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

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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 listed 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 , October 1 - February 14, 8:00 AM-8:00 PM, seven days a week, and February 15 - September 30, 8:00 AM - 8:00 PM Monday - Friday, 9:00 AM - 1:00 PM Saturday. Customer Service is available in English and other languages. TTY/TDD users should call or 711. PA Criteria Prior Authorization Group ACTEMRA 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. 1 year Updated 07/01/2016 1

2 Prior Authorization Group ACTHAR HP H.P. ACTHAR 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. Prior Authorization Group ACTIMMUNE ACTIMMUNE All FDA approved indications not otherwise excluded from Part D. 12 months Prior Authorization Group ADEMPAS ADEMPAS PAH and CTEPH- must be prescribed 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 catheterization is not required in pts who are currently receiving Adempas or another agent indicated for WHO group 1. Updated 07/01/2016 2

3 Prior Authorization Group AFINITOR AFINITOR, AFINITOR DISPERZ All FDA approved indications not otherwise excluded from Part D. Additional off-label uses covered are the treatment of advanced, unresectable neuroendocrine tumors. 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. Prior Authorization Group ALECENSA ALECENSA 1 year Prior Authorization Group ALPHA-1 PROTEINASE INHIBITORS ARALAST NP, GLASSIA, PROLASTIN-C, ZEMAIRA 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. 12 months 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. Updated 07/01/2016 3

4 Prior Authorization Group AMPYRA 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 lifetime Prior Authorization Group ANDROGENS ANDRODERM, ANDROGEL, ANDROGEL PUMP, DEPO-TESTOSTERONE All medically accepted 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. All indications 5 years, except delayed puberty: 6 months Updated 07/01/2016 4

5 Prior Authorization Group ANTIFUNGAL THERAPY ITRACONAZOLE 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 A4 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 12 weeks for onychomycosis Prior Authorization Group ANTIPSYCHOTICS ABILIFY, ABILIFY MAINTENA, ARIPIPRAZOLE, ARIPIPRAZOLE ODT, INVEGA, INVEGA TRINZA, PALIPERIDONE ER, REXULTI, VRAYLAR 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. Patients younger than 18 years of age are exempt from the required medical information 1 year Updated 07/01/2016 5

6 Prior Authorization Group ARANESP ARANESP ALBUMIN FREE All medically accepted indications not otherwise excluded from Part D. 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. N/A N/A 3 months Drug Part B vs D coverage determination may apply Updated 07/01/2016 6

7 Prior Authorization Group ARCALYST ARCALYST 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 1 of age. Prescribed by, or in consultation with, a rheumatologist, geneticist, or dermatologist. Initial approval of MWS/FCAS, 90 days. Re-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. Prior Authorization Group AUBAGIO 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. 12 months Updated 07/01/2016 7

8 Prior Authorization Group B VS. D ABELCET, ACETYLCYSTEINE, ACYCLOVIR SODIUM, ADRUCIL, AKYNZEO, ALBUTEROL SULFATE, AMBISOME, AMINOSYN 7%/ELECTROLYTES, AMINOSYN 8.5%/ELECTROLYTE, AMINOSYN II, AMINOSYN II 8.5%/ELECTROL, AMINOSYN M, AMINOSYN-HBC, AMINOSYN-PF, AMINOSYN-PF 7%, AMINOSYN-RF, AMPHOTERICIN B, ATGAM, AZATHIOPRINE, BICNU, BLEOMYCIN SULFATE, BROVANA, BUDESONIDE, CELLCEPT, CELLCEPT INTRAVENOUS, CLADRIBINE, CLINIMIX 2.75%/DEXTROSE 5, CLINIMIX 4.25%/DEXTROSE 1, CLINIMIX 4.25%/DEXTROSE 2, CLINIMIX 4.25%/DEXTROSE 5, CLINIMIX 5%/DEXTROSE 15%, CLINIMIX 5%/DEXTROSE 20%, CLINIMIX 5%/DEXTROSE 25%, CLINIMIX E 4.25%/DEXTROSE, CLINISOL SF 15%, CLOLAR, CROMOLYN SODIUM, CYCLOPHOSPHAMIDE, CYCLOSPORINE, CYCLOSPORINE MODIFIED, CYTARABINE AQUEOUS, DAUNORUBICIN HCL, DOXORUBICIN HCL, DRONABINOL, EMEND, ENGERIX-B, FLUOROURACIL, FREAMINE HBC 6.9%, GENGRAF, GRANISETRON HCL, HEPATAMINE, IDARUBICIN HCL, INTRALIPID, IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE/ALBUT, LEVALBUTEROL, LEVALBUTEROL HCL, METHOTREXATE SODIUM, METHYLPREDNISOLONE, MYCOPHENOLATE MOFETIL, MYCOPHENOLIC ACID DR, NEBUPENT, NEPHRAMINE, NULOJIX, NUTRILIPID, ONDANSETRON HCL, ONDANSETRON ODT, OXALIPLATIN, PENTAM 300, PERFOROMIST, PREDNISONE, PREDNISONE INTENSOL, PREMASOL, PROCALAMINE, PROGRAF, PROSOL, PULMOZYME, RAPAMUNE, RECOMBIVAX HB, SANDIMMUNE, SIMULECT, SIROLIMUS, TACROLIMUS, TOBRAMYCIN, TRAVASOL, TROPHAMINE, VINBLASTINE SULFATE, ZORTRESS Updated 07/01/2016 8

9 Prior Authorization Group BELEODAQ BELEODAQ Prescribed by or in consultation with an oncologist Prior Authorization Group BENLYSTA BENLYSTA Members with severe active lupus nephritis or severe active central nervous system lupus or members with concommitant use of other biologic products or IV cyclophosphamide or member receiving therapy for chronic infection Diagnosis of active, autoantibody-positive systemic lupus erythematous(sle) evidenced by ANA greater than 1:80 or anti-ds DNA greater than 30IU/ml. Member shows intolerance/failure to any 2 of the following: Corticosteroids, Immunosuppressive/cytotoxic agents or antimalarials. Must be used in combination with standard therapy excluding IV cyclophosphamide. 12 months Updated 07/01/2016 9

10 Prior Authorization Group BOSULIF BOSULIF 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 Prior Authorization Group BOTULINUM TOXINS BOTOX, DYSPORT, XEOMIN Infection at injection site AbobotulinumtoxinA diagnosis of cervical dystonia. Incobotulinumtoxin diagnosis must be blepharospasm or cervical dystonia. OnabotulinumtoxinA diagnosis must be blepharospasm, cervical dystonia, migraine prophylaxis, neurogenic or overactive bladder, spasticity, strabismus or urinary incontinence. 12months Prior Authorization Group CAPRELSA CAPRELSA Dx: metastatic or unresectable medullary thyroid cancer Oncologist Updated 07/01/

11 Prior Authorization Group CERDELGA CERDELGA Biochemical assay of glucocerebrosidase activity in member's WBC or skin fibroblast is less than 30% of normal activity and genotype mutation of two mutant alleles of the glucocerebrosidase gene and member experiencing symptomatic manifestations of the disease. Member has FDA-approved genotyping test that has determined that the member is a CYP2D6 extensive metabolizer, intermediate metabolizer or poor metabolizer. 18 years of age or older 12 months Prior Authorization Group CHANTIX CHANTIX, CHANTIX CONTINUING MONTH, CHANTIX STARTING MONTH PA 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 6 months Updated 07/01/

12 Prior Authorization Group CIALIS CIALIS 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). 12 months Prior Authorization Group CIMZIA CIMZIA 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 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, psoriatic arthritis, and ankylosing spondylitis 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, Psoriatic Arthritis, and Ankylosing Spondylitis - 12 months, Rheumatoid arthritis - 5 years Renewal coverage is provided in situations where treatment has provided clinical benefit. Updated 07/01/

13 Prior Authorization Group CINRYZE CINRYZE Diagnosis of hereditary angioedema as evidenced by C4 and C1 inhibitor assays. Prescribed by an allergist or immunologist 1 year Prior Authorization Group COMETRIQ COMETRIQ 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. Updated 07/01/

14 Prior Authorization Group COSENTYX COSENTYX SENSOREADY PEN Latent TB screening with either a TB skin test or an interferon gamma release assay (e.g., QFT-GIT, T-SPOT.TB) must be performed prior to initiating Cosentyx (or other biologic). Member has a diagnosis of moderate to severe plaque psoriasis. At least 5% BSA is affected or crucial body areas (eg, feet, hands, face, neck and/or groin) are affected at the time of diagnosis. For new starts, ALL of the following criteria must be met: 1) Member has experienced an inadequate response to phototherapy (e.g., UVB, PUVA), methotrexate, cyclosporine, or acitretin, unless contraindicated or intolerant to such therapies, 2) Member will be assessed for continuation of therapy after 3 months of treatment. For continuation, member must have achieved positive clinical response after 3 months of treatment or has maintained positive clinical response as evidenced by low disease activity or improvement in signs and symptoms. 18 years of age or older Initial: 4 months. Continuation: 1 Year Prior Authorization Group COTELLIC COTELLIC 1 year Must be used in combination with vemurafenib. Updated 07/01/

15 Prior Authorization Group CRESEMBA CRESEMBA Familial Short QT Syndrome Coverage is provided in the treatment of invasive aspergillosis and invasive mucormycosis. 18 years of age or older 1 Year Prior Authorization Group CYRAMZA CYRAMZA 1 year Prior Authorization Group DAKLINZA DAKLINZA Documentation of genotype Criteria will be applied consistent with current AASLD-IDSA guidance. Updated 07/01/

16 Prior Authorization Group DALIRESP 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 1 year Prior Authorization Group DARZALEX DARZALEX 1 year Prior Authorization Group DIFICID DIFICID Required Medical information: -Diagnosis of severe Clostridium difficile-associated diarrhea -Oral vancomycin trial first Adult patients 18 years or older 30 days for each treatment Updated 07/01/

17 Prior Authorization Group EMPLICITI EMPLICITI 1 year Must be used in combination with lenalidomide and dexamethasone. Prior Authorization Group ENBREL ENBREL, ENBREL SURECLICK 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 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 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. 12 months Updated 07/01/

18 Prior Authorization Group EPOETIN ALFA EPOGEN, PROCRIT 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. : 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. 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 Updated 07/01/

19 Prior Authorization Group ERIVEDGE 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. Prior Authorization Group ESBRIET ESBRIET Member has confirmed etiology for interstitial lung disease (e.g. sarcoidosis, scleroderma, SLE, drug toxicity) other than idiopathic pulmonary fibrosis. Cannot be used in combination with nintedanib (Ofev) For initial coverage, all of the following: LFTs on schedule recommended in package insert, High resolution CT of chest, interstitial pneumonia pattern analysis, surgical lung biopsy. For continuation, ALT/AST must be less than 5 times ULN or less than 3 times the upper limit of normal with symptoms of hyperbilirubinemia Prescribed by or in consultation with a pulmonologist Initial 6 months, Renewal:Plan year For continuation only: The patient has experienced a reduction in disease progression. The patient's AST or ALT is not greater than 5x upper limit of normal (ULN) OR the AST or ALT is not greater than 3x and less than 5x ULN with symptoms or hyperbilirubinemia. Updated 07/01/

20 Prior Authorization Group FARYDAK FARYDAK All FDA approved indications not otherwise excluded from Part D. Diagnosis, Previous Therapies Tried 1 year Members diagnosed with multiple myeloma who have received 2 prior therapies (including bortezomib and an immunomodulatory agent). Medication must be used in combination with bortezomib and dexamethasone. Prior Authorization Group FIRAZYR FIRAZYR 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. Prior Authorization Group FLECTOR FLECTOR All medically accepted indications not otherwise excluded from Part D. Authorization will be for 12 months. Patients must try a generic oral NSAID AND Voltaren gel. Updated 07/01/

21 Prior Authorization Group GATTEX GATTEX Active gastric cancer or gastrointestinal malignancy Member is dependent on parenteral nutrition for at least 3 months Prescribed by or in consultation with an gastroenterologist 12 months Updated 07/01/

22 Prior Authorization Group GCSF LEUKINE, NEULASTA, NEUPOGEN, ZARXIO 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. N/A Requesting practitioner must be a oncologist, infectious disease specialist, or gastroenterologist. 3 months, not to exceed manufacturer recommended duration of therapy based on indication. Updated 07/01/

23 Prior Authorization Group GILENYA 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 relapsingremitting 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. 18 years of age and older neurologist 3 months for initial treatment. 1 year for continuation. Approved dosing is 0.5mg daily. Prior Authorization Group GILOTRIF 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 Updated 07/01/

24 Prior Authorization Group GLEEVEC GLEEVEC, IMATINIB MESYLATE 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. 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. Updated 07/01/

25 Prior Authorization Group GROWTH HORMONE OMNITROPE All medically accepted indications not otherwise excluded from Part D. Contraindicated in children with active malignancies and is generally withheld for at least 1 year after completion of successful therapy for a malignancy. Glucocorticoidinduced 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: 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 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 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 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. Omnitrope contains preservative. Members with a contraindication to preservative, Genotropin may be used. N/A N/A 12 months Updated 07/01/

26 Prior Authorization Group HARVONI HARVONI All FDA-approved indications not otherwise excluded from Part D, chronic hepatitis C genotype 4, 5, or 6 infection. None Chronic hepatitis C infection confirmed by presence of HCV RNA in the serum prior to starting tx. For G1 infection, monotherapy: 1)Total 12 wks for tx-naive pts with or without cirrhosis. Tx for 8 wks can be considered in tx-naive pts without cirrhosis who have pre-tx HCV RNA below 6 million IU/mL, 2)For pts who failed prior tx with PEG-IFN and RBV with or without HCV PI: a) total 12 wks if no cirrhosis, b) total 24 wks for cirrhosis. For G4 infection, monotherapy: Total 12 wks for pts who are tx-naive or failed prior tx with PEG-IFN and RBV. For G5 infection, monotherapy: Total 12 wks for pts who are tx-naive or failed prior tx with PEG-IFN and RBV. For G6 infection, monotherapy: Total 12 wks for pts who are tx-naive or failed prior tx with PEG-IFN and RBV. For recurrent HCV infection post liver txp, monotherapy: Total 24 wks for tx-naive pts with G1 or 4 infection and documented anemia or RBV ineligibility. For G1 infection, tx with RBV: 1)Total 12 wks for pts with cirrhosis who failed prior tx with PEG-IFN and RBV with or without an HCV PI, 2)Total 12 wks for pts without cirrhosis who failed prior tx with a SOF-containing regimen, 3)Total 24 wks for pts with cirrhosis who failed prior tx with a SOF-containing regimen. For decompensated cirrhosis (CTP class B or C), tx with RBV: 1)Total 12 wks for pts with G1 or 4 infection, 2)Total 24 wks for pts with G1 or 4 infection who failed prior tx with a SOF-containing regimen, 3)Total 12 wks for pts with recurrent G1 or 4 infection post liver txp. For recurrent HCV infection post liver txp, tx with RBV: Total 12 wks for pts with G1 or 4 infection. For HCV/HIV coinfection, pt meets all of the following: 1)Pt meets the criteria for requested regimen above, 2)Will not receive tx with cobicistat given with tenofovir, 3)Will not receive tx with tipranavir. 12 to 24 weeks Prior Authorization Group HORMONAL AGENTS SYNAREL Diagnosis gynecologist, or endocrinologist, or oncologist 1 year Updated 07/01/

27 Prior Authorization Group HUMIRA HUMIRA, HUMIRA PEDIATRIC CROHNS D, HUMIRA PEN, HUMIRA PEN-CROHNS DISEASE All FDA-approved indications not otherwise excluded from Part D.Additional coverage for off-label use is provided for moderate to severe Hidradenitis suppurativa. RA, Tried 1 conventional or biologic DMARD (brand or generic, oral or injectable) for 3 mos or pt is concurrently receiving methotrexate (MTX), or pt has contraindication or inolerance to MTX and leflunomide, as determined by prescribing physician.patient has early RA (defined as disease duration less than 6 months) with at least one feature of poor prognosis:functional limitation, extraarticular disease such as rheumatoid nodules, RA vasculitis, or Felty syndrome, positive rheumatoid factor or anti-cyclic citrullinated protein antibodies, or bony erosions by radiograph. JIA/JRA. Tried 1 of MTX, sulfasalazine, leflunomide or biologic DMARD (etanercept, abatacept, 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 (MTX, CSA, acritretin, etanercept, infliximab, secukinumab or ustekinumab) for 3 mos or PUVA) for 3 months, or pt experienced intolerance to at least one systemic therapy (oral or biologic therapy), or pt has contraindication to one oral agent for psoriasis such as MTX, as determined by the prescribing physician. CD. Tried corticosteroids (CS) or if CS are contraindicated or if pt currently on CS or patient has tried one other agent for CD (eg, azathioprine, 6-mercaptopurine, MTX, certolizumab, infliximab). UC. Pt has tried a systemic therapy (6-mercaptopurine, azathioprine, CSA, tacrolimus, infliximab, or a CS 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 enema. Must be greater than or equal to of age. For RA, JRA,Ankylosing Spondylitis: provider must be rheumatologist. For plaque psoriasis:provider must be dermatologist.for Psoriatic Arthritis:provider must be rheumatologist or dermatologist.for Crohn's Disease and Ulcerative Colitis: provider must be gastroenterologist. 1 year Updated 07/01/

28 Prior Authorization Group IBRANCE IBRANCE Diagnosis of ER+, HER2-negative advanced breast cancer. Women must be postmenopausal. Must be used in combination with letrozole for initial endocrine based therapy only. Prior Authorization Group ICLUSIG ICLUSIG Member must have T315I-positive mutation in the chronic, accelerated or blast phase of CML. If member is on concurrent strong CYP3A4 inhibitors, dose should be reduced to 30mg daily. If member is not on strong CYP3A4 inhibitors, dose should be 45mg daily. If member cannot use any other TKI for CML, Iclusig may be prescribed with dosing as previously discussed Prescribed by or in consultation with an oncologist Updated 07/01/

29 Prior Authorization Group ILARIS ILARIS When used in combination with concurrent biologic therapy (e.g.tnf antagonists, etanercept, adalimumab, certolizumab pegol, golimumab, infliximab), anakinra, or rilonacept. CAPS-4 years of age and older. SJIA- of age and older. CAPS/MWS/FCAS initial- Prescribed by or in consultation with a rheumatologist, geneticist, or dermatologist. SJIA initial- prescribed by or in consultation with a rheumatologist CAPS/MWS/FCAS-Initial: 3 months, renewal 12 mos. SJIA initial-3 mos, renewal 12 mos For renewal of CAPS/MWS/FCAS - after pt had been started on Ilaris, approve if the pt had a response to therapy as determined by prescribing physician and the pt is continuing therapy to maintain a response/remission. For treatment of SJIA, initial therapy approve if the pt meets one of the following 1. has tried at least 2 other biologics for SJIA (tocilizumab, abatacept, TNF antagonists (e.g. etanercept, adalimumab, infliximab) OR 2. pt has features of poor prognosis (e.g. arthritis of the hip, radiographic damage, 6-month duration of significant active systemic diease, defined by fever, elevated inflammatory markers, or requirement for treatment with systemic glucocorticoids AND tried Actemra or Kineret. SJIA renewal approve if it patient was already started on Ilaris and the pt had a response (e.g. resolution of fever, improvement in limitions of motion, less joint pain or tenderness, decreased duration of morning stiffness or fatigue, improved function or ADLs, reduced dosage of CS) and the pt is continuing therapy to maintain response/remission. Prior Authorization Group IMBRUVICA 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 Updated 07/01/

30 Prior Authorization Group INCRELEX 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. 12 months Prior Authorization Group INLYTA INLYTA All FDA-approved indications not otherwise excluded from Part D and compendia supported indication of differentiated (papillary, follicular and Hurthle) thyroid cancer. Also, any patient previously on Inlyta for a covered use. Coverage for thyroid cancer: Patient has clinically progressive or symptomatic metastatic disease AND has nonradioiodine-responsive tumors at sites other than central nervous system. Updated 07/01/

31 Prior Authorization Group INTRON-A INTRON A, INTRON A W/DILUENT 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 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. Requesting practitioner must be a oncologist or gastroenterologist. Initial therapy: 3 months. Continuation therapy: 12 months. Prior Authorization Group IRESSA IRESSA 1 year Updated 07/01/

32 Prior Authorization Group IVIG BIVIGAM, GAMMAGARD LIQUID, GAMMAPLEX, GAMUNEX-C, PRIVIGEN 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). 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). 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. HIVinfected kids PRB, on highly active antiretroviral therapy (HAART), 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 Updated 07/01/

33 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.HIV-kids/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 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. Updated 07/01/