Prior Authorization Criteria

2023 PPREF

Last Updated: 12/1/2023

ABIRATERONE

Products Affected

• Abiraterone Acetate

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of prostate cancer. One of the following: 1) Disease is

metastatic, 2) Disease is regional node positive (e.g., Any T, N1, M0), 3)

Patient is in a very-high-risk group receiving external beam radiation

therapy (EBRT), or 4) Positive pelvic persistence/recurrence after

prostatectomy. Used in combination with prednisone or dexamethasone.

One of the following: 1) Used in combination with a gonadotropin-

releasing hormone (GnRH) analog [e.g. Lupron (leuprolide), Zoladex

(goserelin), Trelstar (triptorelin), Vantas (histrelin), Firmagon (degarelix)]

or 2) Patient received bilateral orchiectomy.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

ABRYSVO

Products Affected

• Abrysvo

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Vaccine is being used for the prevention of lower respiratory tract disease

(LRTD) caused by respiratory syncytial virus (RSV). Patient has not

received an RSV vaccine (i.e., Abrysvo, Arexvy) in the previous 2 years.

One of the following: 1) Age greater than or equal to 60 years, OR 2)

Both of the following: a) Will be used for active immunization of

pregnant individuals at 32 through 36 weeks gestational age, and b) Will

also be used for the prevention of severe LRTD caused by RSV in infants

from birth through 6 months of age.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

6 months (1 injection per 2 years)

Other Criteria

N/A

ACTEMRA SC

Products Affected

• Actemra INJ 162MG/0.9ML

• Actemra Actpen

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Rheumatoid Arthritis (RA) (Initial): Diagnosis of moderately to severely

active RA. One of the following: 1) Trial and failure, contraindication, or

intolerance (TF/C/I) to two of the following: Enbrel (etanercept),

Formulary adalimumab product, Rinvoq (upadacitinib), or

Xeljanz/Xeljanz XR (tofacitinib), OR 2) for continuation of prior therapy

if within the past 120 days. Giant Cell Arteritis (GCA) (Initial): Diagnosis

of GCA. TF/C/I to a glucocorticoid (e.g., prednisone). Systemic Juvenile

Idiopathic Arthritis (SJIA) (Initial): Diagnosis of active SJIA. TF/C/I to

one of the following conventional therapies at maximally tolerated doses:

a) minimum duration of a one month trial of a nonsteroidal anti-

inflammatory drug (NSAID) (eg, ibuprofen, naproxen), b) minimum

duration of a 3-month trial of methotrexate, or c) minimum duration of a

2-week trial of a systemic glucocorticoid (eg, prednisone). Polyarticular

Juvenile Idiopathic Arthritis (PJIA) (Initial): Diagnosis of active PJIA.

One of the following: 1) TF/C/I to two of the following: Enbrel

(etanercept), Formulary adalimumab product, Xeljanz (tofacitinib), OR 2)

for continuation of prior therapy if within the past 120 days. Systemic

sclerosis-associated interstitial lung disease (SSc-ILD) (Initial): Diagnosis

of SSc-ILD as documented by the following: a) Exclusion of other known

causes of ILD AND b) One of the following: i) In patients not subjected

to surgical lung biopsy, the presence of idiopathic interstitial pneumonia

(eg, fibrotic nonspecific interstitial pneumonia [NSIP], usual interstitial

pneumonia [UIP] and centrilobular fibrosis) pattern on high-resolution

computed tomography (HRCT) revealing SSc-ILD or probable SSc-ILD,

OR ii) In patients subjected to a lung biopsy, both HRCT and surgical

lung biopsy pattern revealing SSc-ILD or probable SSc-ILD.

Age Restrictions

N/A

Prescriber

Restrictions

RA, GCA, SJIA, PJIA (Initial): Prescribed by or in consultation with a

rheumatologist. SSc-ILD (Initial): Prescribed by or in consultation with a

pulmonologist or rheumatologist.

Coverage

Duration

All uses (initial): 6 months. All uses (reauth): plan year.

Other Criteria

RA, PJIA (Reauth): Documentation of positive clinical response to

therapy as evidenced by at least one of the following: reduction in the

total active (swollen and tender) joint count from baseline, OR

improvement in symptoms (eg, pain, stiffness, inflammation) from

baseline. SJIA (Reauth): Documentation of positive clinical response to

therapy as evidenced by at least one of the following: reduction in the

total active (swollen and tender) joint count from baseline, OR

improvement in clinical features or symptoms (eg, pain, fever,

inflammation, rash, lymphadenopathy, serositis) from baseline. GCA,

SSc-ILD (Reauth): Documentation of positive clinical response to

therapy.

ADEMPAS

Products Affected

• Adempas

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Pulmonary arterial hypertension (PAH): Diagnosis of PAH AND PAH is

symptomatic AND One of the following: A) Diagnosis of PAH was

confirmed by right heart catheterization or B) Patient is currently on any

therapy for the diagnosis of PAH. Chronic thromboembolic pulmonary

hypertension (CTEPH): One of the following: A) Both of the following:

1) Diagnosis of inoperable or persistent/recurrent CTEPH and 2) CTEPH

is symptomatic OR B) Patient is currently on any therapy for the

diagnosis of CTEPH.

Age Restrictions

N/A

Prescriber

Restrictions

PAH, CTEPH: Prescribed by or in consultation with a pulmonologist or

cardiologist.

Coverage

Duration

PAH, CTEPH: plan year

Other Criteria

N/A

AIMOVIG

Products Affected

• Aimovig

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Episodic Migraines (EM) (initial): Diagnosis of EM with both of the

following: 1) Less than 15 headache days per month and 2) Patient has 4

to 14 migraine days per month. Trial and failure (after a trial of at least

two months), contraindication, or intolerance to two of the following

prophylactic therapies: a) Amitriptyline (Elavil), b) One of the following

beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol, c)

Divalproex sodium (Depakote/Depakote ER), d) Topiramate (Topamax),

e) Venlafaxine (Effexor), f) Candesartan (Atacand). Chronic Migraines

(CM) (initial): Diagnosis of CM with both of the following: 1) Greater

than or equal to 15 headache days per month and 2) Greater than or equal

to 8 migraine days per month. Trial and failure (after a trial of at least two

months), contraindication, or intolerance to two of the following

prophylactic therapies: a) Amitriptyline (Elavil), b) One of the following

beta-blockers: atenolol, metoprolol, nadolol, propranolol, or timolol, c)

Divalproex sodium (Depakote/Depakote ER), d) OnabotulinumtoxinA

(Botox), e) Topiramate (Topamax), f) Venlafaxine (Effexor), g)

Candesartan (Atacand). All Indications (initial): Medication will not be

used in combination with another CGRP inhibitor for the preventive

treatment of migraines.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

EM, CM (initial, reauth): Plan year.

Other Criteria

EM, CM (reauth): Patient has experienced a positive response to therapy,

demonstrated by a reduction in headache frequency and/or intensity.

Medication will not be used in combination with another CGRP inhibitor

for the preventive treatment of migraines.

ALECENSA

Products Affected

• Alecensa

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Non-small cell lung cancer (NSCLC): Diagnosis of metastatic, recurrent,

or advanced NSCLC. Patient has anaplastic lymphoma kinase (ALK)-

positive disease.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

ALOSETRON

Products Affected

• Alosetron Hydrochloride

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

Irritable bowel syndrome (IBS) (Initial): Exclude if patient is of the male

gender.

Required

Medical

Information

IBS (Initial): Diagnosis of chronic severe diarrhea-predominant IBS. IBS

(Reauthorization): Symptoms of IBS continue to persist. Documentation

of positive clinical response to therapy.

Age Restrictions

IBS (Initial): 18 years and older.

Prescriber

Restrictions

N/A

Coverage

Duration

IBS (Initial): 12 weeks. IBS (Reauthorization): 6 months.

Other Criteria

IBS (initial): Trial and failure, contraindication, or intolerance to an anti-

diarrheal agent [eg, loperamide].

ALPHA - 1 PROTEINASE INHIBITORS

Products Affected

• Aralast Np INJ 1000MG

• Prolastin-c INJ 1000MG

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Alpha-1 antitrypsin (AAT) deficiency (initial): Diagnosis of congenital

AAT deficiency. Diagnosis of emphysema. One of the following: Pi*ZZ,

Pi*Z(null) or Pi*(null)(null) protein phenotypes (homozygous) or Other

rare AAT disease genotypes associated with pre-treatment serum AAT

level less than 11 µmol/L [eg, Pi(Malton, Malton), Pi(SZ)]. One of the

following: 1) Circulating pre-treatment serum AAT level less than 11

µmol/L (which corresponds to less than 80 mg/dL if measured by radial

immunodiffusion or less than 57 mg/dL if measured by nephelometry), or

2) Patient has a concomitant diagnosis of necrotizing panniculitis.

Continued conventional treatment for emphysema (eg, bronchodilators).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

AAT deficiency (initial, reauth): plan year

Other Criteria

AAT deficiency (reauth): Documentation of positive clinical response to

therapy. Continued conventional treatment for emphysema (e.g.,

bronchodilators).

ALUNBRIG

Products Affected

• Alunbrig

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Non-small cell lung cancer (NSCLC): Diagnosis of metastatic, recurrent,

or advanced NSCLC and tumor is anaplastic lymphoma kinase (ALK)-

positive.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days

AMBRISENTAN

Products Affected

• Ambrisentan

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Pulmonary arterial hypertension (PAH): Diagnosis of PAH. PAH is

symptomatic. One of the following: A) Diagnosis of PAH was confirmed

by right heart catheterization or B) Patient is currently on any therapy for

the diagnosis of PAH.

Age Restrictions

N/A

Prescriber

Restrictions

PAH: Prescribed by or in consultation with a pulmonologist or

cardiologist.

Coverage

Duration

PAH: plan year

Other Criteria

N/A

APOKYN

Products Affected

• Apomorphine Hydrochloride INJ

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

Not used with any 5-HT3 antagonist (e.g., ondansetron, granisetron,

dolasetron, palonosetron, alosetron).

Required

Medical

Information

Parkinson's disease diagnosis. Unable to control off symptoms with one

conventional oral therapy [eg, Comtan (entacapone), Mirapex

(pramipexole), Requip (ropinirole), Sinemet (carbidopa/levodopa),

Stalevo (carbidopa/levodopa/entacapone), amantadine, Tasmar

(tolcapone)].

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

N/A

APREPITANT

Products Affected

• Aprepitant CAPS

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Acute Chemotherapy-induced Nausea and Vomiting (CINV): Patient is

currently receiving moderately or highly emetogenic chemotherapy.

Patient is concurrently on both corticosteroid [eg, Decadron

(dexamethasone)] and 5-HT3 receptor antagonist [eg, Aloxi

(palonosetron), Anzemet (dolasetron), Kytril (granisetron), Zofran

(ondansetron)]. Delayed Chemotherapy-induced Nausea and Vomiting

Prevention: Patient is currently receiving highly emetogenic

chemotherapy and corticosteroid [eg, Decadron (dexamethasone)], or

patient is receiving an anthracycline [eg, Adriamycin (doxorubicin),

Ellence (epirubicin)] and Cytoxan (cyclophosphamide), or patient is

currently receiving moderately emetogenic chemotherapy and was given

aprepitant (oral or IV) on day 1 of chemotherapy. Postoperative Nausea

and Vomiting (PONV): For the prevention of postoperative nausea and

vomiting when administered prior to the induction of anesthesia.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Acute CINV, Delayed CINV: plan year. PONV: 1 month

Other Criteria

Subject to Part B vs. Part D review.

ARANESP

Products Affected

• Aranesp Albumin Free INJ

100MCG/0.5ML, 100MCG/ML,

10MCG/0.4ML, 150MCG/0.3ML,

200MCG/0.4ML, 200MCG/ML,

25MCG/0.42ML, 25MCG/ML,

300MCG/0.6ML, 40MCG/0.4ML,

40MCG/ML, 500MCG/ML,

60MCG/0.3ML, 60MCG/ML

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Anemia due to Chronic Kidney Disease (CKD) (Initial): Diagnosis of

CKD. Anemia by lab values (Hct less than 30% or Hgb less than 10 g/dL)

within 30 days of request. The rate of hemoglobin decline indicates the

likelihood of requiring a red blood cell (RBC) transfusion, and reducing

the risk of alloimmunization and/or other RBC transfusion-related risks is

a goal. (Reauth): Diagnosis of CKD. Most recent or average (avg) Hct

over 3 mo is 33% or less (Hgb 11 g/dL or less) for patients on dialysis,

without ESRD OR Most recent or average (avg) Hct over 3 mo is 30% or

less (Hgb 10 g/dL or less) for patients not on dialysis OR Most recent or

average (avg) Hct over 3 mo is 36% or less (Hgb 12 g/dL or less) for

pediatric patients. Documentation of a positive clinical response to

therapy from pre-treatment level. Anemia w/ chemo (Initial): Other

causes of anemia ruled out. Anemia w/ labs (Hct less than 30%, Hgb less

than 10 g/dL) within prior 2 weeks of request. Cancer is non-myeloid

malignancy. Patient is receiving chemo. (Reauth): Anemia by labs (Hgb

less than 10 g/dl or Hct less than 30%) collected within the prior 2 weeks

of request. Documentation of a positive clinical response to therapy from

pre-treatment level. Patient is receiving chemo. Anemia in MDS (Init):

Diagnosis of MDS. Serum erythropoietin 500 mU/mL or less, or

transfusion dependent MDS. (Reauth): Most recent or avg Hct over 3

months was 36% or less, OR most recent or avg Hgb over 3 months is 12

g/dl or less. Documentation of a positive clinical response to therapy from

pre-treatment level.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

CKD(Init): 6 mo. CKD(reauth):plan yr. Chemo(init, reauth): 3 mo.

MDS(init): 3 mo,(reauth): plan yr

Other Criteria

ESRD patients: Coverage is excluded under Medicare Part D for patients

with ESRD on dialysis for any indication related or unrelated to treatment

of ESRD since the payment for the drug is included in the ESRD PPS

payment bundle. NON-ESRD PATIENTS for the following indications:

Off-label uses (except Anemia in Myelodysplastic Syndrome (MDS):

Will not be approved if patient has Hgb greater than 10 g/dL or Hct

greater than 30%.CKD (init, reauth), Chemo (init), MDS (init): Verify Fe

eval for adequate Fe stores.

ARCALYST

Products Affected

• Arcalyst

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Cryopyrin-Associated Period Syndromes (CAPS): Diagnosis of CAPS,

Familial Cold Autoinflammatory Syndrome (FCAS) or Muckle-Wells

Syndrome (MWS). Deficiency of Interleukin-1 Receptor Antagonist

(DIRA): Diagnosis of DIRA. Patient weighs at least 10 kg. Patient is

currently in remission (e.g., no fever, skin rash, and bone pain/no

radiological evidence of active bone lesions/C-reactive protein [CRP] less

than 5 mg/L). Recurrent Pericarditis (initial): Diagnosis of recurrent

pericarditis as evidenced by at least 2 episodes that occur a minimum of 4

to 6 weeks apart. Trial and failure, contraindication, or intolerance

(TF/C/I) to at least one of the following: nonsteroidal anti-inflammatory

drugs (e.g., ibuprofen, naproxen), colchicine, or corticosteroids (e.g.,

prednisone).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

CAPS, DIRA: plan year. Recurrent Pericarditis (initial, reauth): plan year.

Other Criteria

Recurrent Pericarditis (reauth): Documentation of positive clinical

response to therapy.

AREXVY

Products Affected

• Arexvy

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Vaccine is being used for the prevention of lower respiratory tract disease

(LRTD) caused by respiratory syncytial virus (RSV). Patient has not

received an RSV vaccine (i.e., Abrysvo, Arexvy) in the previous 2 years.

Age greater than or equal to 60 years.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

6 months (1 injection per 2 years)

Other Criteria

N/A

ARMODAFINIL

Products Affected

• Armodafinil

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Obstructive sleep apnea (OSA) (Initial): Diagnosis (dx) of OSA defined

by one of the following: a) 15 or more obstructive respiratory events per

hour of sleep confirmed by a sleep study (unless prescriber provides

justification confirming that a sleep study is not feasible), or b) both of the

following: 5 or more obstructive respiratory events per hour of sleep

confirmed by a sleep study (unless prescriber provides justification

confirming that a sleep study is not feasible), AND 1 of the following

symptoms: unintentional sleep episodes during wakefulness, daytime

sleepiness, unrefreshing sleep, fatigue, insomnia, waking up breath

holding/gasping/choking, loud snoring, or breathing interruptions during

sleep. Shift-work disorder (SWD) (Initial): Dx of SWD confirmed by one

of the following: 1) Symptoms of excessive sleepiness or insomnia for at

least 3 months, which is associated with a work period (usually night

work) that occurs during the normal sleep period, OR 2) A sleep study

demonstrating loss of a normal sleep-wake pattern (ie, disturbed

chronobiologic rhythmicity). Confirmation that no other medical

conditions or medications are causing the symptoms of excessive

sleepiness or insomnia. Narcolepsy (initial): Dx of narcolepsy as

confirmed by a sleep study (unless prescriber provides justification

confirming that a sleep study is not feasible).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

OSA, SWD: Initial, Reauth: 6 mo. Narcolepsy: Initial, Reauth: Plan Year

Other Criteria

OSA, Narcolepsy (Reauth): Documentation of positive clinical response

to therapy. SWD (Reauth): Documentation of positive clinical response to

therapy.

AURYXIA

Products Affected

• Auryxia

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

Exclude if used for iron deficiency anemia in chronic kidney disease

(CKD) not on dialysis.

Required

Medical

Information

Hyperphosphatemia in chronic kidney disease: Diagnosis of

hyperphosphatemia. Patient has chronic kidney disease (CKD). Patient is

on dialysis.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

N/A

AUSTEDO

Products Affected

• Austedo

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Chorea associated with Huntington's disease (initial): Diagnosis of Chorea

associated with Huntington's disease. Tardive dyskinesia (initial):

Diagnosis of moderate to severe tardive dyskinesia. One of the following:

1) Patient has persistent symptoms of tardive dyskinesia despite a trial of

dose reduction, tapering, or discontinuation of the offending medication

or 2) Patient is not a candidate for a trial of dose reduction, tapering, or

discontinuation of the offending medication.

Age Restrictions

N/A

Prescriber

Restrictions

Huntington's disease chorea (initial): Prescribed by a neurologist. Tardive

dyskinesia (initial): Prescribed by or in consultation with a neurologist or

psychiatrist.

Coverage

Duration

Plan year

Other Criteria

N/A

AYVAKIT

Products Affected

• Ayvakit

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Gastrointestinal stromal tumor (GIST): Diagnosis of GIST. One of the

following: 1) Used as a single agent for continued treatment for limited

progression OR 2) Both of the following: a) Disease is one of the

following: i) unresectable, ii) metastatic, iii) recurrent, iv) persistent

microscopic or gross residual disease, v) residual disease with significant

morbidity, vi) limited progression, or vii) resectable with significant

morbidity AND b) Presence of platelet-derived growth factor receptor

alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V

mutations. Systemic Mastocytosis: Both of the following: 1) Diagnosis of

one of the following: a) advanced systemic mastocytosis (AdvSM), b)

aggressive systemic mastocytosis (ASM), c) systemic mastocytosis with

an associated hematological neoplasm (SM-AHN), or d) mast cell

leukemia (MCL) AND 2) platelet count is greater than 50 x 10^9/L.

Ayvakit 25 mg - Indolent Systemic Mastocytosis (ISM): Diagnosis of

ISM. Platelet count is greater than 50 x 10^9/L.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan Year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

BALVERSA

Products Affected

• Balversa

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Urothelial Carcinoma: Diagnosis of urothelial carcinoma (UC). One of

the following: Locally advanced or metastatic. Patient has fibroblast

growth factor receptor (FGFR) 3 or FGFR2 genetic alterations. One of the

following: 1) Patient has progressed during or following at least one line

of prior chemotherapy (e.g., gemcitabine with cisplatin or carboplatin,

dose dense methotrexate vinblastine doxorubicin cisplatin [DDMVAC]

with growth factor support, etc.) or immunotherapy (e.g., avelumab,

atezolizumab, etc.) OR 2) Patient has progressed within 12 months of

neoadjuvant or adjuvant platinum-containing chemotherapy (e.g.,

[DDMVAC] with growth factor support, gemcitabine with cisplatin, etc.).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

BENLYSTA

Products Affected

• Benlysta INJ 200MG/ML

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Systemic Lupus Erythematosus (SLE) (Initial): Diagnosis of active SLE.

Autoantibody positive (ie, anti-nuclear antibody [ANA] titer greater than

or equal to 1:80 or anti-dsDNA level greater than or equal to 30 IU/mL).

Currently receiving at least one standard of care treatment for active SLE

(eg, antimalarials [eg, Plaquenil (hydroxychloroquine)], corticosteroids

[eg, prednisone], or immunosuppressants [eg, methotrexate, Imuran

(azathioprine)]). Lupus Nephritis (Initial): Diagnosis of active lupus

nephritis. Currently receiving standard of care treatment for active lupus

nephritis (e.g., corticosteroids [e.g., prednisone] with mycophenolate or

cyclophosphamide). SLE, Lupus Nephritis (Reauthorization):

Documentation of positive clinical response to therapy.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

SLE, Lupus Nephritis (initial, reauth): 6 months

Other Criteria

N/A

BERINERT

Products Affected

• Berinert

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Treatment of hereditary angioedema (HAE) attacks: Diagnosis of HAE.

Diagnosis has been confirmed by C1 inhibitor (C1-INh) deficiency or

dysfunction (Type I or II HAE) as documented by ONE of the following:

a) C1-INH antigenic level below the lower limit of normal OR b) C1-INH

functional level below the lower limit of normal. For the treatment of

acute HAE attacks. Not used in combination with other approved

treatments for acute HAE attacks.

Age Restrictions

N/A

Prescriber

Restrictions

HAE: Prescribed by or in consultation with an immunologist or an

allergist

Coverage

Duration

Plan year

Other Criteria

N/A

BESREMI

Products Affected

• Besremi

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of polycythemia vera as confirmed by all of the following: 1)

One of the following: a) Hemoglobin greater than 16.5 g/dL for men or

hemoglobin greater than 16.0 g/dL for women, b) Hematocrit greater than

49% for men or hematocrit greater than 48% for women, or c) Increased

red cell mass, AND 2) Bone marrow biopsy showing hypercellularity for

age with trilineage growth (panmyelosis) including prominent erythroid,

granulocytic and megakaryocytic proliferation with pleomorphic, mature

megakaryocytes, AND 3) One of the following: a) Presence of JAK2 or

JAK2 exon 12 mutation or b) Subnormal serum erythropoietin level. Both

of the following: 1) Trial and failure, contraindication or intolerance

(TF/C/I) to hydroxyurea, AND 2) TF/C/I to one interferon therapy (e.g.,

Intron A, Pegasys, etc.).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan Year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

BEXAROTENE

Products Affected

• Bexarotene

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Cutaneous T-cell lymphoma (CTCL): Diagnosis of cutaneous T-cell

lymphoma (CTCL).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

BOSENTAN

Products Affected

• Bosentan

• Tracleer TBSO

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Pulmonary arterial hypertension (PAH): Diagnosis of PAH AND PAH is

symptomatic AND One of the following: A) Diagnosis of PAH was

confirmed by right heart catheterization or B) Patient is currently on any

therapy for the diagnosis of PAH

Age Restrictions

N/A

Prescriber

Restrictions

PAH: Prescribed by or in consultation with a pulmonologist or

cardiologist

Coverage

Duration

PAH: Plan year

Other Criteria

N/A

BOSULIF

Products Affected

• Bosulif

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of chronic myelogenous/myeloid leukemia (CML).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

BRAFTOVI

Products Affected

• Braftovi CAPS 75MG

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Melanoma: Diagnosis of unresectable melanoma or metastatic melanoma.

Patient is positive for BRAF V600 mutation. Used in combination with

Mektovi (binimetinib). Colorectal Cancer: One of the following

diagnoses: Colon Cancer or Rectal Cancer. One of the following: 1)

Unresectable or advanced disease or 2) Metastatic disease. Patient has

received prior therapy. Patient is positive for BRAF V600E mutation.

Used in combination with one of the following: 1) Erbitux (cetuximab) or

2) Vectibix (panitumumab).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days

BRIVIACT

Products Affected

• Briviact ORAL SOLN

• Briviact TABS

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Partial-onset seizures: Diagnosis of partial-onset seizures.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

BRUKINSA

Products Affected

• Brukinsa

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Mantle Cell Lymphoma (MCL): Diagnosis of MCL. Patient has received

at least one prior therapy for MCL. Waldenstrom's Macroglobulinemia

(WM)/Lymphoplasmacytic Lymphoma (LPL): Diagnosis of WM/LPL.

Marginal Zone Lymphoma (MZL): Diagnosis of MZL. Disease is

relapsed or refractory. Patient has received at least one anti-CD20-based

regimen (e.g., rituximab, obinutuzumab). Chronic Lymphocytic Leukemia

(CLL)/Small Lymphocytic Lymphoma (SLL): Diagnosis of CLL or SLL.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan Year.

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CABLIVI

Products Affected

• Cablivi

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Acquired thrombotic thrombocytopenic purpura (aTTP): Diagnosis of

aTTP. First dose was/will be administered by a healthcare provider as a

bolus intravenous injection. Used in combination with

immunosuppressive therapy (e.g. rituximab, glucocorticoids). One of the

following: 1) Used in combination with plasma exchange or 2) both of the

following: patient has completed plasma exchange and less than 59 days

have or will have elapsed beyond the last plasma exchange.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

3 months

Other Criteria

N/A

CABOMETYX

Products Affected

• Cabometyx

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Renal cell carcinoma (RCC): Diagnosis of advanced RCC. Hepatocellular

Carcinoma (HCC): Diagnosis of HCC. One of the following: a) Trial and

failure, contraindication, or intolerance to Nexavar (sorafenib tosylate), or

b) Patient has metastatic disease, or c) Patient has extensive liver tumor

burden, or d) Patient is inoperable by performance status or comorbidity,

or has local disease or local disease with minimal extrahepatic disease

only, or e) Both of the following: patient is not a transplant candidate and

disease is unresectable. Differentiated Thyroid Cancer (DTC): Diagnosis

of DTC. Disease is one of the following: a) locally advanced or b)

metastatic. Disease has progressed following prior VEGFR-targeted

therapy (e.g., Lenvima [lenvatinib], Nexavar [sorafenib]). Disease is

radioactive iodine-refractory or ineligible.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CALQUENCE

Products Affected

• Calquence

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Mantle Cell Lymphoma: Diagnosis of mantle cell lymphoma (MCL)

AND patient has received at least one prior therapy for MCL. Chronic

Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL):

Diagnosis of CLL or SLL.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan Year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CAPLYTA

Products Affected

• Caplyta

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Schizophrenia: Diagnosis of schizophrenia. Trial and failure,

contraindication, or intolerance to two of the following oral, single-

ingredient, formulary, generic atypical antipsychotics: asenapine,

aripiprazole, paliperidone, olanzapine, quetiapine (IR or ER), risperidone,

or ziprasidone. Bipolar disorder: Diagnosis of bipolar I or II disorder

(bipolar depression). Patient has depressive episodes associated with

bipolar disorder. Used as monotherapy or as adjunctive therapy with

lithium or valproate.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan Year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CAYSTON

Products Affected

• Cayston

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Cystic Fibrosis (CF): Diagnosis of CF and lung infection with positive

culture demonstrating Pseudomonas aeruginosa infection.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

N/A

CHENODAL

Products Affected

• Chenodal

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Initial: Diagnosis of radiolucent gallstones. Patient has a well-opacifying

gallbladder visualized by oral cholecystography. Trial and failure,

contraindication or intolerance to ursodiol. Patient is not a candidate for

surgery. Stones are not calcified (radiopaque) or radiolucent bile pigment

stones.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Initial, reauth: Plan year

Other Criteria

Reauth: Patient’s disease status has been re-evaluated since the last

authorization to confirm the patient’s condition warrants continued

treatment as evidenced by Oral cholecystograms or ultrasonograms.

CHOLBAM

Products Affected

• Cholbam

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Bile acid synthesis disorders due to single enzyme defects (BAS) (initial):

diagnosis of a bile acid synthesis disorder due to a single enzyme defect.

Peroxisomal disorders (PD) (initial): All of the following: 1) diagnosis of

peroxisomal disorder, 2) patient exhibits at least one of the following: a)

liver disease (eg, jaundice, elevated serum transaminases), OR b)

steatorrhea, OR c) complications from decreased fat-soluble vitamin

absorption (eg, poor growth), AND 3) Will be used as an adjunctive

treatment.

Age Restrictions

N/A

Prescriber

Restrictions

Initial: Prescribed by a hepatologist, medical geneticist, pediatric

gastroenterologist, OR other specialist that treats inborn errors of

metabolism.

Coverage

Duration

Initial: 3 months Reauth: Plan year

Other Criteria

All uses (reauth): documentation of positive clinical response to therapy

as evidenced by improvement in liver function (e.g., aspartate

aminotransferase [AST], alanine aminotransferase [ALT]).

CINRYZE

Products Affected

• Cinryze

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Prophylaxis of hereditary angioedema (HAE) attacks: Diagnosis of HAE.

Diagnosis has been confirmed by C1 inhibitor (C1-INh) deficiency or

dysfunction (Type I or II HAE) as documented by ONE of the following:

a) C1-INH antigenic level below the lower limit of normal OR b) C1-INH

functional level below the lower limit of normal. For prophylaxis against

HAE attacks. Not used in combination with other approved treatments for

prophylaxis against HAE attacks.

Age Restrictions

N/A

Prescriber

Restrictions

HAE (prophylaxis): Prescribed by or in consultation with an

immunologist or an allergist

Coverage

Duration

Plan year

Other Criteria

N/A

CLOBAZAM

Products Affected

• Clobazam

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Lennox-Gastaut syndrome: Diagnosis of Lennox-Gastaut syndrome. Used

for the adjunctive treatment of seizures associated with Lennox-Gastaut

syndrome. Dravet syndrome: Diagnosis of seizures associated with Dravet

syndrome (DS). Used in combination with Diacomit.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CLONIDINE ER

Products Affected

• Clonidine Hydrochloride Er

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of attention deficit hyperactivity disorder (ADHD).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

N/A

COMETRIQ

Products Affected

• Cometriq

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Medullary Thyroid Cancer (MTC): Diagnosis of metastatic medullary

thyroid cancer (MTC).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

COPIKTRA

Products Affected

• Copiktra

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma

(SLL): Diagnosis of CLL or SLL. Disease is relapsed or refractory. Trial

and failure, contraindication, or intolerance to at least two prior therapies

for CLL/SLL [e.g., Leukeran (chlorambucil), Gazyva (obinutuzumab),

Arzerra (ofatumumab), Bendeka (bendamustine), Imbruvica (ibrutinib),

etc.].

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CORLANOR

Products Affected

• Corlanor

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Chronic heart failure (CHF) (initial): Diagnosis of CHF. Patient has

NYHA Class II, III, or IV symptoms. Patient has a left ventricular

ejection fraction less than or equal to 35%. Patient is in sinus rhythm.

Patient has a resting heart rate of greater than or equal to 70 beats per

minute. Patient has been hospitalized for worsening HF in the previous 12

months. Trial and failure, contraindication, or intolerance to two of the

following at a maximally tolerated dose: A) One of the following: 1) ACE

inhibitor (e.g., captopril, enalapril, lisinopril), 2) ARB (e.g., candesartan,

losartan, valsartan), or 3) ARNI (e.g., Entresto [sacubitril and valsartan]),

B) One of the following: 1) bisoprolol, 2) carvedilol, or 3) metoprolol

succinate extended release, C) Sodium-glucose co-transporter 2 (SGLT2)

inhibitor [e.g., Jardiance (empagliflozin), Farxiga (dapagliflozin), Xigduo

XR (dapagliflozin and metformin)], or D) Mineralocorticoid receptor

antagonist (MRA) [e.g., eplerenone, spironolactone]. Dilated

Cardiomyopathy (DCM) (initial): Diagnosis of heart failure due to DCM.

Patient has NYHA Class II, III, or, IV symptoms. Patient is in sinus

rhythm. Patient has an elevated heart rate. Trial and failure,

contraindication or intolerance to one of the following: 1) Beta blocker

(e.g., bisoprolol, metoprolol succinate extended release), 2) Angiotensin-

converting enzyme (ACE) inhibitor (e.g., captopril, enalapril), or 3)

Diuretic Agent (e.g., spironolactone, furosemide).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

CHF, DCM (Initial, reauth): plan year

Other Criteria

CHF, DCM (reauth): Documentation of positive clinical response to

therapy.

COSENTYX

Products Affected

• Cosentyx INJ 150MG/ML,

75MG/0.5ML

• Cosentyx Sensoready Pen

• Cosentyx Unoready

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Plaque psoriasis (Initial): Diagnosis of moderate to severe plaque

psoriasis. One of the following: at least 3% body surface area (BSA)

involvement, severe scalp psoriasis, OR palmoplantar (ie, palms, soles),

facial, or genital involvement. One of the following: 1) Trial and failure,

contraindication, or intolerance (TF/C/I) to one of the following: Enbrel

(etanercept), Formulary adalimumab product, Otezla (apremilast), Skyrizi

(risankizumab-rzaa), or Stelara (ustekinumab), OR 2) for continuation of

prior therapy if within the past 120 days. Psoriatic Arthritis (PsA)

(Initial): Diagnosis of active PsA. One of the following: actively inflamed

joints, dactylitis, enthesitis, axial disease, or active skin and/or nail

involvement. One of the following: 1) TF/C/I to one of the following:

Enbrel (etanercept), Formulary adalimumab product, Otezla (apremilast),

Skyrizi (risankizumab-rzaa), Stelara (ustekinumab), Rinvoq

(upadacitinib), or Xeljanz/Xeljanz XR (tofacitinib), OR 2) for

continuation of prior therapy if within the past 120 days. Ankylosing

Spondylitis (AS) (Initial): Diagnosis of active AS. Minimum duration of a

one-month TF/C/I to one non-steroidal anti-inflammatory drug (NSAID)

(eg, ibuprofen, naproxen) at maximally tolerated doses. One of the

following: 1) TF/C/I to one of the following: Enbrel (etanercept),

Formulary adalimumab product, Rinvoq, or Xeljanz/Xeljanz XR

(tofacitinib), OR 2) for continuation of prior therapy if within the past 120

days. Non-radiographic axial spondyloarthritis (nr-axSpA, initial): Dx of

active nr-axSpA with signs of inflammation. Minimum duration of a one-

month TF/C/I to two non-steroidal anti-inflammatory drugs (NSAIDs)

(eg, ibuprofen, naproxen) at maximally tolerated doses.

Age Restrictions

N/A

Prescriber

Restrictions

Plaque psoriasis (Initial): Prescribed by or in consultation with a

dermatologist. Psoriatic Arthritis (initial): Prescribed by or in consultation

with a dermatologist or rheumatologist. AS, nr-axSpA, ERA (initial):

Prescribed by or in consultation with a rheumatologist.

Coverage

Duration

All uses (Initial): 6 months. All uses (Reauth): plan year.

Other Criteria

Enthesitis-Related Arthritis (ERA) (Initial): Diagnosis of active ERA.

Minimum duration of a one-month TF/C/I to two NSAIDs (eg, ibuprofen,

naproxen) at maximally tolerated doses. PsA (Reauth): Documentation of

positive clinical response to therapy as evidenced by at least one of the

following: reduction in the total active (swollen and tender) joint count

from baseline, improvement in symptoms (eg, pain, stiffness, pruritus,

inflammation) from baseline, OR reduction in the BSA involvement from

baseline. Plaque psoriasis (Reauth): Documentation of positive clinical

response to therapy as evidenced by one of the following: reduction in the

BSA involvement from baseline, OR improvement in symptoms (eg,

pruritus, inflammation) from baseline. AS, nr-axSpA (Reauth):

Documentation of positive clinical response to therapy as evidenced by

improvement from baseline for at least one of the following: disease

activity (eg, pain, fatigue, inflammation, stiffness), lab values (erythrocyte

sedimentation rate, C-reactive protein level), function, axial status (eg,

lumbar spine motion, chest expansion), OR total active (swollen and

tender) joint count. ERA (Reauth): Documentation of a positive clinical

response to therapy as evidenced by at least one of the following:

Reduction in the total active (swollen and tender) joint count from

baseline, OR improvement in symptoms (eg, pain, stiffness,

inflammation) from baseline.

COTELLIC

Products Affected

• Cotellic

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Melanoma: Diagnosis of unresectable or metastatic melanoma. Disease is

positive for BRAF V600E or V600K mutation. Used in combination with

Zelboraf (vemurafenib). Histiocytic Neoplasm: Diagnosis of one of the

following: 1) Langerhans Cell Histiocytosis, 2) Erdheim-Chester Disease,

or 3) Rosai-Dorfman Disease. One of the following: 1) Mitogen-activated

protein (MAP) kinase pathway mutation, 2) No detectable mutation, or 3)

Testing not available.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

CRINONE

Products Affected

• Crinone

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

All indications: Excluded if for fertility uses.

Required

Medical

Information

Secondary amenorrhea: Diagnosis of secondary amenorrhea (the absence

of menses in women who have already started menstruation who are not

pregnant, breastfeeding, or in menopause).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan Year

Other Criteria

N/A

CYCLOSET

Products Affected

• Cycloset

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Diabetes Mellitus (Initial): Diagnosis of type 2 diabetes mellitus (DM).

Both of the following: 1) Trial and failure, contraindication, or intolerance

to metformin or a metformin containing product AND 2) Trial and failure,

contraindication or intolerance to a medication from one of the following

drug classes: sulfonylurea (e.g., glipizide, glimepiride), thiazolidinedione

(e.g., pioglitazone), DPP-4 Inhibitor [e.g., Tradjenta (linagliptin)], SGLT2

inhibitor [e.g., Jardiance (empagliflozin)], GLP-1 receptor agonist [e.g.,

Trulicity (dulaglutide), Victoza (liraglutide)], or basal insulin (e.g., insulin

glargine).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

DM (Reauth): Patient has experienced an objective response to therapy

demonstrated by an improvement in HbA1c from baseline.

CYLTEZO

Products Affected

• Cyltezo

• Cyltezo Starter Package For Crohns

Disease/uc/hs

• Cyltezo Starter Package For Psoriasis

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Rheumatoid Arthritis (RA)(Initial): Diagnosis (Dx) of moderately to

severely active RA. Minimum duration of a 3-month trial and failure,

contraindication, or intolerance (TF/C/I) to one of the following

conventional therapies at maximally tolerated doses: methotrexate

(MTX), leflunomide, sulfasalazine. Polyarticular Juvenile Idiopathic

Arthritis (PJIA)(Initial): Dx of moderately to severely active PJIA.

Minimum duration of a 6-week TF/C/I to one of the following

conventional therapies at maximally tolerated doses: leflunomide or

methotrexate. Psoriatic Arthritis (PsA)(Initial): Dx of active PsA. One of

the following: actively inflamed joints, dactylitis, enthesitis, axial disease,

or active skin and/or nail involvement. Plaque psoriasis (PSO)(Initial): Dx

of moderate to severe chronic PSO. One of the following: at least 3%

body surface area (BSA) involvement, severe scalp psoriasis, OR

palmoplantar (ie, palms, soles), facial, or genital involvement. Ankylosing

Spondylitis (AS) (Initial): Dx of active AS. Minimum duration of a one-

month TF/C/I to one NSAID (eg, ibuprofen, naproxen) at maximally

tolerated doses. Crohn's Disease (CD)(Initial): Dx of moderately to

severely active CD. One of the following: frequent diarrhea and

abdominal pain, at least 10% weight loss, complications (eg, obstruction,

fever, abdominal mass), abnormal lab values (eg, CRP), OR CD Activity

Index (CDAI) greater than 220. TF/C/I to one of the following

conventional therapies: 6-mercaptopurine (6-MP), azathioprine,

corticosteroid (eg, prednisone), MTX.

Age Restrictions

N/A

Prescriber

Restrictions

RA, AS, JIA: (Initial) Prescribed by or in consultation with a

rheumatologist. PsA: (Initial) Prescribed by or in consultation with a

dermatologist or rheumatologist. Plaque Psoriasis, HS: (Initial) Prescribed

by or in consultation with a dermatologist. CD, UC: (Initial) Prescribed by

or in consultation with a gastroenterologist.

Coverage

Duration

UC: (Initial) 12 wks. Other uses (initial): 6 months. All uses (reauth): plan

year.

Other Criteria

Ulcerative Colitis (UC) (Initial): Dx of moderately to severely active UC.

One of the following: greater than 6 stools per day, frequent blood in the

stools, frequent urgency, presence of ulcers, abnormal lab values (eg,

hemoglobin, ESR, CRP), OR dependent on, or refractory to,

corticosteroids. TF/C/I to one of the following conventional therapies: 6-

MP, azathioprine, corticosteroid (eg, prednisone), aminosalicylate (eg,

mesalamine, olsalazine, sulfasalazine). Hidradenitis suppurativa (HS)

(Initial): Dx of moderate to severe hidradenitis suppurativa (ie, Hurley

Stage II or III). RA, PJIA (Reauth): Documentation of positive clinical

response to therapy as evidenced by at least one of the following:

reduction in the total active (swollen and tender) joint count from

baseline, OR improvement in symptoms (eg, pain, stiffness,

inflammation) from baseline. PsA (Reauth): Documentation of positive

clinical response to therapy as evidenced by at least one of the following:

reduction in the total active (swollen and tender) joint count from

baseline, improvement in symptoms (eg, pain, stiffness, pruritus,

inflammation) from baseline, OR reduction in the BSA involvement from

baseline. HS (Reauth): Documentation of positive clinical response to

therapy. Plaque psoriasis (Reauth): Documentation of positive clinical

response to therapy as evidenced by one of the following: reduction in the

BSA involvement from baseline, OR improvement in symptoms (eg,

pruritus, inflammation) from baseline. AS (Reauth): Documentation of

positive clinical response to therapy as evidenced by improvement from

baseline for at least one of the following: disease activity (eg, pain,

fatigue, inflammation, stiffness), lab values (erythrocyte sedimentation

rate, C-reactive protein level), function, axial status (eg, lumbar spine

motion, chest expansion), OR total active (swollen and tender) joint

count. CD (Reauth): Documentation of positive clinical response to

therapy as evidenced by at least one of the following: improvement in

intestinal inflammation (eg, mucosal healing, improvement of lab values

[platelet counts, erythrocyte sedimentation rate, C-reactive protein level])

from baseline, OR reversal of high fecal output state. UC (Reauth): For

patients who initiated therapy within the past 12 weeks: Documentation of

clinical remission or significant clinical benefit by eight weeks (Day 57)

of therapy OR For patients who have been maintained on therapy for

longer than 12 weeks: Documentation of positive clinical response to

therapy as evidenced by at least one of the following: improvement in

intestinal inflammation (eg, mucosal healing, improvement of lab values

[platelet counts, erythrocyte sedimentation rate, C-reactive protein level])

from baseline, OR reversal of high fecal output state.

DALVANCE

Products Affected

• Dalvance

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Acute bacterial skin and skin structure infection (aSSSI): One of the

following: a) Both of the following: i) Diagnosis (dx) of aSSSI with

infection caused by methicillin-resistant Staphylococcus aureus (MRSA)

documented by culture and sensitivity report OR empirical treatment of

patients with aSSSI where presence of MRSA infection is likely AND ii)

trial and failure to one or resistance, contraindication, or intolerance to all

of the following antibiotics: sulfamethoxazole-trimethoprim (SMX-TMP),

a tetracycline, clindamycin. OR b) both of the following: i) dx of aSSSI,

and infection caused by methicillin-susceptible Staphylococcus aureus

(MSSA), Streptococcus pyogenes, Streptococcus agalactiae,

Streptococcus dysgalactiae, Streptococcus anginosus Group (including

Streptococcus anginosus, Streptococcus intermedius, and Streptococcus

constellatus), or Enterococcus faecalis (vancomycin susceptible strains)

documented by culture and sensitivity report, and ii) trial and failure to

two or resistance, contraindication, or intolerance to all of the following

antibiotics: dicloxacillin, a cephalosporin, a tetracycline,

amoxicillin/clavulanate, clindamycin, SMX-TMP, a fluoroquinolone.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

aSSSI: 8 Day

Other Criteria

Approve for continuation of therapy upon hospital discharge (patients

who are transitioning from the hospital are allowed to continue use of the

drug and other prior authorization requirements do not apply). aSSSI:

Patient does not have osteomyelitis or diabetic foot infection.

DAURISMO

Products Affected

• Daurismo

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Acute myeloid leukemia (AML): Diagnosis of newly-diagnosed acute

myeloid leukemia (AML) AND Daurismo therapy to be given in

combination with low-dose cytarabine AND One of the following: 1)

Patient is greater than or equal to 75 years old, or 2) Patient has

significant comorbidities that preclude the use of intensive induction

chemotherapy.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

DEFERASIROX

Products Affected

• Deferasirox

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Chronic Iron Overload due to Blood Transfusions (initial): Diagnosis of

chronic iron overload (eg, sickle cell anemia, thalassemia, etc.) due to

blood transfusion. Patient has blood transfusion of at least 100 mL/kg of

packed red blood cells (eg, at least 20 units of packed red blood cells for a

40-kg person or more in individuals weighing more than 40 kg) prior to

initiation of treatment with deferasirox. Patient has serum ferritin levels

consistently greater than 1000 mcg/L prior to initiation of treatment with

deferasirox. Chronic Overload in non-transfusion dependent thalassemia

syndromes (initial): Diagnosis of chronic iron overload in non-transfusion

dependent thalassemia syndrome. Patient has liver iron (Fe) concentration

(LIC) levels consistently greater than or equal to 5 mg Fe per gram of dry

weight prior to initiation of treatment with deferasirox. Patient has serum

ferritin levels consistently more than 300 mcg/L prior to initiation of

treatment with deferasirox. Chronic Iron Overload due to Blood

Transfusions, Chronic Overload in non-transfusion dependent thalassemia

syndromes (reauthorization): Documentation of positive clinical response

to therapy.

Age Restrictions

N/A

Prescriber

Restrictions

Initial: Prescribed by a hematologist/oncologist or hepatologist.

Coverage

Duration

Plan year

Other Criteria

N/A

DEFERIPRONE

Products Affected

• Deferiprone

• Ferriprox SOLN

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Transfusional iron overload: Diagnosis of transfusional iron overload due

to one of the following: thalassemia syndromes, sickle cell disease, other

transfusional-dependent anemia. Absolute Neutrophil Count (ANC)

greater than 1.5 x 10^9/L. One of the following: A) Trial and failure to

one chelation therapy (e.g., generic deferasirox) OR B) History of

contraindication or intolerance to one chelation therapy (e.g., generic

deferasirox).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

All uses (reauth): Documentation of positive clinical response to therapy.

ANC greater than 1.5 x 10^9/L.

DEGARELIX

Products Affected

• Firmagon INJ 120MG/VIAL, 80MG

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Prostate Cancer: Diagnosis of advanced prostate cancer.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

DICLOFENAC GEL 3%

Products Affected

• Diclofenac Sodium GEL 3%

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Actinic Keratosis (initial): Diagnosis of Actinic Keratosis. Actinic

Keratosis (reauthorization): Documentation of positive clinical response

to therapy. At least 30 days have elapsed since cessation of diclofenac

sodium 3% topical gel therapy.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

90 days

Other Criteria

N/A

DIHYDROERGOTAMINE NASAL

Products Affected

• Dihydroergotamine Mesylate NASAL

SOLN

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Initial: Diagnosis of migraine headaches with or without aura. Will be

used for the acute treatment of migraine. One of the following: Trial and

failure or intolerance to one triptan (e.g., eletriptan, rizatriptan,

sumatriptan) or contraindication to all triptans.

Age Restrictions

N/A

Prescriber

Restrictions

Initial: Prescribed by or in consultation with one of the following

specialists with expertise in the treatment of migraine: neurologist, pain

specialist, headache specialist.

Coverage

Duration

Plan year

Other Criteria

Reauth: Patient has experienced a positive response to therapy (e.g.,

reduction in pain, photophobia, phonophobia, nausea).

DOPTELET

Products Affected

• Doptelet

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Thrombocytopenia Prior to Planned Procedure (TPPP): Diagnosis (dx) of

thrombocytopenia. Patient has chronic liver disease and is scheduled to

undergo a procedure. Baseline platelet count is less than 50,000/mcL.

Chronic Immune Thrombocytopenia (ITP) (initial): Diagnosis of chronic

immune (idiopathic) thrombocytopenic purpura (ITP) or

relapsed/refractory ITP. Baseline platelet count is less than 30,000/mcL.

Trial and failure, contraindication, or intolerance to at least one of the

following: corticosteroids (e.g., prednisone, methylprednisolone),

immunoglobulins [e.g., Gammagard, immune globulin (human)], or

splenectomy. Patient's degree of thrombocytopenia and clinical condition

increase the risk of bleeding.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

TPPP: 1 month. ITP (initial, reauth): Plan year

Other Criteria

ITP (reauth): Documentation of positive clinical response to therapy as

evidenced by an increase in platelet count to a level sufficient to avoid

clinically important bleeding.

DOXEPIN TOPICAL

Products Affected

• Doxepin Hydrochloride CREA

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Diagnosis of moderate pruritus. Patient has atopic dermatitis or lichen

simplex chronicus. Trial and failure, contraindication, or intolerance to at

least one medium potency topical corticosteroid, or is not a candidate for

topical corticosteroids (e.g., treatment is on face, axilla, or groin).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

14 days

Other Criteria

N/A

DRONABINOL

Products Affected

• Dronabinol

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Nausea and Vomiting Associated with Cancer Chemotherapy (CINV):

Patient is receiving cancer chemotherapy. Trial and failure,

contraindication, or intolerance (TF/C/I) to a 5HT-3 receptor antagonist

(eg, Anzemet [dolasetron], Kytril [granisetron], or Zofran [ondansetron]).

TF/C/I to one of the following: Ativan (lorazepam), Compazine

(prochlorperazine), Decadron (dexamethasone), Haldol (haloperidol),

Phenergan (promethazine), Reglan (metoclopramide), Zyprexa

(olanzapine). AIDS anorexia: Diagnosis of anorexia with weight loss in

patients with AIDS.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

CINV: 6 months. AIDS anorexia: 3 months.

Other Criteria

Subject to Part B vs. Part D review. CINV: Approve for continuation of

therapy for treatment covered under Part B when patient is receiving

cancer chemotherapy.

DROXIDOPA

Products Affected

• Droxidopa

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Neurogenic orthostatic hypotension (NOH): (Initial): Diagnosis of

symptomatic NOH. NOH is caused by one of the following conditions:

primary autonomic failure (eg, Parkinson's disease, multiple system

atrophy, pure autonomic failure), dopamine beta-hydroxylase deficiency,

non-diabetic autonomic neuropathy. (Reauth): Documentation of positive

clinical response to therapy.

Age Restrictions

N/A

Prescriber

Restrictions

NOH (init): Prescribed by or in consultation with one of the following

specialists: cardiologist, neurologist, nephrologist.

Coverage

Duration

Initial: 1 month. Reauth: plan year

Other Criteria

Trial and failure, contraindication, or intolerance to one of the following

agents: Fludrocortisone acetate, midodrine.

DUPIXENT

Products Affected

• Dupixent

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Atopic Dermatitis (AD) (initial): Diagnosis (dx) of chronic AD. One of

the following: a) Involvement of at least 10% body surface area (BSA), or

b) SCORing Atopic Dermatitis (SCORAD) index value of at least 25.

Trial and failure of a minimum 30-day supply (14-day supply for topical

corticosteroids), contraindication (eg, safety concerns, not indicated for

patient's age/weight), or intolerance to at least one of the following: a)

Medium or higher potency topical corticosteroid, b) Pimecrolimus cream,

c) Tacrolimus ointment, or d) Eucrisa (crisaborole) ointment. Eosinophilic

Asthma (EA) (initial): Dx of moderate to severe asthma. Asthma is an

eosinophilic phenotype as defined by a baseline (pre-dupilumab

treatment) peripheral blood eosinophil level greater than or equal to 150

cells/microliter. One of the following: 1) Patient has had two or more

asthma exacerbations requiring systemic corticosteroids (eg, prednisone)

within the past 12 mo, or 2) Prior asthma-related hospitalization within

the past 12 mo. Corticosteroid Dependent Asthma (CDA) (initial): Dx of

moderate to severe asthma. Patient is currently dependent on oral

corticosteroids for the treatment of asthma. EA, CDA (initial): Patient is

currently being treated with ONE of the following unless there is a

contraindication or intolerance to these medications: 1) High-dose inhaled

corticosteroid (ICS) [e.g., greater than 500 mcg fluticasone propionate

equivalent/day] and additional asthma controller medication [e.g.,

leukotriene receptor antagonist (eg, montelukast), long-acting beta-2

agonist (LABA) (eg, salmeterol), tiotropium] OR 2) One max-dosed

combination ICS/LABA product (e.g., Advair [fluticasone

propionate/salmeterol], Symbicort [budesonide/formoterol], Breo Ellipta

(fluticasone/vilanterol)). Prurigo nodularis (PN) (init): Diagnosis of PN.

Trial and failure, contraindication, or intolerance to one medium or higher

potency topical corticosteroid.

Age Restrictions

Asthma (initial): Patient is 6 years of age or older. AD (initial): Patient is

6 months of age or older. CRSwNP, PN: no age restriction. EoE (initial):

Patient is 12 years of age or older.

Prescriber

Restrictions

AD, PN (init): Prescribed by or in consultation with a dermatologist or

allergist/immunologist. Asthma (init): Prescribed by or in consultation

with a pulmonologist or allergist/immunologist. CRSwNP (initial):

Prescribed by or in consultation with an otolaryngologist,

allergist/immunologist, or pulmonologist. EoE (initial): Prescribed by or

in consultation with a gastroenterologist.

Coverage

Duration

CRSwNP, EoE (Init/Reauth): Plan year. Asthma, AD, PN (Init): 6 mo.

Asthma, AD, PN (reauth): Plan yr.

Other Criteria

Eosinophilic esophagitis (EoE) (initial): Dx of EoE. Patient weighs at

least 40 kg. Trial and failure, contraindication, or intolerance to one of the

following: a) proton pump inhibitors (eg, pantoprazole, omeprazole) or b)

topical (esophageal) corticosteroids (eg, budesonide, fluticasone). AD

(reauth): Documentation of a positive clinical response to therapy as

evidenced by at least one of the following: a) Reduction in BSA

involvement from baseline, or b) Reduction in SCORAD index value

from baseline. Chronic rhinosinusitis with nasal polyposis (CRSwNP)

(initial): Diagnosis of CRSwNP. Unless contraindicated, the patient has

had an inadequate response to 2 months of treatment with an intranasal

corticosteroid (eg, fluticasone, mometasone). Used in combination with

another agent for CRSwNP. EA (reauth): Documentation of a positive

clinical response to therapy (e.g., reduction in exacerbations,

improvement in forced expiratory volume in 1 second [FEV1], decreased

use of rescue medications). CDA (reauth): Documentation of a positive

clinical response to therapy (e.g., reduction in exacerbations,

improvement in forced expiratory volume in 1 second [FEV1], reduction

in oral corticosteroid dose). EA, CDA (reauth): Patient continues to be

treated with an inhaled corticosteroid (ICS) (e.g., fluticasone, budesonide)

with or without additional asthma controller medication (e.g., leukotriene

receptor antagonist [e.g., montelukast], long-acting beta-2 agonist

[LABA] [e.g., salmeterol], tiotropium) unless there is a contraindication

or intolerance to these medications. CRSwNP (reauth): Documentation of

a positive clinical response to therapy (e.g., reduction in nasal polyps

score [NPS, 0-8 scale], improvement in nasal congestion/obstruction

score [NC, 0-3 scale]). Used in combination with another agent for

CRSwNP. EoE (reauth): Documentation of a positive clinical response to

therapy as evidenced by improvement of at least one of the following

from baseline: a) Symptoms (eg, dysphagia, chest pain, heartburn), b)

Histologic measures (eg, esophageal intraepithelial eosinophil count), or

c) Endoscopic measures (eg, edema, furrows, exudates, rings, strictures).

PN (reauth): Documentation of a positive clinical response to therapy.

EGRIFTA

Products Affected

• Egrifta Sv

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

(Initial): Diagnosis of HIV-associated lipodystrophy. Waist-

circumference greater than or equal to 95 cm (37.4 inches) in men, or

greater than or equal to 94 cm (37 inches) for women. Waist-to-hip ratio

greater than or equal to 0.94 for men, or greater than or equal to 0.88 for

women. Body mass index (BMI) greater than 20 kg/m2. Fasting blood

glucose (FBG) levels less than or equal to 150 mg/dL (8.33 mmol/L).

Patient has been on a stable regimen of antiretrovirals (eg, NRTIs,

NNRTI, Protease Inhibitors, Integrase Inhibitors) for at least 8 weeks.

(Reauth): Documentation of clinical improvement (eg, improvement in

VAT, decrease in waist circumference, belly appearance) while on Egrifta

therapy.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Initial and reauth: 6 months

Other Criteria

N/A

EMGALITY

Products Affected

• Emgality

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Episodic Migraines (EM) (120 mg/mL strength only) (initial): Diagnosis

of EM with both of the following: 1) Less than 15 headache days per

month and 2) Patient has 4 to 14 migraine days per month. Trial and

failure (after a trial of at least two months), contraindication, or

intolerance to two of the following prophylactic therapies: a)

Amitriptyline (Elavil), b) One of the following beta-blockers: atenolol,

metoprolol, nadolol, propranolol, or timolol, c) Divalproex sodium

(Depakote/Depakote ER), d) Topiramate (Topamax), e) Venlafaxine

(Effexor), f) Candesartan (Atacand). Medication will not be used in

combination with another CGRP inhibitor for the preventive treatment of

migraines. Chronic Migraines (CM) (120 mg/mL strength only) (initial):

Diagnosis of CM with both of the following: 1) Greater than or equal to

15 headache days per month and 2) Greater than or equal to 8 migraine

days per month. Trial and failure (after a trial of at least two months),

contraindication, or intolerance to two of the following prophylactic

therapies: a) Amitriptyline (Elavil), b) One of the following beta-blockers:

atenolol, metoprolol, nadolol, propranolol, or timolol, c) Divalproex

sodium (Depakote/Depakote ER), d) OnabotulinumtoxinA (Botox), e)

Topiramate (Topamax), f) Venlafaxine (Effexor), g) Candesartan

(Atacand). Medication will not be used in combination with another

CGRP inhibitor for the preventive treatment of migraines. Episodic

Cluster Headaches (ECH) (100 mg/mL strength only) (initial): Diagnosis

of ECH. Patient has experienced at least 2 cluster periods lasting from 7

days to 365 days, separated by pain-free periods lasting at least three

months. Medication will not be used in combination with another

injectable CGRP inhibitor.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

EM, CM, ECH (initial, reauth): Plan year.

Other Criteria

ECH (reauth): Patient has experienced a positive response to therapy,

demonstrated by a reduction in headache frequency and/or intensity.

Medication will not be used in combination with another injectable CGRP

inhibitor. EM, CM (reauth): Patient has experienced a positive response to

therapy, demonstrated by a reduction in headache frequency and/or

intensity. Medication will not be used in combination with another CGRP

inhibitor for the preventive treatment of migraines.

ENBREL

Products Affected

• Enbrel INJ 25MG/0.5ML, 50MG/ML

• Enbrel Mini

• Enbrel Sureclick

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Rheumatoid Arthritis (RA) (Initial): Diagnosis of moderately to severely

active RA. Minimum duration of a 3-month trial and failure,

contraindication, or intolerance (TF/C/I) to one of the following

conventional therapies at maximally tolerated doses: methotrexate,

leflunomide, sulfasalazine. Polyarticular Juvenile Idiopathic Arthritis

(PJIA) (Initial): Diagnosis of moderately to severely active PJIA.

Minimum duration of a 6-week trial and failure, contraindication, or

intolerance to one of the following conventional therapies at maximally

tolerated doses: leflunomide or methotrexate. Psoriatic Arthritis (PsA)

(Initial): Diagnosis of active PsA. One of the following: actively inflamed

joints, dactylitis, enthesitis, axial disease, or active skin and/or nail

involvement. Plaque psoriasis (Initial): Diagnosis of moderate to severe

chronic plaque psoriasis. One of the following: at least 3% body surface

area (BSA) involvement, severe scalp psoriasis, OR palmoplantar (ie,

palms, soles), facial, or genital involvement. Ankylosing Spondylitis (AS)

(Initial): Diagnosis of active AS. Minimum duration of a one-month

TF/C/I to one nonsteroidal anti-inflammatory drug (NSAID) (eg,

ibuprofen, naproxen) at maximally tolerated doses.

Age Restrictions

N/A

Prescriber

Restrictions

RA, JIA, AS (Initial): Prescribed by or in consultation with a

rheumatologist. PsA (Initial): Prescribed by or in consultation with a

rheumatologist or dermatologist. Plaque Psoriasis (Initial): Prescribed by

or in consultation with a dermatologist.

Coverage

Duration

All indications (initial): 6 months, (reauth): plan year

Other Criteria

RA, PJIA (Reauth): Documentation of positive clinical response to

therapy as evidenced by at least one of the following: reduction in the

total active (swollen and tender) joint count from baseline, OR

improvement in symptoms (eg, pain, stiffness, inflammation) from

baseline. PsA (Reauth): Documentation of positive clinical response to

therapy as evidenced by at least one of the following: reduction in the

total active (swollen and tender) joint count from baseline, improvement

in symptoms (eg, pain, stiffness, pruritus, inflammation) from baseline,

OR reduction in the BSA involvement from baseline. Plaque psoriasis

(Reauth): Documentation of positive clinical response to therapy as

evidenced by one of the following: reduction in the BSA involvement

from baseline, OR improvement in symptoms (eg, pruritus, inflammation)

from baseline. AS (Reauth): Documentation of positive clinical response

to therapy as evidenced by improvement from baseline for at least one of

the following: disease activity (eg, pain, fatigue, inflammation, stiffness),

lab values (erythrocyte sedimentation rate, C-reactive protein level),

function, axial status (eg, lumbar spine motion, chest expansion), OR total

active (swollen and tender) joint count.

EPCLUSA

Products Affected

• Epclusa

• Sofosbuvir/velpatasvir

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Criteria will be applied consistent with current AASLD/IDSA guideline.

Diagnosis of chronic hepatitis C virus. Patient is not receiving

sofosbuvir/velpatasvir in combination with another HCV direct acting

antiviral agent [e.g., Sovaldi (sofosbuvir)].

Age Restrictions

N/A

Prescriber

Restrictions

Prescribed by or in consultation with one of the following: Hepatologist,

Gastroenterologist, Infectious disease specialist, HIV specialist certified

through the American Academy of HIV Medicine

Coverage

Duration

12 to 24 weeks. Criteria applied consistent with current AASLD/IDSA

guideline

Other Criteria

N/A

EPIDIOLEX

Products Affected

• Epidiolex

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Lennox-Gastaut syndrome (LGS): Diagnosis of seizures associated with

LGS. Trial of, contraindication, or intolerance to two formulary

anticonvulsants (e.g., topiramate, lamotrigine, valproate). Dravet

syndrome (DS): Diagnosis of seizures associated with DS. Tuberous

sclerosis complex (TSC): Diagnosis of seizures associated with TSC.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

EPOETIN ALFA (PREFERRED)

Products Affected

• Procrit

• Retacrit

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Anemia due to Chronic Kidney Disease (CKD) (Initial): Diagnosis (dx) of

CKD. Anemia by lab values (Hct less than 30% or Hgb less than 10 g/dL)

within 30 days of request. The rate of hemoglobin decline indicates the

likelihood of requiring a red blood cell (RBC) transfusion, and reducing

the risk of alloimmunization and/or other RBC transfusion-related risks is

a goal. (Reauth): Diagnosis of CKD. Most recent or average (avg) Hct

over 3 months is 33% or less (Hgb 11 g/dL or less) for patients on

dialysis, without ESRD OR Most recent or average (avg) Hct over 3

months is 30% or less (Hgb 10 g/dL or less) for patients not on dialysis

OR Most recent or average (avg) Hct over 3 months is 36% or less (Hgb

12 g/dL or less) for pediatric patients. Documentation of a positive

clinical response to therapy from pre-treatment level. Anemia w/ HIV

(Initial): Anemia by labs (Hgb less than 12 g/dL or Hct less than 36%)

within 30 days of request. Serum erythropoietin level less than or equal to

500 mU/mL. Receiving zidovudine therapy or dx of HIV. (Reauth): Most

recent or avg Hct over 3 months is below 36% or most recent or avg Hgb

over 3 months is below 12 g/dl. Documentation of a positive clinical

response to therapy from pre-treatment level. Anemia with chemo

(Initial):Other causes of anemia ruled out. Anemia with labs (Hct less

than 30%, Hgb less than 10 g/dL) within prior 2 weeks of request. Cancer

is non-myeloid malignancy. Patient is receiving chemo. (Reauth): Anemia

by labs (Hgb less than 10 g/dl or Hct less than 30%) collected within the

prior 2 wks of request. Documentation of a positive clinical response to

therapy from pre-treatment level. Patient is receiving chemo.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

CKD,HIV(Init):6mo.(reauth):plan yr.Chemo(init,

reauth):3mo.MDS(init):3mo,(reauth):plan yr.Preop:1mo.

Other Criteria

Anemia in Myelodysplastic Syndrome (MDS) (Init): Diagnosis of MDS.

Serum erythropoietin 500 mU/mL or less, or transfusion dependent MDS.

(Reauth): Most recent or avg Hct over 3 months was 36% or less, OR

most recent or avg Hgb over 3 months is 12 g/dl or less. Documentation

of a positive clinical response to therapy from pre-treatment level.

Preoperative for reduction of allogeneic blood transfusion: Patient is

scheduled to undergo elective, non-cardiac, non-vascular surgery. Hgb is

greater than 10 to less than or equal to 13 g/dL. Patient is at high risk for

perioperative transfusions. Patient is unwilling or unable to donate

autologous blood pre-operatively. ESRD patients: Coverage is excluded

under Medicare Part D for patients with ESRD on dialysis for any

indication related or unrelated to treatment of ESRD since the payment

for the drug is included in the ESRD PPS payment bundle. NON-ESRD

PATIENTS for the following indications: Off-label uses (except Anemia

in MDS and Hep C patients being treated with combo ribavirin and

interferon/peginterferon): Will not be approved if patient has Hgb greater

than 10 g/dL or Hct greater than 30%.CKD (init, reauth), Chemo (init),

preop, MDS (init): Verify Fe eval for adequate Fe stores.

ERIVEDGE

Products Affected

• Erivedge

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Metastatic basal cell carcinoma (BCC): Diagnosis of metastatic basal cell

carcinoma. Advanced basal cell carcinoma: Diagnosis of locally advanced

basal cell carcinoma. One of the following: Cancer has recurred following

surgery, Patient is not a candidate for surgery, or Patient is not a candidate

for radiation.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

ERLEADA

Products Affected

• Erleada

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Non-metastatic castration-resistant prostate cancer (NM-CRPC):

Diagnosis of non-metastatic, castration-resistant (chemical or surgical)

prostate cancer. One of the following: 1) Used in combination with a

gonadotropin-releasing hormone (GnRH) analog (e.g., Zoladex

[goserelin], Vantas [histrelin], Lupron [leuprolide], Trelstar [triptorelin])

OR 2) Patient received a bilateral orchiectomy. Metastatic castration-

sensitive prostate cancer (M-CSPC): Diagnosis of metastatic, castration-

sensitive prostate cancer. One of the following: 1) Used in combination

with a gonadotropin-releasing hormone (GnRH) analog (e.g.,

Lupron[leuprolide], Trelstar[triptorelin], etc.) OR 2) Patient received

bilateral orchiectomy.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days

ERLOTINIB

Products Affected

• Erlotinib Hydrochloride TABS

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Non-Small Cell Lung Cancer (NSCLC): 1) Diagnosis of NSCLC. Disease

is one of the following: a) advanced, b) metastatic, or c) recurrent.

Tumors are positive for epidermal growth factor receptor (EGFR) exon 19

deletion mutations or exon 21 (L858R) substitution mutations or a known

sensitizing EGFR mutation (e.g., in-frame exon 20 insertions, exon 18

G719 mutation, exon 21 L861Q mutation). Pancreatic cancer: Diagnosis

of locally advanced, unresectable or metastatic pancreatic cancer. Used in

combination with Gemzar (gemcitabine).

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

Approve for continuation of prior therapy if within the past 120 days.

ESBRIET

Products Affected

• Esbriet

• Pirfenidone

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Idiopathic pulmonary fibrosis (IPF) (initial): Diagnosis of IPF, defined as

exclusion of other known causes of interstitial lung disease and either the

presence of usual interstitial pneumonia (UIP) pattern on high-resolution

computed tomography (HRCT) revealing IPF or probable IPF in patients

not subjected to lung biopsy, or HRCT and surgical lung biopsy pattern

revealing IPF or probable IPF in patients subjected to a lung biopsy. IPF

(reauth): Documentation of positive clinical response to therapy.

Age Restrictions

N/A

Prescriber

Restrictions

(initial): Prescribed by or in consultation with a pulmonologist.

Coverage

Duration

(initial, reauth): plan year

Other Criteria

N/A

EVEROLIMUS

Products Affected

• Everolimus TABS 10MG, 2.5MG,

5MG, 7.5MG

PA Criteria

Criteria Details

Indications

All Medically-accepted Indications.

Off-Label Uses

N/A

Exclusion

Criteria

N/A

Required

Medical

Information

Advanced Neuroendocrine Tumors (NET): Diagnosis (Dx) of

neuroendocrine tumors of pancreatic origin, gastrointestinal origin, lung

origin, or thymic origin. Disease is progressive. Disease is unresectable,

locally advanced or metastatic. Advanced Renal Cell Carcinoma/Kidney

Cancer: Dx of advanced renal cell cancer/kidney cancer. Disease is one of

the following: (1) relapsed or (2) stage IV disease. Renal angiomyolipoma

with tuberous sclerosis complex (TSC): Dx of renal angiomyolipoma and

TSC, not requiring immediate surgery. Subependymal Giant Cell

Astrocytoma (SEGA) with tuberous sclerosis (TS): Dx of SEGA

associated with TS. Patient is not a candidate for curative surgical

resection. Breast Cancer: Dx of recurrent or metastatic breast cancer. One

of the following: Disease is hormone receptor positive (HR+) [i.e.,

estrogen-receptor-positive (ER+) or progesterone-receptor-positive

(PR+)] OR both of the following: disease is HR- and disease has clinical

characteristics that predict a HR+ tumor. Disease is HER2-negative. One

of the following: Patient is a postmenopausal woman, patient is a

premenopausal woman being treated with ovarian ablation/suppression, or

patient is male. One of the following: A) Both of the following: a) one of

the following: 1) Disease progressed while on or within 12 months of

non-steroidal aromatase inhibitor [e.g., Arimidex (anastrozole), Femara

(letrozole)] therapy or 2) patient was treated with tamoxifen at any time

AND b) Used in combination with Aromasin (exemestane) OR B) Used

in combination with Fulvestrant or Tamoxifen.

Age Restrictions

N/A

Prescriber

Restrictions

N/A

Coverage

Duration

Plan year

Other Criteria

All uses: Approve for continuation of prior therapy if within the past 120

days.

EVEROLIMUS SOLUTION

Products Affected

• Everolimus TBSO