Emblem MAPD 2016 Part D Prior Authorization Criteria 5

User Manual: Part-D-Prior-Authorization-Criteria-5

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2016 Prior Authorization (PA) Criteria
Certain drugs require prior authorization from GuildNet Gold Plus FIDA Plan Medicare
Plans. 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
 Acthar H.P.

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
1

ACTIMMUNE
 Actimmune

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
2

ADCIRCA
 Adcirca

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
3

ADEMPAS
 Adempas

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
4

AFINITOR
 Afinitor Disperz

Products Affected
 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: 09/2016
H0811_GN134_Web Prior Auth_Approved
5

ALECENSA
 Alecensa

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
6

AMPYRA
 Ampyra

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
7

ANTICONVULSANTS
 topiramate oral tablet
 zonisamide

Products Affected

 topiramate oral capsule, sprinkle
 topiramate oral capsule,sprinkle,ER 24hr

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
8

APOKYN
 APOKYN

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
9

APTIOM
 Aptiom

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
10

ARCALYST
 Arcalyst

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
11

AVONEX
 Avonex intramuscular pen injector kit
 Avonex intramuscular syringe kit

Products Affected

 Avonex (with albumin)

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
12

BANZEL
 Banzel oral tablet

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
13

BOSULIF
 Bosulif

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
14

BRIVIACT
 Briviact

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
15

CABOMETYX
 Cabometyx

Products Affected
PA Criteria

Criteria Details

Covered Uses

All medically accepted indications not otherwise excluded from Part D

Exclusion
Criteria

N/A

Required
Medical
Information

Diagnosis, medication history, histology, RET gene rearrangement status

Age Restrictions

N/A

Prescriber
Restrictions

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
16

CARBAGLU
 Carbaglu

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
17

CHOLBAM
 Cholbam

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
18

CHORIONIC GONADOTROPINS (HCG)
 Novarel
 Pregnyl

Products Affected

 chorionic gonadotropin, human

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
19

CIALIS
 Cialis oral tablet 2.5 mg, 5 mg

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
20

CINRYZE
 Cinryze

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
21

COMETRIQ
 Cometriq

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
22

COPAXONE
 Copaxone subcutaneous syringe 20 mg/mL, 40
mg/mL
 Glatopa

Products Affected

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
23

COTELLIC
 Cotellic

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
24

CYRAMZA
 Cyramza

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
25

DARZALEX
 Darzalex

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
26

DEMSER
 Demser

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
27

DICLOFENAC GEL
 diclofenac sodium topical gel 3 %

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
28

EGRIFTA
 Egrifta subcutaneous recon soln 1 mg

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
29

EMPLICITI
 Empliciti

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
30

ERIVEDGE
 Erivedge

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
31

ERWINAZE
 Erwinaze

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
32

ESBRIET
 Esbriet

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
33

EXTAVIA
 Extavia subcutaneous kit

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
34

FARYDAK
 Farydak

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
35

FERRIPROX
 Ferriprox oral tablet

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
36

FIRAZYR
 Firazyr

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
37

FYCOMPA
 Fycompa oral tablet

Products Affected

 Fycompa 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

N/A

Age Restrictions

N/A

Prescriber
Restrictions

N/A

Coverage
Duration

Plan Year

Other Criteria

N/A

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
38

GATTEX
 Gattex One-Vial

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
39

GILOTRIF
 Gilotrif

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
40

GLEEVEC
 Gleevec oral tablet 100 mg, 400 mg

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
41

GROWTH HORMONE
 Norditropin FlexPro

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
42

HARVONI
 Harvoni

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
43

HETLIOZ
 Hetlioz

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_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: 09/2016
H0811_GN134_Web Prior Auth_Approved
45

HRM - BENZODIAZEPINES
 lorazepam oral tablet
 oxazepam
 temazepam

Products Affected

 alprazolam
 Lorazepam Intensol

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: 09/2016
H0811_GN134_Web Prior Auth_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: 09/2016
H0811_GN134_Web Prior Auth_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: 09/2016
H0811_GN134_Web Prior Auth_Approved
48

HYDROXYPROGESTERONE
 hydroxyprogesterone caproate

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
49

IBRANCE
 Ibrance

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
50

ICLUSIG
 Iclusig

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
51

ILARIS
 Ilaris (PF)

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
52

IMBRUVICA
 Imbruvica

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
53

INLYTA
 Inlyta

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
54

IRESSA
 Iressa

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
55

IVIG
 Gamunex-C injection solution 1 gram/10 mL
(10 %)

Products Affected

 Gammagard Liquid

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
56

JAKAFI
 Jakafi oral tablet 10 mg, 15 mg, 20 mg, 25 mg, 5
mg

Products Affected

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
57

JUXTAPID
 Juxtapid

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
58

KALYDECO
 Kalydeco

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
59

KEVEYIS
 Keveyis

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
60

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
61

KORLYM
 Korlym

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
62

KUVAN
 Kuvan oral tablet,soluble

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
63

LENVIMA
 Lenvima

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
64

LETAIRIS
 Letairis

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
65

LEUKINE
 Leukine injection recon soln

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
66

LEUPROLIDE
 Lupron Depot (4 Month)
 Lupron Depot (6 Month)
 Lupron Depot-Ped intramuscular kit 11.25 mg,
15 mg

Products Affected

 Eligard
 Lupron Depot
 Lupron Depot (3 Month)

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
67

LIDOCAINE PATCH
 lidocaine topical adhesive patch,medicated

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
68

LONSURF
 Lonsurf

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
69

LYNPARZA
 Lynparza

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
70

MEKINIST
 Mekinist

Products Affected
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: 09/2016
H0811_GN134_Web Prior Auth_Approved
71

NAMENDA
 Namenda Titration Pak
 Namenda XR

Products Affected
 memantine
 Namenda

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: 09/2016
H0811_GN134_Web Prior Auth_Approved
72

NATPARA
 Natpara

Products Affected
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.

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NEUPOGEN
 Neupogen

Products Affected
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: 09/2016
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NEUPRO
 Neupro

Products Affected
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: 09/2016
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NEXAVAR
 Nexavar

Products Affected
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: 09/2016
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NINLARO
 Ninlaro

Products Affected
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.

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NORTHERA
 Northera

Products Affected
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

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NUPLAZID
 Nuplazid

Products Affected
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: 09/2016
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NUVIGIL/PROVIGIL
 modafinil

Products Affected
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.

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OCTREOTIDE
 octreotide acetate injection solution 100
mcg/mL, 200 mcg/mL, 50 mcg/mL

Products Affected

 octreotide acetate injection solution 1,000
mcg/mL, 500 mcg/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: 09/2016
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ODOMZO
 Odomzo

Products Affected
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.

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OFEV
 Ofev

Products Affected
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.

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ONCASPAR
 Oncaspar

Products Affected
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: 09/2016
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ONFI
 Onfi oral tablet 10 mg, 20 mg

Products Affected

 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: 09/2016
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OPDIVO
 Opdivo intravenous solution 40 mg/4 mL

Products Affected
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: 09/2016
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OPSUMIT
 Opsumit

Products Affected
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.

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PEGINTRON
 PegIntron Redipen

Products Affected
 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.

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PENICILLAMINE
 Depen Titratabs

Products Affected
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: 09/2016
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PHENOXYBENZAMINE
 phenoxybenzamine

Products Affected
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: 09/2016
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POMALYST
 Pomalyst

Products Affected
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.

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POTIGA
 Potiga

Products Affected
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: 09/2016
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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

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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: 09/2016
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PROCRIT
 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

Products Affected

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.

Coverage
Duration

Anemia w/myelosuppress = 4 mos.Transfus=1 mo.Other= 6mo. HIV +
zidovudine = 4 mo

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PA Criteria

Criteria Details

Other Criteria

Part B versus Part D determination will be made at time of prior
authorization review per CMS guidance to establish if the drug prescribed
is to be used for an end-stage renal disease (ESRD)-related condition.

Updated: 09/2016
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PROMACTA
 Promacta oral tablet 12.5 mg, 25 mg, 50 mg

Products Affected
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 .

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QUININE
 quinine sulfate

Products Affected
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: 09/2016
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RAVICTI
 Ravicti

Products Affected
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: 09/2016
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REBIF
 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

Products Affected

 Rebif (with albumin)

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: 09/2016
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REMICADE
 Remicade

Products Affected
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

Coverage
Duration

Initial: 3 months for Crohn's disease and UC, plan year for all others.
Renewal: plan year

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PA Criteria

Criteria Details

Other Criteria

For continuation of therapy, patient's condition must have improved or
stabilized.

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REPATHA
 Repatha Syringe

Products Affected

 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: 09/2016
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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: 09/2016
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REVATIO
 sildenafil oral

Products Affected
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

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REVLIMID
 Revlimid

Products Affected
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.

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RIBAVIRIN
 ribavirin oral tablet 200 mg

Products Affected

 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

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RITUXAN
 Rituxan

Products Affected
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.

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SABRIL
 Sabril

Products Affected
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

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SAMSCA
 Samsca oral tablet 15 mg, 30 mg

Products Affected
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

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SANDOSTATIN LAR
 Sandostatin LAR Depot intramuscular
suspension,extended rel recon

Products Affected

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

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SIGNIFOR
 Signifor

Products Affected
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.

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SOVALDI
 Sovaldi

Products Affected
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

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SPRYCEL
 Sprycel oral tablet 100 mg, 140 mg, 20 mg, 50
mg, 70 mg, 80 mg

Products Affected

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

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STIVARGA
 Stivarga

Products Affected
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).

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SUTENT
 Sutent

Products Affected
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.

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SYLATRON
 Sylatron

Products Affected
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

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SYNAGIS
 Synagis intramuscular solution 50 mg/0.5 mL

Products Affected
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

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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.

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TAFINLAR
 Tafinlar

Products Affected
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

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TAGRISSO
 Tagrisso

Products Affected
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.

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TARCEVA
 Tarceva oral tablet 100 mg, 150 mg, 25 mg

Products Affected
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

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TARGRETIN
 Targretin oral

Products Affected
 bexarotene

PA Criteria

Criteria Details

Covered Uses

All medically accepted indications not otherwise excluded from Part D

Exclusion
Criteria

Pregnancy

Required
Medical
Information

For capsules, patient meets one of the following: 1) cutaneous T cell
lymphoma (includes mycosis fungoides [MF] and Sezary syndrome [SS])
refractory to prior systemic therapy, 2) advanced-stage MF/Sezary
syndrome, 3) early-stage MF refractory/progressive to skin-directed
therapy, or 4) early-stage MF with blood involvement or
folliculotropic/large cell transformation.

Age Restrictions

N/A

Prescriber
Restrictions

N/A

Coverage
Duration

Plan Year

Other Criteria

Patient has been instructed on the importance of and proper utilization of
contraception.

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TASIGNA
 Tasigna

Products Affected
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.

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TECENTRIQ
 Tecentriq

Products Affected
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

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THALOMID
 Thalomid

Products Affected
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.

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THIORIDAZINE
 thioridazine

Products Affected
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

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THIOTEPA
 thiotepa

Products Affected
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

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TIRF MEDICATIONS
 fentanyl citrate buccal lozenge on a handle
1,200 mcg, 1,600 mcg, 200 mcg, 400 mcg, 600
mcg, 800 mcg

Products Affected

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).

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TRETINOIN
 tretinoin microspheres topical gel with pump
 tretinoin topical

Products Affected

 adapalene topical cream
 adapalene topical gel

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

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TYKERB
 Tykerb

Products Affected
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

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TYSABRI
 Tysabri

Products Affected
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

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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.

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VENCLEXTA
 Venclexta Starting Pack

Products Affected
 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.

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VIEKIRA
 Viekira Pak

Products Affected
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.

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VIMPAT
 Vimpat oral solution
 Vimpat oral tablet

Products Affected

 Vimpat intravenous

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: 09/2016
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VOTRIENT
 Votrient

Products Affected
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

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XALKORI
 Xalkori

Products Affected
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: 09/2016
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XENAZINE
 Xenazine

Products Affected
 tetrabenazine

PA Criteria

Criteria Details

Covered Uses

All FDA-approved indications not otherwise excluded from Part D.
Tardive dyskinesia (TD). Tourette syndrome and related tic disorders.
Hyperkinetic dystonia. Hemiballism.

Exclusion
Criteria

N/A

Required
Medical
Information

N/A

Age Restrictions

N/A

Prescriber
Restrictions

For treatment of chorea associated with Huntington's disease, Tourette
syndrome or related tic disorders, hyperkinetic dystonia, or hemiballism,
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: 09/2016
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XOLAIR
 Xolair

Products Affected
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.

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XTANDI
 Xtandi

Products Affected
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: 09/2016
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YERVOY
 Yervoy intravenous solution 50 mg/10 mL (5
mg/mL)

Products Affected

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: 09/2016
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ZELBORAF
 Zelboraf

Products Affected
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.

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ZYDELIG
 Zydelig

Products Affected
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: 09/2016
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ZYKADIA
 Zykadia

Products Affected
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: 09/2016
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ZYVOX
Products Affected

 linezolid intravenous
 linezolid oral suspension for reconstitution
 linezolid oral tablet

 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: 09/2016
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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

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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
cefuroxime sodium intravenous

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CellCept Intravenous
CellCept oral suspension for reconstitution
Cerezyme intravenous recon soln 400 unit
chloramphenicol sod succinate
cidofovir
Cimzia Powder for Reconst
ciprofloxacin lactate intravenous solution 400
mg/40 mL
cisplatin
cladribine
clindamycin phosphate intravenous solution 600
mg/4 mL
Clinimix 5%/D15W Sulfite Free
Clinimix 5%/D25W sulfite-free
Clinimix 2.75%/D5W Sulfit Free
Clinimix 4.25%/D10W Sulf Free
Clinimix 4.25%/D5W Sulfit Free
Clinimix 4.25%-D20W sulf-free
Clinimix 4.25%-D25W sulf-free
Clinimix 5%-D20W(sulfite-free)
Clinimix E 2.75%/D10W Sul Free
Clinimix E 2.75%/D5W Sulf Free
Clinimix E 4.25%/D10W Sul Free
Clinimix E 4.25%/D25W Sul Free
Clinimix E 4.25%/D5W Sulf Free
Clinimix E 5%/D15W Sulfit Free
Clinimix E 5%/D20W Sulfit Free
Clinimix E 5%/D25W Sulfit Free
colistin (colistimethate Na)
cromolyn inhalation
Cubicin
cyclophosphamide oral capsule
cyclosporine intravenous
cyclosporine modified
cyclosporine oral capsule
cytarabine
D2.5 %-0.45 % sodium chloride
D5 % and 0.9 % sodium chloride
D5 %-0.45 % sodium chloride
dacarbazine intravenous recon soln 200 mg
daunorubicin intravenous solution
decitabine
Delestrogen intramuscular oil 10 mg/mL

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 Depo-Provera intramuscular solution
 dexamethasone sodium phosphate injection
solution
 dexrazoxane HCl intravenous recon soln 250 mg
 dextrose 10 % and 0.2 % NaCl
 dextrose 10 % in water (D10W)
 dextrose 5 % in water (D5W) intravenous
parenteral solution
 dextrose 5 %-lactated ringers
 dextrose 5%-0.2 % sod chloride
 dextrose 5%-0.3 % sod.chloride
 Dextrose With Sodium Chloride
 Dextrose-KCl-NaCl
 diltiazem HCl intravenous
 diphenhydramine HCl injection solution 50
mg/mL
 doxorubicin intravenous solution 50 mg/25 mL
 doxorubicin, peg-liposomal
 Doxy-100
 doxycycline hyclate intravenous
 dronabinol oral capsule 10 mg
 dronabinol oral capsule 2.5 mg, 5 mg
 Duramorph (PF) injection solution 0.5 mg/mL, 1
mg/mL
 Elaprase
 Elelyso
 Elitek
 Emend oral capsule
 Emend oral capsule,dose pack
 Engerix-B (PF) intramuscular syringe
 Engerix-B Pediatric (PF)
 Envarsus XR
 epirubicin intravenous solution 50 mg/25 mL
 Erythrocin intravenous recon soln 500 mg
 esomeprazole sodium
 estradiol valerate intramuscular oil 20 mg/mL,
40 mg/mL
 etoposide intravenous
 Fabrazyme intravenous recon soln 35 mg
 famotidine (PF)
 famotidine (PF)-NaCl (iso-os)
 Faslodex
 fluconazole in dextrose(iso-o) intravenous
piggyback 400 mg/200 mL

 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 oral capsule 100 mg, 25 mg
 Gengraf oral solution
 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
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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
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) intravenous
piggyback 1 gram/50 mL
 oxacillin in dextrose(iso-osm) intravenous
piggyback 2 gram/50 mL
 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
Updated: 09/2016
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150

 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
 Somavert

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streptomycin intramuscular
sulfamethoxazole-trimethoprim intravenous
Synercid
Synribo
tacrolimus oral capsule 0.5 mg, 1 mg
tacrolimus oral capsule 5 mg
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.

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Index
APOKYN .................................................... 9
Aptiom ...................................................... 10
Aralast NP ............................................... 147
Arcalyst ..................................................... 11
Astagraf XL ............................................ 147
Avastin .................................................... 147
Avelox in NaCl (iso-osmotic) ................. 147
Avonex (with albumin) ............................. 12
Avonex intramuscular pen injector kit ...... 12
Avonex intramuscular syringe kit ............. 12
Azasan ..................................................... 147
azathioprine ............................................. 147
azathioprine sodium ................................ 147
azithromycin ........................................... 147
B
BACiiM................................................... 147
bacitracin ................................................. 147
Banzel oral tablet ...................................... 13
BCG vaccine, live (PF) ........................... 147
Beleodaq ................................................. 147
Benlysta................................................... 147
benztropine.............................................. 147
benztropine oral ........................................ 45
bexarotene ............................................... 123
Bicillin C-R ............................................. 147
BiCNU .................................................... 147
bleomycin ................................................ 147
Bosulif ....................................................... 14
Briviact ...................................................... 15
budesonide .............................................. 147
buprenorphine HCl.................................. 147
Busulfex .................................................. 147
butalbital-acetaminop-caf-cod .................. 45
C
Cabometyx ................................................ 16
calcitriol .................................................. 147
Cancidas .................................................. 147
Capastat ................................................... 147
Carbaglu .................................................... 17
carboplatin............................................... 147
cefazolin .................................................. 147
cefazolin in dextrose (iso-os) .................. 147
cefepime .................................................. 147
cefotaxime ............................................... 147

A
Abelcet .................................................... 147
Abilify Maintena ..................................... 147
Abraxane ................................................. 147
acetylcysteine .......................................... 147
Actemra ................................................... 147
Acthar H.P................................................... 1
Actimmune.................................................. 2
acyclovir sodium ..................................... 147
Adagen .................................................... 147
adapalene topical cream .......................... 130
adapalene topical gel ............................... 130
Adcirca ........................................................ 3
Adempas ..................................................... 4
Adrucil .................................................... 147
Afinitor........................................................ 5
Afinitor Disperz .......................................... 5
A-Hydrocort ............................................ 147
albuterol sulfate ....................................... 147
Aldurazyme ............................................. 147
Alecensa ...................................................... 6
Alimta ..................................................... 147
alprazolam ................................................. 46
AmBisome .............................................. 147
amifostine crystalline .............................. 147
amikacin .................................................. 147
amino acids 15 % .................................... 147
Aminosyn 8.5 %-electrolytes .................. 147
Aminosyn II 10 % ................................... 147
Aminosyn II 15 % ................................... 147
Aminosyn II 7 % ..................................... 147
Aminosyn II 8.5 % .................................. 147
Aminosyn II 8.5 %-electrolytes .............. 147
Aminosyn M 3.5 % ................................. 147
Aminosyn-HBC 7% ................................ 147
Aminosyn-PF 10 % ................................. 147
Aminosyn-PF 7 % (sulfite-free).............. 147
Aminosyn-RF 5.2 % ............................... 147
amiodarone .............................................. 147
amitriptyline .............................................. 48
amphotericin B ........................................ 147
ampicillin sodium.................................... 147
ampicillin-sulbactam ............................... 147
Ampyra ....................................................... 7
Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
152

cefoxitin .................................................. 147
cefoxitin in dextrose, iso-osm ................. 147
ceftazidime .............................................. 147
ceftriaxone............................................... 147
cefuroxime sodium.................................. 147
CellCept .................................................. 148
CellCept Intravenous .............................. 147
Cerezyme ................................................ 148
chloramphenicol sod succinate ............... 148
Cholbam .................................................... 18
chorionic gonadotropin, human ................ 19
Cialis oral tablet 2.5 mg, 5 mg .................. 20
cidofovir .................................................. 148
Cimzia Powder for Reconst .................... 148
Cinryze ...................................................... 21
ciprofloxacin lactate ................................ 148
cisplatin ................................................... 148
cladribine................................................. 148
clemastine oral tablet 2.68 mg .................. 45
clindamycin phosphate............................ 148
Clinimix 5%/D15W Sulfite Free ........... 148
Clinimix 5%/D25W sulfite-free ............. 148
Clinimix 2.75%/D5W Sulfit Free ........... 148
Clinimix 4.25%/D10W Sulf Free ........... 148
Clinimix 4.25%/D5W Sulfit Free ........... 148
Clinimix 4.25%-D20W sulf-free ............ 148
Clinimix 4.25%-D25W sulf-free ............ 148
Clinimix 5%-D20W(sulfite-free) ............ 148
Clinimix E 2.75%/D10W Sul Free ......... 148
Clinimix E 2.75%/D5W Sulf Free .......... 148
Clinimix E 4.25%/D10W Sul Free ......... 148
Clinimix E 4.25%/D25W Sul Free ......... 148
Clinimix E 4.25%/D5W Sulf Free .......... 148
Clinimix E 5%/D15W Sulfit Free ........... 148
Clinimix E 5%/D20W Sulfit Free ........... 148
Clinimix E 5%/D25W Sulfit Free ........... 148
clomipramine ............................................ 48
clonazepam ............................................... 47
clorazepate dipotassium ............................ 47
colistin (colistimethate Na) ..................... 148
Cometriq ................................................... 22
Copaxone subcutaneous syringe 20 mg/mL,
40 mg/mL .............................................. 23
Cotellic ...................................................... 24
cromolyn ................................................. 148
Cubicin .................................................... 148

cyclobenzaprine oral tablet ....................... 45
cyclophosphamide................................... 148
cyclosporine ............................................ 148
cyclosporine modified ............................. 148
cyproheptadine .......................................... 45
Cyramza .................................................... 25
cytarabine ................................................ 148
D
D2.5 %-0.45 % sodium chloride ............. 148
D5 % and 0.9 % sodium chloride ........... 148
D5 %-0.45 % sodium chloride ................ 148
dacarbazine ............................................. 148
Darzalex .................................................... 26
daunorubicin ........................................... 148
decitabine ................................................ 148
Delestrogen ............................................. 148
Demser ...................................................... 27
Depen Titratabs ......................................... 89
Depo-Provera .......................................... 148
dexamethasone sodium phosphate .......... 148
dexrazoxane HCl ..................................... 148
dextrose 10 % and 0.2 % NaCl ............... 148
dextrose 10 % in water (D10W) ............. 148
dextrose 5 % in water (D5W) ................. 148
dextrose 5 %-lactated ringers .................. 148
dextrose 5%-0.2 % sod chloride ............. 148
dextrose 5%-0.3 % sod.chloride ............. 148
Dextrose With Sodium Chloride ............. 148
Dextrose-KCl-NaCl ................................ 148
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
digoxin oral tablet ..................................... 45
diltiazem HCl .......................................... 148
diphenhydramine HCl ............................. 148
doxepin oral .............................................. 48

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
153

doxorubicin ............................................. 148
doxorubicin, peg-liposomal .................... 148
Doxy-100 ................................................ 148
doxycycline hyclate ................................ 148
dronabinol ............................................... 148
Duramorph (PF) ...................................... 148
E
Egrifta subcutaneous recon soln 1 mg ...... 29
Elaprase ................................................... 148
Elelyso..................................................... 148
Eligard ....................................................... 67
Elitek ....................................................... 148
Emend ..................................................... 148
Empliciti.................................................... 30
Engerix-B (PF) ........................................ 148
Engerix-B Pediatric (PF)......................... 148
Envarsus XR ........................................... 148
epirubicin ................................................ 148
ergoloid ..................................................... 45
Erivedge .................................................... 31
Erwinaze ................................................... 32
Erythrocin ............................................... 148
Esbriet ....................................................... 33
esomeprazole sodium .............................. 148
estradiol oral.............................................. 48
estradiol valerate ..................................... 148
etoposide ................................................. 148
Extavia subcutaneous kit........................... 34
F
Fabrazyme ............................................... 148
famotidine (PF) ....................................... 148
famotidine (PF)-NaCl (iso-os) ............... 148
Farydak ..................................................... 35
Faslodex .................................................. 148
fentanyl citrate buccal lozenge on a handle
1,200 mcg, 1,600 mcg, 200 mcg, 400
mcg, 600 mcg, 800 mcg ...................... 129
Ferriprox oral tablet .................................. 36
Firazyr ....................................................... 37
fluconazole in dextrose(iso-o)................. 148
fluconazole in NaCl (iso-osm) ................ 149
fludarabine .............................................. 149
fluorouracil .............................................. 149
fluphenazine decanoate ........................... 149
fluphenazine HCl .................................... 149
fomepizole............................................... 149

fosphenytoin ............................................ 149
furosemide............................................... 149
Fycompa oral suspension .......................... 38
Fycompa oral tablet................................... 38
G
Gammagard Liquid ................................... 56
Gamunex-C injection solution 1 gram/10
mL (10 %) ............................................. 56
ganciclovir sodium .................................. 149
Gattex One-Vial ........................................ 39
gemcitabine ............................................. 149
Gengraf ................................................... 149
gentamicin ............................................... 149
gentamicin in NaCl (iso-osm) ................. 149
Geodon .................................................... 149
Gilotrif....................................................... 40
Glatopa ...................................................... 23
Gleevec oral tablet 100 mg, 400 mg ......... 41
granisetron (PF) ...................................... 149
granisetron HCl ....................................... 149
H
haloperidol decanoate ............................. 149
haloperidol lactate ................................... 149
Harvoni ..................................................... 43
heparin (porcine) ..................................... 149
heparin (porcine) in 5 % dex ................... 149
Hepatamine 8% ....................................... 149
Herceptin ................................................. 149
Hetlioz ....................................................... 44
hydralazine .............................................. 149
hydromorphone (PF) ............................... 149
hydroxyprogesterone caproate .................. 49
hydroxyzine HCl ..................................... 149
I
Ibrance....................................................... 50
Iclusig ........................................................ 51
idarubicin ................................................ 149
ifosfamide ............................................... 149
Ilaris (PF) .................................................. 52
Imbruvica .................................................. 53
imipenem-cilastatin ................................. 149
imipramine HCl ........................................ 48
imipramine pamoate.................................. 48
Increlex ................................................... 149
Inlyta ......................................................... 54
Intralipid .................................................. 149

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
154

Intron A ................................................... 149
Invanz ...................................................... 149
Invega Sustenna ...................................... 149
Invega Trinza .......................................... 149
Ionosol-B in D5W ................................... 149
Ionosol-MB in D5W ............................... 149
ipratropium bromide ............................... 149
ipratropium-albuterol .............................. 149
Iressa ......................................................... 55
irinotecan................................................. 149
Istodax ..................................................... 149
J
Jakafi oral tablet 10 mg, 15 mg, 20 mg, 25
mg, 5 mg ............................................... 57
Juxtapid ..................................................... 58
K
Kadcyla ................................................... 149
Kalydeco ................................................... 59
Keveyis ..................................................... 60
Keytruda .................................................. 149
Korlym ...................................................... 62
Kuvan oral tablet,soluble .......................... 63
L
labetalol ................................................... 149
Lanoxin oral .............................................. 45
Lenvima .................................................... 64
Letairis ...................................................... 65
leucovorin calcium .................................. 149
Leukine injection recon soln ..................... 66
levalbuterol HCl ...................................... 149
levetiracetam ........................................... 149
levetiracetam in NaCl (iso-os) ................ 149
levocarnitine ............................................ 149
levocarnitine (with sugar) ....................... 149
levofloxacin............................................. 149
levoleucovorin calcium ........................... 149
lidocaine (PF) .......................................... 149
lidocaine HCl .......................................... 149
lidocaine topical adhesive patch,medicated
............................................................... 68
linezolid intravenous ............................... 146
linezolid oral suspension for reconstitution
............................................................. 146
linezolid oral tablet ................................. 146
Lonsurf ...................................................... 69
Lorazepam Intensol ................................... 46

lorazepam oral tablet ................................. 46
Lupron Depot ............................................ 67
Lupron Depot (3 Month) ........................... 67
Lupron Depot (4 Month) ........................... 67
Lupron Depot (6 Month) ........................... 67
Lupron Depot-Ped intramuscular kit 11.25
mg, 15 mg ............................................. 67
Lynparza ................................................... 70
M
magnesium sulfate .................................. 149
megestrol oral tablet .................................. 48
Mekinist .................................................... 71
melphalan HCl ........................................ 149
memantine ................................................. 72
meprobamate ............................................. 45
meropenem .............................................. 149
mesna ...................................................... 149
metaxalone ................................................ 45
methadone ............................................... 149
methotrexate sodium ............................... 149
methotrexate sodium (PF) ....................... 149
methyldopa-hydrochlorothiazide .............. 45
methylprednisolone acetate ..................... 149
methylprednisolone sodium succ ............ 149
metoclopramide HCl ............................... 149
metoprolol tartrate ................................... 149
Miacalcin................................................. 149
mitomycin ............................................... 149
mitoxantrone ........................................... 149
modafinil ................................................... 80
morphine ................................................. 150
Mozobil ................................................... 150
Mustargen ............................................... 150
mycophenolate mofetil............................ 150
mycophenolate sodium ........................... 150
N
nafcillin ................................................... 150
nafcillin in dextrose iso-osm ................... 150
Naglazyme .............................................. 150
nalbuphine ............................................... 150
Namenda ................................................... 72
Namenda Titration Pak ............................. 72
Namenda XR ............................................. 72
Natpara ...................................................... 73
Nebupent ................................................. 150
Neoral ...................................................... 150

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
155

Nephramine 5.4 % .................................. 150
Neupogen .................................................. 74
Neupro....................................................... 75
Nexavar ..................................................... 76
Ninlaro ...................................................... 77
nitroglycerin ............................................ 150
Norditropin FlexPro .................................. 42
Normosol-M in 5 % dextrose.................. 150
Normosol-R in 5 % dextrose................... 150
Normosol-R pH 7.4................................. 150
Northera .................................................... 78
Novarel ...................................................... 19
Nulojix .................................................... 150
Nuplazid .................................................... 79
O
octreotide acetate injection solution 1,000
mcg/mL, 500 mcg/mL .......................... 81
octreotide acetate injection solution 100
mcg/mL, 200 mcg/mL, 50 mcg/mL ...... 81
Odomzo ..................................................... 82
Ofev........................................................... 83
Oncaspar ................................................... 84
ondansetron ............................................. 150
ondansetron HCl ..................................... 150
ondansetron HCl (PF) ............................. 150
Onfi oral suspension ................................. 85
Onfi oral tablet 10 mg, 20 mg ................... 85
Opdivo intravenous solution 40 mg/4 mL 86
Opsumit ..................................................... 87
Orencia (with maltose) ............................ 150
oxacillin................................................... 150
oxacillin in dextrose(iso-osm)................. 150
oxaliplatin ............................................... 150
oxazepam .................................................. 46
P
paclitaxel ................................................. 150
pamidronate............................................. 150
paricalcitol............................................... 150
PegIntron ................................................... 88
PegIntron Redipen .................................... 88
penicillin G potassium ............................ 150
penicillin G procaine ............................... 150
penicillin G sodium ................................. 150
Pentam..................................................... 150
Perforomist .............................................. 150
Perjeta ..................................................... 150

perphenazine-amitriptyline ....................... 48
phenobarbital............................................. 48
phenoxybenzamine ................................... 90
phenytoin sodium .................................... 150
piperacillin-tazobactam ........................... 150
Plasma-Lyte 148 ..................................... 150
Plasma-Lyte A ........................................ 150
Plasma-Lyte-56 in 5 % dextrose ............. 150
Pomalyst .................................................... 91
potassium chlorid-D5-0.45%NaCl .......... 150
potassium chloride in 0.9%NaCl ............ 150
potassium chloride in 5 % dex ................ 150
potassium chloride in LR-D5 .................. 150
potassium chloride-D5-0.2%NaCl .......... 150
potassium chloride-D5-0.3%NaCl .......... 150
potassium chloride-D5-0.9%NaCl .......... 150
Potiga ........................................................ 92
Praluent Pen subcutaneous pen injector 150
mg/mL, 75 mg/mL ................................ 93
Praluent Syringe subcutaneous syringe 150
mg/mL, 75 mg/mL ................................ 93
Pregnyl ...................................................... 19
Premarin .................................................. 150
Premasol 10 % ........................................ 150
Premasol 6 % .......................................... 150
Procalamine 3% ...................................... 150
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
............................................................... 95
Proleukin ................................................. 150
Prolia ....................................................... 150
Promacta oral tablet 12.5 mg, 25 mg, 50 mg
............................................................... 97
promethazine oral tablet ............................ 45
propranolol .............................................. 150
Prosol 20 % ............................................. 150
Pulmozyme ............................................. 150
Q
quinine sulfate ........................................... 98
R
ranitidine HCl.......................................... 150
Rapamune ............................................... 150
Ravicti ....................................................... 99
Rebif (with albumin) ............................... 100

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
156

Rebif Rebidose subcutaneous pen injector
22 mcg/0.5 mL, 44 mcg/0.5 mL,
8.8mcg/0.2mL-22 mcg/0.5mL (6) ...... 100
Rebif Titration Pack ................................ 100
Recombivax HB (PF) .............................. 150
Remicade................................................. 101
Remodulin ............................................... 150
Repatha SureClick .................................. 103
Repatha Syringe ...................................... 103
reserpine .................................................... 45
Revlimid.................................................. 106
Rheumatrex ............................................. 150
ribavirin oral capsule............................... 107
ribavirin oral tablet 200 mg..................... 107
rifampin ................................................... 150
ringers ..................................................... 150
Risperdal Consta ..................................... 150
Rituxan .................................................... 108
S
Sabril ....................................................... 109
Samsca oral tablet 15 mg, 30 mg ............ 110
Sancuso ................................................... 150
Sandimmune ........................................... 150
Sandostatin LAR Depot intramuscular
suspension,extended rel recon ............ 111
Signifor ................................................... 112
sildenafil oral .......................................... 105
Simulect .................................................. 150
sirolimus.................................................. 150
Solu-Cortef (PF)...................................... 150
Somatuline Depot.................................... 150
Somavert ................................................. 150
Sovaldi .................................................... 113
Sprycel oral tablet 100 mg, 140 mg, 20 mg,
50 mg, 70 mg, 80 mg .......................... 114
Stivarga ................................................... 115
streptomycin ............................................ 151
sulfamethoxazole-trimethoprim .............. 151
Surmontil................................................... 48
Sutent ...................................................... 116
Sylatron ................................................... 117
Synagis intramuscular solution 50 mg/0.5
mL ....................................................... 118
Synercid .................................................. 151
Synribo .................................................... 151

T
tacrolimus ................................................ 151
Tafinlar .................................................... 120
Tagrisso ................................................... 121
Tarceva oral tablet 100 mg, 150 mg, 25 mg
............................................................. 122
Targretin oral .......................................... 123
Tasigna .................................................... 124
Tecentriq ................................................. 125
Teflaro ..................................................... 151
temazepam ................................................ 46
terbutaline ............................................... 151
testosterone cypionate ............................. 151
testosterone enanthate ............................. 151
tetanus-diphtheria toxoids-Td ................. 151
tetrabenazine ........................................... 139
Thalomid ................................................. 126
thioridazine ............................................. 127
thiotepa.................................................... 128
tobramycin in 0.225 % NaCl .................. 151
tobramycin sulfate ................................... 151
topiramate oral capsule, sprinkle ................ 8
topiramate oral capsule,sprinkle,ER 24hr ... 8
topiramate oral tablet .................................. 8
Toposar ................................................... 151
topotecan ................................................. 151
tranexamic acid ....................................... 151
Travasol 10 % ......................................... 151
Treanda ................................................... 151
Trelstar .................................................... 151
tretinoin microspheres topical gel with pump
............................................................. 130
tretinoin topical ....................................... 130
trihexyphenidyl ......................................... 45
trimipramine.............................................. 48
Trisenox .................................................. 151
TrophAmine 10 %................................... 151
Trophamine 6% ....................................... 151
Twinrix (PF)............................................ 151
Tykerb ..................................................... 131
Tysabri .................................................... 132
V
valproate sodium ..................................... 151
vancomycin ............................................. 151
Velcade ................................................... 151
Venclexta ................................................ 134

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
157

Venclexta Starting Pack .......................... 134
verapamil................................................. 151
Viekira Pak.............................................. 135
Vimpat intravenous ................................. 136
Vimpat oral solution ............................... 136
Vimpat oral tablet ................................... 136
vinblastine ............................................... 151
Vincasar PFS ........................................... 151
vincristine................................................ 151
vinorelbine .............................................. 151
Virazole ................................................... 151
voriconazole ............................................ 151
Votrient ................................................... 137
VPRIV..................................................... 151
X
Xalkori .................................................... 138
Xenazine ................................................. 139
Xgeva ...................................................... 151
Xolair ...................................................... 140

Xtandi ...................................................... 141
Y
Yervoy intravenous solution 50 mg/10 mL
(5 mg/mL) ........................................... 142
Z
Zaltrap ..................................................... 151
Zelboraf ................................................... 143
Zemplar ................................................... 151
zoledronic acid ........................................ 151
zoledronic acid-mannitol-water .............. 151
Zometa .................................................... 151
zonisamide .................................................. 8
Zortress ................................................... 151
Zydelig .................................................... 144
Zykadia ................................................... 145
Zyprexa Relprevv.................................... 151
Zyvox intravenous parenteral solution 600
mg/300 mL .......................................... 146
Zyvox oral ............................................... 146

Updated: 09/2016
H0811_GN134_Web Prior Auth_Approved
158

GuildNet Gold Plus FIDA Plan is a managed care plan that contracts with both Medicare and
New York State Department of Health (Medicaid) to provide benefits of both programs to
Participants through the Fully Integrated Duals Advantage (FIDA) Demonstration.
Beneficiaries must use network pharmacies to access their premium and/or
copayment/coinsurance may change on January 1, 2017.
This document includes GuildNet Gold Plus FIDA Plan’s partial formulary as of September 1,
2016 For a complete, updated formulary, please visit our website at www.guildnetny.org or call
1-800-815-0000 (TTY 1-800-662-1220).
For alternative formats or language, please call Participant Services toll free at: 1-800-815-0000,
Monday through Sunday from 8am to 8pm. TTY/TDD users should call 1-800-662-1220.
You can get this information for free in other languages. Call 1-800-815-0000 and TTY/TDD 1800-662-1220 during 8am to 8pm. The call is free.
Usted puede obtener esta información en otros idiomas gratis. Llame al 1-800-815-0000 o
TTY/TDD al 1-800-662-1220, de lunes a domingo de 8am a 8pm. La llamada es gratis.
Queste informazioni sono disponibili gratuitamente in altre lingue. Chiamare il numero verde 1800-815-0000 o 1-800-662-1220 mediante un telefono testuale per non udenti (TTY/TDD), da
lunedì a domenica, dalle 8 alle 20. La chiamata è gratuita.
您可以免費獲得本信息的其他語言版本。請撥打 1-800-815-0000 或聽障/語障人士專線
(TTY/TDD) 1-800-662-1220,星期一至星期日上午 8 時至晚上 8 時。撥打該電話免費。
Ou kapab jwenn enfòmasyon sa yo gratis nan lòt lang. Rele nimewo 1-800-815-0000 oswa
TTY/TDD 1-800-662-1220, lendi jiska dimanch, depi 8am jiska 8pm. Koutfil la gratis.
다른 언어로 작성된 이 정보를 무료로 얻으실 수 있습니다. 월요일 - 일요일 오전 8시부터
오후 8시 사이에 1-800-815-0000번이나 TTY/TDD 1-800-662-1220번으로 전화주세요.
통화는 무료입니다.
Вы можете бесплатно получить эту информацию на других языках. Позвоните по
телефону 1-800-815-0000 и TTY/TDD 1-800-662-1220. Служба работает с понедельника по
воскресенье с 08:00 до 20:00 ч. Звонок бесплатный.
The State of New York has created a participant ombudsman program called the Independent
Consumer Advocacy Network (ICAN) to provide Participants free, confidential assistance on
any services offered by GuildNet Gold Plus FIDA Plan. ICAN may be reached toll-free at 1-844614-8800 or online at icannys.org.

16143 v14
Updated: 09/2016
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Subject                         : Prior Authorization
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