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

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1 Drugs That Require Prior Authorization (PA) Before Being Approved for Coverage You will need authorization by AvMed Medicare Choice and AvMed Medicare Choice Elect before filling prescriptions for the drugs shown in the chart below. AvMed Medicare Choice and AvMed Medicare Choice Elect 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 AvMed at , 8:30AM - 5:30PM, Monday - Friday. Member Service is available in English and other languages. TTY/TDD PRIOR AUTHORIZATION MEDICATIONS ACTEMRA Tocilizumab should not be given in combination with tumor necrosis factor (TNF) antagonists (adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), abatacept, anakinra, rituximab, or tofacitinib. Coverage for adults with RA is provided in situations where the patient experienced intolerance/failure to Humira AND Enbrel. Coverage for Systemic-onset JIA is provided in situations where the patient 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). For rheumatoid arthritis (RA), patient must be 18 years of age or older Prescribed by or in consultation with a rheumatologist. Coverage Duration Authorization will be for 12 months. ACTHAR HP 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. Coverage Duration 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. CMS Approval Date: Page 1

2 ACTIMMUNE Covered Uses All FDA approved indications not otherwise excluded from Part D. ADEMPAS PAH and CTEPH- must be precribed by or in consultation with a cardiologist or a pulmonologist. 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. AFINITOR All FDA approved indications not otherwise excluded from Part D. Additional off-label uses covered are the treatment Covered Uses of advanced, unresectable neuroendocrine tumors. Combination use with sorafenib or sunitinib. Coverage for RCC is provided after failure of treatment with sunitinib or sorafenib. Coverage for SEGA is provided for patients who are not candidates for curative surgical resection. CMS Approval Date: Page 2

3 ALPHA-1 PROTEINASE INHIBITORS All FDA-approved indications not otherwise excluded from Part D. Alpha-1 antitrypsin (AAT) deficiency-associated Covered Uses panniculitis. 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. Coverage Duration 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. AMPYRA History of seizures/evidence of epileptiform activity on EEG, moderate to severe renal impairment (CrCl less than or equal to 50 ml/min), patient not able to walk 25 feet in 8-45 seconds Diagnosis of multiple sclerosis Greater than or equal to 18 years of age Coverage Duration lifetime ANDROGENS Covered Uses All FDA approved indications not otherwise excluded from Part D. Coverage is provided for females for the palliative treatment of breast cancer. Coverage is provided for males for delayed puberty or the treatment of hypogonadism in situations where the patient has a baseline (pre-treatment) serum testosterone level of less than or equal to 300 ng/dl (less than 10.4 nmol/l) OR has symptoms suggestive of androgen deficiency with a baseline free testosterone levels below the lower limit of normal. Coverage Duration All indications 5 years, except delayed puberty: 6 months CMS Approval Date: Page 3

4 ANTIEMETICS Patient must have tried and failed one formulary non high risk medication alternative (prochlorperazine, ondansetron, granisetron ) or have a documented contraindication to all of these alternatives. PA required for age 65 years and older. Coverage is provided immediately in situations where the patient is younger than 65 years of age. Coverage Duration 1 year ANTIFUNGAL THERAPY Onychomycosis in patients with evidence of ventricular dysfunction such as CHF or a history of CHF. Coadministration with certain drugs metabolized by the cytochrome P-450 3A4 isoenzyme system (CYP3A4), cisapride, oral midazolam, pimozide, quinidine, dofetilide, triazolam, HMG-CoA reductase inhibitors metabolized by CYP3A4, such as lovastatin and simvastatin, and ergot alkaloids metabolized by CYP3A4, such as dihydroergotamine, ergotamine, ergonovine, and methylergonovine. KOH smear, or dermatophyte test medium, or fungal culture. For Sporanox for onychomycosis: diagnosis of onychomycosis of the toenail and/or fingernail determined by the presence of dermatophytes that must be verified by 1 of the following: KOH smear or dermatophyte test medium or fungal culture. Immunosppression as identified by any of the following: diabetes mellitus, concurrent cancer chemotherapy, concurrent chronic oral corticosteroid use, history of solid organ transplant, HIV, or severe peripheral vascular disease. For Sporanox for a topical fungal infection other than onychomycosis: failed an adequate trial of topical antifungal therapy. For Sporanox for a systemic fungal infection: a systemic fungal infection including, but not limited to: blastomycosis, histoplasmosis, aspergillosis, candidiasis, sporotrichosis, paracoccidioidomycosis N/A N/A Coverage Duration 12 weeks for onychomycosis CMS Approval Date: Page 4

5 ANTIHISTAMINES MD has been made aware that the incoming drugs is a high risk medications and wishes to proceed with originally prescribed medication. PA required for age 65 years and older. Coverage is provided immediately in situations where the patient is younger than 65 years of age. Coverage Duration 1 year ANTIPSYCHOTICS Covered Uses All medically accepted indications not otherwise excluded from Part D For paliperidone: diagnosis must be schizoaffective disorder OR for other indications patient must have intolerance/failure with the use of Seroquel XR, Risperdal Consta, or a generic atypical antipsychotic. For aripiprazole: patient must have intolerance/failure with the use of Seroquel XR, Risperdal Consta, or a generic atypical antipsychotic. Coverage Duration Patients younger than 18 years of age are exempt from the required medical information Lifetime CMS Approval Date: Page 5

6 ARANESP For CKD not on dialysis for initial therapy:inadequate response to epoetin alfa therapy as defined as failure to achieve target H/H in the presence of adequate iron stores within 4 to 6 months or failure to maintain target H/H subsequently at that dose, and diagnosis of CKD defined as GFR less than 60mL/min or creatinine greater than 1.8mg/dL and lab values within the past 30 days indicating H/H less than 10g/dL/30% or H/H greater than 9.9g/dL/29.9% with documentation of S/Sx of anemia, and transferrin saturation greater than 20% and ferritin greater than 100ng/ml. For CKD not on dialysis continuation therapy: current progress notes indicating symptomatic response to therapy and lab values in the past 30 days indicating: H/H less than 12g/dL/36% and iron panel equivalent to initiation criteria. For anemia due to chemotherapy for nonmyeloid malignancies initial therapy: received chemotherapy within the past 8 weeks and inadequate response to epoetin alfa therapy, as defined previously, diagnosis of non-excluded cancer type, chemotherapy regimen noted, and lab values in the past 30 days indicating: H/H less than 10 g/dl/30% or H/H greater than 9.9 g/dl /29.9% with documentation of S/Sx of anemia. For anemia due to chemotherapy for nonmyeloid malignancies continuation therapy: received chemotherapy within the past 8 weeks and lab values within the past 30 days indicating H/H less than 12g/dL/36% and symptomatic response noted. For anemia associated with MDS initial therapy: inadequate response to epoetin alfa therapy, as defined previously, and diagnosis of MDS confirmed by bone marrow aspiration or biopsy and lab values within the past 30 days indicating: H/H less than 10g/dL/30% or H/H greater than 9.9g/dL/29.9% with documentation of S/Sx of anemia. For anemia associated with MDS continuation therapy:lab values in the past 30 days indicating H/H less than 12g/dL/36% and symptomatic response noted. Dose should be based upon maintaining Hgb level between g/dl. Coverage Duration N/A N/A Approve up to 3 months. Drug Part B vs D coverage determination may apply CMS Approval Date: Page 6

7 ARCALYST All FDA-approved indications not otherwise excluded from Part D. Plus patient already started on rilonacept for Muckle Covered Uses 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. Coverage Duration 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. AUBAGIO Concurrent use of Aubagio with other disease-modifying agents used for multiple sclerosis (MS) [eg, Avonex, Rebif, Betaseron, Copaxone, or Gilenya]. The prescriber has considered and screened for the presence of latent TB infection prior to starting teriflunomide. The patient must still either be able to walk at least a few steps or alternatively must have some functional arm/ hand use consistent with performing activities of daily living. Patient must have inadequate response or intolerance to Rebif AND Copaxone. Aubagio will not be used in combination with an interferon, Copaxone or Gilenya. Coverage will not be provided for the treatment of primary progressive MS. BELEODAQ Covered Uses All FDA approved indications not otherwise excluded from Part D. Diagnosis of relapsed or refractory T cell lymphoma. CMS Approval Date: Page 7

8 BOSULIF Covered Uses All FDA approved indications not otherwise excluded from Part D. Coverage is not provided in those that have the BCR-ABL1 T315I mutation and use Bosulif in combination with other kinase inhibitors (for example sorafenib, sunitinib, etc.) Coverage is provided for the treatment of chronic, accelerated, or blast phase Philadelphia chromosome-positive chronic myelogenous leukemia (CML) in situations where the patient has experienced resistance or intolerance to prior therapy with imatinib. Coverage is only provided in patients at least 18 years of age and older CAPRELSA Dx: metastatic or unresectable medullary thyroid cancer Oncologist Coverage Duration 1 year CELEBREX Covered Uses All medically accepted indications not otherwise excluded from Part D Coverage is not provided for the treatment/prevention of Alzheimer's disease or cancer. Coverage is provided when the pt has previously been unable to tolerate therapy with at least two other different NSAIDs OR is at high risk of NSAID induced adverse GI events evidenced by any of the following: 1. history of peptic ulcer disease, history of NSAID related ulcer, or history of clinically significant GI bleeding or 2. Concomitant therapy with anticoagulants (e.g. warfarin, heparin, or LMWH), chronic use of oral corticosteroids, or Non-aspirin anti-platelet agents (e.g. clopidogrel, ticagrelor, or prasugrel). Patients 65 years of age and older are exempt from the required medical information. For JRA, pt must be 2 years of age or older Coverage Duration Lifetime for JRA/ 12 months for all other indications CMS Approval Date: Page 8

9 CHANTIX The patient must be enrolled in a behavioral support/ modification program (e.g., community program, manufacturer sponsored program, counseling by the physician, internet, or telephone quitline). The patient must be 18 years of age or older Coverage Duration 6 months CIALIS Covered Uses All FDA approved indications not otherwise excluded from Part D Indication for which Taladafil is being prescribed. Coverage for Benign Prostatic Hyperplasia (BPH) is provided in situations where the the patient experienced intolerance/failure with two of the preferred medications such as tamsulosin, alfuzosin, terazosin, doxazosin, finasteride, dutasteride (Avodart), dutasteride plus tamsulin (Jalyn). Coverage Duration Up to 1 year CIMZIA Covered Uses All FDA-approved indications not otherwise excluded from Part D Coverage is not provided for use of Cimzia in combination with other biologics e.g., Humira, Kineret, Remicade, etc Coverage Duration Coverage is provided in situations where the patient has been evaluated and screened for the presence of latent TB infection, where warranted, prior to initiating treatment with Cimzia. Coverage for Crohn's disease is provided in situations where the patient experienced intolerance/failure to Humira. Coverage for rheumatoid arthritis is provided in situations where the patient experienced intolerance/failure to Humira AND Enbrel Patient must be 18 years of age or older Crohn's - 12 months, Rheumatoid arthritis - 5 years Renewal coverage is provided in situations where treatment has provided clinical benefit. CMS Approval Date: Page 9

10 COMETRIQ All FDA approved indications not otherwise excluded from Part D. Plus patients already started on Cometriq for a Covered Uses Covered Use. Diagnosis of progressive, metastatic medullary thyroid cancer. Coverage Duration Authorization will be for 12 months. CRINONE All FDA approved indications not otherwise excluded from Part D. Additional coverage for off-label use is provided to Covered Uses support established pregnancy Coverage is not provided for infertility Coverage Duration 9 months for support of established pregnancy, 12 months for secondary amenorrhea DALIRESP Coverage is provided 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). Adult patients 18 years or older Coverage Duration 1 year CMS Approval Date: Page 10

11 DIFICID Required Medical information: -Diagnosis of severe Clostridium difficile-associated diarrhea -Oral vancomycin trial first Adult patients 18 years or older Coverage Duration 30 days for each treatment ENBREL Concurrent use of more than 1 biological response modifier including, but not limited to: adalimumab, infliximab. Diagnosis of guttate, erythrodermic, or pustular psoriasis. Individual experiencing acute infection or significant chronic infection. 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. Must be greater than or equal to 2 years of age. For JRA: must be between 2 and 17 years of age. For Ankylosing Spondylitis and Psoriatic Arthritis: must be greater than or equal to 18 years of age. For RA, JRA, Ankylosing Spondylitis: provider must be a rheumatologist. For Psoriatic Arthritis: provider must be a rheumatologist or dermatologist. For Plaque Psoriasis: provider must be a dermatologist. Coverage Duration May approve for up to 1 year. CMS Approval Date: Page 11

12 Covered Uses EPOETIN ALFA All medically accepted indications not otherwise excluded from Part D For CKD and not on dialysis: hypersensitivity to mammalian-cell derived products or to human albumin, untreated iron or folate deficiencies, hemolysis, or GI bleeding, uncontrolled hypertension, or in need of immediate correction of severe anemia. For covered indications other than CKD/ESRD: Anemia that is secondary to the malignancy, hypersensitivity to mammalian-cell derived products, or to human albumin, untreated iron or folate deficiencies, hemolysis, or GI bleeding, uncontrolled hypertension, need for immediate correction of severe anemia, inadequate iron stores including transferrin saturation less than 20% and ferritin less than 100ng/mL, endogenous erythropoietin levels greater than 500 mu/ml for zidovudine induced anemia or greater than 200 mu/ml for anemia secondary to cancer. rmation: Diagnosis of CKD: GFR, creatinine, lab values Hgb/Hct (H/H), transferrin saturation and ferritin level within the past 30 days, current body weight, cancer and chemotherapy history. Criteria for anemia secondary to CKD not on dialysis, anemia due to chemotherapy for nonmyeloid malignancies, anemia associated with MDS equivalent to criteria outlined in the Aranesp prior authorization criteria. In addition, for anemia associated with RA initial therapy: diagnosis of RA and within the past 30 days: H/H less than 10g/dL/30%, or H/H greater than 9.9g/dL/29.9% with S/Sx of anemia. For anemia associated with RA continuation therapy: symptomatic response noted and within past 30 days H/H less than 12g/36%. For anemia secondary to zidovudine initial therapy: diagnosis of HIV, currently receiving zidovudine and within the past 30 days: H/H less than 10g/dL/30%, or H/H greater than 9.9g/dL/29.9% with S/Sx of anemia. For anemia secondary to zidovudine continuation therapy: currently receiving zidovudine, symptomatic response noted and within past 30 days H/H less than 12g/dL/36%. For anemia associated with the management of Hep C initial therapy: currently on interferon or peginterferon plus ribavirin and within the past 30 days: H/H less than 10g/dL/30% or H/H greater than 9.9g/dL/29.9% with S/Sx of anemia. For anemia associated with the management of Hep C continuation therapy: continued antiviral regimen, symptomatic response noted and within past 30 days Hgb/Hct less than 12g/36%. For reduction of allogeneic blood transfusion for surgery: scheduled to undergo major elective non-cardiac, non-vascular surgery, expected to require more than 2 units of blood, unable or unwilling to participate in autologous blood donation, and within the past 30 days H/H greater than 10g/dL/30% and less than 13 g/dl/39%.the rate of Hgb increase should not exceed 1 g/dl in a 2-week period. Dose should be based upon maintaining a Hgb level between g/dl. Coverage Duration N/A N/A Up to 3 months, not to exceed manufacturer recommended duration of therapy based on indication. Drug Part B vs D coverage determination may apply CMS Approval Date: Page 12

13 ERIVEDGE For locally advanced BCC, the patient must have disease reoccurance following surgery or not be a candidate for surgery, and not be a candidate for radiation. ESTROGENS Breast cancer, endometrial cancer, prior history of stroke, thrombophlebitis or thromboembolic disease or myocardial infarction. Patient must have tried and failed one formulary alternative (topical estrogen-estrace Cream, Premarin Cream) or vaginal ring (Femring,Estring) or vaginal tablet (Vagifem) for atrophic vaginitis. For osteoporosis prophylaxis, patient must intolerance/failure of a bisphosphonate. For ERT or dysfunctional uterine bleeding, failure/intolerance to 1 formulary alternative (progesterone, norethindrone or medroxyprogesterone). For estrogen replacement due to oophorectomy, primary ovarian failure or female hypogonadism, failure/intolerance to estradiol valerate. No prerequisite medications for palliative treatment of prostate cancer. PA required for age 65 years and older. Coverage is provided immediately in situations where the patient is younger than 65 years of age. Coverage Duration 1 year FIRAZYR Prescribed by, or in consultation with, an allergist/immunologist or a physican that specializes in the treatment of HAE or related disorders. Coverage Duration Authorization will be for 12 mos. CMS Approval Date: Page 13

14 FORTEO Hypersensitivity to Forteo, diagnosis of Paget's disease, unexplained elevations of alkaline phosphatase, open epiphyses, previously treated with external beam or implant radiation therapy involving the skeleton, bone metastases or a history of skeletal malignancies, metabolic bone diseases other than osteoporosis, pre-existing hypercalcemia, dose greater than 20 mcg per day, total duration of therapy equal to or greater than 2 years. Diagnosis of osteoporosis. Total hip and/or spine T-score, current body weight, fracture history, bone mineral density scan, history of bisphosphonate use. Records maintained by the requesting independent practioner verifying that no severe adverse reactions are experienced for continuation of Forteo. N/A N/A Coverage Duration For initial therapy up to 1 year. Continuation up to 1 year not to exceed 2 years of total therapy. For initial therapy: Females must have a diagnosis of osteoporosis as evidenced by: 1. Postmenopausal with a total hip and/or spine T-score of less than -2.5, and history of non-traumatic fracture or failure of bisphosphonate therapy as evidenced by increased bone mineral density in hip or spine after 2 or more years of therapy. 2. Postmenopausal with a total hip and/or spine T-score score between -2.0 and -2.5 AND at least 1 risk factor, such as non-vertebral nontraumatic fracture, low body weight (less than 127 lbs or 57.7 kg), history of first-degree relative with a non-traumatic hip or vertebral fracture. 3. Males must be diagnosed with primary or hypogonadal osteoporosis as evidenced by total hip and/or spine T-score of less than -2.5 or total hip and/or spine T-score between -2.0 and -2.5 with history of nontraumatic non-vertebral fracture. For continuation therapy: records maintained by the requesting independent practioner verifying that no severe adverse reactions are experienced. FULYZAQ Coverage is provided for the treatment of HIV related diarrhea in situations where the patient has experienced intolerance or failure to loperamide AND diphenoxylate/atropine CMS Approval Date: Page 14

15 GCSF For Neupogen: Hypersensitivity to E. coli-derived proteins, filgrastim, or any component of the product. For Neulasta: Hypersensitivity to pegfilgrastim or filgrastim. For Leukine: In patients with excessive leukemic myeloid blasts in the bone marrow or peripheral blood (10% or greater), hypersensitivity to GM-CSF, yeast-derived products or any component of the product, concomitant use with chemotherapy and radiotherapy. CBC with differential, platelet count, and ANC obtained within the last 30 days. For primary prophylaxis (first and subsequent cycle) of febrile neutropenia due to cytotoxic chemotherapy for nonmyeloid malignancies: must be on chemotherapy. For treatment of febrile neutropenia: if prescriber is not an oncologist, documentation of high risk features must include: expected (greater than 10 days) and profound (less than 0.1 x 10^9/L) neutropenia, age greater than 65 years, uncontrolled primary disease, pneumonia, sepsis syndrome (hypotension and multi-organ dysfunction), invasive fungal infection, hospitalization at development of fever. For initiation for treatment of ganciclovir or zidovudine induced neutropenia: current treatment and experiencing neutropenia characterized by an ANC below 1000 cells/ul within the last 30 days. For continuation for treatment of ganciclovir or zidovudine induced neutropenia: CBC with differential and platelet count is obtained 2-3 times weekly during initial filgrastim dosing to maintain an ANC between 2,000-10,000 cells/ul, CBC with differential and platelet count is monitored every 2 weeks once ANC is stabilized within the target range until therapy is discontinued. For treatment of pegylated interferon and ribavirin induced neutropenia: current treatment and experiencing neutropenia characterized by an ANC below 1000 cells/ul obtained within the last 30 days. Filgrastim is administered at a dose of 5 mcg/kg/day IV/SC or by continuous IV/SC infusion. Duration is usually 14 days but will be determined by the desired ANC following the expected chemotherapyinduced neutrophils nadir. If the ANC is above 1000/mm3 for 3 consecutive days, filgrastim may be discontinued. Filgrastim must be discontinued when ANC reaches 10,000/mm^3. Administer medication 24 hours after the completion of myelosuppressive chemotherapy for non-myeloid malignancies and pegfilgrastim should not be given within 14 days of next chemotherapy administration. Coverage Duration N/A Requesting practitioner must be a oncologist, infectious disease specialist, or gastroenterologist. Up to 3 months, not to exceed manufacturer recommended duration of therapy based on indication. CMS Approval Date: Page 15

16 GILENYA Concurrent use of Gilenya with other disease-modifying agents used for multiple sclerosis (MS). Diagnosis of relapsing MS (RMS), secondary progresive MS (SPMS) or relapsing-remitting MS (RRMS). Initial treatment: Member has a documented complete blood count (CBC) within the last six (6) months AND Members currently using antiarrhythmics (including beta-blockers, calcium channel blockers, Class Ia and Class III antiarrhythmics) or with cardiac risk factors (2nd degree or higher AV blocks, sick sinus syndrome, prolonged QT interval, ischemic heart disease, or congestive heart failure, bradycardia less than 55 beats per minute) have a documented EKG (electrocardiogram) within the last six (6) months AND Member has a documented liver transaminase and bilirubin level within the last six (6) months AND Member has a documented ophthalmologic evaluation at time of initiation (within two (2) weeks AND A documented history of chicken pox or administration of the varicella zoster vaccine (VZV). If no history or administration of VZV, then titers should be drawn and if low VZV should be considered AND Member has had an inadequate response (as demonstrated by continued disease activity measured clinically or by MRI) and/or intolerance to Rebif and Copaxone. Continuation of treatment: Documented adherence to fingolimod dosing regimen AND Member is responding to therapy evidenced by no elapse AND Documented absence of disability progression. Coverage Duration Covered Uses Coverage Duration 18 years of age and older neurologist 3 months for initial treatment. 1 year for continuation. Approved dosing is 0.5mg daily. GILOTRIF All FDA approved indications not otherwise excluded from Part D Coverage is provided for the treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 substitution mutations as detected by an FDA-approved test Authorization will be for 12 months. CMS Approval Date: Page 16

17 Covered Uses Coverage Duration GLEEVEC All medically-accepted indications not otherwise excluded from Part D. Plus patients already started on Gleevec for a Covered Use. 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 Phpositive ALL for approval of Gleevec. CMS Approval Date: Page 17

18 GROWTH HORMONE Contraindicated in children with active malignancies and is generally withheld for at least 1 year after completion of successful therapy for a malignancy. Glucocorticoid-induced growth failure, renal transplantation, and genetic and chromosomal disorders (except PWS and Turner Syndrome) associated with short stature are not covered. If while on growth hormone, growth rate decreases to less than 2.5 cm/year. Bones age suggests no further growth potential (14 years for females and 16 years for males). Reached the 10th percentile for normal adult height. Achieved height consistent with midparental height. Fused epiphyses. Growth rate and height chart, endogenous pituitary growth hormone level, 2 growth hormone tests excluding GHRH tests, current bone age, pretreatment growth rate, BMI, blood glucose levels. Diagnosis of: chronic renal insufficiency up to the time of renal transplan, diagnosis of Turner Syndrome or Prader-Willi Syndrome. For growth hormone deficiency initial therapy: height is less than 5th percentile, growth rate is less than 4 cm/year, endogenous pituitary growth hormone level is less than 10mg/ml on 2 standard growth hormone tests excluding GHRH tests, delayed bone age greater or equal to 2 years below actual age. For growth hormone deficiency continuation therapy: pretreatment growth rate has doubled while on growth hormone or growth rate is at least 3 cm/year in children with extremely low pretreatment growth rates. For chronic renal insufficiency up to renal transplant initial therapy: diagnosis of chronic renal insufficiency, height less than 5th percentile, growth rate less than 4 cm/year, delayed bone age greater or equal to 2 years below actual age. For chronic renal insufficiency up to renal transplant continuation therapy: pretreatment growth rate doubled on growth hormone or growth rate at least 3 cm/year in children with extremely low pretreatment growth rates. For Turner Syndrome initial therapy: diagnosis confirmed by karyotype genetic testing, height less than 5th percentile, growth rate less than 4 cm/year, delayed bone age greater or equal to 2 years below actual age. For Turner Syndrome continuation therapy: pretreatment growth rate doubled while on growth hormone or growth rate is at least 3 cm/year in children with extremely low pretreatment growth rates. For Prader-Willi Syndrome initial therapy: diagnosis confirmed by genetic testing, diet to maintain low BMI, 5% reduction body fat, 5% increase fat free mass, blood glucose levels. Omnitrope contains preservative. Members with a contraindication to preservative, Genotropin may be used. Coverage Duration N/A N/A May approve for up to 1 year. CMS Approval Date: Page 18

19 HIGH RISK MEDICATION MD has been made aware that the incoming drugs is a high risk medications and wishes to proceed with originally prescribed medication. PA required for age 65 years and older. Coverage is provided immediately in situations where the patient is younger than 65 years of age. Coverage Duration 1 year HORMONAL AGENTS Diagnosis gynecologist, or endocrinologist, or oncologist Coverage Duration 1 year CMS Approval Date: Page 19

20 HUMIRA 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 anticyclic citrullinated protein antibodies, or bony erosions by radiograph. JIA/JRA. Tried MTX, sulfasalazine, leflunomide 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. 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). UC. Pt has tried a systemic therapy (eg, 6-mercaptopurine, azathioprine, CSA, tacrolimus, infliximab, or a corticosteroid such as prednisone or methylprednisolone) for 3 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. Must be greater than or equal to 4 years of age. For RA, JRA, and Ankylosing Spondylitis: provider must be a rheumatologist. For Psoriatic Arthritis: provider must be a rheumatologist or dermatologist. For Crohn's Disease and Ulcerative Colitis: provider must be a gastroenterologist. Coverage Duration Initial therapy approve up to 6 months. Continuation therapy approve up to 1 year. CMS Approval Date: Page 20

21 IMBRUVICA Coverage is provided for the treatment of mantle cell lymphoma (MCL) in patients who have received at least one prior therapy. Coverage is provided for the treatment of chronic lymphocytic leukemia (CLL) in patients who have received at least one prior therapy Coverage Duration Authorization will be for 12 months. INCIVEK Coverage is not provided for genotypes other than type 1. Previous failure to Incivek or Victrelis. Chronic Hep C, in patients with genotype 1 who have a quantifiable viral load. Must be used in combination with a pegylated interferon and ribavirin. gastroenterologist, hepatologist, or infectious disease physician specializing in the treatment of Hepatitis C Coverage Duration 3 months INCRELEX Diagnosis of Primary insulin-like growth factor-1 deficiency (IGFD) or Growth hormone gene deletion with the development of growth hormone neutralizing antibodies. Confirmation that epiphyses open via wrist film. For continuation therapy confirmation of epiphyses open via wrist film is required. Coverage Duration Approve up to 1 year. CMS Approval Date: Page 21

22 INLYTA For RCC coverage is provided after failure with one prior systemic therapy INTRON-A Hypersensitivity to interferon alfa or any of its components, diagnosis of autoimmune hepatitis, hepatic decompensation (Child-Pugh class B and C) before, or during treatment, unstable laboratory values: neutrophil count less than 1500/mm3, platelet count less than 70,000/mm3, hemoglobin less than 10g/dL, serum creatinine greater than 1.5 mg/dl. Laboratory reports indicating all of the following: presence of antibody to HCV, bilirubin level, platelet count, WBC count, creatinine, albumin level, ALT levels. For initial therapy: diagnosis of hairy cell leukemia, or diagnosis of malignant melanoma and free of disease, but at a high risk for systemic recurrence (within 56 days of surgery), or diagnosis of follicular Non-Hodgkins lymphoma, and used in conjunction with anthracycline-containing chemotherapy, or diagnosis of condylomata acuminate, or diagnosis of AIDS-related Kaposi s sarcoma or diagnosis of chronic hepatitis C virus (HCV): liver biopsy (genotype 1) verifying the diagnosis of HCV, and laboratory reports indicating all of the following: presence of antibody to HCV, bilirubin level of 2mg/dL or greater, platelet count of 70,000/mm3 or greater, white blood cell count of 3,000/mm3 or greater, serum creatinine WNL, albumin level WNL or diagnosis of chronic hepatitis B (HBV): laboratory reports indicating all of the following: serum hepatitis surface antigen (HbsAg) positive for at least six (6) months, evidence of HBV replication (or HbeAg positive), elevated ALT levels for at least 3 months, bilirubin level WNL, albumin level WNL, white blood cell (WBC) count of 4,000/ mm3 or greater, platelet count of 100,000/mm3 (adults) or 150,000/mm3 (pediatrics). For continuation therapy: no severe adverse reactions. Coverage Duration Requesting practitioner must be a oncologist or gastroenterologist. Initial therapy approve up to 3 months. Continuation therapy may approve for up to 1 year. CMS Approval Date: Page 22

23 Covered Uses IVIG 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). HIVassociated 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). CMS Approval Date: Page 23

24 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). 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,hema.KD,ped cardiol or ped ID.B-cell CLL/ BMT/HSCT/CMV interstit pneumonia HCT pts/mm,oncol,hematol,or ID.CIDP/MMN/MG/SPS,neurol.HIVkids/VPP,ID or immunol.hiv-infected,id MD. Dermatomyo/polymyositis,neurol or rheuma. BS,neurol or GBS special.hiv-ass thrombo,id or HIV special.ms exac,msppr,ms special or neuro.prca infxn/prca, ID,immuno, hema, transplant MD.TCP,fetal alloimmune thrombo,hematol or OB.Vasculitic syndromes,rheuma or nephro CMS Approval Date: Page 24

25 Coverage Duration 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 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 age-appropriate vaccination) or pt immunocompromised, or pregnant woman. VSS, patient has anti-neutrophil antibodyassociated vasculitis, tried a systemic CS and either CPA, methotrexate (MTX), Rituxan, or AZA. CMS Approval Date: Page 25

26 JAKAFI JEVTANA Patient has been previously treated with a Taxotere (docetaxel) containing treatment regimen AND is being treated with prednisone in combination with Jevtana. Coverage Duration 1 year Subject to Part B vs D review JUXTAPID Members with moderate or severe hepatic impairment (Child-Pugh Class B or C) or active liver disease, including unexplained persistent elevations of serum transaminases. Members who are pregnant. Members taking strong or moderate CYP3A4 inhibitors (i.e ritonavir, nelfinavir, ketoconazole, verapamil, diltiazem-list not all inclusive) Diagnosis of homozygous familial hypercholesterolemia, LDL C levels,total cholesterol, Apolipoprotein, non-high density lipoprotein cholesterol levels, LFTs, bilirubin levels 18 years of age and older Lipidologist Coverage Duration 6 months Medication must be used as adjunct with medications from at least 2 different lipid lowering classes and LDL apheresis. Coverage may be renewed if LDL reduction is sufficient and LFTs are not persistently elevated or clinically significant. CMS Approval Date: Page 26

27 KADCYLA Coverage for Metastatic breast cancer is provided in situations where the patient is human epidermal growth factor receptor 2 (HER2) positive and previously received trastuzumab (Herceptin) and a taxane, separately or in combination. Patients should have either received prior therapy for metastatic disease or developed disease recurrence during or within 6 months of completing adjuvant therapy. KALYDECO Coverage is NOT provided in patients who are homozygous for F508 deletion or who have other mutations in the CFTR gene. Coverage is provided in the treatment of cyctic fibrosis in patients who have a mutation (G551D,G178R, S549N, S549R, G551S, G1244E, S1251N, S1255P and G1349D) in the CFTR gene as detected by a FDA cleared CF mutation test. Coverage may be renewed in situations where the patient is continuing to derive benefit from treatment (for example, improved or stable lung function measured by FEV1) KINERET Concurrent use of biological response modifier including, but not limited to Enbrel, Humira, or Remicade. Diagnosis, drugs tried and failed. Diagnosis moderate to severe Rheumatoid Arthritis (RA). Previous trial of one of the following: Humira, Enbrel, Remicade, Simponi, or Methotrexate and trial of one DMARD therapy Must be greater than or equal to 18 years of age. Prescriber must be a Rheumatologist. Coverage Duration Initially approved for 3 months, with adequate response approve for 1 year CMS Approval Date: Page 27

28 KORLYM Covered Uses All medically accepted indications not otherwise excluded from Part D Coverage Duration 6 months KUVAN Covered Uses All medically accepted indications not otherwise excluded from Part D. Diagnosis, phenylalanine levels Coverage Duration 3 months initially KYNAMRO Members with moderate or severe hepatic impairment (Child-Pugh Class B or C) or active liver disease, including unexplained persistent elevations of serum transaminases Diagnosis of homozygous familial hypercholesterolemia, LDL C levels,total cholesterol, Apolipoprotein, non-high density lipoprotein cholesterol levels, LFTs, bilirubin levels 18 years of age and older Lipidologist Coverage Duration 6 months Medication must be used as adjunct with medications from at least 2 different lipid lowering classes. Coverage may be renewed if LDL reduction is sufficient to warrant potential risk of liver toxicity. CMS Approval Date: Page 28

29 LETAIRIS Covered Uses All FDA approved indications not otherwise excluded from Part D. Coverage is provided for use in combination with two or more PAH therapies when treatment with one PAH agent failed to adequately control the patient s symptoms. Coverage is provided in situations where it is being prescribed under the care or referral of a cardiologist or pulmonologist. Renewal coverage is provided in situations where treatment has provided clinical benefit. LEUPROLIDE (LONG ACTING) All FDA-approved indications not otherwise excluded from Part D but specific to the following drugs as follows: Prostate cancer (Lupron Depot OR Eligard), Endometriosis (Lupon Depot), Uterine leiomyomata (Lupon Depot), Treatment of central precocious puberty (Lupron Depot Ped). Ovarian cancer (Lupron Depot, Lupron Depot Ped). Breast Covered Uses 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). Coverage Duration 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]). CMS Approval Date: Page 29

30 MEKINIST Coverage is provided in the treatment of unresectable or metastatic melanoma with BRAF V600E or BRAF V600K mutation as detected by an FDA-approved test MIRVASO Covered Uses All medically accepted indications not otherwise excluded from Part D. Greater than or equal to 18 years of age Coverage Duration Authorization will be for 12 months, unless otherwise noted. MOZOBIL Covered Uses All medically accepted indications not otherwise excluded from Part D Diagnosis: Harvesting of peripheral blood stem cells, In patients with non-hodgkin's lymphoma and multiple myeloma. Patients weight for dosage determination. Concurrent Treatments: used in combination with granulocyte-colony stimulating factor Approve for those patients 18 years of age or older CMS Approval Date: Page 30