UPMC Medicare 2016

ABILIFY Products Affected aripiprazole oral tablet,disintegrating 10 mg, 15 aripiprazole oral tablet 10 mg, 15 mg, 2 mg, 20 mg mg, 30 mg, 5 mg PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion No Exclusion Criteria Criteria Required Diagnosis. For Major Depressive Disorder without psychosis, must have Medical adequate trial and failure or inadequate response, duration of at least 4 Information weeks, or intolerance to monotherapy with 2 different antidepressant therapies (e.g. SSRIs or SNRIs) and must be on concomitant therapy with an SSRI or SNRI as adjunctive treatment (which can include medication from monotherapy trial above) Age Restrictions No Age Restrictions Prescriber No Prescriber Restrictions Restrictions Coverage 365 days Duration Other Criteria Not Applicable 1 ACITRETIN Products Affected acitretin PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion No Exclusion Criteria Criteria Required Diagnosis. Must have severe disease. Must have adequate trial of Medical methotrexate or cyclosporine with inadequate response or significant side Information effect/toxicity or have a contraindication to these therapies. Age Restrictions Age 18 years or older. Prescriber Dermatologist Restrictions Coverage 365 days Duration Other Criteria Not Applicable 2 ACNE PRODUCTS Products Affected Fabior adapalene topical cream Tazorac adapalene topical gel 0.1 % tretinoin topical cream Avita topical cream tretinoin topical gel 0.01 %, 0.025 % PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Diagnoses not covered: solar elastosis, sun damage, wrinkles, actinic Criteria damage, melasma, lentigines / freckles (hyperpigmented macules, liver spots), heliodermatosis, dermatoheliosis Required Diagnosis. For reauth: must have documentation from prescriber Medical indicating improvement in condition. Information Age Restrictions No Age Restrictions Prescriber No Prescriber Restrictions Restrictions Coverage 365 days Duration Other Criteria Not Applicable 3 ACTEMRA Products Affected Actemra subcutaneous Actemra intravenous PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Evidence of infection. Use of TNF-blocking or other biologic agent in Criteria combination with tocilizumab. Required Diagnosis. Negative tuberculosis skin test prior to use of tocilizumab. Medical Baseline AST and ALT labs less than 1.5x upper limit of normal, ANC Information greater than 2000 cells per cubic mm, platelet count greater than 100,000 cells per cubic mm. For RA and polyarticular JIA (PJIA): must have moderately to severely active disease and must have adequate trials of etanercept and adalimumab with inadequate responses or significant side effects/toxicities unless contraindicated. For active systemic JIA (SJIA): must have active disease (defined as active fever, active arthritis, OR erythrocyte sedimentation rate or C-reactive protein level greater than 2x upper limit of normal), must have chart documentation of clinical work- up to rule out other diagnoses and rationale for diagnosis and exclusion of other diagnoses (including all of the following: history of fever for at least 2 weeks, history of arthritis in 1 more more joints, and history of at least one of the following: erythematous rash, generalized lymph node enlargement, hepatomegaly or splenomegaly, or pericarditis, pleuritis, or peritonitis), must have adequate trial of methotrexate with inadequate response or significant side effects or toxicity unless there is a contraindication when there is active arthritis OR must have adequate trial of 1 NSAID and 1 corticosteroid with inadequate response or significant side effects or toxicity unless there is a contraindication when there are active systemic features such as rash and fever. For reauth: improvement in condition, AST and ALT labs less than or equal to 5x upper limit of normal, ANC greater than or equal to 500 cells per cubic mm, and platelet count greater than or equal to 50,000 cells per cubic mm. Age Restrictions RA: age 18 years and older. JIA: age 2 years and older Prescriber RA, poylarticular JIA: rheumatologist. Systemic JIA: pediatric Restrictions rheumatologist. Coverage 365 Days Duration 4 PA Criteria Criteria Details Other Criteria Not Applicable 5 ACTHAR Products Affected Acthar H.P. PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion No Exclusion Criteria Criteria Required Diagnosis. For infantile spasms: EEG confirming diagnosis of infantile Medical spasms. For following diagnoses where IV steroid trial(s) required: Information examples include methylprednisolone acetate, methylprednisolone sodium succinate, and triamcinolone acetonide, all of which have FDA- approval for use in these diagnoses. For MS: must be experiencing acute exacerbation of MS and have adequate trial of 2 IV steroids w/ inadequate response or significant side effects/toxicity. For severe erythema multiforme (Stevens-Johnsons Syndrome), serum sickness, severe acute or chronic allergic or inflammatory processes involving eye and its adnexa (e.g. keratitis, iritis, iridocyclitis, diffuse posterior uveitis and choroditis, optic neuritis, chorioretinitis, anterior segment inflammation), symptomatic sarcoidosis: must have adequate trial of 2 IV steroids w/ inadequate response or significant side effects/toxicity. For RA (incl. Juvenile RA), psoriatic arthritis, ankylosing spondylitis: must be using as adjunctive therapy for short-term administration (to tide over an acute episode or exacerbation) and have adequate trial of 2 IV steroids w/ inadequate response or significant side effects/toxicity. For systemic lupus erythematosis, dermatomyositis (polymyositis): may be used during exacerbation or as maintenance therapy and must have adequate trial of 2 IV steroids w/ inadequate response or significant side effects/toxicity. For nephrotic syndrome: must be used to induce diuresis or remission of proteinuria, must be experiencing acute exacerbation of nephrotic syndrome, must have adequate trial of 1 IV steroid w/ inadequate response or significant side effect/toxicity AND 1 cytotoxic/immunosuppressive medication (e.g. cyclophosphamide, cyclosporine, mycophenolate) w/ inadequate response or significant side effect/toxicity unless contraindicated. For reauth: must have documentation from prescriber describing initial response to therapy and need for continuation or retreatment. Age Restrictions Infantile spasms: age 2 years or younger. MS: age 18 years or older. 6 PA Criteria Criteria Details Prescriber Infantile spasm: pediatric neurologist. MS: neurologist. RA, Psoriatic Restrictions Arthritis, Ankylosing Spondylitis: rheumatologist. Lupus, dermatomyositis: dermatologist or rheumatologist. Eye dx: ophthamologist. Nephrotic syndrome: nephrologist. All other dx: no prescriber restrictions. Coverage 30 days Duration Other Criteria Not Applicable 7 ACTIMMUNE Products Affected Actimmune PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion Diagnoses not covered: basal cell carcinoma of the skin, breast cancer, Criteria burn infection, Chronic Myeloid Leukemia, condyloma acuminatum, graft vs. host disease, idiopathic pulmonary fibrosis, kaposi's Sarcoma, malignant mesothelioma, mycobacteriosis, ovarian cancer, rheumatoid arthritis, scleroderma, chronic hepatitis B, Whipple's disease Required Diagnosis. For severe malignant osteopetrosis: must have diagnosis Medical confirmed by radiological evidence. For reauth: must have documentation Information from prescriber indicating improvement in condition. Age Restrictions No Age Restrictions Prescriber For chronic granulomatous disease: by or in consultation with Restrictions immunologist, hematologist, or infectious disease physician. For severe malignant osteopetrosis: by or in consultation with orthopedic surgeon, hematologist, or endocrinologist. Coverage 365 days Duration Other Criteria Not Applicable 8 ACUTE HAE Products Affected Firazyr Berinert intravenous kit Ruconest PA Criteria Criteria Details Covered Uses All FDA-approved indications not otherwise excluded from Part D Exclusion No Exclusion Criteria Criteria Required Diagnosis of HAE confirmed by following laboratory values on 2 Medical separate instances (copy of laboratory reports required, must include Information reference ranges): low C4 complement level in mg/dL, normal C1q complement component level in mg/dL (C1q complement component level not required for patients under age of 18 or patients whose symptoms began before age 18), and either low C1 esterase inhibitor antigenic level in mg/dL or low C1 esterase inhibitor functional level expressed as a percent. Must have chart documentation indicating member has received at least one dose of requested product as treatment for HAE attack in past, responded to medication, and was able to tolerate medication. For reauth, must have documentation from prescriber indicating improvement in condition. Age Restrictions No Age Restrictions Prescriber By or under the direction of a HAE specialist (defined as an Restrictions allergist/immunologist who demonstrates clinical expertise in HAE through research, publication, referrals/consults). Coverage Initial: 1 month. Reauth: 365 days. Duration Other Criteria If clinical documentation

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