenous solution ... 175 Adagen intramuscular solution ............... 175 adapalene topical cream .......................... 154 adapalene topical gel ............................... 154 Adcirca ........................................................ 3 Adempas ..................................................... 4 Adriamycin intravenous solution 20 mg/10 mL ....................................................... 175 Adrucil intravenous solution 500 mg/10 mL ............................................................. 175 Afinitor........................................................ 5 Afinitor Disperz .......................................... 5 albuterol sulfate inhalation solution for nebulization 0.63 mg/3 mL, 1.25 mg/3 mL, 2.5 mg /3 mL (0.083 %), 5 mg/mL ............................................................. 175 Aldurazyme intravenous solution ........... 175 Alecensa ...................................................... 6 Alimta intravenous recon soln 500 mg ... 175 allopurinol sodium intravenous recon soln ............................................................. 175 alosetron ...................................................... 7 alprazolam oral tablet extended release 24 hr 1 mg, 2 mg, 3 mg .................................. 55 Alunbrig ...................................................... 8 AmBisome intravenous suspension for reconstitution....................................... 175 amikacin injection solution 500 mg/2 mL ............................................................. 175 amino acids 15 % intravenous parenteral solution................................................ 175 182 cefuroxime sodium intravenous recon soln ............................................................. 176 CELLCEPT INTRAVENOUS RECON SOLN .................................................. 176 CellCept oral suspension for reconstitution ............................................................. 176 Cerezyme intravenous recon soln 400 unit ............................................................. 176 chloramphenicol sod succinate intravenous recon soln ............................................ 176 Cholbam .................................................... 22 chorionic gonadotropin, human ................ 23 Cialis oral tablet 2.5 mg, 5 mg .................. 24 cidofovir intravenous solution ................ 176 Cimzia Powder for Reconst subcutaneous kit ........................................................ 176 Cinryze ...................................................... 25 ciprofloxacin lactate intravenous solution 400 mg/40 mL ..................................... 176 cisplatin intravenous solution ................. 176 cladribine intravenous solution ............... 176 clemastine oral tablet 2.68 mg .................. 54 clindamycin phosphate injection solution176 clindamycin phosphate intravenous solution 600 mg/4 mL ....................................... 176 CLINIMIX 5%/D15W SULFITE FREE INTRAVENOUS PARENTERAL SOLUTION......................................... 176 Clinimix 5%/D25W sulfite free intravenous parenteral solution ............................... 176 Clinimix 2.75%/D5W Sulfite Free intravenous parenteral solution ........... 176 Clinimix 4.25%/D10W Sulfite Free intravenous parenteral solution ........... 176 Clinimix 4.25%/D5W Sulfite Free intravenous parenteral solution ........... 176 Clinimix 4.25%-D20W Sulfite Free intravenous parenteral solution ........... 176 Clinimix 4.25%-D25W Sulfite Free intravenous parenteral solution ........... 176 Clinimix 5%-D20W Sulfite Free intravenous parenteral solution ............................... 176 Clinimix E 2.75%/D10W Sulfite Free intravenous parenteral solution ........... 176 Clinimix E 2.75%/D5W Sulfite Free intravenous parenteral solution ........... 176 Avonex intramuscular syringe kit ............. 16 Azasan oral tablet .................................... 175 azathioprine oral tablet ............................ 175 azathioprine sodium injection recon soln 175 azithromycin intravenous recon soln ...... 175 B Banzel oral tablet ...................................... 17 Bavencio ................................................... 18 BCG vaccine, live (PF) percutaneous suspension for reconstitution .............. 175 Beleodaq intravenous recon soln ............ 175 Benlysta intravenous recon soln ............. 175 benztropine injection solution ................. 175 benztropine oral ........................................ 54 bexarotene ............................................... 146 BiCNU intravenous recon soln ............... 175 bleomycin injection recon soln 30 unit ... 175 Bosulif ....................................................... 19 Briviact ...................................................... 20 budesonide inhalation suspension for nebulization 0.25 mg/2 mL, 0.5 mg/2 mL, 1 mg/2 mL ........................................... 175 buprenorphine HCl injection solution..... 175 buprenorphine HCl injection syringe ...... 175 Busulfex intravenous solution................. 175 butalbital-acetaminop-caf-cod .................. 54 butalbital-acetaminophen-caff oral capsule 50-325-40 mg ........................................ 54 butalbital-aspirin-caffeine oral capsule ..... 54 C Cabometyx ................................................ 21 calcitriol intravenous solution 1 mcg/mL 175 calcitriol oral capsule .............................. 175 calcitriol oral solution ............................. 175 Cancidas intravenous recon soln............. 175 Capastat injection recon soln .................. 175 carboplatin intravenous solution ............. 175 cefazolin injection recon soln 1 gram, 10 gram, 500 mg ...................................... 175 cefepime injection recon soln ................. 175 cefoxitin intravenous recon soln ............. 176 ceftriaxone injection recon soln 10 gram, 250 mg, 500 mg .................................. 176 ceftriaxone intravenous recon soln ......... 176 cefuroxime sodium injection recon soln 750 mg ....................................................... 176 183 Demser ...................................................... 33 Depen Titratabs ....................................... 109 Depo-Provera intramuscular solution ..... 176 dexamethasone sodium phosphate injection solution................................................ 176 dexrazoxane HCl intravenous recon soln 250 mg ................................................ 176 dextrose 10 % and 0.2 % NaCl intravenous parenteral solution ............................... 176 dextrose 10 % in water (D10W) intravenous parenteral solution ............................... 176 dextrose 5 % in water (D5W) intravenous parenteral solution ............................... 176 dextrose 5 %-lactated ringers intravenous parenteral solution ............................... 176 dextrose 5%-0.2 % sod chloride intravenous parenteral solution ............................... 176 dextrose 5%-0.3 % sod.chloride intravenous parenteral solution ............................... 177 Dextrose With Sodium Chloride intravenous parenteral solution ............................... 177 Diazepam Intensol .................................... 56 diazepam oral solution 5 mg/5 mL (1 mg/mL) ................................................. 56 diazepam oral tablet .................................. 56 diclofenac sodium topical gel 3 % ............ 34 Digitek....................................................... 35 digoxin injection solution ......................... 35 digoxin oral solution 50 mcg/mL.............. 35 digoxin oral tablet ..................................... 35 diltiazem HCl intravenous recon soln ..... 177 diltiazem HCl intravenous solution ........ 177 diphenhydramine HCl injection solution 50 mg/mL ................................................. 177 doxepin oral .............................................. 57 doxorubicin intravenous solution 50 mg/25 mL ....................................................... 177 doxorubicin, peg-liposomal intravenous suspension ........................................... 177 dronabinol oral capsule ........................... 177 Duramorph (PF) injection solution 0.5 mg/mL, 1 mg/mL ................................ 177 E Egrifta subcutaneous recon soln 1 mg ...... 36 Elaprase intravenous solution ................. 177 Elelyso intravenous recon soln ............... 177 Clinimix E 4.25%/D10W Sulfite Free intravenous parenteral solution ........... 176 Clinimix E 4.25%/D25W Sulfite Free intravenous parenteral solution ........... 176 Clinimix E 4.25%/D5W Sulfite Free intravenous parenteral solution ........... 176 Clinimix E 5%/D15W Sulfite Free intravenous parenteral solution ........... 176 Clinimix E 5%/D20W Sulfite Free intravenous parenteral solution ........... 176 Clinimix E 5%/D25W Sulfite Free intravenous parenteral solution ........... 176 clofarabine intravenous solution ............. 176 clomipramine ............................................ 57 clonazepam oral tablet,disintegrating ....... 56 clorazepate dipotassium ............................ 56 colistin (colistimethate Na) injection recon soln ...................................................... 176 Cometriq ................................................... 26 Corlanor .................................................... 27 Cotellic ...................................................... 28 Crinone...................................................... 29 cromolyn inhalation solution for nebulization ......................................... 176 cyclobenzaprine oral tablet ....................... 54 cyclophosphamide oral capsule .............. 176 cyclosporine intravenous solution........... 176 cyclosporine modified oral capsule ........ 176 cyclosporine modified oral solution........ 176 cyclosporine oral capsule ........................ 176 cyproheptadine .......................................... 54 Cyramza .................................................... 30 cytarabine injection solution ................... 176 D D2.5 %-0.45 % sodium chloride intravenous parenteral solution............................... 176 D5 % and 0.9 % sodium chloride intravenous parenteral solution ........... 176 D5 %-0.45 % sodium chloride intravenous parenteral solution............................... 176 dacarbazine intravenous recon soln 200 mg ............................................................. 176 Daraprim ................................................... 31 Darzalex .................................................... 32 daunorubicin intravenous solution .......... 176 decitabine intravenous recon soln ........... 176 184 fluphenazine decanoate injection solution ............................................................. 177 fluphenazine HCl injection solution ....... 177 fomepizole intravenous solution ............. 177 fosphenytoin injection solution 100 mg PE/2 mL ....................................................... 177 furosemide injection syringe ................... 177 Fycompa oral suspension .......................... 47 Fycompa oral tablet................................... 47 G Gammagard Liquid ................................... 67 Gammagard S-D (IgA < 1 mcg/mL) intravenous recon soln ........................ 177 Gamunex-C injection solution 1 gram/10 mL (10 %) ............................................. 67 ganciclovir sodium intravenous recon soln ............................................................. 177 Gattex 30-Vial ........................................... 48 gemcitabine intravenous recon soln 1 gram ............................................................. 177 Gengraf oral capsule ............................... 177 Gengraf oral solution .............................. 177 gentamicin injection solution 40 mg/mL 177 Geodon intramuscular recon soln ........... 177 Gilotrif....................................................... 49 Glatopa ...................................................... 50 granisetron (PF) intravenous solution 100 mcg/mL ............................................... 177 granisetron HCl intravenous solution ..... 177 granisetron HCl oral tablet ...................... 177 H haloperidol decanoate intramuscular solution................................................ 177 haloperidol lactate injection solution ...... 177 Harvoni ..................................................... 52 heparin (porcine) in 5 % dex intravenous parenteral solution 20,000 unit/500 mL (40 unit/mL), 25,000 unit/250 mL(100 unit/mL), 25,000 unit/500 mL (50 unit/mL) .............................................. 177 heparin (porcine) injection solution ........ 177 Hepatamine 8% intravenous parenteral solution................................................ 177 Herceptin intravenous recon soln 440 mg ............................................................. 177 Hetlioz ....................................................... 53 Eligard ....................................................... 84 Eligard (3 month) ...................................... 84 Eligard (4 month) ...................................... 84 Eligard (6 month) ...................................... 84 Elitek intravenous recon soln .................. 177 Emend oral suspension for reconstitution177 Empliciti.................................................... 37 Engerix-B (PF) intramuscular syringe .... 177 Engerix-B Pediatric (PF) intramuscular suspension ........................................... 177 Engerix-B Pediatric (PF) intramuscular syringe ................................................. 177 Envarsus XR oral tablet extended release 24 hr ......................................................... 177 Epclusa ...................................................... 38 epirubicin intravenous solution 200 mg/100 mL ....................................................... 177 ergoloid ..................................................... 54 Erivedge .................................................... 39 Erwinaze ................................................... 40 Erythrocin intravenous recon soln 500 mg ............................................................. 177 Esbriet ....................................................... 41 esomeprazole sodium intravenous recon soln ............................................................. 177 estradiol oral.............................................. 57 etoposide intravenous solution................ 177 Extavia subcutaneous kit........................... 42 F Fabrazyme intravenous recon soln 35 mg 43 famotidine (PF) intravenous solution...... 177 famotidine (PF)-NaCl (iso-osm) intravenous piggyback ............................................ 177 Farydak ..................................................... 44 Faslodex intramuscular syringe .............. 177 fentanyl citrate buccal lozenge on a handle 1,200 mcg, 1,600 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg ...................... 153 Ferriprox oral tablet .................................. 45 Firazyr ....................................................... 46 fluconazole in NaCl (iso-osm) intravenous piggyback 200 mg/100 mL, 400 mg/200 mL ....................................................... 177 fludarabine intravenous recon soln ......... 177 fluorouracil intravenous solution 2.5 gram/50 mL......................................... 177 185 Kisqali oral tablet 200 mg/day (200 mg x 1), 400 mg/day (200 mg x 2), 600 mg/day (200 mg x 3) .......................................... 75 Korlym ...................................................... 76 Kuvan oral tablet,soluble .......................... 77 Kynamro ................................................... 78 Kyprolis..................................................... 79 L labetalol intravenous solution ................. 178 Lartruvo..................................................... 80 Lenvima .................................................... 81 Letairis ...................................................... 82 leucovorin calcium injection recon soln 100 mg, 350 mg ......................................... 178 Leukine injection recon soln ..................... 83 leuprolide subcutaneous kit....................... 84 levalbuterol HCl inhalation solution for nebulization 0.31 mg/3 mL, 0.63 mg/3 mL, 1.25 mg/0.5 mL, 1.25 mg/3 mL .. 178 levetiracetam intravenous solution ......... 178 levocarnitine (with sugar) oral solution .. 178 levocarnitine oral tablet........................... 178 levofloxacin intravenous solution ........... 178 levoleucovorin intravenous solution ....... 178 lidocaine (PF) injection solution 10 mg/mL (1 %), 5 mg/mL (0.5 %) ...................... 178 lidocaine HCl injection solution 20 mg/mL (2 %).................................................... 178 lidocaine topical adhesive patch,medicated ............................................................... 85 linezolid..................................................... 86 Lonsurf ...................................................... 87 Lorazepam Intensol ................................... 55 lorazepam oral tablet ................................. 55 Lupron Depot ............................................ 84 Lupron Depot (3 month) ........................... 84 Lupron Depot (4 month) ........................... 84 Lupron Depot (6 Month) ........................... 84 Lupron Depot-Ped intramuscular kit 11.25 mg, 15 mg ............................................. 84 Lynparza oral capsule ............................... 88 M magnesium sulfate injection solution...... 178 magnesium sulfate injection syringe ....... 178 megestrol oral suspension 400 mg/10 mL (40 mg/mL), 625 mg/5 mL ................... 89 hydralazine injection solution ................. 177 hydromorphone (PF) injection solution .. 177 hydroxyprogesterone caproate .................. 58 hydroxyzine HCl intramuscular solution 177 I Ibrance....................................................... 59 Iclusig........................................................ 60 idarubicin intravenous solution ............... 177 ifosfamide intravenous recon soln 1 gram ............................................................. 177 Ilaris (PF) subcutaneous recon soln .......... 61 imatinib oral tablet 100 mg, 400 mg ......... 62 Imbruvica .................................................. 63 Imfinzi ....................................................... 64 imipenem-cilastatin intravenous recon soln ............................................................. 177 imipramine HCl ........................................ 57 imipramine pamoate.................................. 57 Increlex subcutaneous solution ............... 177 Inlyta ......................................................... 65 Intralipid intravenous emulsion 20 % ..... 177 Intralipid intravenous emulsion 30 % ..... 177 Intron A injection recon soln .................. 177 Intron A injection solution 6 million unit/mL ............................................................. 177 ipratropium bromide inhalation solution 177 ipratropium-albuterol inhalation solution for nebulization ......................................... 177 Iressa ......................................................... 66 irinotecan intravenous solution 100 mg/5 mL ....................................................... 177 Istodax intravenous recon soln................ 178 J Jakafi oral tablet 10 mg, 15 mg, 20 mg, 25 mg, 5 mg ............................................... 68 Juxtapid ..................................................... 69 K Kadcyla intravenous recon soln 100 mg ... 70 Kalydeco ................................................... 71 Keveyis ..................................................... 72 Keytruda .................................................... 74 Kisqali Femara Co-Pack oral tablet 200 mg/day(200 mg x 1)-2.5 mg, 400 mg/day(200 mg x 2)-2.5 mg, 600 mg/day(200 mg x 3)-2.5 mg ................. 75 186 megestrol oral tablet .................................. 57 Mekinist .................................................... 90 melphalan HCl intravenous recon soln ... 178 memantine oral solution............................ 92 memantine oral tablet ................................ 92 memantine oral tablets,dose pack ............. 92 meprobamate ............................................. 54 meropenem intravenous recon soln 500 mg ............................................................. 178 mesna intravenous solution ..................... 178 metaxalone ................................................ 54 methadone injection solution .................. 178 methamphetamine ..................................... 91 methotrexate sodium (PF) injection recon soln ...................................................... 178 methotrexate sodium (PF) injection solution ............................................................. 178 methotrexate sodium oral tablet .............. 178 methyldopa-hydrochlorothiazide .............. 54 methylprednisolone acetate injection suspension ........................................... 178 methylprednisolone sodium succ injection recon soln 125 mg, 40 mg ................... 178 methylprednisolone sodium succ intravenous recon soln ........................ 178 metoclopramide HCl injection solution .. 178 metoprolol tartrate intravenous solution . 178 metoprolol tartrate intravenous syringe .. 178 Miacalcin injection solution.................... 178 mitomycin intravenous recon soln .......... 178 mitoxantrone intravenous concentrate .... 178 modafinil ................................................. 100 morphine intravenous syringe 10 mg/mL, 8 mg/mL ................................................. 178 Mozobil subcutaneous solution............... 178 Mustargen injection recon soln ............... 178 mycophenolate mofetil HCl intravenous recon soln ............................................ 178 mycophenolate mofetil oral capsule ....... 178 mycophenolate mofetil oral suspension for reconstitution....................................... 178 mycophenolate mofetil oral tablet .......... 178 mycophenolate sodium oral tablet,delayed release (DR/EC) .................................. 178 N nafcillin injection recon soln 1 gram, 10 gram .................................................... 178 Naglazyme intravenous solution ............. 178 nalbuphine injection solution 10 mg/mL, 20 mg/mL ................................................. 178 Namenda XR ............................................. 92 Natpara ...................................................... 93 Nebupent inhalation recon soln .............. 178 Neoral oral capsule ................................. 178 Neoral oral solution................................. 178 Nephramine 5.4 % intravenous parenteral solution................................................ 178 Neupogen .................................................. 94 Neupro....................................................... 95 Nexavar ..................................................... 96 Ninlaro ...................................................... 97 nitroglycerin intravenous solution .......... 178 Norditropin FlexPro .................................. 51 Normosol-M in 5 % dextrose intravenous parenteral solution ............................... 178 Normosol-R in 5 % dextrose intravenous parenteral solution ............................... 178 Normosol-R pH 7.4 intravenous parenteral solution................................................ 178 Northera .................................................... 98 Novarel intramuscular recon soln 10,000 unit ........................................................ 23 Nulojix intravenous recon soln ............... 178 Nuplazid .................................................... 99 O octreotide acetate injection solution........ 101 Odomzo ................................................... 102 Ofev......................................................... 103 ondansetron HCl (PF) injection solution 178 ondansetron HCl (PF) injection syringe . 178 ondansetron HCl oral solution ................ 178 ondansetron HCl oral tablet .................... 178 ondansetron oral tablet,disintegrating ..... 178 Onfi oral suspension ............................... 104 Onfi oral tablet 10 mg, 20 mg ................. 104 Opdivo intravenous solution 40 mg/4 mL ............................................................. 105 Opsumit ................................................... 106 Orkambi .................................................. 107 187 Praluent Pen subcutaneous pen injector 150 mg/mL, 75 mg/mL .............................. 113 Pregnyl ...................................................... 23 Premarin injection recon soln ................. 179 Premasol 10 % intravenous parenteral solution................................................ 179 Premasol 6 % intravenous parenteral solution................................................ 179 Procalamine 3% intravenous parenteral solution................................................ 179 Procrit injection solution 10,000 unit/mL, 2,000 unit/mL, 20,000 unit/mL, 3,000 unit/mL, 4,000 unit/mL, 40,000 unit/mL ............................................................. 115 Proleukin intravenous recon soln ............ 179 Prolia ....................................................... 117 Promacta ................................................. 119 promethazine oral tablet ............................ 54 propranolol intravenous solution ............ 179 Prosol 20 % intravenous parenteral solution ............................................................. 179 Pulmozyme inhalation solution............... 179 Q quinine sulfate ......................................... 120 R Rapamune oral solution .......................... 179 Rapamune oral tablet .............................. 179 Ravicti ..................................................... 121 Rebif (with albumin) ............................... 122 Rebif Rebidose subcutaneous pen injector 22 mcg/0.5 mL, 44 mcg/0.5 mL, 8.8mcg/0.2mL-22 mcg/0.5mL (6) ...... 122 Rebif Titration Pack ................................ 122 Recombivax HB (PF) intramuscular suspension 10 mcg/mL, 40 mcg/mL ... 179 Recombivax HB (PF) intramuscular syringe ............................................................. 179 Remicade......................................... 123, 124 Remodulin injection solution .................. 179 Repatha Pushtronex ................................ 125 Repatha SureClick .................................. 125 Repatha Syringe ...................................... 125 Revlimid.................................................. 128 ribavirin oral capsule............................... 129 ribavirin oral tablet 200 mg..................... 129 rifampin intravenous recon soln.............. 179 oxaliplatin intravenous solution 100 mg/20 mL ....................................................... 178 oxazepam .................................................. 55 P paclitaxel intravenous concentrate .......... 178 pamidronate intravenous solution ........... 178 paricalcitol oral capsule .......................... 178 Pegasys subcutaneous solution ............... 108 Pegasys subcutaneous syringe ................ 108 penicillin G potassium injection recon soln 5 million unit .......................................... 178 penicillin G sodium injection recon soln 178 Pentam injection recon soln .................... 178 Perforomist inhalation solution for nebulization ......................................... 178 Perjeta ..................................................... 110 perphenazine-amitriptyline ....................... 57 phenobarbital............................................. 57 phenoxybenzamine ................................. 111 phenytoin sodium intravenous solution .. 178 piperacillin-tazobactam intravenous recon soln 3.375 gram, 4.5 gram, 40.5 gram 178 Plasma-Lyte 148 intravenous parenteral solution................................................ 178 Plasma-Lyte A intravenous parenteral solution................................................ 179 Pomalyst .................................................. 112 potassium chlorid-D5-0.45%NaCl intravenous parenteral solution ........... 179 potassium chloride in 0.9%NaCl intravenous parenteral solution 20 mEq/L, 40 mEq/L ............................................................. 179 potassium chloride in 5 % dex intravenous parenteral solution 20 mEq/L, 40 mEq/L ............................................................. 179 potassium chloride in LR-D5 intravenous parenteral solution 20 mEq/L.............. 179 potassium chloride-D5-0.2%NaCl intravenous parenteral solution 20 mEq/L ............................................................. 179 potassium chloride-D5-0.3%NaCl intravenous parenteral solution 20 mEq/L ............................................................. 179 potassium chloride-D5-0.9%NaCl intravenous parenteral solution ........... 179 188 tetanus-diphtheria toxoids-Td intramuscular suspension ........................................... 179 tetrabenazine ........................................... 149 Thalomid ................................................. 150 thioridazine ............................................. 151 thiotepa.................................................... 152 tobramycin in 0.225 % NaCl inhalation solution for nebulization ..................... 179 tobramycin sulfate injection solution ...... 179 topiramate oral capsule, sprinkle .............. 11 topiramate oral capsule,sprinkle,ER 24hr . 11 topiramate oral tablet ................................ 11 Toposar intravenous solution .................. 179 topotecan intravenous recon soln ............ 179 tranexamic acid intravenous solution...... 179 Travasol 10 % intravenous parenteral solution................................................ 179 Treanda intravenous recon soln 100 mg . 179 Trelstar intramuscular syringe ................ 179 tretinoin microspheres topical gel ........... 154 tretinoin topical topical cream 0.025 %, 0.05 %, 0.1 % .............................................. 154 tretinoin topical topical gel 0.01 %, 0.025 % ............................................................. 154 trihexyphenidyl ......................................... 54 trimipramine.............................................. 57 Trisenox intravenous solution ................. 179 TrophAmine 10 % intravenous parenteral solution................................................ 179 Trophamine 6% intravenous parenteral solution................................................ 179 Twinrix (PF) intramuscular suspension .. 179 Tykerb ..................................................... 155 Tysabri .................................................... 156 U Uptravi oral tablet ................................... 158 Uptravi oral tablets,dose pack ................. 158 V valproate sodium intravenous solution ... 179 vancomycin intravenous recon soln 1,000 mg, 10 gram, 500 mg .......................... 179 Varubi oral tablet .................................... 179 Velcade injection recon soln ................... 179 Venclexta ................................................ 159 Venclexta Starting Pack .......................... 159 verapamil intravenous solution ............... 179 Ringer's intravenous parenteral solution . 179 Risperdal Consta intramuscular syringe . 179 Rituxan .................................................... 130 Rubraca oral tablet 200 mg, 300 mg ....... 131 Rydapt ..................................................... 132 S Sabril ....................................................... 133 Samsca oral tablet 15 mg, 30 mg ............ 134 Sancuso transdermal patch weekly ......... 179 Sandimmune oral capsule ....................... 179 Sandimmune oral solution ...................... 179 Sensipar oral tablet 30 mg, 60 mg, 90 mg ............................................................. 179 Signifor ................................................... 135 sildenafil (antihypertensive) oral ............ 127 Simulect intravenous recon soln 20 mg .. 179 sirolimus oral tablet................................. 179 Solu-Cortef (PF) injection recon soln 100 mg/2 mL, 250 mg/2 mL ...................... 179 Somatuline Depot subcutaneous syringe 179 Somavert subcutaneous recon soln ......... 179 Sovaldi .................................................... 136 Sprycel oral tablet 100 mg, 140 mg, 20 mg, 50 mg, 70 mg, 80 mg .......................... 137 Stivarga ................................................... 138 streptomycin intramuscular recon soln ... 179 sulfamethoxazole-trimethoprim intravenous solution................................................ 179 Sutent ...................................................... 139 Sylatron ................................................... 140 Synagis intramuscular solution 50 mg/0.5 mL ............................................... 141, 142 Synercid intravenous recon soln ............. 179 Synribo subcutaneous recon soln ............ 179 T tacrolimus oral capsule ........................... 179 Tafinlar .................................................... 143 Tagrisso ................................................... 144 Tarceva oral tablet 100 mg, 150 mg, 25 mg ............................................................. 145 Tasigna .................................................... 147 Tecentriq ................................................. 148 Teflaro intravenous recon soln................ 179 temazepam ................................................ 55 testosterone cypionate intramuscular oil . 179 testosterone enanthate intramuscular oil . 179 189 Vimpat intravenous ................................. 160 Vimpat oral solution ............................... 160 Vimpat oral tablet ................................... 160 vinblastine intravenous solution ............. 179 Vincasar PFS intravenous solution 1 mg/mL ............................................................. 179 vincristine intravenous solution 1 mg/mL ............................................................. 179 vinorelbine intravenous solution 50 mg/5 mL ....................................................... 179 voriconazole intravenous solution .......... 179 Votrient ................................................... 161 VPRIV intravenous recon soln ............... 179 X Xalkori .................................................... 162 Xermelo................................................... 163 Xgeva subcutaneous solution.................. 179 Xolair ...................................................... 164 Xtandi ...................................................... 165 Y Yervoy intravenous solution 50 mg/10 mL (5 mg/mL) ........................................... 166 Yondelis .................................................. 167 Z Zaltrap intravenous solution 100 mg/4 mL (25 mg/mL) ......................................... 168 Zejula ...................................................... 169 Zelboraf ................................................... 170 Zemplar intravenous solution ................. 180 zoledronic acid intravenous solution ...... 180 zoledronic acid-mannitol-water .............. 171 Zometa intravenous piggyback ............... 180 zonisamide ................................................ 11 Zortress oral tablet .................................. 180 Zydelig .................................................... 173 Zykadia ................................................... 174 Zyprexa Relprevv intramuscular suspension for reconstitution 210 mg .................... 180 190
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