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Prior Authorization Criteria

2014

For information on obtaining an updated coverage determination or an exception to a coverage determination please contact Easy Choice Health Plan of New York’s Member Services at 1-888-300-9320 or, for

TTY/TDD users 1-800-662-1220. Our hours of operation are Monday through Friday from 8:00 AM to 8:00 PM from February 15, 2013 to September 30, 2013; 7 days a week from 8:00 AM to 8:00 PM from October 1, 2013 to February 14, 2014; Monday through Friday from 8:00 AM to 8:00 PM from February 15, 2014 to September 30, 2014 or visit https://www.easychoiceny.com.

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Table of contents

Actemra ... 5 Actimmune ... 5 Adcirca, Sildenafil ... 6 Aldurazyme ... 6 Ampyra ... 6

Analgesics (High Risk Medications) ... 7

Androgens (High Risk Medications) ... 7

Apokyn ... 8

Aralast, Zemaira ... 8

Aranesp ... 9

Arcalyst ... 9

Arixtra ... 10

Attention Deficit Hyperactivity Disorder Agents (High Risk Medications) ... 10

Aubagio ... 10 Avonex ... 11 Benlysta ... 11 Benzodiazepines ... 12 Betaseron ... 12 Botox ... 13 Butrans ... 14 Cayston ... 14 Cerezyme ... 15 Cesamet ... 15

Chorionic gonadotropin, Pregnyl ... 16

Cialis ... 16

Cimzia ... 16

Cinryze ... 17

Copaxone ... 17

Dementia Agents (High Risk Medications) ... 18

Effient ... 18 Elaprase ... 18 Eleyso ... 19 Eligard, leuprolide ... 19 Emsam ... 19 Enbrel ... 20 Epogen ... 21 Fabrazyme ... 22 Fentora ... 22 Ferriprox ... 22 Firazyr ... 23 Flector ... 23 Forteo ... 24

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3

Gastrointestinal Agents (High Risk Medications) ... 24

Gattex ... 25 Gilenya ... 25 Glassia ... 25 Gleevec ... 26 Humira ... 26 Ilaris ... 27 Incivek ... 28 Increlex ... 28 Infergen ... 29 Intron-A ... 29 Itraconazole ... 30 Juxtapid ... 31 Kalydeco ... 31 Kineret ... 31 Kuvan ... 32 Kynamro ... 32 Letairis ... 33 Leukine ... 33 Linzess ... 34 Lumizyme, Myozyme ... 34 Lyrica ... 35 Mozobil ... 35 Neulasta ... 36 Neumega ... 36 Neupogen ... 36

Octreotide, Sandostatin, Zorbtive ... 37

Oral Estrogens (High Risk Medications) ... 37

Orencia ... 38 Pegasys ... 38 Peg-Intron ... 39 Prolastin-C ... 39 Promacta ... 40 Qualaquin ... 40 Relistor ... 41 Remicade ... 41 Revlimid ... 42 Sabril ... 42 Somatropin ... 43 Somavert ... 44

Sulfonylureas (High Risk Medications) ... 45

Tarceva ... 45

Testosterone ... 46

Tetrahydrocannabinol ... 47

Tracleer ... 47

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4

Tretinoin (topical) ... 48

UTI Antibacterials (High Risk Medications) ... 49

Vasodilators (High Risk Medications) ... 49

Ventavis, Remodulin ... 49 Victrelis ... 50 Vimpat ... 51 Vpriv ... 51 Xenazine ... 51 Xgeva ... 52 Xolair ... 53 Xyrem ... 53 Zoledronic Acid ... 54 Zyvox ... 54

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Prior_Authorization_Group_Desc Actemra

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis. Labs: ANC and Platelet Count.The patient must have had an inadequate response to conventional

treatment including methotrexate with or without one or more disease modifying anti- rheumatic drugs (DMARDs) +/- NSAIDs for at least 3 consecutive months within the last 12 months, unless contraindicated or intolerant. The patient has had an inadequate response to one the TNF

antagonist therapy Remicade, Humira, or Enbrel. An inadequate response can be defined as therapy was ineffective, not tolerated, or other clinical circumstance exists that precludes use.

Age_Restrictions

Prescriber_Restrictions

Licensed Practioner highly familiar with the use and monitoring of special biologic response modifiers Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Actimmune

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Hypersensitivity to interferon gamma, E. coli derived

proteins, or any component of the formulation. Treatment of IPF (not FDA approved)

Required_Medical_Information

Medical documentation of FDA approved diagnosis of chronic granulomatous disease or severe malignant osteopetrosis.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. ONLY APPLIES to NEW STARTS

(6)

6 Prior_Authorization_Group_Desc

Adcirca, Sildenafil

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage not provided for patients currently receiving nitrate therapy

Required_Medical_Information

Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) WHO Group I with NYHA functional class II or III OR Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) (WHO Group I) WHO/NYHA functional class IV and documentation that the patient refuses IV therapy, is not capable of managing the complex delivery system, or is intolerant to or has contraindications to IV prostanoid therapy (i.e. epoprostenol, treprostinil).

Age_Restrictions

Prescriber_Restrictions

Prescription is written by a pulmonologist or cardiologist or documentation of consultation with pulmonologist or

cardiologist Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Aldurazyme

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information Diagnosis

Age_Restrictions Patients must be greater than 5 years old Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Ampyra

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage is not provided for patients who have a history of seizures, moderate or severe renal impairment (CrCl less than 50 mL/min) or is currently using any other forms of

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4-7 aminopyridine.

Required_Medical_Information

Patient has a documented diagnosis of one of the four types of multiple sclerosis (MS) AND, Patient is ambulatory (able to walk with or without an assistive device, at least 25 feet in 8 to 45 seconds).

Age_Restrictions Patient must be 18 years of age or older Prescriber_Restrictions

Coverage_Duration 3 months

Other_Criteria

Renewal review: patient has demonstrated documented improvement by maintaining a stable walking speed without worsening of ambulation AND, at least a 20% improvement in the T25FW from baseline.

Prior_Authorization_Group_Desc Analgesics (High Risk Medications)

PA_Criteria_Change_Indicator 1

Covered_Uses

Exclusion_Criteria

All FDA-approved indications not otherwise excluded from Part D.

Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication, OR, 2.) Patient has already tried and failed any TWO non-high risk formulary drug alternatives (narcotic analgesics)

Age_Restrictions

Applies to patients 65 years or older Prescriber_Restrictions

Coverage_Duration

Plan year

Other_Criteria

Prior_Authorization_Group_Desc Androgens (High Risk Medications)

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

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8 Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication. Age_Restrictions Applies to patients 65 years or older

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Apokyn

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Patient that has not been previously treated with standard dopaminergic therapy

Required_Medical_Information

Advanced Parkinson’s Disease: 1. Confirmed diagnosis of advanced Parkinson's disease, AND 2. inability to control 'off' symptom’s with any TWO of the following drugs: levodopa/carbidopa AND a dopamine agonist

(bromocriptine, pramipexole, or ropinirole) or COMT inhibitor (tolcapone or entacapone) AND 3. Used in combination with a non-5-HT3 antagonist antiemetic for initial therapy, AND 4. Not used in combination with 5-HT3 antagonists

Age_Restrictions Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Aralast, Zemaira

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

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9 Exclusion_Criteria

Patients with IgA deficiency who have known antibodies against IgA, anaphylaxis or hypersensitivity to IgA products or components or a history of severe systemic response to A1-PI products.

Required_Medical_Information Diagnosis

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Aranesp

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Uncontrolled hypertension, known hypersensitivity to the active substance or any excipients, iron stores are inadequate, pre-treatment Hgb greater than 12 g/dl.

Required_Medical_Information Diagnosis and the following Labs: Hgb, Ferritin, and Tstats

Age_Restrictions Prescriber_Restrictions Coverage_Duration 3 months Other_Criteria Prior_Authorization_Group_Desc Arcalyst PA_Criteria_Change_Indicator 1 Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Rilonacept is not considered medically necessary when members have the following concomitant conditions: Active Tuberculosis, HIV, Hepatitis B, Hepatitis C, Neonatal-Onset Multisystem inflammatory disease, or currently utilizing tumor necrosis factor inhibitors or interleukinn-1 blockers.

Required_Medical_Information

Diagnosis of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS)

Age_Restrictions The patient must be 12 years and older Prescriber_Restrictions

Coverage_Duration Plan year

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10

Prior_Authorization_Group_Desc Arixtra

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information Diagnosis

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc

Attention Deficit Hyperactivity Disorder Agents (High Risk Medications)

PA_Criteria_Change_Indicator 1

Covered_Uses

ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication, OR, 2.) Patient has already tried and failed any ONE non-high risk formulary alternative (Strattera)

Age_Restrictions

Applies to patients 65 years or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Aubagio

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Severe hepatic impairment. Current treatment with leflunomide. Patients who are pregnant or women of childbearing potential not using reliable contraception.

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11 Required_Medical_Information

Diagnosis of relapsing forms of multiple sclerosis

(relapsing-remitting MS or progressive-relapsing MS) OR patient has experienced a first clinical episode and has MRI features consistent with multiple sclerosis.

Age_Restrictions 18 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Avonex

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Hypersensitivity to human albumin (Avonex(R) lyophilized powder vials and Rebif(R) prefilled syringes),

hypersensitivity to natural or recombinant interferon

Required_Medical_Information

Diagnosis from neurologist of definite or probable relapsing remitting MS, secondary progressive MS with relapses, or progressive relapsing MS. Statement may include a first MS attack with documented MRI scan abnormalities

characteristic of MS, OR evaluation documenting EITHER: history of at least two focal neurological deficits (e.g. loss of vision, double vision, localized numbness or weakness), in which the first resolved and the second followed after a period of at least 6 months, OR history of one focal

neurological deficit which has resolved, and documentation of an MRI suggestive of MS.

Age_Restrictions

Prescriber_Restrictions Prescribing physician must be a neurologist Coverage_Duration

1 year, only extend for 3 months at a time beyond this duration

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage.

Prior_Authorization_Group_Desc Benlysta

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Receiving other biologic therapy or intravenous cyclophosphamide

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12 Required_Medical_Information

Diagnosis of active, autoantibody-positive (acceptable assays include ANA, anti-ds-DNA, anti-Sm, etc.) systemic lupus erythematosus AND patient is currently receiving one or more of the following standard therapies: corticosteroids, antimalarials, NSAIDs, immunosuppressants.

Age_Restrictions 18 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Benzodiazepines

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage not provided for contraindications to therapy: acute closed-angle glaucoma (with the exception of oxazepam) and for lorazepam injection only: sleep apnea syndrome or severe respiratory insufficiency except in those patients receiving lorazepam for amnestic effects while being mechanically ventilated.

Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication, OR, 2.) Patient has already tried and failed any ONE non-high risk formulary alternative, OR, 3.) Prescriber has been made aware that the requested drug is a high risk

medication and wishes to proceed with the originally prescribed medication.

Age_Restrictions Applies to patients 65 years or older Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Betaseron

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Hypersensitivity to E. coli-derived products, natural or recombinant interferon beta, albumin human or any other component of the formulation

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Age_Restrictions

Prescriber_Restrictions Prescribing physician must be a nuerologist Coverage_Duration Plan year

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage.

Prior_Authorization_Group_Desc Botox

PA_Criteria_Change_Indicator 0

Covered_Uses

ALL FDA-APPROVED INDICATIONS NOT OTHERWISE EXCLUDED FROM PART D.

Exclusion_Criteria

Infection at the proposed injection site. Cosmetic use (e.g., wrinkles).

Required_Medical_Information

Diagnosis of one of the following: A) strabismus, OR B) blepharospasm associated with dystonia, OR C) Urinary incontinence and condition is associated with a neurologic condition and Patient tried and had an inadequate

response to at least one antimuscarinic agent, unless contraindicated or intolerant to antimuscarinics (e.g., narrow angle glaucoma) and patient does not have a urinary tract infection and patient is routinely performing clean intermittent self-catheterization (CIC) or is willing/able to perform CIC, OR D) Chronic migraine and medication will be used as prophylaxis and experiences headaches on 15 or more days per month lasting four hours or longer and patient has tried and had an inadequate response with at least two first-line therapies from two different therapeutic classes (i.e. antiepileptics, beta-blockers, triptans, and tricyclic antidepressants) OR E) Cervical dystonia

(including spasmodic torticollis) F) Overactive bladder and has symptoms (e.g., urge urinary incontinence, urgency, and frequency) and patient has tried and had an

inadequate response to at least one antimuscarinic agent, unless contraindicated or intolerant to anti-muscarinics (e.g., narrow angle glaucoma) OR F) Axillary hyperhidrosis and patient’s condition significantly interferes with patient's daily activities and condition is refractory after 30 days of treatment with topical aluminum chloride OR G) Upper limb

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14 spasticity.

Age_Restrictions 12 years of age or older - strabismus or blepharospasm

Prescriber_Restrictions

Urinary incontinence - prescribed by or in consultation with an urologist

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Butrans

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Significant respiratory depression or severe bronchial asthma. Known or suspected paralytic ileus. The medication will not be used for one of the following:

management of acute pain or requires opioid analgesia for a short period of time (management of post-operative pain, including use after outpatient or day surgeries),

management of mild pain, or management of intermittent pain (e.g., use on an as needed basis).

Required_Medical_Information

Patient is in hospice care (age restriction does not apply) OR Patient has a diagnosis of moderate to severe chronic pain requiring continuous, around-the-clock opioid

analgesic for an extended period of time AND patient tried and failed, is unable to tolerate, or has a contraindication to at least one therapy from each of the following two drug categories: NSAIDs and generic extended-release opioid product and/or opioid combination product, unless the patient has documented swallowing difficulties. Age_Restrictions

18 years of age or older (does not apply to hospice patients)

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Cayston

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15 Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Required_Medical_Information

Diagnosis of cystic fibrosis AND patient has evidence of P. aeruginosa in the lungs

Age_Restrictions 7 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Cerezyme

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of non-neuropathic Gaucher’s disease with one of the following: anemia, thrombocytopenia, bone disease, hepatomegaly or splenomegaly, it has been designated an orphan product for use in the treatment of types I and III Gaucher's disease.

Age_Restrictions Patient must be at least 2 years of age Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Cesamet

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of chemotherapy-induced nausea and vomiting AND patient has tried and failed conventional antiemetic treatments (e.g., aprepitant/fosaprepitant, dexamethasone, t-hydroxytriptamine-3 serotonin receptor antagonists, butyrophenones, phenothiazines, metoclopramide) AND patient has tried and failed dronabinol.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration 6 months

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16

Prior_Authorization_Group_Desc Chorionic gonadotropin, Pregnyl

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Pregnancy or suspected pregnancy. Use for infertility or sexual dysfunction.

Required_Medical_Information Diagnosis required

Age_Restrictions Must be at least 4 years of age Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Cialis

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage is not provided for erectile dysfunction without signs and symptoms of BPH or concurrent use with nitrates.

Required_Medical_Information

Patient has a diagnosis of benign prostatic hyperplasia (BPH) AND 1.) Tadalafil 2.5 mg or 5 mg is being requested AND 2.) Patient has experienced intolerance to or

treatment failure with an alpha-blocker (e.g. doxazosin, prazosin, tamsulosin) and a 5-alpha reductase inhibitors (e.g. dutasteride, finasteride)

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Cimzia

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

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17 Required_Medical_Information

Diagnosis of moderate to severe rheumatoid arthritis and patient had an inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs for at least 3 consecutive months OR Diagnosis of moderate to severe Crohn's disease and patient has an inadequate response to, is intolerant to, or a contraindication exists to conventional therapy with one of the following: corticosteroids (i.e. Entocort EC, prednisone, methylprednisolone).

Age_Restrictions

18 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Patient has been tested for TB and latent TB has been ruled out or is being treated.

Prior_Authorization_Group_Desc Cinryze

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

History of life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product. Required_Medical_Information

Diagnosis of hereditary angioedema AND Medicaton will be used for routine prophylaxis against angioedema.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Copaxone

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of relapsing-remitting multiple sclerosis OR diagnosis of first clinical episode with MRI features consistent with multiple sclerosis

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18

Age_Restrictions 18 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Dementia Agents (High Risk Medications)

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication, OR, 2.) Patient has already tried and failed any ONE non-high risk formulary alternative (donepezil or galantamine)

Age_Restrictions

Applies to patients 65 years or older Prescriber_Restrictions Plan Year

Coverage_Duration

Other_Criteria

Prior_Authorization_Group_Desc Effient

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Patients with active pathological bleeding or history of TIA or stroke. Patients over 75 years of age who do not have high risk situations such as diabetes or a history of prior MI. Required_Medical_Information Documented treatment failure or intolerance to Plavix.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Elaprase

PA_Criteria_Change_Indicator 0

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19 Part D. Exclusion_Criteria

Required_Medical_Information

Diagnosis of Hunter syndrome (Mucopolysaccaridosis II or MPS II)

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Eleyso

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information Diagnosis of type 1 Gaucher disease Age_Restrictions 18 years of age or older

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Eligard, leuprolide

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Must have a dx of at least one: Prostatic Carcinoma, Endometroisis, Uterine Leiomyomata (Fibroids), Central Precocious Puberty, Amenorrhea.

Age_Restrictions

Patient must be at least 18 years of age for all diagnoses, except for central precocious puberty

Prescriber_Restrictions

Coverage_Duration 3 mo - 2 yrs (diagnosis dependent)

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Applies to new starts only for Prostatic Carcinoma.

Prior_Authorization_Group_Desc Emsam

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20 Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Failure of two (2) preferred antidepressants which should be from different classes of antidepressants, one of which should be Mirtazapine orally disintegrating tablets for patients unable to swallow tablets/capsules

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Patient must have tried at least 2 of the following Preferred agents, one which should be mirtazapine ODT: Fluoxetine capsules, Paroxetine, Citalopram, Bupropion, Mirtazapine/ Mirtazapine ODT, Trazodone, Amitriptyline, or Venlafaxine. Recommended treatment dose of Emsam is 6mg/24hr, maximum dose is 12mg/24hr. ONLY APPLIES TO NEW STARTS.

Prior_Authorization_Group_Desc Enbrel

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Patients with sepsis or active infection

Required_Medical_Information

Rheumatoid Arthritis(RA): diagnosis of moderate to severe, active RA and documented failure of adequate trial, defined by the ACR, of one DMARD (Methotrexate, leflunomide, sulfasalazine, hydroxychloroquine, azathioprine) and one NSAID (ibuprofen, naproxen, ketoprofen, meloxicam). Ankylosing Spondylitis: documented failure of maximum doses of at least 2 nonsteroidal anti-inflammatory drugs (NSAIDS) OR a cyclo-oxygenase (COX)-2-selective

inhibitor. Psoriatic arthritis: diagnosis of moderate to severe disease with documented intolerance to at least 2 different preferred drugs. Preferred drugs include: DMARD’s – methotrexate, sulfasalazine, hydroychloroquine,

azathioprine, lefludomide AND/OR NSAIDs – ibuprofen, naproxen, ketoprofen, meloxicam. Plaque Psoriasis: Failure of two oral agents including methotrexate and a steroid OR Puva therapy. One of the treatments listed below: The use of topical steroids. The use of either Tazorac (tazorotene), Methotrexate Cyclosporine, UVB phototherapy and/or PUVA therapy.

Age_Restrictions

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21 Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Epogen

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Pre-treatment Hct greater than 36%, patients not receiving iron supplementation if iron stores are inadequate,

unspecified diagnosis of “anemia”, uncontrolled

hypertension. Patients with an allergy to albumin, or any component of epoetin or allergy to mammalian cell-derived products

Required_Medical_Information

Diagnosis with corresponding criteria outlined below, no active gastrointestinal bleed and lab data within 30 days prior to request. Anemia associated with one of the

following: Chronic renal failure patients on dialysis with hgb less than 11g/dL (prior to treatment) or non dialiysis

patients with hgb less than 10g/dL AND transferrin saturation should be at least 20% AND ferritin at least 100ng/mL. Zidovudine-treated HIV-infected patients with zidovudine dose less than 4,200 mg/week. Hgb below 10g/dL for initiation, serum erythropoietin levels

500mUnits/mL or less, Serum ferritin greater than100ng/ml, and transferrin sat.greater than 20%. Continuation of

therapy is approved for hgb level less than 12g/dL. Anemia due to chemotherapy treatment of non-myeloid

malignancies (where anemia is not caused by other factors) and hgb prior to therapy initation is less than 10g/dL (or Hct is less than 30%), continuation of therapy during concomitant chemotherapy requires Hgb less than 12 g/dL. Reduction of allogenic blood transfusion for patients scheduled to undergo elective, cardiac, non-vascular surgery with anemia and hemoglobin greater than10 g/dL but less than 12 g/dL.

Age_Restrictions

Prescriber_Restrictions

For patients with cancer: prescribers must be under the ESA APPRISE Oncology program

Coverage_Duration 3 months

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage.

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22

Prior_Authorization_Group_Desc Fabrazyme

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information Diagnosis

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Fentora

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage not provided in the management of acute or postoperative pain, opiod non-tolerant patients, patients with known intolerance or hypersensitivity to the drug or fentanyl

Required_Medical_Information

Diagnosis of cancer and use is for breakthrough cancer pain AND other formulary short acting narcotics have been ineffective, not tolerated, or contraindicated AND patient is opioid tolerant and taking at least 60 mg morphine/day or an equianalgesic dose of another opioid for a week or longer

Age_Restrictions Patient must be at least 18 years of age Prescriber_Restrictions

Coverage_Duration 6 months

Other_Criteria

Patient must have tried and failed or not responded to the following formulary short acting narcotics, Oxycodone and morphine.

Prior_Authorization_Group_Desc Ferriprox

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

(23)

23 Required_Medical_Information

Diagnosis of transfusional iron overload due to thalassemia syndromes AND patient has failed prior chelation therapy with Desferal or Exjade (failure is defined as a serum ferritin level greater than 2,500 mcg/L) or patient has a contraindication or intolerance to Desferal or Exjade AND Patient has an absolute neutrophil count greater than 1.5 x 109/L.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

For renewal, patient has experienced at least a 20% reduction in serum ferritin levels and has an absolute neutrophil count greater than 0.5 x 109/L

Prior_Authorization_Group_Desc Firazyr

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Required_Medical_Information

Diagnosis of hereditary angioedema AND medication will be used for the treatment of acute attacks.

Age_Restrictions 18 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Flector

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Known hypersensitivity to diclofenac. Previously

experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Use for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery. Application to non-intact or damaged skin resulting from any etiology (e.g., exudative dermatitis, eczema, infected lesion, burns or wounds).

Required_Medical_Information

Patient is receiving treatment for acute pain due to minor strains, sprains and contusions AND patient had

experienced treatment failure with at least 2 prescription strength oral NSAIDs or patient has a documented swallowing disorder.

(24)

24 Age_Restrictions Prescriber_Restrictions Coverage_Duration 14 days Other_Criteria Prior_Authorization_Group_Desc Forteo PA_Criteria_Change_Indicator 1 Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

BMD scan with a T score of -2.5 or less AND High risk of fracture or those with a history of a previous fracture who have failed treatment with bisphosphonates. Member has had at least one fracture or has multiple risk factors for fracture OR member has BMD screening results of -2.5 or below AND member has had a 3 month trial, failure or adverse reaction to 1 oral bisphosphonate (alendronate and ibandronic acid) and Boniva Inj.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year Other_Criteria

Preferred bisphosphonate agents include: Alendronate,Ibandronic Acid, and Boniva.

Prior_Authorization_Group_Desc Gastrointestinal Agents (High Risk Medications)

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication

Age_Restrictions

Applies to patients 65 years or older Prescriber_Restrictions

Coverage_Duration Plan Year

(25)

25

Prior_Authorization_Group_Desc Gattex

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Active gastrointestinal malignancy (gastrointestinal tract, hepatobiliary, pancreatic), colorectal cancer, or small bowel cancer

Required_Medical_Information

Diagnosis of short bowel syndrome AND patient is receiving specialized nutritional support (i.e. parenteral nutrition)

Age_Restrictions 18 years of age or older Prescriber_Restrictions

Coverage_Duration Plan Year Other_Criteria

For renewal, patient has a reduced need for parenteral support (20% reduction) after at least 6 months of therapy.

Prior_Authorization_Group_Desc Gilenya

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Patient is diagnosed with a relapsing form of MS. AND, Has had a trial and failure or intolerance to one of the following preferred therapies: Avonex or Betaseron Age_Restrictions Patient is 18 years of age or older

Prescriber_Restrictions

Coverage_Duration Plan year Other_Criteria

Patient should be monitored following the first dose for signs and symptoms of bradycardia.

Prior_Authorization_Group_Desc Glassia

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

IgA deficiency with known anti-IgA antibody, current smoker

(26)

26 Required_Medical_Information

Diagnosis of emphysema AND patient has alpha-1

proteinase inhibitor deficiency AND patient has a high-risk phenotype (PiZZ, PiZ(null), Pi(null) (null), or other

phenotype associated with serum alpha-1 antitrypsin concentrations of less than 11 uM/L (80 mg/dL).

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Gleevec

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information Diagnosis

Age_Restrictions

Prescriber_Restrictions

Prescribing physician must be a hematology/oncology specialist or have consulted with one

Coverage_Duration Plan year

Other_Criteria ONLY APPLIES to NEW STARTS

Prior_Authorization_Group_Desc Humira

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Patients with mild rheumatoid arthritis, patients with mild Crohn’s disease, patients with an active, serious infection, patients with a latent tuberculosis infection, concurrent use of anakinra

(27)

27 Required_Medical_Information

Rheumatoid and Psoriatic arthritis: Patient has had an inadequate response to one or more disease modifying antirheumatic drugs (DMARDS): Methotrexate,

Sulfasalazine, hydroxychloroquine, injectable gold, azathioprine, or penicillamine.(Humira can be used in combination with methotrexate for patients who do not respond adequately to methotrexate alone.) Juvenile rheumatoid arthritis: diagnosis of moderate to severe, active polyarticular JIA and documented failure of

methotrexate, following an appropriate treatment period, and one (preferably ibuprofen, naproxen or meloxicam). Moderate to Severe Active Crohn's disease: Patient has had inadequate response to one or more of the following: Sulfasalazine or azathioprine only, oral 5-ASA products (mesalamine, Asacol, Pentasa, Apriso, etc.),

corticosteroids (Entocort EC, prednisone, etc.).

Ankylosing Spondylitis: Non-therapeutic response to the maximum tolerated dose of at least two nonsteroidal anti-inflammatory drugs (NSAIDS: sulindac, naproxen,

diclofenac) or including a cyclo-oxygenase (COX)-2-selective inhibitor Celebrex. Plaque Psoriasis - At least 2 of the following treatment:: The use of topical steroids, the use of either Tazorac (tazorotene), Methotrexate,

Oxsoralen, UVB phototherapy and/or PUVA treatment.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Ilaris

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of cryopyrin-associated period syndromes (CAPS), including Familial Cold Auto-inflammatory

Syndrome (FCAS) and/or Muckle-Wells Syndrome (MWS), or Systemic Juvenile Idiopathic Arthritis (SJIA).

Age_Restrictions

(28)

28 Prescriber_Restrictions

Prescribed by or in consultation with or recommendation of, an immunologist, allergist, dermatologist, rheumatologist, neurologist, or other medical specialist

Coverage_Duration Plan Year Other_Criteria

Approve doses based on FDA labeling

Prior_Authorization_Group_Desc Incivek

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Pregnant. Unwilling to comply with required contraception methods. Co-administration with alfuzosin, cisapride, dihydroergotamine, drosperinone, ergonovine, ergotamine, lovastatin, methylergonovine, midazolam (oral), pimozide, rifampin, sildenafil (Revatio), simvastatin, St. John's wort, tadalafil (Adcirca), triazolam

Required_Medical_Information

Diagnosis of chronic hepatitis C genotype 1 with

compensated liver disease AND medication will be used with ribavirin and peginterferon alfa AND Has not

previously failed a treatment regimen with a hepatitis C protease inhibitor.

Age_Restrictions Patient is 18 years of age or older Prescriber_Restrictions

Coverage_Duration Initial - 8 weeks. Renewal - 4 weeks for a total of 12 weeks.

Other_Criteria

For renewal, patient continue to receive concurrent therapy with ribavirin and peginterferon alfa AND viral load at week 4 is 1,000 IU/mL or less, the patient has not experienced a serious skin reaction while on therapy.

Prior_Authorization_Group_Desc Increlex

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Insulin-like growth factor therapy is considered NOT medically necessary when any of the following criteria are met: Final adult height has been reached as determined by the 5th percentile of adult height OR the bone epiphyses are closed OR the patient is older than 18 years of age. Required_Medical_Information Diagnosis, Labs (IGF-1, GH)

(29)

29 Age_Restrictions

The patient is between 2 years -18 years old for Increlex therapy

Prescriber_Restrictions Licensed Practioner Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Infergen

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Uncontrolled depression. Autoimmune hepatitis or other autoimmune condition known to be exacerbated by interferon and ribavirin. Excluded from use with protease inhibitors as triple therapy.

Required_Medical_Information For Hepatitis C: positive hepatitis C viral load.

Age_Restrictions

Prescriber_Restrictions

Prescribing physician must be gastroenterologist, hepatologist or infectious disease specialist Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Intron-A

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Uncontrolled depression. Solid organ transplant other than liver. Autoimmune hepatitis or other autoimmune condition known to be exacerbated by interferon and ribavirin. Excluded from use as triple therapy with protease inhibitors.

(30)

30 Required_Medical_Information

Diagnosis of hairy cell leukemia OR Diagnosis of Condylomata acuminata OR Diagnosis of AIDS-related Kaposi's sarcoma OR Clinically aggressive follicular lymphoma and the medication will be used concurrently with anthracycline-containing chemotherapy or is not a candidate for anthracycline-containing chemotherapy OR Malignant melanoma and the request for coverage is within 56 days of surgery and the patient is at high risk of disease recurrence OR Diagnosis of chronic hepatitis B with

compensated liver disease and patient has evidence of hepatitis B viral replication and patient has been serum hepatitis B surface antigen-positive for at least 6 months OR DIagnosis of chronic hepatitis C with compensated liver disease and is receiving combination therapy with ribavirin, unless ribavirin is contraindicated.

Age_Restrictions Prescriber_Restrictions

Coverage_Duration

1 yr chronic Hep C, 6 mo-1yr Hep B, All other approved indications - plan year

Other_Criteria

ONLY APPLIES to NEW STARTS for Cancer Patients.

Prior_Authorization_Group_Desc Itraconazole

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coadministration with cisapride, dofetilide, oral midazolam, pimozide, levacetylmethadol, quinidine, lovastatin,

simvastatin, triazolam, ergot alkaloids metabolized by CYP3A4 (such as dihydroergotamine, ergometrine, ergotamine and methylergometrine), congestive heart failure or history of (capsules for treatment of

onychomycosis), pregnant women or women contemplating pregnancy (capsules for treatment of onychomycosis),

hypersensitivity to itraconazole.

Required_Medical_Information

Onychomycosis: documented positive KOH test or other lab documenting diagnosis AND trial/failure or

contraindication to terbinafine and topical ciclopirox. For Aspergillosis, histoplasmosis, or blastomycosis: Approve.

(31)

31 Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Juxtapid

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Moderate to severe liver impairment or active liver disease including unexplained persistent abnormal liver function tests. Pregnancy. Concomitant use with strong or moderate CYP3A4 inhibitors.

Required_Medical_Information

Diagnosis of homozygous familial hypercholesterolemia AND Medication will be used as adjunct to a low-fat diet and other lipid-lowering treatments AND Patient has tried and had an inadequate response or intolerance to statins AND Patient has tried and had an inadequate response or intolerance to the following: lipid apheresis.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Initial - 6 months. Renewal - Plan Year Other_Criteria

For renewal, patient has responded to therapy with a decrease in LDL levels.

Prior_Authorization_Group_Desc Kalydeco

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of cystic fibrosis AND Patient has a known G551D mutation on at least one allele in the cystic fibrosis transmembrane conductance regulator gene documented by an FDA-cleared cystic fibrosis-mutation test that

includes measurement of the G551D mutation. Age_Restrictions 6 years of age or older

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

(32)

32

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of moderate to severe rheumatoid arthritis and patient had an inadequate response to, intolerance to, or contraindication to one or more non-biologic disease modifying anti-rheumatic drugs (DMARDs)for at least 3 consecutive months OR Diagnosis of cryopyrin-associated periodic syndrome (CAPS) with neonatal-onset multisystem inflammatory disease (NOMID).

Age_Restrictions 18 years of age or older for rheumatoid arthritis

Prescriber_Restrictions

For CAPS, diagnosed by, or upon consultation with or recommendation of, an immunologist, allergist,

dermatologist, rheumatologist, neurologist or other medical specialist.

Coverage_Duration

6 mo-refractory chronic infantile neurological, cutaneous and articular syndrome, 1 yr-all others

Other_Criteria

Patient has been tested for TB and latent TB has been ruled out or is being treated. Dosing as per the FDA labeling for rheumatoid arthritis.

Prior_Authorization_Group_Desc Kuvan

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Required_Medical_Information

Diagnosis of phenylketonuria (PKU) and patient is and will be maintained on a phenylalanine-restricted diet

Age_Restrictions

Prescriber_Restrictions Coverage_Duration

2 months to determine response, if response is positive, then approve for remainder of plan year.

Other_Criteria

Response is defined as a 20% or greater reduction of blood Phe level from baseline during treatment for 1 – 2 months

Prior_Authorization_Group_Desc Kynamro

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

(33)

33 Exclusion_Criteria

Moderate to severe liver impairment or active liver disease including unexplained persistent abnormal liver function tests.

Required_Medical_Information

Diagnosis of homozygous familial hypercholesterolemia AND Medication will be used as adjunct to a low-fat diet and other lipid-lowering treatments AND Patient has tried and had an inadequate response or intolerance to statins AND Patient has tried and had an inadequate response or intolerance to at least one of the following: ezetimibe, cholestyramine, or lipid apheresis.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Initial - 6 months. Renewal - Plan Year Other_Criteria

For renewal, patient has responded to therapy with a decrease in LDL levels.

Prior_Authorization_Group_Desc Letairis

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Letairis: known or suspected pregnancy

Required_Medical_Information

Diagnosis of PAH with WHO class II or III symptoms, a negative response to the acute vasoreactivity test, and documented trial/failure to sildenafil or Adcirca. The dose/quantity requested must be supported by one of the three CMS accepted compendia (DrugDex, USP or AHFS) or a published, peer reviewed article found on Medline with the supporting documentation in such literature being specific to that indication.

Age_Restrictions

Prescriber_Restrictions

Must be a provider enrolled in the Letairis Education Access Program (LEAP)

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Leukine

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

(34)

34 Required_Medical_Information

Diagnosis of one of the following: A) Patient has undergone allogeneic or autologous bone marrow transplant (BMT) and engraftment is delayed or failed and Patient does not have excessive leukemic myeloid blasts in bone

marrow/peripheral blood (more than 10%) OR B) Patient is undergoing autologous peripheral-blood progenitor cell transplant to mobilize progenitor cells for collection by leukapheresis OR C) Medication will be used for myeloid reconstitution after an autologous or allogeneic BMT OR D) Patient has acute myeloid leukemia and administration will be after completion of induction chemotherapy.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Linzess

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Mechanical gastrointestinal obstruction.

Required_Medical_Information

Diagnosis of irritable bowel syndrome-constipation for at least 12 non-consecutive weeks and patient has tried and failed increasing fluid and fiber intake and patient has tried and failed or has an intolerance to osmotic laxatives, stimulant laxatives or probiotics OR Diagnosis of chronic idiopathic constipation for at least 3 months and patient has tried and failed increasing fluid and fiber intake and patient has tried and failed or has an intolerance to osmotic

laxatives, stimulant laxatives and stool softeners. Age_Restrictions 18 years of age or older

Prescriber_Restrictions

Coverage_Duration Initial - 4 months. Renewal - Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Lumizyme, Myozyme

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

(35)

35 Required_Medical_Information

Diagnosis: 1) Lumizyme used for late (non-infantile) onset Pompe disease (GAA) deficiency and the patient does not have evidence of cardiac hypertrophy. 2) Myozyme used for patients with infantile-onset Pompe disease (GAA deficiency).

Age_Restrictions Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Lyrica

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Approve for the diagnosis of seizure disorder. For post herpetic neuralgia, trial and failure of preferred alternative, gabapentin is required. For Fibromyalgia: trial and failure or intolerance to Cymbalta is required. For Diabetic Peripheral Neuroathy trial and failure or intolerance to Cymbalta is required.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria ONLY APPLIES TO NEW STARTS for Seizure Disorders.

Prior_Authorization_Group_Desc Mozobil

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria Pregnant. Breast feeding.

Required_Medical_Information

Patient is to undergo autologous stem cell transplantation for the treatment of non-Hodgkin's lymphoma or multiple myeloma AND Patient will concomitantly receive a daily dose of a granulocyte colony-stimulating factor (G-CSF) for 4 days prior to the first evening dose of Mozobil and on each day prior to apheresis while using Mozobil.

Age_Restrictions

Prescriber_Restrictions Coverage_Duration 4 days

(36)

36

Other_Criteria

Prior_Authorization_Group_Desc Neulasta

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information Diagnosis, chemo regimen, patient history when applicable.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. Forward to clinical pharmacist to review.

Prior_Authorization_Group_Desc Neumega

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Documented diagnosis of Chemo-induced

thrombocytopenia AND Platelet count less than 50,000 cells/microliter.

Age_Restrictions

Prescriber_Restrictions Certified hematologist and/or oncologist Coverage_Duration Plan year

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage.

Prior_Authorization_Group_Desc Neupogen

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

(37)

37 Required_Medical_Information

Diagnosis of the any of the indications and the following information must be obtained before approval is authorized: patient’s weight, most recent (within the past week) CBC with differential or absolute neutrophil count (ANC) (for chemotherapeutic regimens where patient has had history of significant neutropenia while on chemotherapy, provide CBC with diff. or ANC of last chemo cycle where patient experienced neutropenia), dose to administer, duration of therapy, target ANC or target WBC.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Clinical trial data shows no clinical benefit seen once an ANC is greater than 10,000/mm3. Home or LTC

administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage.

Prior_Authorization_Group_Desc Octreotide, Sandostatin, Zorbtive

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of acromegaly OR Diagnosis of metastatic carcinoid tumor requiring symptomatic treatment of severe diarrhea and flushing episodes OR Diagnosis of vasoactive intestinal peptide tumor requiring treatment of profuse watery diarrhea. Labs, IGF-1, Glucose.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage.

Prior_Authorization_Group_Desc Oral Estrogens (High Risk Medications)

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

(38)

38 Required_Medical_Information

Diagnosis: AND, 1.) The prescribing physician has been made aware that the requested drug is considered a high risk medication for elderly patients (age 65 and older) and wishes to proceed with the originally prescribed medication

Age_Restrictions

Applies to patients 65 years or older

Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Orencia

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Moderate to severe rheumatoid arthritis. The patient must have had an inadequate response to conventional

treatment including methotrexate with or without one or more disease modifying anti- rheumatic drugs (DMARDs) +/- NSAIDs unless contraindicated or intolerant.The patient has had an inadequate response to one TNF antagonist therapy Remicade, Humira, or Enbrel. Moderate to severe polyarticular juvenile idiopathic arthritis and patient had an inadequate response, intolerance or contraindication to one or more non-biologic DMARDs for at least 3 consecutive months and patient had an inadequate response to one or more tumor necrosis factor inhibitors. An inadequate response can be defined as therapy was ineffective, not tolerated, or other clinical circumstance exists that precludes use.

Age_Restrictions

Prescriber_Restrictions

Licensed Practioner highly familiar with the use and monitoring of special biologic response modifiers Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Pegasys

PA_Criteria_Change_Indicator 1

(39)

39 Part D. Exclusion_Criteria

Required_Medical_Information

Hepatitis C: positive hepatitis C viral load, with

compensated liver disease AND no signs or symptoms of jaundice, ascites, active gastrointestinal bleeding, and encephalopathy. Required information for HCV:Baseline serunm HCV RNA and Statement indicating Hep C

genotype. For Hepatitis B with compensated liver disease and evidence of viral replication and live inflammation.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Peg-Intron

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Approved for the following diagnosis.Hepatitis C AND the following labs are provided: HCV RNA levels, AST/ALT levels, genotype, with or without results of liver biopsy.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Prolastin-C

PA_Criteria_Change_Indicator 0

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

IgA deficiency with known anti-IgA antibody

Required_Medical_Information

Diagnosis of emphysema AND patient has alpha-1

proteinase inhibitor deficiency AND patient has a high-risk phenotype (PiZZ, PiZ(null), Pi(null) (null), or other

phenotype associated with serum alpha-1 antitrypsin concentrations of less than 11 uM/L (80 mg/dL) Age_Restrictions

(40)

40 Prescriber_Restrictions

Coverage_Duration Plan Year

Other_Criteria

Prior_Authorization_Group_Desc Promacta

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of one of the following: A) Relapsed/refractory chronic immune (idiopathic) thrombocytopenic purpura (ITP) for greater than 6 months AND Baseline platelet count is less than 50,000/mcL AND Degree of

thrombocytopenia and clinical condition increase the risk of bleeding AND Patient had an insufficient response,

intolerance, contraindication to corticosteroids or immune globulin or inadequate response or contraindication to splenectomy, B)Chronic hepatitis C and patient has thrombocytopenia defined as platelets less than 90,000/mcL for initiation (pre-treatment) of interferon therapy.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Qualaquin

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage is not provided for patients with any of the following contraindications to therapy: prolongation of QT interval, glucose-6-phosphate dehydrogenase (G6PD) deficiency, myasthenia gravis, Known hypersensitivity to quinine, mefloquine, or quinidine, or optic neuritis.

Required_Medical_Information

Patient is being treated for uncomplicated Plasmodium falciparum malaria

Age_Restrictions Patient is 16 years of age or older Prescriber_Restrictions

Coverage_Duration 1 month

(41)

41

Prior_Authorization_Group_Desc Relistor

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Coverage is not provided for use nausea, vomiting, pruritis, or urinary retention related to morphine or other opioids.

Required_Medical_Information

Diagnosis of opioid-induced constipation AND Patient has used opioid medication for a minimum of 2 weeks AND Patient is experiencing fewer than 3 bowel movements in a week or no bowel movement for longer than 2 days AND Patient is diagnosed with an advanced illness (e.g.,

incurable cancer, end-stage chronic obstructive pulmonary disease/emphysema, cardiovascular disease/heart failure, Alzheimer's disease/dementia, HIV/AIDS, etc.) AND Patient is receiving palliative care AND Patient has tried and had an insufficient response to at least 2 formulary agents: lactulose, PEG 3350 or Amitiza.

Age_Restrictions Prescriber_Restrictions Coverage_Duration 4 Months Other_Criteria Prior_Authorization_Group_Desc Remicade PA_Criteria_Change_Indicator 1 Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis, AND documentation of trial and failure or intolerance with the following: Rheumatoid Arthritis: Either Methotrexate OR generic leflunomide (Arava). Ankylosing Spondylitis: One nonsteroidal anti-inflammatory drugs (NSAIDS) OR a cyclo-oxygenase (COX)-2-selective inhibitor. Chronic Plaque Psoriasis: Member must have tried a DMARD in the past year. Psoriatic Arthritis: The member must have used two corticosteroids. Moderately to severely active ulcerative colitis. The member must have an inadequate response to conventional therapy including: 5-aminosalicylic acids (5-ASAs) OR Corticosteroids.

(42)

42

Moderately active Crohn's disease: Inadequate response to Entocort EC.

Age_Restrictions

Prescriber_Restrictions

Coverage_Duration Plan year

Other_Criteria

Prior_Authorization_Group_Desc Revlimid

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis of multiple myeloma: LABS, Platelet count, ANC, pregnancy test if female. Diagnosis of

transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional

cytogenetic abnormalities. Diagnosis of mantle cell

lymphoma (MCL): documentated treatment with at least 1 prior agent, either Velcare or Rituxan, AND Labs including ANC and platelet count, pregnancy test if female.

Age_Restrictions Prescriber_Restrictions

Coverage_Duration 6 months

Other_Criteria

Patient is enrolled in the RevAssist Program. ONLY APPLIES to NEW STARTS

Prior_Authorization_Group_Desc Sabril

(43)

43 Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Required_Medical_Information

Diagnosis and treatment failure or intolerence with one or more of lower tier AED drugs: carbamazepine, phenytoin, lamotrigine, valproic acid, levetiracetam.

Age_Restrictions

Prescriber_Restrictions Neurologist Coverage_Duration Plan year

Other_Criteria ONLY APPLIES TO NEW STARTS

Prior_Authorization_Group_Desc Somatropin

PA_Criteria_Change_Indicator 1

Covered_Uses

All FDA-approved indications not otherwise excluded from Part D.

Exclusion_Criteria

Growth promotion in pediatric patients with closed

epiphyses, evidence of active malignancy, progression of any underlying intracranial lesion or actively growing

intracranial tumor, acute critical illness due to complications following open heart or abdominal surgery, multiple

accidental trauma or acute respiratory failure, active

proliferative or severe nonproliferative diabetic retinopathy, or in patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment.

References

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