Drugs That Require Prior Authorization (PA) Before Being Approved for Coverage

Value Drugs That Require Prior Authorization (PA) Before Being Approved for You will need authorization by your Express Scripts Medicare (PDP) before filling prescriptions for the drugs shown in the chart below. The Express Scripts Medicare (PDP) will only provide coverage after it determines that the drug is being prescribed according to the criteria specified in the chart. You, your appointed representative, or your prescriber can request prior authorization by calling Express Scripts toll-free at 1.800.935.6103, 24 hours 7 days a week, including Thanksgiving and Christmas. Customer Service is available in English and other languages. TTY/TDD users should call 1.800.716.3231. Express Scripts Medicare (PDP) is a prescription drug plan with a Medicare contract. Enrollment in Express Scripts Medicare depends on contract renewal. Y0046_LT44441EB Approved No changes made since 09/2014 LT44441EB

ACTEMRA Actemra INJ 200MG/10ML PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on tocilizumab for a Covered Use. Tocilizumab should not be given in combination with tumor necrosis factor (TNF) antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, anakinra, rituximab, or tofacitinib. For rheumatoid arthritis (RA), approve for adults. Prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months. Adults with RA, approve for patients who have tried for at least 3 months or who were intolerant to adalimumab, or etanercept. Systemic-onset JIA, approve for patients who have tried a systemic corticosteroid or MTX, leflunomide, or sulfasalazine or another DMARD such as etanercept, adalimumab, infliximab, or anakinra OR have systemic arthritis with active systemic features and features of poor prognosis (eg, arthritis of the hip, radiographic damage). 2

ACTEMRA SQ Actemra INJ 162MG/0.9ML PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on tocilizumab for a Covered Use. Concurrent use with another biologic therapy (e.g., certolizumab, etanercept, adalimumab, anakinra, abatacept, infliximab, rituximab, golimumab) or with tofacitinib. RA - adults Prescribed by or in consultation with a rheumatologist. 12 months RA - The pt had a 3 month trial with tofacitinib or one of the following biologic DMARDs, unless intolerant: Actemra (IV), abatacept, rituximab, or a tumor necrosis factor (TNF) antagonist (e.g., etanercept, adalimumab, certolizumab, infliximab, or golimumab 3

ACTHAR H.p. Acthar PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Use in patients with multiple sclerosis (MS) as pulse therapy on a monthly basis. MS exacerbation, history of corticosteroid use. Infantile spasms, prescribed by or in consultation with a neurologist or an epileptologist. MS exacerbation, prescribed by or in consultation with a neurologist or physician that specializes in the treatment of MS. Infantile spasms, 12 months. MS exacerbation, approve 1 month. For MS exacerbation, approve if the patient cannot use high-dose IV corticosteroids because IV access is not possible or if the patient has tried high-dose corticosteroids administered IV for an acute MS exacerbation and has experienced a severe or limiting adverse effect. 4

ADEMPAS Adempas PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other PAH and CTEPH- must be precribed by or in consultation with a cardiologist or a pulmonologist. 12 months For PAH - must have PAH (WHO Group 1) and had a right heart catheterization to confirm the diagnosis of PAH (WHO Group 1). Right heart cathererization is not required in pts who are currently receiving Adempas or another agent indicated for WHO group 1. 5

ADHD NON-STIMULANT MEDICATIONS Intuniv Strattera PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Authorization will be for 12 months. 6

AFINITOR Afinitor Afinitor Disperz PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already taking Afinitor for a Covered Use. Advanced, unresectable neuroendocrine tumors. Perivascular Epitheloid Cell Tumors (PEComa), Recurrent Angiomyolipoma, Lymphangioleiomyomatosis. HER2 status. Advanced HER2-negative breast cancer, hormone receptor (HR) status. Authorization will be for 12 months. Advanced HER2-negative breast cancer, approve if the patient is a postmenopausal woman and has HR+ disease and Afinitor will be used in combination with exemestane or tamoxifen and the patient has tried letrozole or anastrozole. Renal cell carcinoma (RCC), approve if patient meets one of the following: 1) patient has advanced RCC with predominant clear cell histology AND the patient has tried Inlyta, Votrient, has tried Sutent or Nexavar OR 2) patient has relapsed or medically unresectable RCC with non-clear cell histology.tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA), approve if the patient requires therapeutic intervention but cannot be curatively resected. 7

ALPHA-1 PROTEINASE INHIBITORS Aralast Np INJ 400MG Prolastin-c PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Alpha-1 antitrypsin (AAT) deficiency-associated panniculitis. Age Other For AAT deficiency with emphysema (or COPD), approve in patients with baseline (pretreatment) alpha1-antitrypsin serum concentration less than 11 microm (11 micromol/l) or 80 mg/dl. Authorization will be for 12 months, unless otherwise specified. For all covered uses, the patient is required to try Aralast NP first line. For AAT deficiency with emphysema (or COPD), approve in patients with baseline (pretreatment) alpha1-antitrypsin serum concentration less than 11 microm (11 micromol/l) or 80 mg/dl. 8

AMPYRA Ampyra PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on dalfampridine extended-release for Multiple Sclerosis (MS). MS. If prescribed by, or in consultation with, a neurologist or MS specialist. Authorization will be for 12 mos. 9

ANABOLIC STEROIDS Oxandrolone ORAL TABS PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Girls w/turner's Syndrome or Ullrich-Turner Syndrome, management of protein catabolism w/burns or burn injury, AIDS wasting and cachexia. Authorization will be for 12 months, unless otherwise specified. 10

ARCALYST Arcalyst PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on rilonacept for Muckle Wells Syndrome (MWS) or Familial Cold Autoinflammatory Syndrome (FCAS). Rilonacept should not be given in combination with tumor necrosis factor (TNF) blocking agents (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), anakinra, or canakinumab. Greater than or equal to 12 years of age. Prescribed by, or in consultation with, a rheumatologist, geneticist, or dermatologist. Initial approval of MWS/FCAS, 2 mos. Subsequent authorization for 12 mos if patient had a response. Patients already started on rilonacept for MWS/FCAS may receive authorization if they have had a response and are continuing therapy to maintain response/remission. 11

BOSULIF Bosulif PA Covered Uses Age Other Details All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Bosulif for a Covered Use. Diagnosis for which Bosulif is being used. For chronic myelogenous leukemia (CML), the Philadelphia chromosome (Ph) status of the leukemia must be reported. For CML, prior therapies tried must be reported to confirm resistance or intolerance. Authorization will be for 12 months. For CML, patient must have Ph-positive CML and must have resistance or intolerance to prior therapy for approval. 12

BOTOX Botox INJ 100UNIT PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D. Plus Achalasia. Anal Fissure. BPH. Chronic facial pain/pain associated with TMJ dysfunction. Chronic low back pain. Headache (migraine, chronic tension HA, whiplash, chronic daily HA). Palmar/plantar and facial hyperhidrosis. Myofascial pain. Salivary hypersecretion. Spasticity (eg, due to cerebral palsy, stroke, brain injury, spinal cord injury, MS, hemifacial spasm). Essential tremor. Dystonia other than cervical (eg, focal dystonias, tardive dystonia, anismus). Frey's syndrome (gustatory sweating). Ophthalmic disorders (eg, esotropia, exotropia, nystagmus, facial nerve paresis). Speech/voice disorders (eg, dysphonias). Tourette's syndrome. Additional indications will be evaluated by a pharmacist and/or a physician on a case-by-case basis. Use in the management of cosmetic uses (eg, facial rhytides, frown lines, glabellar wrinkling, horizontal neck rhytides, mid and lower face and neck rejuvenation, platsymal bands, rejuvenation of the peri-orbital region), allergic rhinitis, gait freezing in Parkinsons disease, vaginismus, interstitial cystitis, trigeminal neuralgia, or Crocodile tears syndrome. Headache if prescribed by, or after consultation with, a neurologist or HA specialist. Authorization will be for 12 months, unless otherwise specified. 13

Other Primary axillary hyperhydrosis after trial with at least 1 topical agent (eg, aluminum chloride). BPH after trial with at least 2 other therapies (eg, alpha1-blocker, 5 alpha-reductase inhibitor, TURP, transurethral microwave heat treatment, TUNA, interstitial laser therapy, stents, various forms of surgery). Chronic low back pain after trial with at least 2 other pharmacologic therapies (eg, NSAID, antispasmodics, muscle relaxants, opioids, antidepressants) and if being used as part of a multimodal therapeutic pain management program. Headache (eg, migraine, chronic tension headache, whiplash, chronic daily headache) after a trial with at least 2 other pharmacologic therapies (eg, anticonvulsants, antidepressants, beta-blockers, calcium channel blockers, non-steroidal anti-inflammatory drugs). Palmar/plantar and facial hyperhidrosis after a trial with at least 1 topical agent (eg, aluminum chloride). Essential tremor after a trial with at least 1 other pharmacologic therapy (eg, primidone, propranolol, benzodiazepines, gabapentin, topiramate). Urinary incontinence after a trial with at least 1 other pharmacologic therapy (eg, oral antimuscarinic agents). Tourette s syndrome if after a trial with at least 1 more commonly used pharmacologic therapy (eg, neuroleptics, clonidine, SSRIs, psychostimulants). 14

CHENODAL Chenodal PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Authorization will be for 12 months. For the treatment of gallstones, approve if the patient has tried or is currently using an ursodiol product. 15

CHORIONIC GONADOTROPINS (HCG) Chorionic Gonadotropin INJ PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Prepubertal cryptorchidism, 4 years or older. Authorization will be for 12 months, unless noted otherwise. Hypogonadotropic hypogonadism in males. 16

CIALIS Cialis ORAL TABS 2.5MG, 5MG PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Indication for which tadalafil is being prescribed. Authorization will be for 12 mos. Benign prostatic hyperplasia (BPH), after confirmation that tadalafil is being prescribed to treat the signs and symptoms of BPH and not for the treatment of erectile dysfunction (ED) and after a trial of an alpha-1 blocker (eg, doxazosin [Cardura XL], terazosin, tamsulosin [Flomax], alfuzosin extended-release [UroXatral]) or 5 alpha reductase inhibitor (eg, finasteride, dutasteride [Avodart]). 17

CIMZIA Cimzia PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D plus patients already started on certolizumab pegol for Covered use. Concurrent use with tumor necrosis factor (TNF) alpha antagonists (eg, adalimumab, etanercept, golimumab, and infliximab), or anakinra, rituximab, abatacept, natalizumab, tocilizumab. Adults. RA, prescribed by or in consultation with a rheumatologist. Crohn s disease, prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months. Other Adult RA, approve if the patient has tried Enbrel or Humira for at least 3 months OR the patient is concurrently receiving MTX OR the patient has a contraindication or intolerance to MTX and leflunomide OR the patient has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation (eg, based on HAQ-DI score), extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph. Adult CD, approve if patient has previously tried Humira OR the patient has tried or is currently taking corticosteroids, unless contraindicated. 18

CINRYZE Cinryze PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus for the acute treatment of Hereditary Angioedema (HAE). Must be prescribed by, or in consultation with, an allergist/immunologist or a physician that specializes in the treatment of HAE or related disorders. Authorization will be for 12 months. 19

COMETRIQ Cometriq PA Covered Uses Age Other Details All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Cometriq for a Covered Use. Diagnosis of progressive, metastatic medullary thyroid cancer. Authorization will be for 12 months. 20

COPAXONE Copaxone INJ 20MG/ML PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Concurrent use with other disease-modifying agent used for multiple scelorosis (ie, interferon beta-1a, interferon beta-1b, natalizumab, fingolimod). Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months, unless otherwise specified. 21

CRINONE GEL Crinone GEL 8% PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, secondary amenorrhea, support of an established pregnancy. Use in patients to supplement or replace progesterone in the management of infertility. Secondary amenorrhea, 12 months.support of an established pregnancy, 9 months. 22

DALIRESP Daliresp PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D Chronic Obstructive Pulmonary Disease (COPD), FEV1 results to confirm severity, medications tried. Authorization will be for 12 months. COPD, approve in patients who meet all of the following conditions: Patients has severe COPD (defined as an FEV1 less than 50% predicted) or very severe COPD (defined as FEV1 less than 30% predicted), AND Patient has chronic bronchitis, AND Patient has a history of exacerbations, AND Patient has tried a medication from two of the three following drug categories: long-acting beta2-agonist (LABA) [eg, salmeterol, formoterol], long-acting anticholinergic (eg, tiotropium), inhaled corticosteroid (eg, fluticasone). 23

ENBREL Enbrel PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D plus patient already on etanercept for a Covered Use.Graft versus host disease (GVHD). Behcet's disease. Autoimmune mucocutaneous blistering diseases (pemphigus vulgaris, mucous membrane pemphigoid [cicatricial pemphigoid]) (AMBD). Uveitis Concurrent use with adalimumab, anakinra, abatacept, certolizumab pegol, ustekinumab, infliximab, rituximab, golimumab, or tocilizumab. For use in rheumatoid arthritis (RA), approve for adults. For juvenile idiopathic arthritis (JIA) approve for children aged 2 years and older. RA/Ankylosing spondylitis/jia/jra,prescribed by or in consult w/ rheumatologist. Psoriatic arthritis, prescribed by or in consultation w/ rheumatologist or dermatologist.plaque psoriasis (PP)/AMBD, prescribed by or in consult w/ dermatologist.gvhd,prescribed by or in consult w/ oncologist,hematologist,or physician affiliated w/ transplant center.behcet s disease,prescribed by or in consult w/ rheumatologist,dermatologist,ophthalmologist,gastroenterologist,or neurologist. Uveitis- ophthalmol Authorization will be for 12 months, unless otherwise specified. 24

Other RA, Tried 1 DMARD for 3 mos or is also receiving MTX, has a contraindication or intolerance to MTX and leflunomide, or has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph. JIA/JRA, approve if the pt has aggressive disease or the pt has tried one other agent for this condition (eg, MTX, sulfasalazine, leflunomide, NSAID, biologic DMARD or the pt will be started on Enbrel concurrently with MTX, sulfasalazine, or leflunomide or the pt has an absolute contraindication to MTX (eg, pregnancy, breast feeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias), sulfasalazine, or leflunomide.plaque psoriasis (PP). Approve if the patient has tried at least one of the following agents for at least 3 months for plaque psoriasis: an oral therapy for psoriasis (eg, MTX, cyclosporine, Soriatane), oral methoxsalen plus PUVA, or a biologic agent OR the patient had intolerance to a trial of at least one oral or biologic therapy for plaque psoriasis OR the patient has a contraindication to one oral agent for psoriasis such as MTX. GVHD. Tried or currently is receiving with etanercept 1 conventional GVHD tx (high-dose SC, CSA, tacrolimus, MM, thalidomide, antithymocyte globulin, etc.). Behcet's. Have not responded to at least 1 conventional tx (eg, CS, immunosuppressant, interferon alfa, MM, etc) or adalimumab or infliximab. AMBD. Tried 2 conventional txs (eg, systemic corticosteroids, azathioprine, cyclophosphamide, dapsone, MTX, cyclosporine, mycophenolate mofetil). Uveitis, tried 1 of the following periocular, intraocular, or systemic CS, immunosuppressives, Humira or Remicade 25

EPOETIN/PROCRIT Procrit PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Plus anemia in patients with HIV who are receiving zidovudine. Anemic patients (Hb of 13.0 g/dl or less) at high risk for perioperative transfusions (secondary to significant, anticipated blood loss and are scheduled to undergo elective, noncardiac, nonvascular surgery to reduce the need for allogeneic blood transfusions). Anemia due to myelodysplastic syndrome (MDS). Anemia associated with use of ribavirin therapy for hepatitis C (in combination with interferon or pegylated interferon alfa 2a/2b products with or without the direct-acting antiviral agents Victrelis or Incivek). Anemia in HIVinfected patients. Confirmation of adequate iron stores (eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%).CRF anemia in patients on dialysis.hemoglobin (Hb) of less than 10.0 g/dl for adults or less than or equal to 11 g/dl for children to start.hb less than or equal to 11.5 g/dl for adults or 12 g/dl or less for children if previously on epoetin alfa or Aranesp.CRF anemia in patients not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dl for adults or less than or equal to 11 g/dl in children to start or Hb less than or equal to 11.5 g/dl in adults or 12 g/dl or less in children.anemia w/myelosuppressive chemotx.hb 10.0 g/dl or less to start.hb less than or equal to 12.0 g/dl if previously on epoetin alfa or Aranesp.MDS, approve if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start.previously receiving Aranesp or EA, approve if Hb is 12.0 g/dl or less. Anemia in HIV (with or without zidovudine), Hb is 10.0 g/dl or less or endogenous erythropoetin levels are 500 munits/ml or less at tx start.previously on EA approve if Hb is 12.0 g/dl or less.anemia due to ribavirin for Hep C, Hb is 10.0 g/dl or less at tx start. Previously on EA or Aranesp approve if Hb is 12.0 g/dl or less. MDS anemia/hepc anemia = 18 years of age and older 26

Other MDS anemia, prescribed by or in consultation with, a hematologist or oncologist. Hep C anemia, prescribed by or in consultation with hepatologist, gastroenterologist or infectious disease physician who specializes in the management of hepatitis C. Anemia w/myelosuppressive = 4 mos.mds=6mo.transfus=1 mo.other=6mo. HIV + zidovudine = 4 mo Part B versus Part D determination will be made at time of prior authorization review per CMS guidance to establish if the drug prescribed is to be used for an end-stage renal disease (ESRD)-related condition. 27

ERIVEDGE Erivedge PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patient already started on Erivedge for a covered use. Authorization will be for 12 months Locally advanced basal cell carcinoma (LABCC), approve if the patient s BCC has recurred following surgery or the patient is not a candidate for surgery or radiation therapy. 28

FIRAZYR Firazyr PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Prescribed by, or in consultation with, an allergist/immunologist or a physican that specializes in the treatment of HAE or related disorders. Authorization will be for 12 mos. 29

FORTEO Forteo PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Concomitant use with other medications for osteoporosis (eg, denosumab [Prolia], bisphosphonates, raloxifene, calcitonin nasal spray [Miacalcin, Fortical]), except calcium and Vitamin D. Authorization will be for up to 2 years in a patient s lifetime. Treatment of PMO, approve if pt has tried one oral bisphosphonate OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried an IV bisphosphonate (ibandronate or zoledronic acid), OR pt has severe renal impairment (creatinine clearance less than 35 ml/min) or CKD or pt has had multiple osteoporotic fractures. Increase bone mass in men with primary or hypogondal osteoporosis/treatment of men and women with GIO, approve if pt tried one oral bisphosphonate OR pt cannot take an oral bisphosphonate because the patient cannot swallow or has difficulty swallowing or the patient cannot remain in an upright position post oral bisphosphonate administration or has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried zoledronic acid (Reclast), OR pt has severe renal impairment (CrCL less than 35 ml/min) or has CKD or has had multiple osteoporotic fractures. 30

GILENYA Gilenya PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Concurrent use of Gilenya with other disease-modifying agents used for multiple sclerosis (MS). For use in MS, patient has a relapsing form of MS. Prescribed by, or in consultation with, a neurologist or an MS specialist. Authorization will be for 12 months. For use in MS, patient has a relapsing form of MS and is not currently taking Gilenya, approve if the patient has tried interferon beta-1a intramuscular (Avonex), interferon beta-1a subcutaneous (Rebif), interferon beta-1b (Betaseron or Extavia), glatiramer acetate (Copaxone), teriflunomide (Aubagio), or natalizumab (Tysabri) or if the patient is unable to administer injections due to dexterity issues or visual impairment. Patient has a relapsing form of MS and is currently receiving Gilenya, approve without a trial of a disease modifying injectable for MS. 31

GILOTRIF Gilotrif PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other For NSCLC - EGFR exon deletions or mutations Authorization will be for 12 months. For the treatment of metastatic non small cell lung cancer (NSCLC) must be used in tumors with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations 32

GLEEVEC Gleevec PA Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Plus patients already started on Gleevec for a Covered Use. Age Other Diagnosis for which Gleevec is being used. For indications of CML and ALL, the Philadelphia chromosome (Ph) status of the leukemia must be reported. New patients with CML and ALL which is Ph-positive may receive authorization for Gleevec. Authorization will be for 12 months. For CML, new patient must have Ph-positive CML for approval of Gleevec. For ALL, new patient must have Ph-positive ALL for approval of Gleevec. 33

GROWTH HORMONES Norditropin Flexpro Norditropin Nordiflex Pen INJ 30MG/3ML Omnitrope INJ 5MG/1.5ML PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Growth hormone (GH) deficiency (DF). Non-GH deficient short stature (idiopathic short stature, ISS). Turner s syndrome (TS). SHOX (short stature homeobox-containing gene) deficiency. Chronic kidney disease (CKD). Prader-Willi syndrome (PW). Noonan syndrome (NS). Short bowel syndrome (SBS). Use in the management of acute critical illness due to complications of surgery, trauma, or with acute respiratory failure, as antiaging therapy, to improve functional status in elderly, somatopause, enhancement of athletic ability, bone marrow transplant (BMT) without total body irradiation, bony dysplasias, burn injury, cardiac transplantation, central precocius puberty, chronic fatigue syndrome, congenital adrenal hyperplasia, constitutional delay of growth and puberty, corticosteroidinduced short stature including a variety of chronic glucocorticoiddependent conditions, such as asthma, juvenile rheumatoid arthritis, after renal, heart, liver, or BMT, Crohn's disease, cystic fibrosis, dilated cardiomyopathy/heart failure, end-stage renal disease in adults undergoing hemodialysis, Down's syndrome, familial dysautonomia, fibromyalgia, HIV-infected patients with alterations in body fat distribution, infertility, kidney transplant patients (children) with a functional renal allograft, liver transplantation, multiple system atrophy, myelomeningocele, obesity, osteogenesis imperfecta, osteoporosis (postmenopausal, idiopathic in men, glucocorticoid-induced), thalassemia, and X-linked hypophosphatemic rickets (familial hypophosphatemia, hypophosphatemic rickets). 34

Child/adol GH DF initial tx, eval by an endocrin, documented GH stim test w/gh response less than 10 ng/ml AND base Ht less than the 10th pct for gender/age + pretx Ht growth rate (GR) child less than 3 yrs of less than 7 cm/yr and child greater than or equal to 3 yrs of less than 4 cm/yr OR child/adol less than 18 yrs of age GR less than the 10th pct for age/gender based on min 6 mo data.child w/brain radiation does not have to meet bas Ht crit.congenital hypopituit does not have to meet Ht or GR crit.child w/hypophysectomy,approve.child/adol GH DF cont tx, GR increased by 4 cm/yr or more in most recent yr (MRY) + epiphyses open (between 12 and 18 yrs),both crit exclude adol w/hypopituit.review GR annually.adoles/yng adult w/completed linear growth (GR less than 2 cm/yr), review for adult GH DF.Greater than 18 yrs,gr increased by 4 cm/yr or more in MRY AND epiphyses open, auth not allowed if midparental ht attained.iss child w/open epiphyses,6 mo trial if base Ht less than 5th pct + pretx GR child greater than or equal to 7 yrs of less than 4 cm/yr and child 3 or more yrs of less than 4 cm/yr OR child any age GR less than the 10th pct for age/gender based on min 6 mo of data and has condition which GH effective + endocrinol certifies via bone-age x-ray, + the pt doesn t have constitutional delay of growth and puberty (CDGP).Auth after initial tx based on adequate clinical response (annualized GR doubles).cont tx, at least 7 yrs and received somatropin on 6 mo trial, if GR has doubled in comparison to previous yr. At least 7 and less than 12 yrs, GR increased by 4 cm/yr or more in MRY. At least 12 and less than or equal to 18 yrs), GR increased by 4 cm/yr or more in MRY AND epiphyses open).greater than 18 yrs, GR increased by 4 cm/yr or more in MRY,+ epiphyses open auth not allowed if midparental ht attained.adult GH DF or PW/trans adoles, eval by endocrinol (start and annually).ns/shox/child PW, eval by an endocrinol, CKD, eval by an endocrinol or nephrologist. Age Child/adolesc w/gh DF (initial tx), adolescent is less than or equal to 18 years of age.ts, children. SHOX/CRI/NS, children/adolescents.hiv infection w/wasting or cachexia, less than or equal to 18 years of age.sbs/hiv cachexia/wasting, adults. For adults, the endocrinologist must certify that the somatropin is not being prescribed for anti-aging therapy or to enhance athletic ability. GH DF 12 mos.sbs 4-8wks/yr.Non-GH DF ISS 6 mos.hiv wast/cach 24 wks. 35

Other Adult GH DF (start), document diagnosis of GH DF due to adult-onset (GH alone or multiple hormone deficiencies/hypopituitarism from pituitary dz, hypothalamic dz, surgery, cranial radiation tx, tumor txment, traumatic brain injury, or subarachnoid hemorrhage) or due to childhoodonset (GH not rec in adults who had GH tx as child for uses not due to GH DF) AND negative response to 1 GH stim test (insulin tolerance [peak less than 5 mcg/l], or glucagon [peak less than 3 mcg/l]) [GHRH plus arginine may be used if available] (exclude stim test for childhoodonset due to mutations, lesions, congenital defects), transition adoles off somatropin 1 mo before retesting, OR 3 or more pituitary hormone deficiencies (TSH, ACTH, LH/FSH, or AVP) AND serum IGF-1 84 microg/l or less using the Esoterix ECB RIA or age/gender adjusted serum IGF-1 SDS below the lower limits of the normal reference range for the reporting laboratory.ts start, female and has short stature (SS).SHOX start, open epiphyses AND baseline Ht less than the 3rd percentile for gender/age.cri w/growth failure (GF), start, approve.child PW w/gf or adult PW, approve.ns start, baseline ht less than 5th percentile.ts/shox/ckd/child PW/NS, cont tx, GR increased by 2.5 cm/yr or more in most recent yr (MRY) AND epiphyses open.pw, Cont tx in Adult OR adolescent, GR increased by 2.5 cm/yr or more in most recent yr.hiv w/wasting or cachexia, HIV-positive AND have 1 of the following, documented unintentional wt loss of greater than or equal to 10% from baseline OR wt less than 90% of the lower limit of ideal body wt OR BMI less than or equal to 20 kg/m2 AND wasting or cachexia that is due to malabsorption, poor diet, opportunistic infection, depression, and other causes have been addressed prior to starting somatropin AND on antiretroviral tx greater than or equal to 30 days prior to beginning GH tx and will continue antiretroviral tx throughout GH txment. Repeat 12 or 24-wk courses of GH may be authorized after initial 12 or 24-wk GH course for HIV infection w/wasting or cachexia provided that they are off GH for at least 1 mo and meet all of previous HIV criteria.hiv-assoc failure to thrive.able to consume or be fed via parenteral or enteral feedings 75% or more of maintenance energy requirements based on current body wt AND on antiretroviral tx for greater than or equal to 30 days prior to beginning GH tx and will continue antiretroviral tx.sbs, receiving specialized nutritional support.sbs pts approve for a second 4- wk course if adult responded to somatropin therapy w/ a decrease in requirement for specialized nutritional support according to prescribing physician. 36

HIGH RISK MEDICATIONS - BENZODIAZEPINES Clonazepam ORAL TABS Clonazepam Odt Clorazepate Dipotassium ORAL TABS 15MG Diazepam RECTAL GEL Lorazepam ORAL TABS 0.5MG Onfi ORAL TABS 10MG, 20MG Onfi SUSP Oxazepam Temazepam PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Procedure-related sedation = 1mo. All other conditions = 12 months. All medically accepted indications other than Restless Leg Syndrome and insomnia, authorize use. Restless Leg Syndrome, approve clonazepam or temazepam if the patient has tried one other agent for this condition (eg, ropinirole, pramipexole, carbidopa-levodopa [immediate-release or extended-release]). Insomnia, approve lorazepam, oxazepam, or temazepam if the patient has had a trial with two of the following: ramelteon, trazodone, doxepin 3mg or 6 mg, eszopiclone, zolpidem, or zaleplon. 37

HIGH RISK MEDICATIONS - FIRST GENERATION ANTIHISTAMINES Hydroxyzine Hcl ORAL SOLN Hydroxyzine Hcl ORAL TABS Promethazine Hcl ORAL TABS Promethazine Hcl SYRP PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Authorization will be for 12 months. For promethazine tablets/syrup, authorize use without a previous drug trial for all FDA-approved indications other than emesis, including cancer/chemo-related emesis. For diphenhydramine capsules/elixir, authorize use without a previous drug trial for all FDA-approved indications other than insomnia. For hydroxyzine hydrochloride tablets/syrup, authorize use without a previous drug trial for all FDAapproved indications other than anxiety. For the treatment of noncancer/chemo related emesis, approve promethazine hydrochloride tablets or syrup if the patient has tried a prescription oral anti-emetic agent (ondansetron, granisetron, dolasetron, palonosetron, aprepitant) for the current condition. Approve diphenhydramine (capsules or elixir) if the patient has tried at least two other FDA-approved products for the management of insomnia. Approve hydroxyzine hydrochloride (tablets and syrup) or hydroxyzine pamoate (capsules) if the patient has tried at least two other FDA-approved products for the management of anxiety. 38

HIGH RISK MEDICATIONS - TERTIARY TRICYCLIC ANTIDEPRESSANTS Amitriptyline Hcl ORAL TABS Clomipramine Hcl ORAL CAPS Clorazepate Dipotassium ORAL TABS 3.75MG, 7.5MG Diazepam ORAL TABS Diazepam SOLN Diazepam Intensol Doxepin Hcl CONC Doxepin Hcl ORAL CAPS Imipramine Hcl ORAL TABS Imipramine Pamoate Lorazepam ORAL TABS 1MG, 2MG Lorazepam Intensol Trimipramine Maleate ORAL CAPS PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Patients aged less than 65 years, approve. Patients aged 65 years and older, other criteria apply. Authorization will be for 12 months. 39

Other For the treatment of depression, approve if the patient has tried at least two of the following agents (brand or generic): citalopram, escitalopram, fluoxetine, paroxetine, sertraline, venlafaxine, desvenlafaxine, duloxetine, bupropion, mirtazapine, nortriptyline, desipramine, or trazodone. For the treatment of pain, may approve amitriptyline (single-entity only, not amitriptyline combination products) or imipramine (brand or generic) if the patient has tried at least two of the following agents: duloxetine, pregabalin, gabapentin, venlafaxine, venlafaxine Er, desipramine, or notriptyline. For the mangement of insomnia, may approve amitriptyline (single-entity only, not amitriptyline combination products), doxepin greater than 6 mg, or imipramine (brand or generic) if the patient has tried at least two of the following medications: ramelteon, trazodone, or doxepin 3 mg or 6 mg. For the treatment of obessessive compulsive disorder (OCD), may approve clomipramine (brand or generic) if the patient has tried at least two of the following medications: fluoxetine, fluvoxamine, paroxetine, sertraline, citalopram, escitalopram, or venlafaxine. 40

HUMIRA Humira Humira Pen-crohns Diseasestarter PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D plus patients already started on adalimumab for a Covered Use. Concurrent use with anakinra, abatacept, rituximab, ustekinumab, certolizumab pegol, etanercept, infliximab, or golimumab. RA, adults. Crohn's disease (CD), 6 or older.ulcerative colitis (UC), adults. RA/JIA/JRA/Ankylosing spondylitis, prescribed by or in consultation with rheumatologist. Psoriatic arthritis (PsA), prescribed by or in consultation with a rheumatologist or dermatologist. Plaque psoriasis (PP), prescribed by or in consultation with a dermatologist. UC/ CD, prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months. 41

Other RA, Tried 1 DMARD (brand or generic, oral or injectable) for 3 mos (this includes patients who have tried other biologic DMARDs for 3 mos), or pt is concurrently receiving methotrexate (MTX), or pt has a contraindication or inolerance to MTX and leflunomide, as determined by prescribing physician, or pt has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-cyclic citrullinated protein antibodies, or bony erosions by radiograph. JIA/JRA. Tried another agent (e.g MTX, sulfasalazine, leflunomide, NSAID, or biologic DMARD (eg, etanercept, abatacept, infliximab, anakinra, tocilizumab) or will be starting on adalimumab concurrently with MTX, sulfasalazine, or leflunomide. Approve without trying another agent if pt has absolute contraindication to MTX, sulfasalazine, or leflunomide or if pt has aggressive disease. Plaque psoriasis (PP). Pt has tried a systemic therapy (eg, MTX, CSA, acritretin, etanercept, infliximab, or ustekinumab) for 3 mos or PUVA) for 3 months, or pt experienced an intolerance to a trial of at least one systemic therapy (oral or biologic therapy), or pt has a contraindication to one oral agent for psoriasis such as MTX, as determined by the prescribing physician. CD. Tried corticosteroids (CSs) or if CSs are contraindicated or if pt currently on CSs or patient has tried one other agent for CD (eg, azathioprine, 6-mercaptopurine, MTX, certolizumab, infliximab) OR pt had ilecolonic resection. UC. Pt has tried a systemic therapy (eg, 6- mercaptopurine, azathioprine, CSA, tacrolimus, infliximab, or a corticosteroid such as prednisone or methylprednisolone) for 3 2 months or was intolerant to one of these agents, or the pt has pouchitis and has tried therapy with an antibiotic, probiotic, corticosteroid enema, or mesalamine (Rowasa) enema. 42

ILARIS Ilaris PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on canakinumab (Ilaris) for a Covered Use. When used in combination with tumor necrosis factor (TNF) blocking agents (e.g., etanercept, adalimumab, certolizumab pegol, golimumab, infliximab), anakinra, or rilonacept. CAPS/MWS/FCAS intial tx- Prescribed by or in consultation with a rheumatologist, geneticist, or dermatologist. SJIA initial tx - prescribed by or in consultation with a rheumatologist Initial approval for MWS or FCAS, one dose, subsequent auth 12 mo if response. SJIA, 12 mos. Other For initial approval for MWS or FCAS, authorize one dose. After up to 8 weeks of therapy if the patient has had a response to therapy as determined by prescribing physician an additional 12 months authorization is allowed. For treatment of SJIA, approve. 43

INCIVEK Incivek PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients current taking Incivek for a Covered Use. Patients who have failed therapy with Incivek or another NS3/4A protease inhibitor (e.g., Victrelis) for HCV. Adults. Must be prescribed by or in consultation with a gastroenterologist, hepatologist, infectious disease physician, or a liver transplant physician. Authorization will be for 3 months. Must be prescribed in combination with peginterferon alfa and ribavirin. 44

INLYTA Inlyta PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Inlyta for a Covered Use. Authorization will be for 12 months Advanced renal cell carcinoma, approve the patient has failed at least one prior systemic therapy (eg, Torisel, Avastin, Sutent, IFN-alpha, IL-2, Votrient, Nexavar). 45

IVIG Privigen INJ 20GM/200ML PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Idiopathic thrombocytopenic purpura (ITP) or immune thrombocytopenia, acute and chronic treatment. Kawasaki disease (KD). B-cell CLL in patients with hypogammaglobulinemia and previous history of a serious bacterial infection. Chronic inflammatory demyelinating polyneuropathy (CIDP). Allogeneic bone marrow transplant (BMT) or hematopoietic stem cell transplantation (HSCT). HIV-infected infants and children less than 13 yrs old - prevention of recurrent bacterial infections (PRB) or passive immunization of varicella (chickenpox) [PIV]. Autoimmune hemolytic anemia (AIHA). Autoimmune mucocutaneous blistering diseases (AMBD). CMV interstitial pneumonia in allogeneic BMT or HSCT patients. Dermatomyositis and polymyositis (DaP). End stage heart failure, ESRD, end stage liver or lung disease, or small bowel transplant awaiting transplant or post-transplant, to lower allosensitization. Desensitization therapy prior to and immediately after solid organ (kidney, heart, lung, liver, intestinal) transplantation. Evans syndrome (EvS). Guillan-Barre syndrome (GBS). HIV-associated thrombocytopenia (HAT). Multifocal acquired demyelinating sensory and motor neuropathy or Lewis-Sumner syndrome. Multifocal motor neuropathy (MMN), treatment. Multiple myeloma (MM). Multiple sclerosis (MS), acute severe exacerbations (MSase). MS, post-partum to prevent relapses (MSppr). Myasthenia gravis (MG). Pure red blood cell aplasia (PRCA) secondary to chronic parvovirus B19 infection (infxn). PRCA, immunologic subtype. Stiff-person syndrome (SPS). Thrombocytopenia, fetal alloimmune (TFA). Varicella, postexposure prophylaxis (VPP). Vasculitic syndromes, systemic (VSS). Lambert-Eaton Myasthenic syndrome (LEMS) 46

Age ITP acute bleed, tried systemic corticosteroid (CS), or has a CI to tx w/ a CS according to prescribing physician or before surgery/procedure if PC less than 75,000 for majory surgery or less than 50,000 for other. Chronic ITP if patient (pt) tried a systemic CS, or has a CI to tx w/ a CS according to prescribing physician OR there is an urgent need to increase the plt count quickly AND IVIG will be started with a systemic CS. BMT/HSCT in previous yr, AND according to prescribing physician, pt has a significant risk of having frequent and/or severe bacterial infections despite antibiotic therapy, 6 mos if IgG is less than 500 mg/dl (not applicable to MM, malignant macroglobulinemia). HIV-infected kids PRB, on highly active antiretroviral therapy (HAART), IgG less than 400 mg/dl or functional antibody deficiency (2 or more serious bacterial infections (SBis) in 1 yr-period of HAART and antibiotic prophylaxis or absence of detectable antibody response). HIV-infected kids (PIV), 1 dose if VariZIG unavailable and no history of varicella infection, or seronegative for varicella-zoster virus, or has not received 2 varicella vaccine doses, or is immunized but is moderately/severely immunocompromised, and no IVIG dose within 2-3 wks of varicella exposure.evs, refer to ITP or AIHA criteria depending on predominant symptoms.gbs, approve if IVIG started within 2 wks and no longer than 4 wks of neuropathic symptoms onset or initial response to IVIG now having a relapse.hat, approve 1 mo if significant bleeding or on antiretroviral therapy (ART)/HAART. MM stable disease, recurrent SBis. LEMS - has paraneoplastic LEMS, tried one CS, AZA, or other immunosuppressive (CSA, MM), OR has contraind to BOTH CS AND AZA or immunosuppressive. HIV-infected infants and children less than 13 yrs old - prevention of recurrent bacterial infxns or passive immunization of varicella (chickenpox). Still's disease, adult. Retractable epilepsy, children. ITP acute bleed or chronic ITP less than 17 yrs old and adults greater than 17 yrs old. PID,allergist/immunol,immuno,otolaryng,pulmon,or ID.ITP/AIHA,hematol.KD,ped cardio or ped ID.B-cell CLL/ BMT/HSCT/CMV interstit pneumonia HCT/MM,oncol,hematol,or ID.CIDP/MMN/MG/SPS,neurol.HIV-kids/VPP,ID or immunol.hivinfected,id.dap,neurol or rheuma.gbs,neurol or GBS special.hat,id or HIV special.ms exac,msppr,ms special/neuro.prca infxn/prca, ID,immunol, hematol, transplant MD.Scleromyxedema,dermatol or rheumatol.tcp,fetal alloimmune,hematol or OB.Vasculitic syndromes,rheum or nephrol. Acute or surgery ITP,1 mo.cmv/prca,2 mo.gbs,1 mo. Fetal allo thrombo,6 mo.preg ITP,3 mo.others 12 mo 47

Other Part B versus D determination per CMS guidance to establish if drug used for PID in pt s home. KD, 2nd dose if failed to respond to initial therapy (tx). AIHA, tried systemic CS,or Rituxan (rituximab), OR has a CI to tx w/ a CS or Rituxan (rituximab) according to prescribing physician, or had splenectomy. AMBD, tried conventional txs (eg, systemic CS and immunosuppresive) OR has a CI to tx w/ a CS according to prescribing physician, or disease rapidly progressive/extensive/debilitating, or inadequate time for tx to have rapid effect. DaP, tried conventional tx of systemic CS and immunosuppressive, OR has a CI to tx w/ a CS or according to prescribing physician. Retractable epilepsy, tried an anticonvulsant and CS. MSase, 1 5-day course if not responded to or significant AE from 2 of following: oral/iv CS tx (if possible), plasma exchange, or adrencorticotropic hormone and continuing to deteriorate. MSppr, 6 mo in women not currently receiving disease-modifying tx. MG, 1 5-day course if MG exacerbation, requires stabilization before surgery, has been started on immunosuppressive drug or responded to previous IVIG course but weakens/relapses and no response to other drugs. PRCA from B19 infxn, 3 mos if chronic immunodeficient condition and clinically significant anemia or transfusion dependent. PRCA immunologic, tried prednisone and CPA or cyclosporine (CSA). VPP, 1 dose if VariZIG not available AND pt does not have evidence of immunity to varicella (i.e. pt has no history of the disease or ageappropriate vaccination) or pt immunocompromised, or pregnant woman. VSS, patient has anti-neutrophil antibody-associated vasculitis, tried a systemic CS and either CPA, methotrexate (MTX), Rituxan, or AZA. 48

JAKAFI Jakafi PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Jakafi for a Covered Use. Authorization will be for 12 months. 49

LETAIRIS/TRACLEER Letairis Tracleer PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Patients currently on Letairis or Tracleer for a Covered Use. Chronic thromboembolic pulmonary hypertension (CTEPH) (Tracleer). Age Other Pulmonary arterial hypertension (PAH) WHO Group 1patients not currently on Letairis or Tracleer or another agent indicated for WHO Group 1 PAH are required to have had a right-heart catheterization to confirm the diagnosis of PAH to ensure appropriate medical assessment. PAH WHO Group 1 patients currently on Letairis or Tracleer or another agent indicated for WHO Group 1 PAH may continue therapy without confirmation of a right-heart catheterization. For treatment of pulmonary arterial hypertension, Letairis or Tracleer must be prescribed by or in consultation with a cardiologist or a pulmonologist. Authorization will be for 12 months, unless otherwise specified. 50

LEUPROLIDE (LONG ACTING) Lupron Depot INJ 22.5MG, 3.75MG, 30MG, 45MG Lupron Depot-ped PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D but specific to the following drugs as follows: Prostate cancer (Lupron Depot), Endometriosis (Lupon Depot), Uterine leiomyomata (Lupon Depot), Treatment of central precocious puberty (Lupron Depot Ped). Ovarian cancer (Lupron Depot, Lupron Depot Ped). Breast cancer (Lupron Depot, Lupron Depot Ped). Induce amenorrhea during bone marrow transplant (Lupron Depot, Lupron Depot Ped). Premenstral syndrome (Lupron Depot, Lupron Depot Ped). Catamenial pneumothorax (Lupron Depot, Lupron Depot Ped). Paraphilias or other inappropriate sexual behaviors or disorders (Lupron Depot, Lupron Depot Ped). Dysfunctional uterine bleeding (Lupron Depot, Lupron Depot Ped). For dysfunctional uterine bleeding approve for up to 6 months and all other indications x 12 mos. Premenstrual syndrome (PMS) for patients that have tried two other therapies (e.g., selective serotonin reuptake inhibitors [SSRIs], oral contraceptives [OCs]). 51

LIDODERM Lidocaine PTCH Lidoderm PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus diabetic neuropathic pain. Authorization will be for 12 months, unless otherwise specified. 52

MEKINIST Mekinist PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Mekinist for a Covered Use. Diagnosis for which Mekinist is being used. For unresectable or metastatic melanoma must have documentation of BRAF V600E or V600K mutations Authorization will be for 12 months. For unresectable or metastatic melanoma must be used in patients with BRAF V600E or V600K mutations 53

NEULASTA Neulasta PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D but worded more broadly as cancer patients receiving myelosuppressive chemotherapy. Plus patients undergoing PBPC collection and therapy Cancer patients receiving chemotherapy, if prescribed by or in consultation with an oncologist or hematologist. Authorization will be for 6months. Cancer patients receiving chemotherapy, approve if the patient is receiving myelosuppressive anti-cancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen), OR the patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen and the patient has one or more risk factors for febrile neutropenia (eg, older patient [aged greater than or equal to 65 years]), history of previous chemotherapy or radiation therapy, pre-existing neutropenia, open wounds or active infection, poor performance status, OR the patient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony stimulating factor and a reduced dose or frequency of chemotherapy may compromise treatment. 54

NEUPOGEN Neupogen INJ 300MCG/0.5ML, 480MCG/0.8ML, 480MCG/1.6ML PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D worded more broadly as cancer patients receiving myelosuppressive chemotherapy, patients with acute myeloid leukemia (AML) receiving chemotherapy, cancer patients receiving bone marrow transplantation (BMT), patients undergoing peripheral blood progenitor cell (PBPC) collection and therapy, and patients with severe chronic neutropenia [SCN] (e.g., congenital neutropenia, cyclic neutropenia, idiopathic neutropenia). Neutropenia associated with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS). Treatment of myelodysplastic syndromes (MDS). Drug induced agranulocytosis or neutropenia. Aplastic anemia (AA). Acute lymphocytic leukemia (ALL). Cancer/AML, MDS, ALL, oncologist or a hematologist. Cancer patients receiving BMT and PBPC, prescribed by or in consultation with an oncologist, hematologist, or a physician who specializes in transplantation. SCN, AA- hematologist. HIV/AIDS neutropenia, infectious disease (ID) physician (MD), hematologist, or MD specializing in HIV/AIDS. chemo/scml-6mo.hiv/aids/4mo.mds- 3mo.PBPC,agranulocytosis,neutropenia,AA,ALL-1mo.All others=12mo 55

Other Cancer patients receiving chemotherapy, approve if the patient meets one of the following conditions: patient is receiving myelosuppressive anticancer medications that are associated with a high risk of febrile neutropenia (the risk is at least 20% based on the chemotherapy regimen), patient is receiving myelosuppressive anti-cancer medications that are associated with a risk of febrile neutropenia but the risk is less than 20% based on the chemotherapy regimen and the patient has one or more risk factors for febrile neutropenia (eg, older patient [aged greater than or equal to 65 years], history of previous chemotherapy or radiation therapy, pre-existing neutropenia, open wounds or active infection, poor performance status), patient has had a neutropenic complication from prior chemotherapy and did not receive prophylaxis with a colony stimulating factor (eg, Leukine, Neulasta, Neupogen) and a reduced dose or frequency of chemotherapy may compromise treatment, patient has received chemotherapy has febrile neutropenia and has at least one risk factor (eg, sepsis syndrome, aged greater than 65 years, severe neutropenia [absolute neutrophil account less than 100 cells/mm3], neutropenia expected to be greater than 10 days in duration, invasive fungal infection). 56

NEXAVAR Nexavar PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Nexavar for a covered use, osteosarcoma, angiosarcoma, advanced or unresectable desmoids tumors, gastrointestinal stromal tumors (GIST), differentiated (ie, papillary, follicular, Hurthle) thyroid carcinoma, medullary thyroid carcinoma. Authorization will be for 12 months. Osteosarcoma, approve if the patient has tried standard chemoterhapy and have relapsed/refractory or metastatic disease. GIST, approve if the patient has tried imatinib mesylate (Gleevec) and sunitinib (Sutent). Differentiated thyroid carcinoma, approve if the patient has clinically progressive or symptomatic metastatic disease and the patient has nonradioiodine-responsive tumors at sites other than the central nervous system. Medullary thyroid carcinoma, approve if the patient has disseminated symptomatic disease and the patient has tried vandetanib (Caprelsa) or cabozantinib (Cometriq). 57

NUVIGIL/PROVIGIL Modafinil PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Fatigue associated with multiple sclerosis (MS) - modafinil only. Excessive daytime sleepiness (EDS) due to myotonic dystrophy - modafinil only. Adjunctive/augmentation for treatment of depression in adults - modafinil only. Idiopathic hypersomnolence - modafanil only Age Patients must be greater than or equal to 17 years of age. Authorization will be for 12 months, unless otherwise specified. Other Excessive sleepiness due to SWSD if the patient is working at least 5 overnight shifts per month. Adjunctive/augmentation treatment for depression in adults if the patient is concurrently receiving other medication therapy for depression. Idiopathic hypersomnolence is covered diagnosis is confirmed by a sleep specialist physician or at an institution that specializes in sleep disorders (i.e., sleep center). 58

OLYSIO Olysio PA Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Age Other 18 years or older Prescribed by or in consultation with a GI, hepatologist, ID, or a liver transplant MD 12 weeks Genotype 1 - prescribed in combination with PegINF and RBV or in combination with Sovaldi. Has not failed therapy with Olysio or another NS3/4A Protease Inhibitor for HCV (i.e., Incivek or Victrelis). Pts with genotype 1a must NOT have the Q80K polymorphism (unknown Q80K status is not covered). 59

ORENCIA Orencia PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients who have already been started on abatacept for a covered use. Concurrent use with a tumor necrosis factor (TNF) alpha antagonist (e.g., etanercept, adalimumab, certolizumab pegol, golimumab, or infliximab) with anakinra, rituximab, or tocilizumab. Rheumatoid arthritis (RA), adults. RA and JIA/JRA prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months, unless otherwise specified. RA, approve if the patient has tried adalimumab, or etanercept for at least 3 months, or was intolerant to one of these therapies OR the patient has moderate or high disease activity or features of poor prognosis (ie, functional limitation [eg, based on HAQ-DI score], extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph), and the patient has tried one oral DMARD (eg, MTX, leflunomide, sulfasalazine, hyroxychloroquine) for at least 3 months. Juvenile idiopathic arthritis (JIA) [or Juvenile Rheumatoid Arthritis (JRA)], approve Orencia IV only if the patient has tried adalimumab or etanercept for at least 2 months or was intolerant to one of these therapies (Orencia SC is not FDA-approved for the treatment of JIA/JRA). 60

OTEZLA Otezla PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Otezla for a Covered Use. Must not be used combination in with a biologic DMARD or targeted synthetic DMARD. Prescribed by or in consultation with a dermatologist or rheumatologist. 12 months For psoriatic arthritis, must have tried or previously used a conventional synthetic DMARD (eg, MTX, leflunomide, sulfasalazine) for at least 3 months. If the patient has had a 3-month trial of a biologic DMARD such as Cimzia, Enbrel, Humira, Remicade, Simponi SC, or Stelara, the patient is not required to try a conventional synthetic DMARD. 61

PEGYLATED INTERFERONS Pegasys Pegasys Proclick INJ 135MCG/0.5ML Peg-intron Peg-intron Redipen PA Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Patient has been started on Pegasys for a Covered use. Patient has been started on PegIntron for a Covered use. Age CHC approve Pegasys if 5 years of age or older and PegIntron if 3 years of age or older. For pts with recurrent hep C after liver transplant and pts with CHC on waiting list for liver transplantation, must be prescribed by, or in consultation with, an infectious disease MD, gastroenterologist, hepatologist, or a transplant MD. For all other indications, must be prescribed by, or in consultation with, an infectious disease MD, gastroenterologist, or hepatologist. HepC.24,48,72 wks.acute hepc. 24 wks.chronic hepc waiting for lvr trnplnt 12 mo.non-hepc 12 mo 62

Other Genotype (gtype)1,4,5,or6 chronic hep C (CHC) - Tx- naïve pts, authorize 48 wks if peginterfreron is prescribed in combination with ribavirin unless there is a contraindication (CI) or intolerance to ribavirin AND the pt is not on a waiting list for liver transplantation AND the pt does not have recurrent hepc after liver transplantation.gtype 2or3 CHC-Tx-naïve pts, w/o hep B or HIV co-infection, auth 24 wks if peginterferon prescribed in comb w/ ribavirin unless CI or intolerance AND pt does not have gtype 3 CHC and high viral titer or adv fibrosis AND the pt is not on a waiting list for liver transplant AND the pt does not have recurrent hepc after liver transplant.gtype 2or3 CHC-Tx-naïve pts, w/ HIV or hepb co-infection, auth 48 wks if peginterferon prescribed in comb w/ ribavirin unless CI or intolerance AND pt is not on a waiting list for liver transplant AND pt does not have recurrent hepc after liver transplant.gtype 2or3 CHC-Txnaïve pts, pediatric pt with high iron load at baseline,auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt is not on a waiting list for liver transplant AND the pt does not have recurrent hepc after liver transplant. Gtype 3 CHC-Tx-naïve pts and high level of HCV RNA or advanced fibrosis, auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt is not on a waiting list for liver transplant AND pt does not have recurrent hepc after liver transplant.chc (any viral gtype).retx pts,auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt has previously received tx w/ or w/o ribavirin for tx of hepc AND its been at least 3 mo since completion of the prior interferon/peginterferon tx course AND the pt is not on a waiting list for liver transplant AND pt does not have recurrent hepc after liver transplant. Acute hepc,auth 24 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance to ribavirin AND its been at least 8 wks after acute onset. Extend tx to 72 wks in slow responders.tx naïve pts (gtype 1,4,5,or6), auth 24 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND the pt does not have HIV coinfection AND is not on a waiting list for liver transplant AND the pt does not have recurrent hepc after liver transplantat AND the viral titer has decreased by at least 2 log 10, but the virus was still detectable at wk 12, AND the virus was undetectable at wk 24.Pts with recurrent hepc after liver transplant, auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance AND pt has grade 2 fibrosis or greater.chc, on a waiting list for liver transplantat, auth 48 wks if peginterfreron prescribed in comb w/ ribavirin unless CI or intolerance to ribavirin. 63

PHOSPHODIESTERASE-5 INHIBITORS FOR PAH Revatio INJ Sildenafil PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Pulmonary arterial hypertension (PAH) WHO Group 1, patients not currently taking an agent indication for WHO Group 1 PAH are required to have had a right-heart catheterization to confirm diagnosis of PAH to ensure appropriate medical assessment. PAH WHO Group 1patients currently receiving an agent indicated for WHO Group 1 PAH may continue therapy without confirmation of a right-heart catheterization. For PAH, if prescribed by, or in consultation with, a cardiologist or a pulmonologist. Authorization will be for 12 months, unless otherwise specified. For approval of sildenafil injection, patient must be unable to take an oral PDE-5 inhibitor. 64

PROMACTA Promacta PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Thrombocytopenia due to hepatitis C virus (HCV)-related cirrhosis. Age Other Use in the management of thrombocytopenia in myelodysplastic syndrome (MDS). Use in combination with Nplate for treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia purpura. Cause of thrombocytopenia. Thrombocytopenia due to HCV-related cirrhosis, platelet counts. Adults Treatment of thrombocytopenia due to chronic immune (idiopathic) thrombocytopenic purpura (ITP), approve if prescribed by, or after consultation with, a hematologist. Treatment of thrombocytopenia due to HCV-related cirrhosis, approve if prescribed by, or after consultation with, either a gastroenterologist, a hepatologist, or a physician who specializes in infectious disease. Authorization will be for 12 months. Thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenia purpura, approve if the patient has tried corticosteroids or IVIG or has undergone a splenectomy. Treatment of thrombocytopenia due to HCV-related cirrhosis, approve to allow for initiation of antiviral therapy if the patient has low platelet counts (eg, less than 75,000 mm3) and the patient has chronic HCV infection and is a candidate for hepatitis C therapy (eg, Pegasys or PegIntron plus ribavirin, with or without directacting antiviral agents [boceprevir, telaprevir]). 65

REBIF Rebif Rebif Titration Pack PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Concurrent use with other disease-modifying agent used for multiple sclerosis (ie, interferon beta-1a, interferon beta-1b, glatiramer, natalizumab, fingolimod). Diagnosis of MS includes the following patient types: patients with actual diagnosis of MS, patients who have experienced an MS attack, and patients who are at risk for developing MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 12 months, unless otherwise specified. 66

REGRANEX Regranex PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D Diabetic neuropathic ulcer(s), NPUAP Stage III or IV. 12 months Diabetic neuropathic ulcer(s) that is/are classified as NPUAP Stage III or IV - approve if being used as an adjunct to good wound/ulcer care practices (e.g., sharp debridement, pressure relief, and infection control). 67

REMICADE Remicade PA Covered Uses Age Details All FDA-approved indications not otherwise excluded from Part D plus patients already started on infliximab for non-crohn's disease covered uses. Behcet's disease (BD). Still's disease (SD). Uveitis (UV). Sarcoidosis (Sarc). Undifferentiated spondylarthroplasty, Pyoderma gangrenosum (PG). Hidradenitis suppurativa (HS). Graft-versus-host disease (GVHD). Juvenile Idiopathic Arthritis (JIA). Crohn's disease after ileocolonic resection, to reduce the chance of recurrence. Concurrent use with anakinra, abatacept, rituximab, ustekinumab, certolizumab pegol, etanercept, adalimumab, golimumab, or tocilizumab. Rheumatoid arthritis (RA), Adults. CD and UC, Pts aged 6 years or more. Prescribed by or in consult w/:ra/plaque psor/ankyl spondyl/still s/undifferent spondyl/jia-rheumatol.plaque Psor/Pyoderma gangrenosum/hidradenitis supperativa-dermatol.psoriatic Arthritisrheumatol or dermatol.cd/uc-gastroenterol.uveitis/scleritis/sterile Corneal Ulceration-ophthalmol.GVHD-transplant center, oncol, or hematol.behcet s- rheumatol, dermatol,ophthalmol, gastroenterol, or neurol.sarcoidosis-pulmonol, ophthalmol, or dermatol. Authorization will be for 12 months. 68

Other Approve for RA if pt will be taking Remicade in combination with MTX or one other traditional DMARD (eg, leflunomide, sulfasalazine, hydroxychloroquine) unless the pt has a contraindication or intolerance to MTX and leflunomide, AND pt has tried one DMARD (brand or generic, oral or injectable) for at least 3 mo, OR pt has a contraindication or intolerance to MTX and leflunomide, OR pt has early RA (defined as disease duration of less than 6 mo) with at least one of the following features of poor prognosis: functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph. Approve for CD if the pt has tried corticosteroid (CS) or if CSs contraindicated or if currently on CS or if the patient has tried one other agent for CD (eg, azathioprine, 6-MP, MTX, certolizumab, adalimumab) OR the patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas OR the patient has had ileocolonic resection.plaque psoriasis (PP).Pt tried at least 1 of the following therapies: MTX, CSA, acritretin, etanercept, adalimumab, or ustekinumab) for 3 mos or or the pt experienced an intolerance or has a contraindication to one oral agent for psoriasis such as MTX.Ulcerative colitis (UC).Tried 2-mo trial of systemic CS, 6-MP, AZA, CSA or tacrolimus or was intolerant to one of these agents OR the patient has pouchitis AND has tried therapy with an antibiotic, probiotic, corticosteroid enema, or mesalamine enema. Behcet's.Pt has tried at least one conventional tx (eg, systemic CSs, immunosuppressants [e.g., AZA, MTX, MM, CSA, tacrolimus, chlorambucil, cyclophosphamide] or interferon alfa), Enbrel or Humira. SD.Tried CS AND 1 non-biologic DMARD (eg, MTX) for 2 mos, or was intolerant.uv.tried periocular/intraocular CS, systemic CS, immunosuppressant (eg, MTX, MM, CSA, AZA, CPM), etanercept, adalimumab.sarc.tried CS and immunosuppressant (eg, MTX, AZA, CSA, chlorambucil), or chloroquine, or thalidomide.pyoderma gangrenosum (PG).Tried one systemic CS or immunosuppressant (eg, mycophenolate, CSA) for 2 mos. Hidradenitis suppurativa (HS).Tried 1 tx (eg, intralesional/oral CS, systemic antibiotic, isotretinoin).gvhd.tried 1 tx (eg, high-dose CS, antithymocyte globulin, CSA, thalidomide, tacrolimus, MM, etc.) or receiving IFB concurrently. JIA (regardless of type of onset) approve if Remicade started in combination with MTX or one other traditional DMARD (eg, leflunomide, sulfasalazine) AND the pt has tried 1 other agent for this condition (eg, MTX, sulfasalazine, or leflunomide, an NSAID, or one biologic DMARD [eg, Humira, Orencia, Enbrel, Kineret, Actemra]) or the pt has aggressive disease. 69

REMODULIN Remodulin PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Patients currently on Remodulin for a Covered Use. Age Other Pulmonary arterial hypertension PAH WHO Group 1, patients not currently on Remodulin or another agent indicated for WHO Group 1 PAH are required to have had a right-heart catheterization to confirm the diagnosis of PAH to ensure appropriate medical assessment. Pulmonary arterial hypertension (PAH) WHO Group1, patients currently on Remodulin or another agent indicated for WHO Group 1 may continue therapy without confirmation of a right-heart catheterization. PAH WHO Group 1, prescribed by or in consultation with a cardiologist or a pulmonologist. Authorization will be for 12 months. 70

RITUXAN Rituxan PA Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Patients already started on Rituxan for a Covered Use. Age Other Concurrent use with a tumor necrosis factor (TNF) alpha antagonist (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), or anakinra, abatacept, or tocilizumab. RA, adults. Adult with RA (initial course). Prescribed by a rheumatologist or in consultation with a rheumatologist. RA,1mo(2 doses 2 wks apart).if 16 wks or more since 1st dose,approve 1 mo if response.othr=12 mo. Adult with RA (initial course), approve if Rituxan is prescribed in combination with methotrexate or another traditional DMARD (eg, leflunomide or sulfasalazine) unless the patient has been shown to be intolerant or has a contraindication to one or more traditional DMARDs AND the patient has tried a TNF antagonist (eg, certolizumab pegol, etanercept, adalimumab, infliximab, golimumab) for at least 3 months unless the patient was intolerant to one of these agents OR the patient has moderate or high disease activity or features of poor prognosis (ie, functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti- CCP antibodies, or bony erosions and one oral DMARD (eg, MTX, leflunomide, sulfasalazine, hydroxychloroquine) has been tried for at least 3 months. Adult with RA (repeat course), approve if 16 weeks or more after the first dose of the previous rituximab regimen and the patient has responded (eg, less joint pain, morning stiffness, or fatigue, or improved mobility, or decreased soft tissue swelling in joints or tendon sheaths) as determined by the prescribing physician. 71

SAMSCA Samsca PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D plus patients already started on tolvaptan for the treatment of hyponatremia. Serum sodium less than 125 meq/l at baseline or less marked hyponatremia, defined as serum sodium less than 135 meq/l at baseline, that is symptomatic (eg, nausea, vomiting, headache, lethargy, confusion). Authorization will be for 12 months. For the treatment of clinically significant hypervolemic and euvolemic hyponatremia with serum sodium less than 125 meq/l at baseline or less marked hyponatremia, defined as less than 135 meq/l at baseline, that is symptomatic (eg, nausea, vomiting, headache, lethargy, confusion). 72

SIGNIFOR Signifor PA Details Covered Uses All FDA approved indications not otherwise excluded from Part D. Age Other Diagnosis for which Signifor is being used. Cushing's, 18 years of age and older. Initial course, prescribed by or in consultation with an endocrinologist. Initial therapy, approve for 3 months. Continuation therapy, approve for 12 months. Cushing's disease, approve if according to the prescribing physician the patient is not a candidate for surgery or surgery has not been curative. Patients who have already been started on Signifor for Cushing's disease will be approved if the patient has had a response, as determined by the prescribing physician and the patient is continuing therapy to maintain response. 73

SIMPONI Simponi PA Covered Uses Age Other Details All FDA approved indications not otherwise excluded from Part D. Plus patients already started on golimumab for a covered use. Concurrent use with a tumor necrosis factor (TNF) alpha antagonist (e.g., adalimumab, certolizumab pegol, etanercept, infliximab), or anakinra, rituximab, abatacept, or tocilizumab. Rheumatoid arthritis (RA), adults. Adults with RA/Ankylosing spondylistis, prescribed by or in consultation with a rheumatologist. Psoriatic arthritis, prescribed by or in consultation with a rheumatologist or dermatologist. Authorization will be for 12 months, unless otherwise specified. Adults with rheumatoid arthritis (RA), approve if the patient has tried Enbrel or Humira for at least 3 months OR the patient is concurrently receiving methotrexate OR the patient has a contraindication or intolerance to MTX and leflunomide OR the patient has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis: functional limitation (eg, based on HAQ-DI score), extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-ccp antibodies, or bony erosions by radiograph. Psoriatic arthritis and ankylosing spondylitis, approve if the patient has tried Enbrel or Humira. 74

SIMPONI ARIA Simponi Aria PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Concurrent use with another biologic (for example, tocilizumab, certolizumab, etanercept, adalimumab, anakinra, abatacept, infliximab, rituximab) or tofacitinib. Diagnosis for which Simponi Aria is being prescribed, concurrent medications, previous therapies tried. RA - adults RA - Prescribed by or in consultation with a rheumatologist Authorization will be for 12 months. For RA - in patients who have not been receiving Simponi or Simponi Aria, approve if they will be taking Simponi Aria in combination with MTX or one other traditional disease-modifying antirheumatic drug (DMARD) [e.g., leflunomide, sulfasalazine, hydroxychloroquine], unless intolerant or contraindicated AND meets one of the following criteria: i. Patient has tried one DMARD (brand or generic, oral or injectable) for at least 3 months, (this includes patients who have tried other biologic DMARDs for at least 3 months) OR ii. Patient has a contraindication or intolerance to MTX and leflunomide, as determined by the prescribing physician OR iii. Patient has early RA (defined as disease duration of less than 6 months) with at least one of the following features of poor prognosis - functional limitation (e.g., based on health assessment questionnaire disability index (HAQ-DI) score), extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty s syndrome, positive rheumatoid factor or anti-cyclic citrullinated peptide (CCP) antibodies, or bony erosions by radiograph. 75

SOVALDI Sovaldi PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Will not be used in combination Use with NS3/4A Protease Inhibitor (i.e., telaprevir, boceprevir) 18 years or older Prescribed by or in consultation w/ GI, hepatologist, ID, or a liver transplant MD 12wk-geno 1 triple tx,others.24 wk-geno 1 dual tx,geno 3.48 wk geno 1,2,3,4 waiting liver trans Geno 1 - prescribed in combination with PegINF and RBV (PR), unless pt can't take INF based on a documented comorbid medical condition (e.g., autoimmune disorder, significant psychiatric disease, seizure disorder) then must be used in combo with RBV OR in combination with Olysio. Geno 2/3 - prescribed in combo with RBV. Geno 4 - prescribed in combo with PegINF/RBV. Geno 1, 2, 3, or 4 awaiting liver transplant - has HCC and prescribed in combination with RBV. 76

SPRYCEL Sprycel PA Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Plus GIST and patients already started on Sprycel for a Covered Use. Age Other Diagnosis for which Sprycel is being used. For indications of CML and ALL, the Philadelphia chromosome (Ph) status of the leukemia must be reported. New patients with CML and ALL which is Ph-positive may receive authorization for Sprycel. Authorization will be for 12 months. For CML, new patient must have Ph-positive CML for approval of Sprycel. For ALL, new patient must have Ph-positive ALL for approval of Sprycel. GIST - has D842V mutation AND previously tried Sutent and Gleevec. 77

STIVARGA Stivarga PA Covered Uses Age Other Details All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Stivarga for a Covered Use. Diagnosis for which Stivarga is being used. For metastatic colorectal cancer (CRC), prior therapies tried. For metastatic CRC, KRAS mutation status. Authorization will be for 12 months. For metastatic CRC, patient must have previously been treated with each of the following for approval: a fluoropyrimidine (eg, Xeloda, 5-FU), oxaliplatin, irinotecan, anti-vegf therapy (eg, Avastin, Zaltrap). For metastatic CRC with no detected KRAS mutations (ie, KRAS wild-type), patient must have previously been treated with each of the following for approval: a fluoropyrimidine (eg, Xeloda, 5-FU), oxaliplatin, irinotecan, anti-vegf therapy (eg, Avastin, Zaltrap), anti-egfr therapy (eg, Eribitux, Vectibix). 78

SUTENT Sutent PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Sutent for a Covered Use. Advanced, unresectable neuroendocrine tumors, chordoma, angiosarcoma, solitary fibrous tumor/hemangiopericytoma, alveolar soft part sarcoma (ASPS), differentiated (ie, papillary, follicular, and Hurthle) thyroid carcinoma, medullary thyroid carcinoma. Authorization will be for 12 months. Gastrointestinal stromal tumors (GIST), approve if the patient has previously tried imatinib (Gleevec). Chordoma, approve if the patient has recurrent disease. Differentiated thyroid carcinoma, approve if the patient has clinically progressive or symptomatic metastatic disease and the patient has nonradioiodine-responsive tumors at sites other than the central nervous system. Medullary thyroid carcinoma, approve if the patient has disseminated symptomatic disease and the patient has tried vandetanib (Caprelsa) or cabozantinib (Cometriq). 79

SYMLIN Symlinpen 120 Symlinpen 60 PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D worded as patient has type 1 or 2 diabetes mellitus. Authorization will be for 12 months, unless otherwise specified. 80

TAFINLAR Tafinlar PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Tafinlar for a Covered Use. Diagnosis for which Tafinlar is being used. For unresectable or metastatic melanoma must have documentation of BRAF V600E mutation Authorization will be for 12 months. For unresectable or metastatic melanoma must be used in patients with BRAF V600E mutation 81

TARCEVA Tarceva PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Tarceva for a Covered Use, renal cell carcinoma (RCC). Advanced, recurrent, or metastatic non small cell lung cancer (NSCLC), EGFR mutation or gene amplification status. Authorization will be for 12 months. Advanced, recurrent, or metastatic NSCLC, approve if the patient has EGFR exon 19 deletion or exon 21 (L858R) substitution. Locally advanced or metastatic NSCLC, approve if the patient has failed at least one prior chemotherapy regimen or the patient s disease has not progressed after four cycles of platinum-based first-line chemotherapy (switch-maintenance therapy). Pancreatic locally advanced, unresectable, or metastatic cancer, approve if Tarceva is being prescribed in combination with gemcitabine. RCC, approve if the patient has non-clear cell histology that is Stage IV OR relapsed disease. 82

TASIGNA Tasigna PA Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Plus patients already started on Tasigna for a Covered Use. Age Other Diagnosis for which Tasigna is being used. For indication of CML, the Philadelphia chromosome (Ph) status of the leukemia must be reported. New patients with CML which is Ph-positive may receive authorization for Tasigna. For indication of gastrointestinal stromal tumor (GIST), prior therapies tried. Authorization will be for 12 months. For CML, new patient must have Ph-positive CML for approval of Tasigna. For GIST, patient must have tried sunitinib (Sutent) and imatinib (Gleevec). 83

TECFIDERA Tecfidera Tecfidera Starter Pack PA Covered Uses Age Other Details All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Tecfidera for a Covered Use. Concurrent use with other disease-modifying agents used for multiple sclerosis (MS) [eg, Avonex, Rebif, Betaseron, Extavia, Copaxone, Tysabri, Gilenya, or Aubagio]. MS, patient has a relapsing form of MS. MS, previous MS therapies tried. Prescribed by or in consultation with a neurologist or MS specialist. Authorization will be for 12 months. For use in MS, approve if the patient has a relapsing form of MS (includes relapsing-remitting MS, secondary-progressive MS with relapses, and progressive-relapsing MS) and the patient has tried interferon beta-1a intramuscular (Avonex), interferon beta-1a subcutaneous (Rebif), interferon beta-1b (Betaseron or Extavia), or glatiramer acetate (Copaxone) OR the patient has tried glatiramer acetate but cannot take an interferon beta therapy due to any of the following reasons: depression, suicidality, severe psychiatric disorder, woman who is pregnant or plans to become pregnant, or active liver disease or a history of significant liver disease, history of seizures. Exceptions to having tried an interferon beta- 1a or -1b product (Avonex, Betaseron, Extavia, or Rebif), or glatiramer acetate (Copaxone) can be made if the patient is unable to administer injections due to dexterity issues or visual impairment. 84

THALOMID Thalomid PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Thalomid for a Covered Use, Discoid lupus erythematosus or cutaneous lupus erythematosus, Myelofibrosis, Prurigo nodularis, Recurrent aphthous ulcers or aphthous stomatitis, Waldenstrom s macroglobulinemia/lymphoplasmacytic lymphoma. Authorization will be for 12 months. Discoid lupus erythematosus or cutaneous lupus erythematosus, approve if the patient has tried two other therapies (eg, corticosteroids [oral, topical, intralesional], hydroxychloroquine, tacrolimus [Protopic], methotrexate, dapsone, acitretin [Soriatane]). Myelofibrosis, approve if the patient has tried one other therapy (eg, ruxolitinib [Jakafi], danazol, epoetin alfa [Epogen/Procrit], prednisone, lenalidomide [Revlimid], hydroxyurea). Prurigo nodularis, approve if the patient has tried two other therapies (eg, azathioprine, capsaicin, psoralen plus ultraviolet A [PUVA] therapy, ultraviolet B [UVB] therapy). Recurrent aphthous ulcers or aphthous stomatitis, approve if the patient has tried two other therapies (eg, topical or intralesional corticosteroids, systemic corticosteroids, topical anesthetics/analgesics [eg, benzocaine lozenges], antimicrobial mouthwashes [eg, tetracycline], acyclovir, colchicine). 85

TOPICAL IMMUNOMODULATORS Protopic PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Authorization will be for 12 months. Authorize use in patients who have tried a prescription strength topical corticosteroid (brand or generic) for the current condition in the past 60 days. Dermatologic condition on or around the eyes, eyelids, axilla, or genitalia, authorize use without a trial of a prescription strength topical corticosteroid. 86

TOPICAL RETINOID PRODUCTS Adapalene Avita CREA Tretinoin EXTERNAL CREA Tretinoin EXTERNAL GEL PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Age Other Authorization will be for 12 months, unless otherwise noted. 87

TOPICAL TESTOSTERONE PRODUCTS Androderm TRANSDERMAL PT24 2MG/24HR, 4MG/24HR Androgel GEL 50MG/5GM Androgel Pump GEL 1.62% PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Diagnosis of primary hypogonadism (congenital or acquired) in males. Diagnosis of secondary (hypogonadotropic) hypogonadism (congenital or acquired) in males. Hypogonadism (primary or secondary) in males, serum testosterone level. Authorization will be for 12 months, unless otherwise specified. Hypogonadism (primary or secondary) in males, approve if hypogonadism has been confirmed by a low for age serum testosterone (total or free) level defined by the normal laboratory reference values. 88

TRANSMUCOSAL FENTANYL DRUGS Fentanyl Citrate Oral Transmucosal Lazanda PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Age Other Authorization will be for 12 months, unless otherwise specified. For breakthrough pain in patients with cancer if patient is unable to swallow, has dysphagia, esophagitis, mucositis, or uncontrollable nausea/vomiting OR patient is unable to take 2 other short-acting narcotics (eg, oxycodone, morphine sulfate, hydromorphone, etc) secondary to allergy or severe adverse events AND patient is on or will be on a long-acting narcotic (eg, Duragesic), or the patient is on intravenous, subcutaneous, or spinal (intrathecal, epidural) narcotics (eg, morphine sulfate, hydromorphone, fentanyl citrate). 89

TYKERB Tykerb PA Details Covered Uses All medically-accepted indications not otherwise excluded from Part D. Plus patients already started on Tykerb for a Covered Use. Age Other Diagnosis for which Tykerb is being used. Metastatic breast cancer, HER2 status or hormone receptor (HR) status. Authorization will be for 12 months. HER2-positive advanced or metastatic breast cancer, approve if Tykerb will be used in combination with Xeloda or Herceptin and the patient has received prior therapy with Herceptin. HER2-positive HR positive metastatic breast cancer, approve if the patient is a postmenopausal woman and Tykerb will be used in combination with letrozole (Femara). HER-2 positive early breast cancer, approve if Tykerb will be used in combination with Herceptin. 90

TYSABRI Tysabri PA Covered Uses Age Details All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Tysabri for a Covered Use. Concurrent use with another immunomodulator, or fingolimod (Gilenya) or an immunosuppressant such as mitoxantrone, cyclophosphamide, rituximab, alemtuzumab, azathioprine, MTX, or mycophenolate mofetilin in multiple sclerosis (MS) patients. Concurrent use with immunosuppressants (eg, 6-mercaptopurine, azathioprine, cyclosporine, methotrexate) or tumor necrosis factor (TNF) alfa inhibitors (eg, infliximab, adalimumab, certolizumab pegol) in Crohn's disease (CD) patients. Adults with MS. Patient has a relapsing form of MS (relapsing forms of MS are relapsing remitting [RRMS], secondary progressive [SPMS] with relapses, and progressive relapsing [PRMS]). Adults with CD. Patient has moderately to severely active CD with evidence of inflammation (eg, elevated C-reactive protein). Adults MS. Prescribed by, or in consultation with, a neurologist or a physician who specializes in the treatment of MS.CD. Prescribed by, or in consultation with, a gastroenterologist. Authorization will be for 12 months, unless otherwise specified. 91

Other Adults with a relapsing form of MS. Patient has had an inadequate response to, or is unable to tolerate, therapy with at least ONE of the following MS medications: interferon beta-1a (Avonex, Rebif), interferon beta-1b (Betaseron, Extavia), glatiramer acetate (Copaxone), fingolimod (Gilenya), Tecfidera, or Aubagio OR the patient has highly active or advanced disease according to the prescribing physician. Adults with CD. Patient has moderately to severely active CD with evidence of inflammation (eg, elevated C-reactive protein) and patient has tried two TNF antagonists for CD for at least 2 months each, adalimumab, certolizumab pegol, or infliximab, and had an inadequate response or was intolerant to the TNF antagonists. Exception to the CD criteria of treatment with corticosteroids (systemic) are allowed if steroids are contraindicated or not desired, then azathioprine, 6-mercaptopurine, or methotrexate must be tried if they are not contraindicated. 92

VICTRELIS Victrelis PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already taking Victrelis for a Covered Use. Plus adult patients with Hepatitis B virus (HBV)/chronic HCV genotype 1 co-infection. Adult patients with HIV/chronic HCV genotype 1 co-infection and in adults with HCV genotype 1 post liver transplant. in patients who have failed therapy with boceprevir or another NS3/4A protease inhibitor for HCV (e.g., telaprevir). Tx-naïve pts with chronic HCV-1 monoinfection without cirrhosis AND is not for poor interferon response (less than 1 log10 reduction HCV RNA from baseline at TW 5), and retx of pts with chronic HCV-1 monoinfection who have been previously treated with interferon/peginterferon alfa without cirrhosis. Retx in pts with chronic HCV-1 monoinfection previously treated with interferon/peginterferon alfa without cirrhosis null-responder documentation required (less than 2 log10 reduction HCV RNA after TW 12). Chronic HCV-1 monoinfection and advanced fibrosis/compensated cirrhosis. Adults Prescribed by or in consultation with a gastroenterologist, hepatologist, or infectious disease physician. Patients post liver transplant - may also be prescribed by or in consulation with a liver transplant physician. Authorization will be for 11 months. Boceprevir and boceprevir must be prescribed in combination as tripledrug therapy with peginterferon alfa and ribavirin. 93

VOTRIENT Votrient PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patients already taking Votrient for a Covered Use. Differentiated (ie, papillary, follicular, Hurthle) thyroid carcinoma. Advanced or metastatic Uterine sarcoma. Authorization will be for 12 months. Soft tissue sarcoma, approve, as per product labeling, if the patient has received prior chemotherapy, including anthracycline treatment. Differentiated (ie, papillary, follicular, Hürthle) thyroid carcinoma, approve if the patient has clinically progressive or symptomatic metastatic disease and the patient has nonradioiodine-responsive tumors at sites other than the central nervous system. 94

XALKORI Xalkori PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Additional coverage is provided for Advanced or metastatic soft tissue sarcoma Inflammatory Myofibroblastic Tumor (IMT) with ALK translocation and NSCLC with ROS1 Rearrangement. Plus patients already started on crizotinib for a Covered Use. Age Other For the FDA-approved indication of NSCLC for patients new to therapy, ALK status and ROS1 rearrangement required. For soft tissue sarcoma IMT, ALK translocation. Authorization will be for 12 mos. NSCLC, patient new to therapy must be ALK-positive or have ROS1 rearrangement for approval. 95

XELJANZ Xeljanz PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Xeljanz for a Covered Use. Concurrent use with a biologic for an inflammatory condition (eg, tocilizumab, anakinra, abatacept, rituximab) or a TNF inhibitor (eg, certolizumab pegol, etanercept, adalimumab, infliximab, golimumab). Concurrent use with potent immunosuppressants that are not methotrexate (MTX) [eg, azathioprine, tacrolimus, cyclosporine, mycophenolate mofetil]. Rheumatoid Arthritis (RA), adults. RA, prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months. RA in patients who have had a trial with at least two of the following: tocilizumab, anakinra, abatacept, rituximab, certolizumab, etanercept, adalimumab, infliximab, golimumab - approve. RA in patients who have tried one of the following, but not two: tocilizumab, anakinra, abatacept, rituximab, certolizumab, etanercept, adalimumab, infliximab, golimumab - approve if, the patient has tried etanercept (Enbrel) OR adalimumab (Humira) or Orencia SC for at least 3 months unless intolerant. RA in patients who have not tried a biologic DMARD or a TNF inhibitor (tocilizumab, anakinra, abatacept, rituximab, certolizumab, etanercept, adalimumab, infliximab, golimumab) - approve if the patient has tried MTX or another traditional DMARD (eg, leflunomide, sulfasalazine) for at least 3 months unless the patient has been shown to be intolerant AND the patient has tried etanercept (Enbrel) OR adalimumab (Humira) for at least 3 months unless intolerant. 96

XENAZINE Xenazine PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Tardive dyskinesia (TD). Tourette syndrome and related tic disorders. Hyperkinetic dystonia. Hemiballism. Age Other For treatment of chorea associated with Huntington's disease, Tourette syndrome or related tic disorders, hyperkinetic dystonia, or hemiballism, Xenazine must be prescribed by or after consultation with a neurologist. For TD, Xenazine must be prescribed by or after consultation with a neurologist or psychiatrist. Authorization will be for 12 months, unless otherwise specified. 97

XOLAIR Xolair PA Details Covered Uses All FDA-approved indications not otherwise excluded from Part D. Seasonal or perennial allergic rhinitis (SAR or PAR). Age Moderate to severe persistant asthma and SAR/PAR, baseline IgE level of at least 30 IU/mL. For asthma, patient has a positive skin test or in vitro testing (ie, a blood test for allergen-specific IgE antibodies such as the RAST) for 1 or more perennial aeroallergens (eg, house dust mite, animal dander [dog, cat], cockroach, feathers, mold spores) and/or for 1 or more seasonal aeroallergens (grass, pollen, weeds). For SAR/PAR, patient has positive skin testing (eg, grass, tree, or weed pollen, mold spores, house dust mite, animal dander, cockroach) and/or positive in vitro testing (ie, a blood test for allergen-specific IgE antibodies) for one or more relevant allergens (eg, grass, tree, or weed pollen, mold spores, house dust mite, animal dander, cockroach). Patients aged 12 years and older. Moderate to severe persistent asthma if prescribed by, or in consultation with an allergist, immunologist, or pulmonologist. SAR/PAR if prescribed by or in consultation with an allergist, immunologist, or pulmonologist. Authorization will be for 12 months, unless otherwise specified. 98

Other Moderate to severe persistent asthma must meet all criteria patient s asthma symptoms have not been adequately controlled by concomitant use of at least 3 months of inhaled corticosteroid and a long-acting betaagonist (LABA) or LABA alternative, if LABA contraindicated or pt has intolerance then alternatives include sustained-release theophylline or a leukotriene modifier (eg, montelukast), AND inadequate control demonstrated by hospitalization for asthma, requirement for systemic corticosteroids to control asthma exacerbation(s), or increasing need (eg, more than 4 times a day) for short-acting inhaled beta2 agonists for symptoms (excluding preventative use for exercise-induced asthma). SAR/PAR must meet the following criteria - pt has tried concurrent therapy with at least one drug from 2 of the following classes, a nonsedating or low-sedating anthistamine/nasal antihistamine, a nasal corticosteroid, or montelukast or pt has tried at least one drug from all 3 of these classes during one allergy season AND pt has had immunotherapy, is receiving immunotherapy, or will be receiving immunotherapy, AND for pts with allergies to animals, these animals must be removed from the patient's immediate environment (eg, work, home). 99

XTANDI Xtandi PA Details Covered Uses All medically accepted indications not otherwise excluded from Part D. Plus patients already started on Xtandi for a Covered Use. Age Other Diagnosis for which Xtandi is being used. For metastatic castrationresistant prostate cancer, prior therapies tried. Authorization will be for 12 months. For prostate cancer, patient must have metastatic, castration-resistant prostate cancer for approval. For metastatic, castration-resistant prostate cancer in patients who are not currently taking Xtandi, the patient must have had a trial with abiraterone (Zytiga) unless the patient is unable to try abiraterone due to a contraindication or severe intolerance (eg, difficulty achieving blood glucose control in patients with diabetes, psychiatric reactions) to prednisone. 100

ZELBORAF Zelboraf PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on vemurafenib for a Covered Use. For the FDA-approved indication of melanoma, for patients new to therapy, BRAFV600E status required. Authorization will be for 12 mos. Melanoma, patient new to therapy must have BRAFV600E mutation for approval. 101

ZYTIGA Zytiga PA Covered Uses Age Other Details All FDA-approved indications not otherwise excluded from Part D. Plus, patients already started on Zytiga for a Covered Use. Authorization will be for 12 months. Metastatic castration-resistance prostate cancer, approve if Zytiga is being used in combination with prednisone. 102

PART B VERSUS PART D Acetylcysteine INHALATION SOLN Acyclovir Sodium INJ 50MG/ML Albuterol Sulfate INHALATION NEBU Ambisome Amiodarone Hcl INJ 50MG/ML Amphotericin B INJ Azathioprine TABS Budesonide INHALATION SUSP 0.25MG/2ML, 0.5MG/2ML Cancidas Cellcept SUSR Cellcept Intravenous Cidofovir Cromolyn Sodium NEBU Cyclophosphamide ORAL CAPS Cyclophosphamide ORAL TABS Cyclosporine INJ Cyclosporine ORAL CAPS Cyclosporine Modified Dronabinol Emend ORAL CAPS Engerix-b Foscarnet Sodium Gengraf Granisetron Hcl TABS Ipratropium Bromide INHALATION SOLN 0.02% Ipratropium Bromide/albuterol Sulfate Levalbuterol NEBU Levalbuterol Hcl INHALATION NEBU 0.31MG/3ML, 0.63MG/3ML Lioresal Intrathecal INJ 0.05MG/ML, 10MG/20ML, 10MG/5ML Methotrexate TABS Methotrexate Sodium INJ 1GM, 50MG/2ML Methylprednisolone ORAL TABS Mycophenolate Mofetil Mycophenolic Acid Dr Myfortic Nebupent Neoral Nitroglycerin INJ Nulojix Ondansetron Hcl ORAL SOLN Ondansetron Hcl ORAL TABS Ondansetron Odt Perforomist Prednisone ORAL TABS Prograf INJ Pulmicort SUSP 1MG/2ML Pulmozyme Rapamune Recombivax Hb Rheumatrex Sandimmune Simulect INJ 20MG Sirolimus TABS Tacrolimus ORAL CAPS Thymoglobulin Tobi Tobramycin NEBU Tyvaso Vectibix INJ 100MG/5ML Zortress Details This drug may be covered under Medicare Part B or D depending upon the circumstances. may need to be submitted describing the use and setting of the drug to make the determination. 103

INDEX A Acetylcysteine... 103 Actemra... 2, 3 Actemra Sq... 3 Acthar... 4 Acyclovir Sodium... 103 Adapalene... 87 Adempas... 5 Adhd Non-stimulant Medications... 6 Afinitor... 7 Afinitor Disperz... 7 Albuterol Sulfate... 103 Alpha-1 Proteinase Inhibitors... 8 Ambisome... 103 Amiodarone Hcl... 103 Amitriptyline Hcl... 39 Amphotericin B... 103 Ampyra... 9 Anabolic Steroids... 10 Androderm... 88 Androgel... 88 Androgel Pump... 88 Aralast Np... 8 Arcalyst... 11 Avita... 87 Azathioprine... 103 B Bosulif... 12 Botox... 13 Budesonide... 103 C Cancidas... 103 Cellcept... 103 Cellcept Intravenous... 103 Chenodal... 15 Chorionic Gonadotropin... 16 Chorionic Gonadotropins (hcg)... 16 Cialis... 17 Cidofovir... 103 Cimzia... 18 Cinryze... 19 Clomipramine Hcl... 39 Clonazepam... 37 Clonazepam Odt... 37 Clorazepate Dipotassium... 37, 39 Cometriq... 20 Copaxone... 21 Crinone... 22 Crinone Gel... 22 Cromolyn Sodium... 103 Cyclophosphamide... 103 Cyclosporine... 103 Cyclosporine Modified... 103 D Daliresp... 23 Diazepam... 37, 39 Diazepam Intensol... 39 Doxepin Hcl... 39 Dronabinol... 103 E Emend... 103 Enbrel... 24 Engerix-b... 103 Epoetin/procrit... 26 Erivedge... 28 F Fentanyl Citrate Oral Transmucosal... 89 Firazyr... 29 Forteo... 30 Foscarnet Sodium... 103 104

G Gengraf... 103 Gilenya... 31 Gilotrif... 32 Gleevec... 33 Granisetron Hcl... 103 Growth Hormones... 34 H H.p. Acthar... 4 High Risk Medications - Benzodiazepines... 37 High Risk Medications - First Generation Antihistamines... 38 High Risk Medications - Tertiary Tricyclic Antidepressants... 39 Humira... 41 Humira Pen-crohns Diseasestarter... 41 Hydroxyzine Hcl... 38 I Ilaris... 43 Imipramine Hcl... 39 Imipramine Pamoate... 39 Incivek... 44 Inlyta... 45 Intuniv... 6 Ipratropium Bromide... 103 Ipratropium Bromide/albuterol Sulfate... 103 Ivig... 46 J Jakafi... 49 L Lazanda... 89 Letairis... 50 Letairis/tracleer... 50 Leuprolide (long Acting)... 51 Levalbuterol... 103 Levalbuterol Hcl... 103 Lidocaine... 52 Lidoderm... 52 Lioresal Intrathecal... 103 Lorazepam... 37, 39 Lorazepam Intensol... 39 Lupron Depot... 51 Lupron Depot-ped... 51 M Mekinist... 53 Methotrexate... 103 Methotrexate Sodium... 103 Methylprednisolone... 103 Modafinil... 58 Mycophenolate Mofetil... 103 Mycophenolic Acid Dr... 103 Myfortic... 103 N Nebupent... 103 Neoral... 103 Neulasta... 54 Neupogen... 55 Nexavar... 57 Nitroglycerin... 103 Norditropin Flexpro... 34 Norditropin Nordiflex Pen... 34 Nulojix... 103 Nuvigil/provigil... 58 O Olysio... 59 Omnitrope... 34 Ondansetron Hcl... 103 Ondansetron Odt... 103 Onfi... 37 Orencia... 60 Otezla... 61 Oxandrolone... 10 Oxazepam... 37 P Part B Versus Part D... 103 Pegasys... 62 Pegasys Proclick... 62 Peg-intron... 62 Peg-intron Redipen... 62 Pegylated Interferons... 62 Perforomist... 103 Phosphodiesterase-5 Inhibitors For Pah... 64 105

Prednisone... 103 Privigen... 46 Procrit... 26 Prograf... 103 Prolastin-c... 8 Promacta... 65 Promethazine Hcl... 38 Protopic... 86 Pulmicort... 103 Pulmozyme... 103 R Rapamune... 103 Rebif... 66 Rebif Titration Pack... 66 Recombivax Hb... 103 Regranex... 67 Remicade... 68 Remodulin... 70 Revatio... 64 Rheumatrex... 103 Rituxan... 71 S Samsca... 72 Sandimmune... 103 Signifor... 73 Sildenafil... 64 Simponi... 74 Simponi Aria... 75 Simulect... 103 Sirolimus... 103 Sovaldi... 76 Sprycel... 77 Stivarga... 78 Strattera... 6 Sutent... 79 Symlin... 80 Symlinpen 120... 80 Symlinpen 60... 80 T Tacrolimus... 103 Tafinlar... 81 Tarceva... 82 Tasigna... 83 Tecfidera... 84 Tecfidera Starter Pack... 84 Temazepam... 37 Thalomid... 85 Thymoglobulin... 103 Tobi... 103 Tobramycin... 103 Topical Immunomodulators... 86 Topical Retinoid Products... 87 Topical Testosterone Products... 88 Tracleer... 50 Transmucosal Fentanyl Drugs... 89 Tretinoin... 87 Trimipramine Maleate... 39 Tykerb... 90 Tysabri... 91 Tyvaso... 103 V Vectibix... 103 Victrelis... 93 Votrient... 94 X Xalkori... 95 Xeljanz... 96 Xenazine... 97 Xolair... 98 Xtandi... 100 Z Zelboraf... 101 Zortress... 103 Zytiga... 102 106