Prior Authorization Criteria 2018

Transcription

1 Prior Authorization 2018 For information on obtaining an updated coverage determination or an exception to a coverage determination please contact Optimum HealthCare Member Services at or, for TTY/TDD users 711. Our hours are October 1 to February 14 from 8:00 am to 8:00 pm 7 days a week and February 15 to September 30 from 8:00 am to 8:00 pm Monday through Friday or visit For an indexed list of drugs please go to page 279 Last Updated 10/30/2017 1

2 ABILIFY ABILIFY MAINTENA ARISTADA INTRAMUSCULAR PREFILLED SYRINGE 1064 MG/3.9ML, 441 MG/1.6ML, 662 MG/2.4ML, 882 MG/3.2ML Diagnosis of Schizophrenia and previous use of two of the following agents: aripiprazole, clozapine, olanzapine, quetiapine, risperidone, OR Bipolar Disorder and previous trial of two of the following: aripiprazole, lithium, valproate, risperidone, quetiapine, or ziprasidone OR Major Depression and previous trial of two of the following: sertraline, citalopram, paroxetine, bupropion, mirtazapine, venlafaxine, fluoxetine OR Irritability associated with Autistic Disorder and previous trial of risperidone. Age Other Only applies to new starts 2

3 ACTEMRA ACTEMRA Active serious infection (including tuberculosis) Moderate to severe rheumatoid arthritis with 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 AND 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. For Diagnosis of systemic juvenile idiopathic arthritis OR polyarticular juvenile idiopathc arthritis with previous trial and failure or intolerance to at least one NSAID and/or methotrexate AND trial and failure or intolerance to Enbrel. Age Licensed Practioner highly familiar with the use and monitoring of special biologic response modifiers Other 3

4 ACTIMMUNE ACTIMMUNE Hypersensitivity to interferon gamma, E. coli derived proteins, or any component of the formulation. Treatment of IPF (not FDA approved) documentation of FDA approved diagnosis of chronic granulomatous disease or severe malignant osteopetrosis. Age Other 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. 4

5 ADAGEN ADAGEN Excluded if patient has severe thrombocytopenia Adenosine deaminase (ADA) deficiency: Diagnosis of ADA deficiency in a patient with severe combined immunodeficiency disease (SCID) AND patient is not a suitable candidate for, or who has failed, bone marrow transplantation, hematopoietic stem cell transplant, or gene therapy. Age Other ONLY APPLIES TO NEW STARTS 5

6 ADCIRCA ADCIRCA not provided for patients currently receiving nitrate therapy Patient has a diagnosis of Pulmonary Arterial Hypertension (PAH) AND documented trial and failure of sildenafil. Age Prescription is written by a pulmonologist or cardiologist or documentation of consultation with pulmonologist or cardiologist Other 6

7 ADEMPAS ADEMPAS Age Other Concomitant administration with nitrates or nitric oxide donors (such as amyl nitrate) in any form. Concomitant administration with phosphodiesterase inhibitors, including specific PDE-5 inhibitors (such as sildenafil, tadalafil, or vardenafil) or non-specific PDE inhibitors (such as dipyridamole or theophylline). Pregnancy. Diagnosis of pulmonary arterial hypertension was confirmed by right heart catheterization AND female patients are enrolled in the ADEMPAS REMS program. 18 years of age or older Prescribed by or in consultation with a pulmonologist or cardiologist. 6 months - initial. 12 months - renewal For renewal, medication was effective (i.e. improved 6 minute walk distance, oxygen saturation, etc.) 7

8 AFINITOR AFINITOR AFINITOR DISPERZ Age Other Subependymal Giant Cell Astrocytoma (SEGA) associated with tuberous sclerosis complex (TSC): Diagnosis of SEGA associated with TSC that requires therapeutic intervention but patient is not a candidate for curative surgical resection. Renal cell carcinoma: Diagnosis of advanced or metastatic renal cell carcinoma AND History of failure, contraindication, or intolerance to SUTENT (sunitinib) or NEXAVAR (sorafenib). Neuroendocrine tumors of pancreatic origin (pnet): Diagnosis of progressive pnet that are unresectable, locally advanced, or metastatic. Renal angiomyolipoma: Diagnosis of renal angiomyolipoma and TSC AND Patient does not require immediate surgery. Breast Cancer: Patient is a postmenopausal woman AND Diagnosis of advanced hormone receptor-positive, HER2-negative breast cancer AND History of failure, contraindication, or intolerance to FEMARA (letrozole) or ARIMIDEX (anastrozole) AND Afinitor will be used in combination with AROMASIN (exemestane). Neuroendocrine tumors of gastrointestinal (GI) or lung origin: Diagnosis of progressive, well-differentiated, nonfunctional NET of GI or lung origin AND patient has unresectable, locally advanced or metastatic disease. 18 years of age or older for RCC, pnet, and renal angiomyolipoma with TSC. 1 year of age or older for SEGA Prescribed by or in consultation with an oncologist ONLY APPLIES TO NEW STARTS 8

9 ALDURAZYME ALDURAZYME Diagnosis of mucopolysaccharidosis (MPS 1) with Moderate to severe symptoms. Age Other 9

10 ALECENSA ALECENSA Non-small cell lung cancer (NSCLC): A) Diagnosis of metastatic NSCLC AND B) Patient has anaplastic lymphoma kinase (ALK)-positive disease as detected with an FDA-approved test or Clinical Laboratory Improvement Amendments-approved facility AND C) History of failure, contraindication, intolerance, or progressed on XALKORI (crizotinib) Age Other Prescribed by or in consultation with an oncologist. ONLY APPLIES TO NEW START 10

11 AMITRIPTYLINE HRM amitriptyline hcl oral chlordiazepoxide-amitriptyline Covered Uses All medically accepted indications not otherwise excluded from Part D. Age 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 tried and failed TWO non-high risk formulary alternatives: For depression: paroxetine, sertraline, venlafaxine, duloxetine, citalopram, escitalopram, fluoxetine, and trazodone. For migraine prophylaxis: propranolol, timolol, topiramate, valproic acid and divalproex. For anxiety: paroxetine, venlafaxine, duloxetine, and buspirone. For postherpetic neuralgia: gabapentin Applies to patients 65 years or older Other ONLY APPLIES TO NEW START 11

12 AMPYRA AMPYRA 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 4-aminopyridine Patient has a documented diagnosis of one of the four types of multiple sclerosis (MS) AND Patient has walking impairment but still ambulatory (able to walk with or without an assistive device, at least 25 feet in 8 to 45 seconds) Age Other MS (Initial): Prescribed by or in consultation with a neurologist. MS (Initial): 6 months. (Reauth): 12 months. MS (Reauth): Physician confirmation that the patient's walking improved with Ampyra therapy. One of the following: EDSS score less than or equal to 7, or not restricted to using a wheelchair (if EDSS is not measured). 12

13 ANALGESICS (HIGH RISK MEDICATIONS) ketorolac tromethamine injection solution 15 mg/ml ketorolac tromethamine intramuscular solution 60 mg/2ml ketorolac tromethamine oral Age 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 nonhigh risk formulary drug alternatives (narcotic analgesics) Applies to patients 65 years or older Other 13

14 APOKYN APOKYN SUBCUTANEOUS SOLUTION CARTRIDGE Concomitant therapy with 5HT3 antagonist, sulfite allergy. Confirmed diagnosis of advanced Parkinson's disease, AND inability to control 'off' symptoms with any TWO of the following drugs: levodopa/carbidopa AND a dopamine agonist (bromocriptine, pramipexole, or ropinirole) or COMT inhibitor (tolcapone or entacapone) AND Used in combination with a non-5-ht3 antagonist antiemetic for initial therapy, AND Not used in combination with 5-HT3 antagonists. Age Other 14

15 ARALAST/ZEMAIRA ARALAST NP INTRAVENOUS SOLUTION RECONSTITUTED 500 MG ZEMAIRA 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. Diagnosis Age Other 15

16 ARANESP ARANESP (ALBUMIN FREE) INJECTION SOLUTION 100 MCG/ML, 200 MCG/ML, 25 MCG/ML, 300 MCG/ML, 40 MCG/ML, 60 MCG/ML ARANESP (ALBUMIN FREE) INJECTION SOLUTION PREFILLED SYRINGE Myelodysplastic syndrome (MDS) Uncontrolled hypertension, known hypersensitivity to the active substance or any excipients. Labs collected within 30 days of request. AND Diagnosis of one of the following: A) Anemia due to chronic kidney disease (CKD) with or without hemodialysis and pretreatment hemaglobin is less than 10g/dl. OR B) Anemia in patients with non-myeloid malignancies where anemia is due to the effect of concomitant myelosuppressive chemotherapy and two additional months of chemotherapy is anticipated C) Anemia due to myelodysplastic syndrome (MDS). Age CKD (Init): 6 mo. CKD (reauth): 12 mo. Chemo(init, reauth): 3 mo. MDS: (init) 3 mo,(reauth) 12 mo. Other 16

17 ARCALYST ARCALYST Age Other 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. Diagnosis of cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome (FCAS) and Muckle-Wells syndrome (MWS) The patient must be 12 years and older Prescribed by or in consultation with an immunologist, allergist, dermatologist, rheumatologist, neurologist or other medical specialist. The medication will not be used in combination with another biologic. 17

18 ARIXTRA fondaparinux sodium Diagnosis Age Other 18

19 ARMODAFANIL armodafinil Covered Uses All medically accepted indications not otherwise excluded from Part D. Obstructive sleep apnea/hypopnea syndrome (OSAHS) (Initial): Diagnosis (dx) of OSAHS 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 sleep disorder (SWSD) (Initial):Dx of SWSD confirmed by 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 sleep study demonstrating loss of a normal sleep-wake pattern (ie, disturbed chronobiologic rhythmicity). No other medical condition or medication accounts for the symptoms. Narcolepsy (initial): Dx of narcolepsy as confirmed by sleep study (unless prescriber provides justification confirming that a sleep study is not feasible). Age Other OSAHS (Initial): 3 months (Reauth): 12 months. SWSD (Initial, Reauth): 3 months. Other:12 months OSAHS (Reauth): Documentation of positive clinical response to prior therapy. SWSD (Reauth): Documentation of positive clinical response to prior therapy. Patient still requires treatment for SWSD. Narcolepsy (reauth): Documentation of positive clinical response to prior therapy. 19

20 AUBAGIO AUBAGIO Age Severe hepatic impairment. Current treatment with leflunomide. Patients who are pregnant or women of childbearing potential not using reliable contraception. 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 18 years of age or older Other 20

21 AVONEX AVONEX AVONEX PEN INTRAMUSCULAR AUTO-INJECTOR KIT AVONEX PREFILLED INTRAMUSCULAR PREFILLED SYRINGE KIT Hypersensitivity to human albumin (Avonex(R) lyophilized powder vials and Rebif(R) prefilled syringes), hypersensitivity to natural or recombinant interferon Multiple Sclerosis (MS): Diagnosis of a relapsing form of MS (eg, relapsing-remitting MS, secondary-progressive MS with relapses, progressive-relapsing MS with relapses). Age Other Prescribing physician must be a neurologist Plan Year Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. 21

22 BARACLUDE BARACLUDE ORAL SOLUTION entecavir Age Diagnosis of chronic hepatitis B AND patient is HBsAg-positive for at least 6 months AND For HBeAg-positive patients, serum HBV DNA greater than 20,000 IU/mL (105 copies per ml) and for HBeAg-negative patients, serum HBV DNA greater than 2,000 IU/mL (104 copies/ml) AND Patient has evidence of persistent elevations in serum aminotransferase (ALT or AST) at least 2 times the upper limit of normal or histologically active disease (i.e. necroinflammation on biopsy) AND patient is receiving anti-retroviral therapy if the patient has HIV coinfection 2 years of age or older Other For renewal, patient must be HBeAg negative and have not had HBsAg clearance OR HBeAg positive and have detectable HBV DNA and have not been anti-hbe for at least 6 months 22

23 BELEODAQ BELEODAQ Diagnosis of peripheral T-cell lymphoma AND patient has tried and had an inadequate response, intolerance or contraindication to at least one prior therapy (e.g., conventional chemotherapy) Age Other Prescribed by or in consultation with a hematologist/oncologist ONLY APPLIES TO NEW START 23

24 BENLYSTA BENLYSTA INTRAVENOUS Age Receiving other biologic therapy or intravenous cyclophosphamide 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. 18 years of age or older Other 24

25 BENZTROPINE HRM benztropine mesylate oral Age 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. Applies to patients 65 years or older Other 25

26 BERINERT BERINERT Treatment of hereditary angioedema (HAE) attacks: Diagnosis of HAE. For the treatment of acute HAE attacks. Not used in combination with other approved treatments for acute HAE attacks (eg, Firazyr, Kalbitor, or Ruconest). Age HAE: Prescribed by an immunologist, allergist, or rheumatologist Other 26

27 BETASERON BETASERON SUBCUTANEOUS KIT Hypersensitivity to E. coli-derived products, natural or recombinant interferon beta, albumin human or any other component of the formulation Diagnosis of relapsing form of multiple sclerosis OR diagnosis of first clinical episode and MRI features consistent with MS Age Other Prescribing physician must be a neurologist Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B coverage. 27

28 BOSULIF BOSULIF Age Other Diagnosis of Philadelphia chromosome-positive chronic myelogenous leukemia AND resistance, relapse, inadequate response to prior therapy with a tyrosine kinase inhibitor (TKI) AND if patient had mutation testing, patient does not have T315I or V299L mutation or intolerant to prior TKI therapy. 18 years of age or older Prescribed by or in consultation with an oncologist or hematologist ONLY APPLIES TO NEW START 28

29 BOTOX BOTOX INJECTION SOLUTION RECONSTITUTED 100 UNIT Age Infection at the proposed injection site. Cosmetic use (e.g., wrinkles). Diagnosis of: A) strabismus, B) blepharospasm associated with dystonia, C) Urinary incontinence associated with neurologic condition and inadequate response to at least one antimuscarinic agent, unless contraindicated or intolerant to antimuscarinics (e.g., narrow angle glaucoma), D) Chronic migraine and Botox will be used as prophylaxis and experiences headaches on 15 or more days per month lasting four hours or longer and inadequate response with at least two first-line therapies from two different therapeutic classes (i.e. antiepileptics, betablockers, triptans, and tricyclic antidepressants), E) Cervical dystonia (including spasmodic torticollis) F) Overactive bladder and has symptoms (e.g., urge urinary incontinence, urgency, and frequency) and inadequate response to at least one antimuscarinic agent, unless contraindicated or intolerant to anti-muscarinics, G) Axillary hyperhidrosis, H) Upper limb spasticity and Botox will be used to improve muscle tone at wrist, elbow or finger flexors, I) lower limb spasticity due to stroke, J) achalasia and patient is not suitable for surgery 12 years of age or older - strabismus or blepharospasm Migraine (Initial): Prescribed by a neurologist or pain specialist. CBP (Initial): Prescribed by a neurologist, neurosurgeon, orthopedist, or pain specialist. UI, OAB (initial): Prescribed by a neurologist, neurosurgeon, or urologist. Other 29

30 BUTRANS buprenorphine transdermal patch weekly 10 mcg/hr, 15 mcg/hr, 20 mcg/hr, 5 mcg/hr BUTRANS Age 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). Part D coverage is not allowed if Patient is in Hospice. Patient has a diagnosis of moderate to severe chronic pain requiring continuous, around-the-clock opioid analgesic for an extended period of time (At least 2 weeks) 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. 18 years of age or older (does not apply to hospice patients) Other 30

31 CABOMETYX CABOMETYX Renal cell carcinoma (RCC): Diagnosis of RCC. RCC is advanced. History of failure, contraindication, or intolerance to at least one prior anti-angiogenic therapy [e.g., Nexavar (sorafenib), Sutent (sunitinib)]. Age Other Prescribed by or in consultation with an oncologist. ONLY APPLIES TO NEW START 31

32 CAPRELSA CAPRELSA ORAL TABLET 100 MG, 300 MG Congenital long QT syndrome Diagnosis of symptomatic or progressive medullary thyroid cancer with unresectable locally advanced or metastatic disease Age Other Prescribed by or in consultation with oncologist or endocrinologist. ONLY APPLIES TO NEW START 32

33 CARBAGLU CARBAGLU Diagnosis of N-acetyl glutamate synthase (NAGS) deficiency AND patient is experiencing either acute or chronic hyperammonemia. Age Other 33

34 CAYSTON CAYSTON Age Diagnosis of cystic fibrosis AND patient has evidence of P. aeruginosa in the lungs 7 years of age or older Other 34

35 CEREZYME CEREZYME INTRAVENOUS SOLUTION RECONSTITUTED 400 UNIT Age 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. Patient must be at least 2 years of age Other 35

36 CESAMET CESAMET Diagnosis of chemotherapy-induced nausea and vomiting AND patient has tried and failed one conventional antiemetic treatments (e.g., aprepitant/fosaprepitant, dexamethasone, ondansetron, or metoclopramide) AND patient has tried and failed dronabinol. Age 6 months Other 36

37 CHOLBAM CHOLBAM 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) Cholbam will be used as an adjunctive treatment. Age Other Prescribed by a hepatologist, medical geneticist, pediatric gastroenterologist, OR other specialist that treats inborn errors of metabolism. Reauthorization: documentation of positive clinical response to Cholbam therapy 37

38 CHORIONIC GONADOTROPIN/PREGNYL NOVAREL PREGNYL Age Pregnancy or suspected pregnancy. Use for infertility or sexual dysfunction. Prepubertal Cryptorchidism: Diagnosis of prepubertal cryptorchidism not due to anatomical obstruction. Male Hypogonadotropic Hypogonadism (MHH) (initial): Diagnosis of male hypogonadism secondary to pituitary deficiency, and low testosterone (below normal reference value provided by the physician's laboratory) and one of the following: a) low LH (below normal reference value provided by the physician's laboratory) or b) low FSH (below normal reference value provided by the physician's laboratory). Must be at least 4 years of age Other 38

39 CIALIS CIALIS ORAL TABLET 2.5 MG CIALIS ORAL TABLET 5 MG is not provided for erectile dysfunction without signs and symptoms of BPH or concurrent use with nitrates. 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. Avodart, finasteride). Age Other 39

40 CICLOPIROX ciclopirox external solution All of the following: 1) Patient does not have dermatophytomas or lunula (matrix) involvement, 2) one of the following: a) Diagnosis of onychomycosis of the toenails, OR b) Diagnosis of onychomycosis of the fingernails, 3) Diagnosis of onychomycosis has been confirmed by one of the following: a) positive potassium hydroxide (KOH) preparation, OR b) culture, OR c) histology, 4) Patient has mild to moderate disease defined by the presence the following: a) Involvement of at least 1 great toenail, AND 5) Trial and inadequate response, intolerance or hypersensitivity to oral terbinafine. Age 48 weeks Other 40

41 CIMZIA CIMZIA PREFILLED CIMZIA SUBCUTANEOUS KIT 2 X 200 MG Age Other Active serious infection (including tuberculosis) Rheumatoid Arthritis (RA, initial): Diagnosis (dx) of moderately to severely active RA. Crohn's Disease (CD, initial): Dx of moderately to severely active CD. History (Hx) of failure, contraindication, or intolerance (F/C/I) to one of the following conventional therapies: 6- mercaptopurine (Purinethol), Azathioprine (Imuran), Corticosteroid (eg, prednisone, methylprednisolone), Methotrexate (Rheumatrex, Trexall). Hx of F/C/I to Humira OR for continuation of prior Cimzia therapy. Psoriatic Arthritis (PsA, initial): Dx of active PsA. Ankylosing Spondylitis (AS, initial): Dx of active AS. RA, AS (initial): Hx of F/C/I to Enbrel and Humira OR for continuation of prior Cimzia therapy. PsA: Hx of F/C/I to Cosentyx and either Humira or Enbrel OR for continuation of prior Cimzia therapy. 18 years of age or older Prescribed by or in consulation with a gastroenterologist, rheumatologist, dermatologist or rheumatologist. RA, PsA, AS (init,reauth): 12 mos. CD (init): 16 wks. (reath): 12 mos. Patient has been tested for TB and latent TB has been ruled out or is being treated. 41

42 CINRYZE CINRYZE History of life-threatening immediate hypersensitivity reactions, including anaphylaxis to the product. Diagnosis of hereditary angioedema AND Medication will be used for routine prophylaxis against angioedema AND patient has History of failure, contraindication, or intolerance of one of the following: 17-alpha alkylated androgen (eg, danazol, oxandrolone) or antifibrinolytics (eg, tranexamic acid). Age Prescribed by an immunologist, allergist, or rheumatologist Other 42

43 COMETRIQ COMETRIQ (100 MG DAILY DOSE) COMETRIQ (140 MG DAILY DOSE) COMETRIQ (60 MG DAILY DOSE) Gastrointestinal perforation. Fistula. Severe hemorrhage. Diagnosis of progressive, metastatic medullary thyroid cancer. Age Prescribed by or in consultation with oncologist/ hematologist or Endocrinologist. Other 43

44 COPAXONE GLATOPA Age Diagnosis of relapsing-remitting multiple sclerosis OR diagnosis of first clinical episode with MRI features consistent with multiple sclerosis. 18 years of age or older Other 44

45 CORLANOR CORLANOR Blood Pressure less than 90/50, severe hepatic impairment, Atrial fibrillation. Chronic heart failure (CHF) (initial): Diagnosis of CHF with NYHA Class II, III, or IV symptoms. Left ventricular ejection fraction less than or equal to 35%. Patient is in sinus rhythm with a resting heart rate of greater than or equal to 70 BPM and has been hospitalized for worsening HF in the previous 12 months. History of failure, intolerance, or contraindication to maximally tolerated doses of at least one beta-blocker with proven mortality benefit (i.e., carvedilol, bisoprolol, sustained-release metoprolol) AND history of failure, intolerance, or contraindication to maximally tolerated doses of an ACE inhibitor or ARB. Age CHF (initial): Prescribed by or in consultation with a cardiologist Other 45

46 COSENTYX COSENTYX 300 DOSE COSENTYX SENSOREADY 300 DOSE Plaque psoriasis (Initial): Diagnosis of moderate to severe plaque psoriasis. One of the following: Failure, contraindication, or intolerance to Enbrel (etanercept) OR Humira (adalimumab), OR for continuation of prior Cosentyx therapy. Psoriatic Arthritis (PsA) (Initial): Diagnosis of active PsA. One of the following: Failure, contraindication, or intolerance to both either Enbrel (etanercept) or and Humira (adalimumab), OR for continuation of prior Cosentyx therapy. Ankylosing Spondylitis (AS) (Initial): Diagnosis of active AS. One of the following: Failure, contraindication, or intolerance to both either Enbrel (etanercept) and or Humira (adalimumab), OR for continuation of prior Cosentyx therapy. All indications (Initial, reauth): Patient is not receiving Cosentyx in combination with a biologic DMARD [eg, Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab), Simponi (golimumab)]. Patient is not receiving Cosentyx in combination with a Janus kinase inhibitor [eg, Xeljanz (tofacitinib)]. For a diagnosis of PsA or plaque psoriasis, Patient is not receiving Cosentyx in combination with a phosphodiesterase 4 (PDE4) inhibitor [e.g., Otezla (apremilast)]. Age Other Plaque psoriasis (Initial): Prescribed by or in consultation with a dermatologist. PsA (Initial): Prescribed by or in consultation with a rheumatologist or dermatologist. AS (Initial): Prescribed by or in consultation with a rheumatologist. All indications (Reauth): Documentation of positive clinical response to Cosentyx therapy. 46

47 COTELLIC COTELLIC Melanoma: Diagnosis of unresectable or metastatic melanoma. Patient has a BRAF V600E or V600K mutation as detected by an FDA-approved test (e.g., cobas 4800 BRAF V600 Mutation Test) or performed at a facility approved by Clinical Laboratory Improvement Amendments (CLIA). Used in combination with vemurafenib. Age Other Prescribed by or in consultation with an oncologist Approve for continuation of prior therapy. 47

48 CYCLOBENZAPRINE HRM cyclobenzaprine hcl oral tablet 10 mg, 5 mg Age 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 Applies to patients 65 years or older Other 48

49 CYPROHEPTADINE HRM cyproheptadine hcl oral Age 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 tried and failed TWO non-high risk formulary alternatives such as desloratadine and levocetirizine. Applies to patients 65 years or older Other 49

50 CYRAMZA CYRAMZA Gastric cancer: All of the following: 1) diagnosis of one of the following: a) gastric adenocarcinoma, OR b) gastro-esophageal junction (GEJ) adenocarcinoma, AND 2) disease is one of the following: a) locally advanced, OR b) metastatic, AND 3) disease has progressed on or after one of the following first-line therapies: a) fluoropyrimidine-containing chemotherapy (eg, fluorouracil, capecitabine), OR b) platinum-containing chemotherapy (eg, cisplatin, carboplatin, oxaliplatin). Non-small cell lung cancer: All of the following: 1) diagnosis of metastatic non-small cell lung cancer, AND 2) used in combination with docetaxel, AND 3) disease has progressed on or after platinum-based chemotherapy (eg, cisplatin, carboplatin, oxaliplatin). Metastatic Colorectal Cancer (mcrc): 1) Disease progression on or after prior therapy with bevacizumab, oxaliplatin, and a fluoropyrimidine. Age Other Prescribed by or in consultation with an oncologist Approve for continuation of prior therapy. 50

51 CYSTARAN CYSTARAN Cystinosis: Diagnosis of cystinosis, confirmed by elevated leukocyte cystine levels (LCL), genetic analysis of the CTNS gene or corneal cystine crystal accumulation AND Patient is concomitantly receiving treatment with oral cysteamine Age Other 51

52 DACOGEN decitabine Patient has a diagnosis myelodysplastic syndrome Age Other APPLIES TO NEW STARTS ONLY 52

53 DAKLINZA DAKLINZA Diagnosis of HCV and lab data confirming positive HCV RNA level, taken within the previous 6 months. will be applied consistent with current AASLD/IDSA guideline. For Genotype 1: 1) Patient has a contraindication or intolerance to Harvoni, and used in combination with Sovaldi. 2) Genotype 2 and 3: Used in combination with Sovaldi. HCV co-infected with HIV: Used in combination with Sovaldi. Age 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 12 to 24 weeks. will be applied consistent with current AASLD/IDSA guideline Other 53

54 DALIRESP DALIRESP Age Moderate to severe liver impairment (Child-Pugh B or C) Chronic Obstructive Pulmonary Disease (COPD): (Initial) Diagnosis of severe COPD. Patient has chronic bronchitis. Failure/contraindication/intolerance to two prior therapies for COPD. 18 years of age or older Other 54

55 DARAPRIM DARAPRIM Toxoplasmosis: 1) Patient is using Daraprim for the treatment of toxoplasmic encephalitis, secondary prophylaxis of toxoplasmic encephalitis, or treatment of congenital toxoplasmosis OR 2) Patient is using Daraprim for the primary prophylaxis of toxoplasmic encephalitis, patient has experienced intolerance to prior prophylaxis with trimethoprim-sulfamethoxazole (TMP-SMX), and one of the following: patient has been re-challenged with TMP-SMX using a desensitization protocol and is still unable to tolerate, or evidence of life-threatening reaction to TMP-SMX in the past (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome). Malaria: Patient is using Daraprim for the treatment of acute malaria or chemoprophylaxis of malaria. Patient does not have megaloblastic anemia due to folate deficiency. The provider acknowledges that Daraprim is not recommended by the Centers for Disease Control and Prevention (CDC) for the treatment and/or prophylaxis of malaria. Age Prescribed by or in consultation with an infectious disease specialist Other 55

56 DARZALEX DARZALEX INTRAVENOUS SOLUTION 100 MG/5ML Multiple Myeloma (MM): Diagnosis of MM. One of the following: A) Patient has received at least three prior treatment regimens which included both a proteasome inhibitor (eg, bortezomib [Velcade], carfilzomib [Kyprolis]) and an immunomodulatory agent (eg, lenalidomide [Revlimid], thalidomide [Thalomid]) or patient is double-refractory to a proteasome inhibitor and an immunomodulatory agent. OR B) Patient has received at least one prior therapy. Darzalex will be used in combination with either 1) lenalidomide and dexamethasone or 2) bortezomib and dexamethasone Age Other Prescribed by or in consultation with an oncologist/hematologist Approve for continuation of prior therapy 56

57 DEMENTIA AGENTS (HIGH RISK MEDICATIONS) ergoloid mesylates oral Age 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) Applies to patients 65 years or older Other 57

58 DESOXYN methamphetamine hcl Age Diagnosis of Obesity Diagnosis 6 years of age or older Other 58

59 DICLOFENAC 1% GEL diclofenac sodium transdermal History of severe allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory (NSAIDs), including urticaria and asthma (aspirin-sensitive asthma). Treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. Osteoarthritis pain in joints: Diagnosis of osteoarthritis pain in joints (eg, ankle, elbow, foot, hand, knee, wrist). Patient meets one of the following: 1) Treatment failure with at least two of the following prescription strength oral non-steroidal anti-inflammatory drugs (NSAIDs). celecoxib, meloxicam, diclofenac, naproxen, ibuprofen OR 2) Documented swallowing disorder OR 3) History of peptic ulcer disease/gastrointestinal bleed OR 4) Patient is older than 65 years of age with one additional risk factor for gastrointestinal adverse events (e.g. use of anticoagulants, chronic corticosteroids). Age Other 59

60 DICLOFENAC 1.5% SOLN diclofenac sodium transdermal History of severe allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory (NSAIDs), including urticaria and asthma (aspirin-sensitive asthma). Treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. Osteoarthritis of the knees (initial): Diagnosis of osteoarthritis of the knees. Patient meets one of the following: 1) Treatment failure with at least two prescription strength oral non-steroidal anti-inflammatory drugs (NSAIDs) OR 2) Documented swallowing disorder OR 3) History of peptic ulcer disease/gastrointestinal bleed OR 4) Patient is older than 65 years of age with one additional risk factor for gastrointestinal adverse events (e.g. use of anticoagulants, chronic corticosteroids). Age Other 60

61 DICLOFENAC 3% GEL diclofenac sodium transdermal History of severe allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory (NSAIDs), including urticaria and asthma (aspirin-sensitive asthma). Treatment of peri-operative pain in the setting of coronary artery bypass graft surgery. Actinic Keratosis (AK): Diagnosis: 1) Treatment failure or intolerance to topical fluorouracil cream or solution. Age Prescribed by or in consultation with an Dermatologist Other 61

62 DIGOXIN HRM digitek oral tablet 250 mcg digoxin oral tablet 250 mcg Age 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 AND lab work demostrating safe blood levels. Applies to patients 65 years or older Other 62

63 DISOPYRAMIDE HRM disopyramide phosphate oral Age 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 Applies to patients 65 years or older Other 63

64 DOXEPIN HRM doxepin hcl oral Covered Uses All medically accepted indications not otherwise excluded from Part D. Age 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 tried and failed TWO of the following non-high risk formulary alternatives for Depression: paroxetine, sertraline, venlafaxine, duloxetine, citalopram, escitalopram, fluoxetine, and trazodone. Applies to patients 65 years or older Other 64

65 DUOPA DUOPA ENTERAL Parkinson's disease (PD) (Initial): Diagnosis of PD. Patient is levodoparesponsive and experiences disabling "Off" periods for a minimum of 3 hours/day. Disabling "Off" periods occur despite therapy with both of the following: a) oral levodopa-carbidopa and b) one drug from a different class of anti-parkinson's disease therapy (eg, COMT inhibitor [entacapone, tolcapone], MAO-B inhibitor [selegiline, rasagiline], dopamine agonist [pramipexole, ropinirole]). Age Other PD (Initial): Prescribed by or in consultation with a neurologist Subject to Part B vs. Part D review. PD (Reauth): Documentation of positive clinical response to Duopa therapy. 65

66 DYSPORT DYSPORT Cervical Dystonia (CD) (init): Diagnosis of CD (also known as spasmodic torticollis). Upper limb spasticity (ULS) (init): Diagnosis of ULS as a result of CNS disorder or CNS injury. Lower limb spasticity (LLS) (init): Diagnosis of lower limb muscle spasticity as a result of cerebral palsy Age Other CD (init, reauth): 3 months for a single dose (up to 500 units). ULS, LLS (init, reauth): 3 months CD, ULS, LLS (reauth): Confirmed improvement in symptoms with initial Dysport treatment. At least 3 months have elapsed since the last treatment with Dysport. 66

67 EGRIFTA EGRIFTA SUBCUTANEOUS SOLUTION RECONSTITUTED 1 MG Age HIV-associated lipodystrophy (initial): All of the following: 1) diagnosis of HIV-associated lipodystrophy, 2) one of the following: a) waistcircumference of greater than or equal to 95 cm (37.4 inches) in men, OR b) waist-circumference of greater than or equal to 94 cm (37 inches) for women, 3) one of the following: a) Waist-to-hip ratio of greater than or equal to 0.94 for men, OR b) waist-to-hip ratio of greater than or equal to 0.88 for women, 4) body mass index (BMI) greater than 20 kg/m^2, AND 5) fasting blood glucose (FBG) levels less than or equal to 150 mg/dl (8.33 mmol/l), AND 6) patient has been on a stable regimen of antiretrovirals (eg, NRTIs, NNRTI, Protease Inhibitors, Integrase Inhibitors) for at least 8 weeks. 18 years of age or older for initial coverage Other 6 months for initial and reauthorization reauth: documentation of clinical improvement (eg, improvement in visceral adipose tissue [VAT], decrease in waist circumference, belly appearance, etc) while on Egrifta therapy. 67

68 ELAPRASE ELAPRASE Diagnosis of Hunter syndrome (Mucopolysaccaridosis II or MPS II) Age Other 68

69 ELELYSO ELELYSO Age Diagnosis of type 1 Gaucher disease 4 years of age or older Other 69

70 ELIGARD/LEUPROLIDE ELIGARD SUBCUTANEOUS KIT 22.5 MG, 7.5 MG leuprolide acetate injection LUPRON DEPOT (1-MONTH) INTRAMUSCULAR KIT 3.75 MG LUPRON DEPOT (3-MONTH) INTRAMUSCULAR KIT 22.5 MG Covered Uses All medically accepted indications not otherwise excluded from Part D. Must have a dx of at least one: Prostate Cancer, Endometrioisis, Uterine Leiomyomata (Fibroids), Central Precocious Puberty, Amenorrhea. Age Other Plan Year 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. 70

71 EMPLICITI EMPLICITI Multiple myeloma: Diagnosis of multiple myeloma. Patient has received at least one prior Velcade (bortezomib)-containing regimen for multiple myeloma. Used in combination with Revlimid (lenalidomide) and dexamethasone. Age Other Prescribed by or in consultation with a hematologist/oncologist. plan year Approve for continuation of prior therapy. 71

72 EMSAM EMSAM Diagnosis of Major Depressive disorder AND 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 Other 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 72

73 ENBREL ENBREL SUBCUTANEOUS SOLUTION PREFILLED SYRINGE 50 MG/ML ENBREL SUBCUTANEOUS SOLUTION RECONSTITUTED ENBREL SURECLICK SUBCUTANEOUS SOLUTION AUTO- INJECTOR Patients with sepsis or active infection Rheumatoid Arthritis(RA): diagnosis of moderate to severe, active RA and documented failure, intolerance or contraindication 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, intolerance or contraindication of maximum doses of at least 2 nonsteroidal anti-inflammatory drugs (NSAIDS) OR a cyclooxygenase (COX)-2-selective inhibitor. Psoriatic arthritis: diagnosis of moderate to severe disease with documented failure, intolerance or contraindication to at least 2 different preferred drugs. Preferred drugs include: methotrexate, sulfasalazine, hydroychloroquine, azathioprine, lefludomide AND/OR NSAIDs including ibuprofen, naproxen, ketoprofen, meloxicam. Moderate to severe Plaque Psoriasis affecting greater than 5% of BSA: Failure, intolerance or contraindication of two oral agents for at least 3 consecutive months (agents may be methotrexate, cyclosporine, sulfasalazine etc.) OR a steroid therapy OR either topical steroids or Tazorac (tazorotene), OR UVB phototherapy and/or PUVA therapy. Age RA (Initial), PJIA (Initial), 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. Other 73

74 ENTRESTO ENTRESTO Excluded if patient has a history of angioedema associated with use of the following: Angiotensin converting enzyme (ACE) Inhibitor therapy, Angiotensin receptor blocker (ARB) therapy. Patient is pregnant. Patient is taking aliskiren. Patient is also taking ACE Inhibitor or ARB. Heart failure (HF) (initial): Diagnosis of heart failure (with or without hypertension). Ejection fraction is less than or equal to 40 percent. Heart failure is classified as NYHA Class II, III or IV. Patient is receiving concomitant therapy with one of the following beta-blockers at a maximally tolerated dose or has a contraindication or intolerance to betablocker therapy: bisoprolol, carvedilol or metoprolol succinate. Age HF (initial): Prescribed by or in consultation with a cardiologist Other 74

75 EPCLUSA EPCLUSA will be applied consistent with current AASLD/IDSA guideline and the following: Diagnosis of Chronic hepatitis C infection and A) lab data confirming positive HCV RNA level, taken within the previous 6 months, AND B) HCV genotype 1a, 1b, 2, 3, 4, 5, or 6, without cirrhosis, with compensated cirrhosis or decompensated cirrhosis. Age Infectious disease, gastroenterology, hepatologist : 12 weeks. Other 75

76 EPOGEN EPOGEN INJECTION SOLUTION UNIT/ML, 2000 UNIT/ML, UNIT/ML, 4000 UNIT/ML Covered Uses All medically accepted indications not otherwise excluded from Part D. 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 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 10g/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. Anemia with HIV (Initial): Anemia by lab values (Hgb less than 12 g/dl or Hct less than 36%) collected within 30 days of request. Serum erythropoietin level less than or equal to 500 mu/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 than 100ng/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, non-cardiac, non-vascular surgery with anemia and hemoglobin greater than10 g/dl but less than 12 g/dl. Age Other For patients with cancer: prescribers must be under the ESA APPRISE Oncology program 3 months Home or LTC administration covered under Medicare Part D. Physician office or healthcare setting administration, redirect for Medicare Part B 76

77 coverage. 77

78 ERBITUX ERBITUX INTRAVENOUS SOLUTION 100 MG/50ML Head and Neck Cancer: Diagnosis of locally or regionally advanced squamous cell head and neck cancer and used in combination with radiation therapy, or diagnosis of recurrent or metastatic squamous cell head and neck cancer and 1 of the following: failure of platinum-based chemotherapy, or used in combination with 1 of the following: cisplatin (Platinol AQ), carboplatin (Paraplatin), cisplatin (Platinol AQ) plus 5-FU (Adrucil), or carboplatin (Paraplatin) plus 5-FU (Adrucil). Colorectal Cancer: Diagnosis of metastatic carcinoma of the colon or rectum. One of the following: Used in combination with either FOLFOX (fluorouracil, leucovorin, and oxaliplatin) or FOLFIRI (fluorouracil, leucovorin, and irinotecan), OR failure or intolerance to irinotecan-based chemotherapy, oxaliplatin-based chemotherapy, or intensive therapy (eg, FOLFOX or FOLFIRI), OR used as monotherapy in patients not appropriate for intensive therapy. Tumor expresses wild-type KRAS gene and wild type NRAS gene. Non-Small Cell Lung Cancer (NSCLC): Diagnosis of recurrent or metastatic NSCLC stage IIIB or IV. One of the following: Used in combination with vinorelbine (Navelbine) and cisplatin (Platinol AQ), OR used as a single-agent for continuation maintenance therapy and Erbitux was given first-line with chemotherapy. Epidermal growth factor receptor (EGFR) expression by immunohistochemistry. Age Other Prescribed by or in consultation with an oncologist Subject to Part B vs. Part D review. Approve for continuation of prior therapy. 78

79 ERIVEDGE ERIVEDGE Age Other Diagnosis of metastatic basal cell carcinoma OR Diagnosis of locally advanced basal cell carcinoma that has recurred following surgery or when the patient is not a candidate for surgery and radiation 18 years of age or older Prescribed by or in consultation with an oncologist or dermatologist Approve for continuation of prior therapy. 79

80 ERWINAZE ERWINAZE INJECTION Member has experienced any of the following with prior asparaginase therapy: serious hypersensitivity reactions, including anaphylaxis, serious pancreatitis, serious thrombosis, serious hemorrhagic events Diagnosis of acute lymphoblastic leukemia AND Patient has a hypersensitivity to E. coli-derived asparaginase Age Other 80

81 ESBRIET ESBRIET Exclude if being used with Ofev Idiopathic pulmonary fibrosis (IPF) (initial): Both of the following: 1) diagnosis of IPF as documented by all of the following: a) exclusion of other known causes of interstitial lung disease (ILD) (eg, domestic and occupational environmental exposures, connective tissue disease, drug toxicity), AND b) one of the following: i) in patients not subjected to surgical lung biopsy, the presence of a usual interstitial pneumonia (UIP) pattern on high-resolution computed tomography (HRCT) revealing IPF or probable IPF, OR ii) in patients subjected to a lung biopsy, both HRCT and surgical lung biopsy pattern revealing IPF or probable IPF. Age Other Prescribed by or in consultation with a pulmonologist For renewal, patient experienced stabilization from baseline or a less than 10 percent decline in force vital capacity AND the patient has not experienced AST or ALT elevations greater than 5 times the upper limit of normal or greater than 3 times the upper limit of normal with signs or symptoms of severe liver damage. 81