Emblem MAPD 2016 Part D Prior Authorization Critera 2
User Manual: Part-D-Prior-Authorization-Critera-2
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GuildNet Gold HMO SNP 2016 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. 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. Required Medical Information MS exacerbation, history of corticosteroid use. 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. Coverage Duration Infantile spasms, Plan Year. MS exacerbation, approve 1 month. Other Criteria For MS 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 MS exacerbation and has experienced a severe or limiting adverse effect. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 1 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 2 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 3 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 precribed 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 cathererization is not required in pts who are currently receiving Adempas or another agent indicated for WHO group 1. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 4 AFINITOR Products Affected Afinitor Disperz Afinitor 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 5 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) Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 6 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 7 ANTICONVULSANTS Products Affected topiramate topiramate 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 8 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 9 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 10 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, or dermatologist. Coverage Duration Plan Year Other Criteria CAPS renewal - approve if they have had a response and are continuing therapy to maintain response/remission. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 11 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 N/A Required Medical Information N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 12 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 13 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 N/A Coverage Duration Plan Year Other Criteria For CML, patient must have Ph-positive CML and must have resistance or intolerance to prior therapy for approval. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 14 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 15 CABOMETYX Products Affected Cabometyx PA Criteria Criteria Details Covered Uses All FDA-approved 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 N/A 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]). Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 16 CARBAGLU Products Affected Carbaglu 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 17 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 N/A 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 18 CHORIONIC GONADOTROPINS (HCG) Products Affected chorionic gonadotropin, human Novarel 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 19 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]). Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 20 CINRYZE Products Affected Cinryze PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Plus for the acute treatment of Hereditary Angioedema (HAE). 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 21 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 22 COPAXONE Products Affected Copaxone subcutaneous syringe 20 mg/mL, 40 mg/mL 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 N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan year Other Criteria Patients with previous use (12 or more months) of Copaxone 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 23 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 24 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 N/A 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 platinum-based chemotherapy. Part B versus D determination per CMS guidance. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 25 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 treatment 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 26 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 27 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 28 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 treament 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 29 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 atleast one prior therapy. Part B versus Part D determination will be made at time of prior authorization review per CMS guidance. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 30 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 N/A 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 31 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 32 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 33 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 N/A Age Restrictions N/A Prescriber Restrictions N/A 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 34 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 35 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 36 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 physican that specializes in the treatment of HAE or related disorders. Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 37 FYCOMPA Products Affected 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 38 GATTEX Products Affected Gattex One-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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 39 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 Documentation of metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDAapproved test Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 40 GLEEVEC Products Affected Gleevec 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 Gleevec 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 Gleevec for adjuvant therapy following resection, or 3) use of Gleevec for pre-operative therapy and patient is at risk for significant surgical morbidity. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 41 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 for pediatric patients, growing more than 2.5 cm per year and for PWS only: improved body composition. For renewal for adult patients: 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 42 HARVONI Products Affected Harvoni PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Concurrent treatment with interferon, Sovaldi, Olysio, or Viekira Required Medical Information Prior to initiating therapy, detectable levels of HCV RNA in the serum. Genotype 1, 4, 5, 6. Cirrhosis documented by FibroScan, liver biopsy, or radiological imaging Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation w/ GI, hepatologist, ID, or a liver transplant MD Coverage Duration 24WK: Gen 1-exp w cirr, Gen1/4 trans. 12WK: Gen 1-nv, exp w/o cirr, Gen 4/5/ 6, Gen 1/4 trans +RBV Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 43 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 44 HRM Products Affected benztropine oral butalbital-acetaminop-caf-cod clemastine oral tablet 2.68 mg cyclobenzaprine oral tablet cyproheptadine dicyclomine oral capsule dicyclomine oral solution dicyclomine oral tablet Digitek digoxin injection solution digoxin oral solution 50 mcg/mL digoxin oral tablet ergoloid Lanoxin oral meprobamate metaxalone methyldopa-hydrochlorothiazide promethazine oral tablet reserpine 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 45 HRM - BENZODIAZEPINES Products Affected alprazolam 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 Restless Leg Syndrome and insomnia, authorize use. Restless Leg Syndrome, approve clonazepam if the patient has tried one other agent for this condition (eg, ropinirole, pramipexole, carbidopa-levodopa [immediate-release or extendedrelease]). 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 46 HRM BENZODIAZEPINES/ANTICONVULSANTS Products Affected clonazepam clorazepate dipotassium Diastat Diazepam Intensol diazepam oral solution 5 mg/5 mL (1 mg/mL) diazepam oral tablet diazepam rectal 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 47 HRM PD Products Affected amitriptyline clomipramine doxepin oral estradiol oral imipramine HCl imipramine pamoate megestrol oral tablet perphenazine-amitriptyline phenobarbital Surmontil 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 48 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 49 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 N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 50 ILARIS Products Affected Ilaris (PF) 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, or dermatologist. SJIA initial- prescribed 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 diease, 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 limitions 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 51 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. For patients with chronic lymphoid leukemia (CLL)-one prior treatment or 17p chromosome deletion Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 52 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 N/A 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). Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 53 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 54 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 55 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 56 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 57 KALYDECO Products Affected Kalydeco 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 58 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 Prescribed by or in consultation with a neurologist or a physician who specializes in the care of patients with primary periodic paralysis (e.g., muscle disease specialist, physiatrist). Coverage Duration Initial therapy - 2 months, Continuing therapy - plan year Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 59 PA Criteria Criteria Details 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 in the frequency or severity of paralytic attacks with treatment as determined by the prescribing physician Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 60 KORLYM Products Affected Korlym 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 61 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 1 month 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 62 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 N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 63 LETAIRIS Products Affected Letairis PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Pregnancy Required Medical Information NYHA class II or III symptoms. PAH been confirmed by right heart catheterization. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria UD or two appropriate contraceptive methods will be used for women of childbearing potential. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 64 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 65 LEUPROLIDE Products Affected Eligard 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 66 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 N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 67 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, ananti-EGFR therapy. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 68 LYNPARZA Products Affected Lynparza 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 69 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 70 NAMENDA Products Affected memantine Namenda Namenda Titration Pak 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 71 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 72 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 chemotherapy-induced 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 73 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 74 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 75 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 76 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 N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Initial 4 weeks, renewal 6 months Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 77 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 78 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 79 OCTREOTIDE Products Affected octreotide acetate injection solution 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 80 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 81 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 82 ONCASPAR Products Affected Oncaspar 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 83 ONFI Products Affected Onfi oral tablet 10 mg, 20 mg Onfi oral suspension 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 84 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 N/A Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 85 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 catherization 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 86 PEGINTRON Products Affected PegIntron Redipen PegIntron PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Decompensated liver disease. Autoimmune hepatitis. Concomitant administration of didanosine with ribavirin in patients coinfected with HIV. Required Medical Information HCV: Prior to initiating therapy, detectable levels of HCV RNA in the serum. Age Restrictions N/A Prescriber Restrictions ID specialist, Gastroenterologist, Oncologist Coverage Duration Plan Year Other Criteria Monitor for evidence of depression. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 87 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 88 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 89 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 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 Pomalyst use. Patients should be monitored for signs and symptoms of thromboembolism. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 90 POTIGA Products Affected Potiga 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 91 PRALUENT Products Affected Praluent Pen subcutaneous pen injector 150 mg/mL, 75 mg/mL Praluent Syringe subcutaneous syringe 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 Initial Prior Authorization: 6 months,Continuation of Therapy: Plan Year Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 92 PA Criteria Criteria Details 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 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. 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 by WHO/Dutch Lipid grp criteria OR 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 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 93 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 (in combination with interferon or pegylated interferon alfa 2a/2b products with or without the direct-acting antiviral agents Victrelis or Incivek), 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 for adults or less than or equal to 11 g/dL for children to start.Hb less than or equal to 11.5 g/dL for adults or 12 g/dL or less for children. Anemia w/myelosuppressive chemotx.pt must be currently receiving myelosuppressive chemo and Hb 10.0 g/dL or less to start.Hb less than or equal to 12.0 g/dL . MDS, approve if Hb is 10 g/dL. 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 or infectious disease physician who specializes in the management of hepatitis C. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 94 PA Criteria Criteria Details Coverage Duration Anemia w/myelosuppress = 4 mos.Transfus=1 mo.Other= 6mo. HIV + zidovudine = 4 mo 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 95 PROMACTA Products Affected Promacta oral tablet 12.5 mg, 25 mg, 50 mg 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. Thrombocytopenia due to HCV-related cirrhosis, platelet counts. 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 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 . Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 96 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 97 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 98 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 99 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 N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 100 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 101 REPATHA Products Affected Repatha Syringe Repatha SureClick 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 Initial Prior Authorization: 6 months,Continuation of Therapy: Plan Year Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 102 PA Criteria Criteria Details 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 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. 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 by WHO/Dutch Lipid grp criteria OR 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 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 103 REVATIO Products Affected sildenafil 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. If patient is an infant, PAH diagnosed by Doppler echocardiogram. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 104 REVLIMID Products Affected Revlimid 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) 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 105 RIBAVIRIN Products Affected ribavirin oral tablet 200 mg ribavirin oral capsule PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria Hemoglobin less than 10 g/dL. Hemoglobinopathy. History of preexisting 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, or Sovaldi. Cirrhosis documented by FibroScan, liver biopsy, or radiological imaging 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 Adults: 12wk: geno 1a+no cirr-w/Viekira, geno 2-w/Sovaldi, geno 3, 4, 5, 6-w/PEG/Sovaldi, Gen 1/4 post-transplant +Harvoni. 16wk: geno 2 w/cirr + Sovaldi. 24wk: geno 1a+cirr-w/Viekira, geno 3, 4-w/Sovaldi. Children: 48 wk all genotypes Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 106 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,1mo. 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 107 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 108 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 109 SANDOSTATIN LAR Products Affected Sandostatin LAR Depot intramuscular suspension,extended rel recon PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information Patient received initial treatment with Sandostatin Injection (not the Depot form) for at least 2 weeks and treatment with Sandostatin Injection was effective and tolerable. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 110 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 111 SOVALDI Products Affected Sovaldi PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria N/A Required Medical Information Prior to initiating therapy, detectable levels of HCV RNA in the serum. Must be used in combination with interferon+ribavirin, ribavirin, or Olysio. Cirrhosis documented by FibroScan, liver biopsy, or radiological imaging Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation w/ GI, hepatologist, ID, or a liver transplant MD Coverage Duration 12 wks, 24 wks, or 48 wks as specified in Other Criteria. Other Criteria Geno 1-Patient must have tried Viekira or Harvoni. Geno 2,3,4,5,6 prescribed in combo with RBV. Coverage duration: 12wk: geno 1+no cirr, geno 2 naive-w/RBV, geno 2 prior tx fail w/PEG/RBV or SOV/RBV-w/PEG/RBV, geno 3 naive-w/PEG/RBV, geno 3 prior tx fail w/PEG/RBV or SOV/RBV-w/PEG/RBV, geno 4 naïve w/PEG/RBV, geno 4 prior tx fail w/ PEG/RBV -w/PEG/RB , geno 5/6 naïve/exp w/PEG/RBV. 16wk: geno 2 naive+cirr w/RBV. 24wk: geno 1+cirr, geno 2 prior tx fail w/PEG/RBV (16 weeks if requested by prescriber)-w/RBV, post-liver transplant +cirr w/RBV, geno 3 naive-w/RBV, post-liver transplant + cirr w/RBV, geno 4 naïve w/ RBV, geno 4 prior tx fail w/ PEG/RBV -w/RBV. 48wk: Others Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 112 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 113 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 N/A 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, 5FU), oxaliplatin, irinotecan, anti-VEGF therapy (eg, Avastin, Zaltrap), anti-EGFR therapy (eg, Eribitux, Vectibix). For GIST, patient must have previously been treated with imatinib (Gleevec) and sunitinib (Sutent). Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 114 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 115 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 116 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 Prescriber Restrictions N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 117 PA Criteria Criteria Details 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 118 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 119 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 120 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 121 TARGRETIN Products Affected Targretin oral 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 122 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 N/A 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 123 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 124 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 125 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 126 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 127 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 long-acting narcotic (eg, Duragesic), or the patient is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics (eg, morphine sulfate, hydromorphone, fentanyl citrate). Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 128 TRETINOIN Products Affected adapalene topical cream adapalene topical gel tretinoin microspheres topical gel with pump tretinoin topical 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 129 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 130 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, 6mercaptopurine, 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 131 PA Criteria Criteria Details 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, certolizumab pegol, or infliximab, and had an inadequate response or was intolerant to the TNF antagonists. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 132 VENCLEXTA Products Affected Venclexta Starting Pack Venclexta 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 133 VIEKIRA Products Affected Viekira Pak PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Exclusion Criteria Concurrent treatment with interferon, Sovaldi, Olysio, or Harvoni Required Medical Information Genotype and subtype Age Restrictions 18 years or older Prescriber Restrictions Prescribed by or in consultation w/ GI, hepatologist, ID, or a liver transplant MD Coverage Duration 24 wks G1a w cirrh and prior null response to HVC therapy, Rec HCV Post-Liver Trans, 12 wks others Other Criteria Geno 1a w/ or w/o cirrhosis-prescribed in combination with RBV. Liver transplant recipients with normal hepatic function and metavir score less than 2-prescribed in combination with RBV. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 134 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 A. The patient will receive Vimpat as an adjunctive anticonvulsant for the treatment of partial onset seizures. B. The patient had a previous or present trial/failure/contraindication to two or more of the following: carbamazepine, divalproex, ethosuximide, ethotoin, gabapentin, lamotrigine, levetiracetam, methsuximide, oxcarbazepine, phenytoin, phenobarbital, pregabalin, rufinamide, tiagabine, topiramate, valproic acid or zonisamide. Age Restrictions 17 years of age and older Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 135 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 136 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. 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 137 XENAZINE Products Affected Xenazine 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, Xenazine or tetrabenazine must be prescribed by or after consultation with a neurologist. For TD, Xenazine or tetrabenazine must be prescribed by or after consultation with a neurologist or psychiatrist. Coverage Duration Plan Year Other Criteria N/A Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 138 XOLAIR Products Affected Xolair PA Criteria Criteria Details Covered Uses All FDA approved indications not otherwise excluded from Part D Exclusion Criteria N/A Required Medical Information For IgE-mediated allergic asthma: pre-treatment serum IgE and patient's weight Age Restrictions 12 years of age and older Prescriber Restrictions Pulmonologist, allergist or immunologist Coverage Duration Plan Year Other Criteria To continue therapy, patients must demonstrate an improvement in asthma control with use of Xolair. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 139 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 N/A Required Medical Information Diagnosis for which Xtandi is being used. For metastatic castrationresistant prostate cancer, prior therapies tried. Age Restrictions N/A Prescriber Restrictions N/A Coverage Duration Plan Year Other Criteria For prostate cancer, patient must have metastatic, castration-resistant prostate cancer for approval. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 140 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 141 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 142 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 143 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 144 ZYVOX Products Affected linezolid linezolid Zyvox intravenous parenteral solution 600 mg/300 mL Zyvox oral 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 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 145 PART B VERSUS PART D Products Affected Abelcet Abilify Maintena intramuscular suspension,extended rel recon 300 mg Abilify Maintena intramuscular suspension,extended rel syring Abraxane acetylcysteine Actemra intravenous acyclovir sodium intravenous solution Adagen Adrucil intravenous solution 500 mg/10 mL A-Hydrocort 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 Alimta intravenous recon soln 500 mg AmBisome amifostine crystalline amikacin injection solution 500 mg/2 mL amino acids 15 % Aminosyn 8.5 %-electrolytes Aminosyn II 10 % Aminosyn II 15 % Aminosyn II 7 % Aminosyn II 8.5 % Aminosyn II 8.5 %-electrolytes Aminosyn M 3.5 % Aminosyn-HBC 7% Aminosyn-PF 10 % Aminosyn-PF 7 % (sulfite-free) Aminosyn-RF 5.2 % amiodarone intravenous solution amphotericin B ampicillin sodium injection recon soln 1 gram, 10 gram, 125 mg ampicillin-sulbactam injection recon soln 15 gram, 3 gram Aralast NP intravenous recon soln 500 mg Astagraf XL Avastin Avelox in NaCl (iso-osmotic) Azasan azathioprine azathioprine sodium azithromycin intravenous BACiiM bacitracin intramuscular BCG vaccine, live (PF) Beleodaq Benlysta benztropine injection Bicillin C-R BiCNU 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 syringe Busulfex calcitriol intravenous solution 1 mcg/mL calcitriol oral Cancidas Capastat carboplatin intravenous solution cefazolin in dextrose (iso-os) intravenous piggyback 1 gram/50 mL cefazolin injection recon soln 1 gram, 10 gram, 500 mg cefepime cefotaxime injection recon soln 1 gram, 2 gram, 500 mg cefoxitin cefoxitin in dextrose, iso-osm ceftazidime injection recon soln 1 gram, 2 gram ceftriaxone injection recon soln 10 gram, 250 mg, 500 mg ceftriaxone intravenous cefuroxime sodium injection recon soln 1.5 gram, 750 mg Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 146 cefuroxime sodium intravenous Delestrogen intramuscular oil 10 mg/mL CellCept Intravenous Depo-Provera intramuscular solution CellCept oral suspension for reconstitution dexamethasone sodium phosphate injection solution Cerezyme intravenous recon soln 400 unit dexrazoxane HCl intravenous recon soln 250 mg chloramphenicol sod succinate dextrose 10 % and 0.2 % NaCl cidofovir dextrose 10 % in water (D10W) Cimzia Powder for Reconst dextrose 5 % in water (D5W) intravenous ciprofloxacin lactate intravenous solution 400 parenteral solution mg/40 mL dextrose 5 %-lactated ringers cisplatin dextrose 5%-0.2 % sod chloride cladribine clindamycin phosphate intravenous solution 600 dextrose 5%-0.3 % sod.chloride mg/4 mL Dextrose With Sodium Chloride Clinimix 5%/D15W Sulfite Free Dextrose-KCl-NaCl Clinimix 5%/D25W sulfite-free diltiazem HCl intravenous Clinimix 2.75%/D5W Sulfit Free diphenhydramine HCl injection solution 50 mg/mL Clinimix 4.25%/D10W Sulf Free doxorubicin intravenous solution 50 mg/25 mL Clinimix 4.25%/D5W Sulfit Free Doxy-100 Clinimix 4.25%-D20W sulf-free doxycycline hyclate intravenous Clinimix 4.25%-D25W sulf-free dronabinol Clinimix 5%-D20W(sulfite-free) Duramorph (PF) injection solution 0.5 mg/mL, 1 Clinimix E 2.75%/D10W Sul Free mg/mL Clinimix E 2.75%/D5W Sulf Free Elaprase Clinimix E 4.25%/D10W Sul Free Elelyso Clinimix E 4.25%/D25W Sul Free Elitek Clinimix E 4.25%/D5W Sulf Free Emend oral Clinimix E 5%/D15W Sulfit Free Engerix-B (PF) intramuscular syringe Clinimix E 5%/D20W Sulfit Free Engerix-B Pediatric (PF) Clinimix E 5%/D25W Sulfit Free Envarsus XR colistin (colistimethate Na) epirubicin intravenous solution 50 mg/25 mL cromolyn inhalation Erythrocin intravenous recon soln 500 mg Cubicin esomeprazole sodium cyclophosphamide oral capsule estradiol valerate intramuscular oil 20 mg/mL, cyclosporine intravenous 40 mg/mL cyclosporine modified etoposide intravenous cyclosporine oral capsule Fabrazyme intravenous recon soln 35 mg cytarabine famotidine (PF) D2.5 %-0.45 % sodium chloride famotidine (PF)-NaCl (iso-os) D5 % and 0.9 % sodium chloride Faslodex D5 %-0.45 % sodium chloride fluconazole in dextrose(iso-o) intravenous dacarbazine intravenous recon soln 200 mg piggyback 400 mg/200 mL daunorubicin intravenous solution decitabine Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 147 fluconazole in NaCl (iso-osm) intravenous piggyback 200 mg/100 mL fludarabine intravenous recon soln fluorouracil intravenous solution 2.5 gram/50 mL fluphenazine decanoate fluphenazine HCl injection fomepizole fosphenytoin injection solution 100 mg PE/2 mL furosemide injection ganciclovir sodium gemcitabine intravenous recon soln 1 gram Gengraf gentamicin in NaCl (iso-osm) intravenous piggyback 100 mg/100 mL gentamicin in NaCl (iso-osm) intravenous piggyback 80 mg/100 mL gentamicin injection solution 40 mg/mL Geodon intramuscular granisetron (PF) intravenous solution 100 mcg/mL granisetron HCl intravenous solution 1 mg/mL (1 mL) granisetron HCl oral haloperidol decanoate haloperidol lactate injection 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% Herceptin hydralazine injection hydromorphone (PF) injection solution 10 mg/mL hydroxyzine HCl intramuscular idarubicin ifosfamide intravenous recon soln 1 gram imipenem-cilastatin Increlex Intralipid intravenous emulsion 20 %, 30 % Intron A injection recon soln Intron A injection solution 6 million unit/mL Invanz injection Invega Sustenna Invega Trinza Ionosol-B in D5W Ionosol-MB in D5W ipratropium bromide inhalation ipratropium-albuterol irinotecan intravenous solution 100 mg/5 mL Istodax Kadcyla intravenous recon soln 100 mg Keytruda 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 levetiracetam in NaCl (iso-os) levetiracetam intravenous levocarnitine (with sugar) levocarnitine intravenous levocarnitine oral tablet levofloxacin intravenous levoleucovorin calcium lidocaine (PF) injection solution 5 mg/mL (0.5 %) lidocaine HCl injection solution 20 mg/mL (2 %) magnesium sulfate injection melphalan HCl meropenem intravenous recon soln 500 mg mesna methadone injection methotrexate sodium (PF) methotrexate sodium oral methylprednisolone acetate methylprednisolone sodium succ injection recon soln 125 mg, 40 mg metoclopramide HCl injection solution metoprolol tartrate intravenous Miacalcin injection mitomycin intravenous recon soln 20 mg Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 148 mitoxantrone morphine intravenous syringe 10 mg/mL, 8 mg/mL Mozobil Mustargen mycophenolate mofetil mycophenolate sodium nafcillin in dextrose iso-osm intravenous piggyback 1 gram/50 mL nafcillin injection recon soln 1 gram nafcillin injection recon soln 10 gram Naglazyme nalbuphine injection solution 10 mg/mL, 20 mg/mL Nebupent Neoral Nephramine 5.4 % nitroglycerin intravenous Normosol-M in 5 % dextrose Normosol-R in 5 % dextrose Normosol-R pH 7.4 Nulojix ondansetron ondansetron HCl (PF) ondansetron HCl oral Orencia (with maltose) oxacillin in dextrose(iso-osm) oxacillin injection recon soln 10 gram oxacillin intravenous recon soln 2 gram oxaliplatin intravenous solution 100 mg/20 mL paclitaxel pamidronate intravenous solution paricalcitol oral penicillin G potassium injection recon soln 5 million unit penicillin G procaine intramuscular syringe 1.2 million unit/2 mL penicillin G sodium Pentam Perforomist Perjeta phenytoin sodium intravenous solution piperacillin-tazobactam intravenous recon soln 3.375 gram, 4.5 gram Plasma-Lyte 148 Plasma-Lyte A Plasma-Lyte-56 in 5 % dextrose potassium chlorid-D5-0.45%NaCl 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 Premarin injection Premasol 10 % Premasol 6 % Procalamine 3% Proleukin Prolia propranolol intravenous Prosol 20 % Pulmozyme ranitidine HCl injection solution 25 mg/mL Rapamune Recombivax HB (PF) intramuscular suspension 10 mcg/mL, 40 mcg/mL Recombivax HB (PF) intramuscular syringe Remodulin Rheumatrex rifampin intravenous ringers intravenous Risperdal Consta Sancuso Sandimmune oral Simulect intravenous recon soln 20 mg sirolimus Solu-Cortef (PF) injection recon soln 100 mg/2 mL, 250 mg/2 mL Somatuline Depot Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 149 Somavert streptomycin intramuscular sulfamethoxazole-trimethoprim intravenous Synercid Synribo tacrolimus oral tacrolimus oral Teflaro terbutaline subcutaneous testosterone cypionate testosterone enanthate tetanus-diphtheria toxoids-Td tobramycin in 0.225 % NaCl tobramycin sulfate injection solution Toposar topotecan intravenous recon soln tranexamic acid intravenous Travasol 10 % Treanda intravenous recon soln 100 mg Trelstar intramuscular suspension for reconstitution Trelstar intramuscular syringe 11.25 mg/2 mL, 3.75 mg/2 mL Trisenox TrophAmine 10 % Trophamine 6% Twinrix (PF) intramuscular suspension valproate sodium vancomycin intravenous recon soln 1,000 mg, 10 gram, 500 mg Velcade 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 Virazole voriconazole intravenous VPRIV Xgeva Zaltrap intravenous solution 100 mg/4 mL (25 mg/mL) Zemplar intravenous zoledronic acid intravenous solution zoledronic acid-mannitol-water intravenous solution Zometa intravenous solution 4 mg/100 mL Zortress 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. Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 150 Index A Abelcet .................................................... 146 Abilify Maintena ..................................... 146 Abraxane ................................................. 146 acetylcysteine .......................................... 146 Actemra ................................................... 146 Acthar H.P................................................... 1 Actimmune.................................................. 2 acyclovir sodium ..................................... 146 Adagen .................................................... 146 adapalene topical cream .......................... 129 adapalene topical gel ............................... 129 Adcirca ........................................................ 3 Adempas ..................................................... 4 Adrucil .................................................... 146 Afinitor........................................................ 5 Afinitor Disperz .......................................... 5 A-Hydrocort ............................................ 146 albuterol sulfate ....................................... 146 Aldurazyme ............................................. 146 Alecensa ...................................................... 6 Alimta ..................................................... 146 alprazolam ................................................. 46 AmBisome .............................................. 146 amifostine crystalline .............................. 146 amikacin .................................................. 146 amino acids 15 % .................................... 146 Aminosyn 8.5 %-electrolytes .................. 146 Aminosyn II 10 % ................................... 146 Aminosyn II 15 % ................................... 146 Aminosyn II 7 % ..................................... 146 Aminosyn II 8.5 % .................................. 146 Aminosyn II 8.5 %-electrolytes .............. 146 Aminosyn M 3.5 % ................................. 146 Aminosyn-HBC 7% ................................ 146 Aminosyn-PF 10 % ................................. 146 Aminosyn-PF 7 % (sulfite-free).............. 146 Aminosyn-RF 5.2 % ............................... 146 amiodarone .............................................. 146 amitriptyline .............................................. 48 amphotericin B ........................................ 146 ampicillin sodium.................................... 146 ampicillin-sulbactam ............................... 146 Ampyra ....................................................... 7 APOKYN .................................................... 9 Aptiom ...................................................... 10 Aralast NP ............................................... 146 Arcalyst ..................................................... 11 Astagraf XL ............................................ 146 Avastin .................................................... 146 Avelox in NaCl (iso-osmotic) ................. 146 Avonex (with albumin) ............................. 12 Avonex intramuscular pen injector kit ...... 12 Avonex intramuscular syringe kit ............. 12 Azasan ..................................................... 146 azathioprine ............................................. 146 azathioprine sodium ................................ 146 azithromycin ........................................... 146 B BACiiM................................................... 146 bacitracin ................................................. 146 Banzel oral tablet ...................................... 13 BCG vaccine, live (PF) ........................... 146 Beleodaq ................................................. 146 Benlysta................................................... 146 benztropine.............................................. 146 benztropine oral ........................................ 45 bexarotene ............................................... 122 Bicillin C-R ............................................. 146 BiCNU .................................................... 146 bleomycin ................................................ 146 Bosulif ....................................................... 14 Briviact ...................................................... 15 budesonide .............................................. 146 buprenorphine HCl.................................. 146 Busulfex .................................................. 146 butalbital-acetaminop-caf-cod .................. 45 C Cabometyx ................................................ 16 calcitriol .................................................. 146 Cancidas .................................................. 146 Capastat ................................................... 146 Carbaglu .................................................... 17 carboplatin............................................... 146 cefazolin .................................................. 146 cefazolin in dextrose (iso-os) .................. 146 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 151 cefepime .................................................. 146 cefotaxime ............................................... 146 cefoxitin .................................................. 146 cefoxitin in dextrose, iso-osm ................. 146 ceftazidime .............................................. 146 ceftriaxone............................................... 146 cefuroxime sodium.................................. 146 CellCept .................................................. 147 CellCept Intravenous .............................. 146 Cerezyme ................................................ 147 chloramphenicol sod succinate ............... 147 Cholbam .................................................... 18 chorionic gonadotropin, human ................ 19 Cialis oral tablet 2.5 mg, 5 mg .................. 20 cidofovir .................................................. 147 Cimzia Powder for Reconst .................... 147 Cinryze ...................................................... 21 ciprofloxacin lactate ................................ 147 cisplatin ................................................... 147 cladribine................................................. 147 clemastine oral tablet 2.68 mg .................. 45 clindamycin phosphate............................ 147 Clinimix 5%/D15W Sulfite Free ........... 147 Clinimix 5%/D25W sulfite-free ............. 147 Clinimix 2.75%/D5W Sulfit Free ........... 147 Clinimix 4.25%/D10W Sulf Free ........... 147 Clinimix 4.25%/D5W Sulfit Free ........... 147 Clinimix 4.25%-D20W sulf-free ............ 147 Clinimix 4.25%-D25W sulf-free ............ 147 Clinimix 5%-D20W(sulfite-free) ............ 147 Clinimix E 2.75%/D10W Sul Free ......... 147 Clinimix E 2.75%/D5W Sulf Free .......... 147 Clinimix E 4.25%/D10W Sul Free ......... 147 Clinimix E 4.25%/D25W Sul Free ......... 147 Clinimix E 4.25%/D5W Sulf Free .......... 147 Clinimix E 5%/D15W Sulfit Free ........... 147 Clinimix E 5%/D20W Sulfit Free ........... 147 Clinimix E 5%/D25W Sulfit Free ........... 147 clomipramine ............................................ 48 clonazepam ............................................... 47 clorazepate dipotassium ............................ 47 colistin (colistimethate Na) ..................... 147 Cometriq ................................................... 22 Copaxone subcutaneous syringe 20 mg/mL, 40 mg/mL .............................................. 23 Cotellic ...................................................... 24 cromolyn ................................................. 147 Cubicin .................................................... 147 cyclobenzaprine oral tablet ....................... 45 cyclophosphamide................................... 147 cyclosporine ............................................ 147 cyclosporine modified ............................. 147 cyproheptadine .......................................... 45 Cyramza .................................................... 25 cytarabine ................................................ 147 D D2.5 %-0.45 % sodium chloride ............. 147 D5 % and 0.9 % sodium chloride ........... 147 D5 %-0.45 % sodium chloride ................ 147 dacarbazine ............................................. 147 Darzalex .................................................... 26 daunorubicin ........................................... 147 decitabine ................................................ 147 Delestrogen ............................................. 147 Demser ...................................................... 27 Depen Titratabs ......................................... 88 Depo-Provera .......................................... 147 dexamethasone sodium phosphate .......... 147 dexrazoxane HCl ..................................... 147 dextrose 10 % and 0.2 % NaCl ............... 147 dextrose 10 % in water (D10W) ............. 147 dextrose 5 % in water (D5W) ................. 147 dextrose 5 %-lactated ringers .................. 147 dextrose 5%-0.2 % sod chloride ............. 147 dextrose 5%-0.3 % sod.chloride ............. 147 Dextrose With Sodium Chloride ............. 147 Dextrose-KCl-NaCl ................................ 147 Diastat ....................................................... 47 Diazepam Intensol .................................... 47 diazepam oral solution 5 mg/5 mL (1 mg/mL) ................................................. 47 diazepam oral tablet .................................. 47 diazepam rectal ......................................... 47 diclofenac sodium topical gel 3 % ............ 28 dicyclomine oral capsule........................... 45 dicyclomine oral solution .......................... 45 dicyclomine oral tablet .............................. 45 Digitek....................................................... 45 digoxin injection solution ......................... 45 digoxin oral solution 50 mcg/mL .............. 45 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 152 digoxin oral tablet ..................................... 45 diltiazem HCl .......................................... 147 diphenhydramine HCl ............................. 147 doxepin oral .............................................. 48 doxorubicin ............................................. 147 Doxy-100 ................................................ 147 doxycycline hyclate ................................ 147 dronabinol ............................................... 147 Duramorph (PF) ...................................... 147 E Egrifta subcutaneous recon soln 1 mg ...... 29 Elaprase ................................................... 147 Elelyso..................................................... 147 Eligard ....................................................... 66 Elitek ....................................................... 147 Emend ..................................................... 147 Empliciti.................................................... 30 Engerix-B (PF) ........................................ 147 Engerix-B Pediatric (PF)......................... 147 Envarsus XR ........................................... 147 epirubicin ................................................ 147 ergoloid ..................................................... 45 Erivedge .................................................... 31 Erwinaze ................................................... 32 Erythrocin ............................................... 147 Esbriet ....................................................... 33 esomeprazole sodium .............................. 147 estradiol oral.............................................. 48 estradiol valerate ..................................... 147 etoposide ................................................. 147 Extavia subcutaneous kit........................... 34 F Fabrazyme ............................................... 147 famotidine (PF) ....................................... 147 famotidine (PF)-NaCl (iso-os) ............... 147 Farydak ..................................................... 35 Faslodex .................................................. 147 fentanyl citrate buccal lozenge on a handle 1,200 mcg, 1,600 mcg, 200 mcg, 400 mcg, 600 mcg, 800 mcg ...................... 128 Ferriprox oral tablet .................................. 36 Firazyr ....................................................... 37 fluconazole in dextrose(iso-o)................. 147 fluconazole in NaCl (iso-osm) ................ 147 fludarabine .............................................. 147 fluorouracil .............................................. 148 fluphenazine decanoate ........................... 148 fluphenazine HCl .................................... 148 fomepizole............................................... 148 fosphenytoin ............................................ 148 furosemide............................................... 148 Fycompa oral tablet................................... 38 G Gammagard Liquid ................................... 55 Gamunex-C injection solution 1 gram/10 mL (10 %) ............................................. 55 ganciclovir sodium .................................. 148 Gattex One-Vial ........................................ 39 gemcitabine ............................................. 148 Gengraf ................................................... 148 gentamicin ............................................... 148 gentamicin in NaCl (iso-osm) ................. 148 Geodon .................................................... 148 Gilotrif....................................................... 40 Glatopa ...................................................... 23 Gleevec oral tablet 100 mg, 400 mg ......... 41 granisetron (PF) ...................................... 148 granisetron HCl ....................................... 148 H haloperidol decanoate ............................. 148 haloperidol lactate ................................... 148 Harvoni ..................................................... 43 heparin (porcine) ..................................... 148 heparin (porcine) in 5 % dex ................... 148 Hepatamine 8% ....................................... 148 Herceptin ................................................. 148 Hetlioz ....................................................... 44 hydralazine .............................................. 148 hydromorphone (PF) ............................... 148 hydroxyzine HCl ..................................... 148 I Ibrance....................................................... 49 Iclusig ........................................................ 50 idarubicin ................................................ 148 ifosfamide ............................................... 148 Ilaris (PF) .................................................. 51 Imbruvica .................................................. 52 imipenem-cilastatin ................................. 148 imipramine HCl ........................................ 48 imipramine pamoate.................................. 48 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 153 Increlex ................................................... 148 Inlyta ......................................................... 53 Intralipid .................................................. 148 Intron A ................................................... 148 Invanz ...................................................... 148 Invega Sustenna ...................................... 148 Invega Trinza .......................................... 148 Ionosol-B in D5W ................................... 148 Ionosol-MB in D5W ............................... 148 ipratropium bromide ............................... 148 ipratropium-albuterol .............................. 148 Iressa ......................................................... 54 irinotecan................................................. 148 Istodax ..................................................... 148 J Jakafi oral tablet 10 mg, 15 mg, 20 mg, 25 mg, 5 mg ............................................... 56 Juxtapid ..................................................... 57 K Kadcyla ................................................... 148 Kalydeco ................................................... 58 Keveyis ..................................................... 59 Keytruda .................................................. 148 Korlym ...................................................... 61 Kuvan oral tablet,soluble .......................... 62 L labetalol ................................................... 148 Lanoxin oral .............................................. 45 Lenvima .................................................... 63 Letairis ...................................................... 64 leucovorin calcium .................................. 148 Leukine injection recon soln ..................... 65 levalbuterol HCl ...................................... 148 levetiracetam ........................................... 148 levetiracetam in NaCl (iso-os) ................ 148 levocarnitine ............................................ 148 levocarnitine (with sugar) ....................... 148 levofloxacin............................................. 148 levoleucovorin calcium ........................... 148 lidocaine (PF) .......................................... 148 lidocaine HCl .......................................... 148 lidocaine topical adhesive patch,medicated ............................................................... 67 linezolid................................................... 145 Lonsurf ...................................................... 68 Lorazepam Intensol ................................... 46 lorazepam oral tablet ................................. 46 Lupron Depot ............................................ 66 Lupron Depot (3 Month) ........................... 66 Lupron Depot (4 Month) ........................... 66 Lupron Depot (6 Month) ........................... 66 Lupron Depot-Ped intramuscular kit 11.25 mg, 15 mg ............................................. 66 Lynparza ................................................... 69 M magnesium sulfate .................................. 148 megestrol oral tablet .................................. 48 Mekinist .................................................... 70 melphalan HCl ........................................ 148 memantine ................................................. 71 meprobamate ............................................. 45 meropenem .............................................. 148 mesna ...................................................... 148 metaxalone ................................................ 45 methadone ............................................... 148 methotrexate sodium ............................... 148 methotrexate sodium (PF) ....................... 148 methyldopa-hydrochlorothiazide .............. 45 methylprednisolone acetate ..................... 148 methylprednisolone sodium succ ............ 148 metoclopramide HCl ............................... 148 metoprolol tartrate ................................... 148 Miacalcin................................................. 148 mitomycin ............................................... 148 mitoxantrone ........................................... 148 modafinil ................................................... 79 morphine ................................................. 148 Mozobil ................................................... 148 Mustargen ............................................... 148 mycophenolate mofetil............................ 149 mycophenolate sodium ........................... 149 N nafcillin ................................................... 149 nafcillin in dextrose iso-osm ................... 149 Naglazyme .............................................. 149 nalbuphine ............................................... 149 Namenda ................................................... 71 Namenda Titration Pak ............................. 71 Namenda XR ............................................. 71 Natpara ...................................................... 72 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 154 Nebupent ................................................. 149 Neoral ...................................................... 149 Nephramine 5.4 % .................................. 149 Neupogen .................................................. 73 Neupro....................................................... 74 Nexavar ..................................................... 75 Ninlaro ...................................................... 76 nitroglycerin ............................................ 149 Norditropin FlexPro .................................. 42 Normosol-M in 5 % dextrose .................. 149 Normosol-R in 5 % dextrose................... 149 Normosol-R pH 7.4................................. 149 Northera .................................................... 77 Novarel ...................................................... 19 Nulojix .................................................... 149 Nuplazid .................................................... 78 O octreotide acetate injection solution.......... 80 Odomzo ..................................................... 81 Ofev........................................................... 82 Oncaspar ................................................... 83 ondansetron ............................................. 149 ondansetron HCl ..................................... 149 ondansetron HCl (PF) ............................. 149 Onfi oral suspension ................................. 84 Onfi oral tablet 10 mg, 20 mg ................... 84 Opdivo intravenous solution 40 mg/4 mL 85 Opsumit ..................................................... 86 Orencia (with maltose) ............................ 149 oxacillin................................................... 149 oxacillin in dextrose(iso-osm)................. 149 oxaliplatin ............................................... 149 oxazepam .................................................. 46 P paclitaxel ................................................. 149 pamidronate............................................. 149 paricalcitol............................................... 149 PegIntron ................................................... 87 PegIntron Redipen .................................... 87 penicillin G potassium ............................ 149 penicillin G procaine ............................... 149 penicillin G sodium ................................. 149 Pentam..................................................... 149 Perforomist .............................................. 149 Perjeta ..................................................... 149 perphenazine-amitriptyline ....................... 48 phenobarbital............................................. 48 phenoxybenzamine ................................... 89 phenytoin sodium .................................... 149 piperacillin-tazobactam ........................... 149 Plasma-Lyte 148 ..................................... 149 Plasma-Lyte A ........................................ 149 Plasma-Lyte-56 in 5 % dextrose ............. 149 Pomalyst .................................................... 90 potassium chlorid-D5-0.45%NaCl .......... 149 potassium chloride in 0.9%NaCl ............ 149 potassium chloride in 5 % dex ................ 149 potassium chloride in LR-D5 .................. 149 potassium chloride-D5-0.2%NaCl .......... 149 potassium chloride-D5-0.3%NaCl .......... 149 potassium chloride-D5-0.9%NaCl .......... 149 Potiga ........................................................ 91 Praluent Pen subcutaneous pen injector 150 mg/mL, 75 mg/mL ................................ 92 Praluent Syringe subcutaneous syringe 150 mg/mL, 75 mg/mL ................................ 92 Pregnyl ...................................................... 19 Premarin .................................................. 149 Premasol 10 % ........................................ 149 Premasol 6 % .......................................... 149 Procalamine 3% ...................................... 149 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 ............................................................... 94 Proleukin ................................................. 149 Prolia ....................................................... 149 Promacta oral tablet 12.5 mg, 25 mg, 50 mg ............................................................... 96 promethazine oral tablet ............................ 45 propranolol .............................................. 149 Prosol 20 % ............................................. 149 Pulmozyme ............................................. 149 Q quinine sulfate ........................................... 97 R ranitidine HCl.......................................... 149 Rapamune ............................................... 149 Ravicti ....................................................... 98 Rebif (with albumin) ................................. 99 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 155 Rebif Rebidose subcutaneous pen injector 22 mcg/0.5 mL, 44 mcg/0.5 mL, 8.8mcg/0.2mL-22 mcg/0.5mL (6) ........ 99 Rebif Titration Pack .................................. 99 Recombivax HB (PF) .............................. 149 Remicade................................................. 100 Remodulin ............................................... 149 Repatha SureClick .................................. 102 Repatha Syringe ...................................... 102 reserpine .................................................... 45 Revlimid.................................................. 105 Rheumatrex ............................................. 149 ribavirin oral capsule............................... 106 ribavirin oral tablet 200 mg..................... 106 rifampin ................................................... 149 ringers ..................................................... 149 Risperdal Consta ..................................... 149 Rituxan .................................................... 107 S Sabril ....................................................... 108 Samsca oral tablet 15 mg, 30 mg ............ 109 Sancuso ................................................... 149 Sandimmune ........................................... 149 Sandostatin LAR Depot intramuscular suspension,extended rel recon ............ 110 Signifor ................................................... 111 sildenafil oral .......................................... 104 Simulect .................................................. 149 sirolimus.................................................. 149 Solu-Cortef (PF)...................................... 149 Somatuline Depot.................................... 149 Somavert ................................................. 149 Sovaldi .................................................... 112 Sprycel oral tablet 100 mg, 140 mg, 20 mg, 50 mg, 70 mg, 80 mg .......................... 113 Stivarga ................................................... 114 streptomycin ............................................ 149 sulfamethoxazole-trimethoprim .............. 149 Surmontil................................................... 48 Sutent ...................................................... 115 Sylatron ................................................... 116 Synagis intramuscular solution 50 mg/0.5 mL ....................................................... 117 Synercid .................................................. 149 Synribo .................................................... 149 T tacrolimus ................................................ 149 Tafinlar .................................................... 119 Tagrisso ................................................... 120 Tarceva oral tablet 100 mg, 150 mg, 25 mg ............................................................. 121 Targretin oral .......................................... 122 Tasigna .................................................... 123 Tecentriq ................................................. 124 Teflaro ..................................................... 150 temazepam ................................................ 46 terbutaline ............................................... 150 testosterone cypionate ............................. 150 testosterone enanthate ............................. 150 tetanus-diphtheria toxoids-Td ................. 150 tetrabenazine ........................................... 138 Thalomid ................................................. 125 thioridazine ............................................. 126 thiotepa.................................................... 127 tobramycin in 0.225 % NaCl .................. 150 tobramycin sulfate ................................... 150 topiramate ................................................... 8 Toposar ................................................... 150 topotecan ................................................. 150 tranexamic acid ....................................... 150 Travasol 10 % ......................................... 150 Treanda ................................................... 150 Trelstar .................................................... 150 tretinoin microspheres topical gel with pump ............................................................. 129 tretinoin topical ....................................... 129 trihexyphenidyl ......................................... 45 trimipramine.............................................. 48 Trisenox .................................................. 150 TrophAmine 10 %................................... 150 Trophamine 6% ....................................... 150 Twinrix (PF)............................................ 150 Tykerb ..................................................... 130 Tysabri .................................................... 131 V valproate sodium ..................................... 150 vancomycin ............................................. 150 Velcade ................................................... 150 Venclexta ................................................ 133 Venclexta Starting Pack .......................... 133 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 156 verapamil................................................. 150 Viekira Pak.............................................. 134 Vimpat intravenous ................................. 135 Vimpat oral solution ............................... 135 Vimpat oral tablet ................................... 135 vinblastine ............................................... 150 Vincasar PFS ........................................... 150 vincristine................................................ 150 vinorelbine .............................................. 150 Virazole ................................................... 150 voriconazole ............................................ 150 Votrient ................................................... 136 VPRIV..................................................... 150 X Xalkori .................................................... 137 Xenazine ................................................. 138 Xgeva ...................................................... 150 Xolair ...................................................... 139 Xtandi ...................................................... 140 Y Yervoy intravenous solution 50 mg/10 mL (5 mg/mL) ........................................... 141 Z Zaltrap ..................................................... 150 Zelboraf ................................................... 142 Zemplar ................................................... 150 zoledronic acid ........................................ 150 zoledronic acid-mannitol-water .............. 150 Zometa .................................................... 150 zonisamide .................................................. 8 Zortress ................................................... 150 Zydelig .................................................... 143 Zykadia ................................................... 144 Zyprexa Relprevv.................................... 150 Zyvox intravenous parenteral solution 600 mg/300 mL .......................................... 145 Zyvox oral ............................................... 145 Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 157 Note to existing members: This formulary has changed since last year. Please review this document to make sure that it still contains the drugs you take. Beneficiaries must use network pharmacies to access their prescription drug benefit. Benefits, formulary, pharmacy network, premium and/or copayments/coinsurance may change on January 1, 2017. This document includes GuildNet Gold and GuildNet Health Advantage partial formulary as of August 1, 2016. For a complete, updated formulary, please visit our Web site at www.guildnetny.org or call the Member Services number below. This information is available for free in other languages. Please contact Member Services at 1800-815-0000 for additional information. (TTY users should call 1-800-662-1220). Hours are Monday through Friday, 8 am to 8 pm. Member Services has free language interpreter services available for non-English speakers. Esta información esta disponible en otros idiomas a gratis. Por favor llame a Servicios a los Clientes, al 1-800-815-0000 por información adicional. (Los usuarios de TTY deben llamar al 1800-662-122). Se atiende de lunes a viernes, de 8 a. m. a 8 p. m. Servicios a los Clientes tienen los servicios gratuitos de intérprete de idioma disponibles para altavoces de no-inglés. GuildNet Gold is a HMO SNP plan with Medicare and New York State contracts. Enrollment in GuildNet Gold depends on contract renewal Updated 08/2016 H6864_MGM14_33 PA Criteria Web Posting_Approved 158
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