2019 PRIOR AUTHORIZATION CRITERIA UCare Connect (SNBC) MinnesotaCare Prepaid Medical Assistance Program (PMAP) Minnesota Senior Care Plus (MSC+)

Transcription

1 2019 PRIOR AUTHORIZATION CRITERIA UCare Connect (SNBC) MinnesotaCare Prepaid Assistance Program (PMAP) Minnesota Senior Care Plus (MSC+) UCare requires your physician to get prior authorization for certain drugs. This means that you will need to get approval from UCare before you fill your prescriptions. If you don t get approval, UCare may not cover the drug. UCare PMAP, MinnesotaCare, and MSC+ members with questions should call UCare Customer Services at toll free. UCare Connect members with questions should call toll free. TTY machine users can call Hours of operation are 8 a.m. - 5 p.m., Monday-Friday. Updated 1/2019 Effective 2/1/2019 PMAP MnCare MSC+ SNBC_ DHS Approved ( ) U6429 (10/18)

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5 American Indians can continue or begin to use tribal and Indian Health Services (IHS) clinics. We will not require prior approval or impose any conditions for you to get services at these clinics. For enrollees age 65 years and older this includes Elderly Waiver (EW) services accessed through the tribe. If a doctor or other provider in a tribal or IHS clinic refers you to a provider in our network, we will not require you to see your primary care provider prior to the referral.

6 Actemra ACTEMRA ACTEMRA ACTPEN Other Details All FDA-approved indications not otherwise excluded plus patients already started on tocilizumab for a covered use. Castleman's disease. Still's disease. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis and other medications tried for the diagnosis provided Rheumatoid arthritis (RA), patients 18 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (PJIA) and Systemic Juvenile Idiopathic Arthritis (SJIA), patients 2 years of age and older. All other conditions, 18 years of age and older. For Castleman's disease, must be prescribed by or in consultation with an oncologist or hematologist. For RA, PJIA, SJIA, and Still's Disease, must be prescribed by or in consultation with a rheumatologist. Authorization will be for 12 months. For RA, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For Still's Disease must have tried a corticosteroid and one conventional DMARD, such as methotrexate, given for at least 2 months or was intolerant to a conventional DMARD. For SJIA, must have tried one other systemic agent (e.g., a corticosteroid [oral, IV] or a conventional DMARD [e.g., MTX, leflunomide, sulfasalazine] or a biologic DMARD or a 1-month trial of a nonsteroidal anti-inflammatory drug [NSAID]. For PJIA, must have tried one other systemic agent (e.g., a corticosteroid [oral, IV] or a conventional DMARD [e.g., MTX, leflunomide, sulfasalazine] or a biologic DMARD or a 1-month trial of a nonsteroidal anti-inflammatory drug [NSAID]. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 1

7 Afinitor AFINITOR AFINITOR DISPERZ Details All FDA-approved indications not otherwise excluded. Advanced, unresectable neuroendocrine tumors. Perivascular Epitheloid Cell Tumors (PEComa), Recurrent Angiomyolipoma, Lymphangioleiomyomatosis, relapsed or refractory classical Hodgkin lymphoma, Waldenstrom's Macroglobulinemia/Lymphoplasmacytic Lymphoma (WM/LPL), Advanced Breast Cancer in Patients with HER2- negative Disease Already Started on Afinitor Therapy, Differentiated (i.e. papillary, follicular, and Hürthle cell) Thyroid Carcinoma, Osteosarcoma, Thymomas and Thymic Carcinmoas HER2 status. Advanced HER2-negative breast cancer, hormone receptor (HR) status. Classical Hodgkins Lymphoma patients are 18 years or older Authorization will be for 3 years. 2

8 Other Details Advanced HER2-negative breast cancer, approve if the patient is a postmenopausal woman and has HR+ disease and Afinitor will be used in combination with exemestane or tamoxifen and the patient has tried letrozole, tamoxifen or anastrozole. Renal cell carcinoma (RCC), approve if patient meets one of the following: 1) patient has advanced RCC with predominant clear cell histology AND the patient has tried Inlyta, Votrient, Sutent, or Nexavar OR 2) patient has relapsed or medically unresectable RCC with non-clear cell histology.tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA), approve if the patient requires therapeutic intervention but cannot be curatively resected. NET-approve. Osteosarcoma, approve if the patient has tried standard chemotherapy for osteosarcoma AND the patient has relapsed/refractory or has metastatic disease. Thymomas and Thymic Carcinomas, approve if the patient has tried chemotherapy. Renal angiomyolipoma with TSC-approve. WM/LPL - approve if 1. patient has progressive or relapsed disease OR 2. patient has not responded to primary therapy (e.g., Velcade+/- Rituxan, Velcade with dexamethasone +/-Rituxan, Kyprolis with Rituxan and dexamethasone, cyclophosp/doxorubicin/vincristine/pred/rituxan, Imbruvica, Rituxan, Rituxan with cyclophosphamide and dexamethasone, Thalomid+/- Rituxan OR pt has progressive or relapsed disease. 3

9 Aimovig AIMOVIG AUTOINJECTOR AIMOVIG AUTOINJECTOR (2 PACK) Details All FDA-approved indications not otherwise excluded. Diagnosis, number of migraine headaches per month, prior therapies tried 18 years and older Other Authorization will be for 1 year Patient has greater than or equal to 4 migraine headache days per month (prior to initiating a migraine-preventative medication), AND Patient has tried at least two standard prophylactic pharmacologic therapies, at least one drug each from a different pharmacologic class (e.g., anticonvulsant, ß-blocker), and has had inadequate responses to those therapies or the patient has a contraindication to other prophylactic pharmacologic therapies according to the prescribing physician, AND Patient has tried at least one triptan therapy, unless contraindicated according to the prescribing physician. 4

10 Ajovy AJOVY Details All FDA-approved indications not otherwise excluded from Part D. Diagnosis, number of migraine headaches per month, prior therapies tried 18 years of age and older Other Approval duration of 1 year Patient has greater than or equal to 4 migraine headache days per month (prior to initiating a migraine-preventative medication), AND patient has tried at least two standard prophylactic pharmacologic therapies, at least one drug each from a different pharmacologic class (e.g., anticonvulsant, ß-blocker), and has had inadequate responses to those therapies or the patient has a contraindication to other prophylactic pharmacologic therapies according to the prescribing physician. 5

11 Alecensa ALECENSA Details All FDA-approved indications not otherwise excluded from Part D. Other Authorization for 3 years Metastatic NSCLC - is anaplastic lymphoma kinase (ALK)-positive AND has either progressed on or is intolerant to Xalkori, or is being used as first-line therapy. 6

12 Alunbrig ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG ALUNBRIG ORAL TABLETS,DOSE PACK Details All FDA-approved indication not otherwise excluded. ALK status, treatment history and results Other Authorization will be for 3 years. Metastatic NSCLC, patient new to therapy must be ALK-positive AND experienced progression or intolerance while on Xalkori, Zykadia or Alecensa 7

13 Ampyra dalfampridine Details All FDA-approved indications not otherwise excluded. Other Prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of MS. Authorization will be for 3 years. Used to improve mobility in a patient with MS. 8

14 Anabolic Steroids oxandrolone Details All FDA-approved indications not otherwise excluded. Girls w/turner's Syndrome or Ullrich-Turner Syndrome (oxandrolone only), management of protein catabolism w/burns or burn injury (oxandrolone only), AIDS wasting and cachexia. Authorization will be for 12 months, unless otherwise specified. Other 9

15 Aranesp ARANESP (IN POLYSORBATE) INJECTION SOLUTION ARANESP (IN POLYSORBATE) INJECTION SYRINGE 100 MCG/0.5 ML, 150 MCG/0.3 ML, 200 MCG/0.4 ML, 25 MCG/0.42 ML, 300 MCG/0.6 ML, 40 MCG/0.4 ML, 500 MCG/ML, 60 MCG/0.3 ML Details All FDA-approved indications not otherwise excluded worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Anemia due to myelodysplastic syndrome (MDS). Other CKD and MDS - Authorization will be for 6 months, Other - Authorization will be for 4 months Confirmation of adequate iron stores at intiation of therapy (eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%). Anemia w/crf on and not on dialysis. A hemoglobin (Hb) of less than 10.0 g/dl for patients 18 years and older and less than or equal to 11 g/dl for children required for start,hb has to be less than or equal 11.5 g/dl for patients 18 years of age and older or less than or equal to 12 g/dl in children if currently receiving epoetin alfa (EA) or Aranesp. Anemia due to myelosuppressive chemotx,hb is 10.0 g/dl or less to start.hb less than or equal to 12.0 g/dl if currently on epoetin alfa EA. MDS, approve tx if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start. 10

16 Aubagio AUBAGIO Details All FDA approved indications not otherwise excluded. Plus patients already started on Aubagio for a Covered Use. Concurrent use of Aubagio with other disease-modifying agents used for multiple sclerosis (MS) [eg, Avonex, Rebif, Betaseron, Extavia, Copaxone, Tysabri, Tecfidera, or Gilenya]. MS, patient must have a relapsing form of MS (RRMS, SPMS with relapses, or PRMS). MS, previous MS therapies tried. Other Prescribed by or in consultation with a neurologist or MS specialist. Authorization will be for 12 months For use in a relapsing form of MS, approve if: 1) Patient is currently taking teriflunomide (Aubagio), OR2) Patient has tried fingolimod (Gilenya) or dimethyl fumarate (Tecfidera) AND the patient has tried one of the following injectables: interferon beta-1a intramuscular (Avonex), interferon beta-1a subcutaneous (Rebif), interferon beta-1b (Betaseron or Extavia), glatiramer acetate (Copaxone). If the patient has not yet tried an injectable, the patient must try one of Avonex, Rebif, Betaseron, or Copaxone 20 mg. Exceptions to having tried an injectable product can be made if the patient is unable to administer injections due to dexterity issues or visual impairment. 11

17 Austedo AUSTEDO Details All FDA-approved indications not otherwise excluded Diagnosis, previous medications tried Other Prescribed by or in consultation with a neurologist or psychiatrist Authoization will be for 1 year Chorea associated with Huntington's Disease - approve if, according to the prescribing physician, the patient has previously tried brand or generic tetrabenazine tablets. 12

18 Avonex AVONEX (WITH ALBUMIN) AVONEX INTRAMUSCULAR PEN INJECTOR KIT AVONEX INTRAMUSCULAR SYRINGE KIT Details All FDA-approved indications not otherwise excluded. Concurrent use of other disease-modifying agent used for multiple sclerosis (ie, interferon beta-1a, interferon beta-1b, glatiramer, natalizumab, fingolimod, teriflunomide, dimethyl fumarate DR) Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 3 years. Other 13

19 Betaseron Extavia BETASERON SUBCUTANEOUS KIT EXTAVIA SUBCUTANEOUS KIT Details All FDA-approved indications not otherwise excluded. Concurrent use with other disease-modifying agent used for multiple scelorosis (ie, interferon beta-1a, glatiramer, natalizumab, fingolimod, teriflunomide, dimethyl fumerate ER) Multiple Sclerosis (MS) diagnosis worded or described as patients with a diagnosis of MS or have experienced an attack and who are at risk of MS. Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 3 years. Other 14

20 Bosulif BOSULIF Details All FDA-approved indications not otherwise excluded. Plus patients already started on Bosulif for a covered indication. Diagnosis for which Bosulif is being used. For chronic myelogenous leukemia (CML), the Philadelphia chromosome (Ph) status of the leukemia must be reported. For CML, prior therapies tried must be reported to confirm resistance or intolerance. Other Authorization will be for 3 years. For CML, patient must have Ph-positive CML and have tried one other tyrosine kinase inhibitor indicated for use in Philadelphia chromosome positive CML (e.g., Gleevec [imatinib tablets] Sprycel [dasatinib tablets], or Tasigna [nilotinib capsules]). 15

21 Braftovi BRAFTOVI Details All FDA-approved indications not otherwise excluded from Part D. Plus patients already started on Braftovi for a covered use. Diagnosis, BRAF V600 mutations Other Approval duration of 3 years For unresectable or metastatic malignant melanoma with BRAF V600E or V600K mutation. Must prescribed in combination with Mektovi. 16

22 Cabometyx CABOMETYX Details All FDA-approved indications not otherwise excluded from Part D. Plus patients with Non-Small Cell Lung Cancer with RET Gene Rearrangements. Plus patients already taking Cabometyx for a Covered Use. Diagnosis, medication history, histology, RET gene rearrangement status Authorization will be for 3 years Other Advance Renal Cell Carcinoma-Patients must meet both 1 AND 2. 1) Patient has RCC with predominant clear-cell histology 2) Patient has tried one tyrosine kinase inhibitor therapy (e.g., Sutent [sunitinib malate capsules], Votrient [pazopanib tablets], Inlyta [axitinib tablets], Nexavar [sorafenib tosylate tablets]) OR patient has RCC with non-clear cell histology 17

23 Calquence CALQUENCE Details All medically-accepted and FDA-approved indications not otherwise excluded. Previous medications/therapies tried. Other Authorization will be for 3 years Mantle cell lymphoma-approve if the patient has tried one other therapy (e.g., CALGB regimen [Rituxan (rituximab for intravenous infusion), plus methotrexate with augmented CHOP (cyclophosphamide, doxorubicin, vincristine, prednisone)], hypercvad [cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine] plus Rituxan, NORDIC regimen [dose-intensified induction immunochemotherapy with Rituxan plus cyclophosphamide, vincristine, doxorubicin, prednisone [maxi-chop] alternating with Rituxan plus high-dose cytarabine, alternating RCHOP/RDHAP [Rituxan, cyclophosphamide, doxorubicin, vincristine, prednisone/rituxan, dexamethasone, cisplatin, cytarabine], Treanda [bendamustine injection for intravenous (IV) use] with or without Rituxan, CHOP plus Rituxan, Revlimid [lenalidomide capsules] plus Rituxan, modified RituxanhyperCVAD, Imbruvica [ibrutinib capsules], Revlimid with or without Rituxan, Velcade [bortezomib injection for IV or subcutaneous use], and FC [fludarabine, cyclophosphamide] with or without Rituxan. 18

24 Caprelsa CAPRELSA Details All FDA-approved indications not otherwise excluded. Plus Differentiated (i.e., papillary, follicular, and Hurthle) Thyroid Carcinoma and NSCLC with RET Gene Rearrangements. Other Authorization will be for 3 years. MTC - approve. DTC - approve if refractory to radioactive iodine therapy. 19

25 Cometriq COMETRIQ Details All medically-accepted indications not otherwise excluded worded as NSCLC with RET gene Rearragnements. Authorization will be for 3 years Other 20

26 Corlanor CORLANOR Details All FDA-approved indications not otherwise excluded. Previous use of a Beta-blocker, LVEF, sinus rhythm, and resting HR Other Prior Authorization will be approved for 12 months HF in pts not currently receiving Corlanor - must all of the following: have LVEF of less than or equal 35 percent, have sinus rhythm and a resting HR of greater than or equal to 70 BPM, AND tried or is currently receiving a Beta-blocker for HF (e.g., metoprolol succinate sustained-release, carvedilol, bisoprolol, carvedilol ER) unless the patient has a contraindication to the use of beta blocker therapy (e.g., bronchospastic disease such as COPD and asthma, severe hypotension or bradycardia). HF in pts currently receiving Corlanor - had a LVEF of less than or equal to 35 percent prior to initiation of Corlanor therapy AND has tried or is currently receiving a Beta-blocker for HF unless the patient has a contraindication to the use of beta blocker therapy. 21

27 Cosentyx COSENTYX COSENTYX (2 SYRINGES) COSENTYX PEN COSENTYX PEN (2 PENS) Other Details All FDA-approved indications not otherwise excluded plus patients already started on secukinumab for a covered use. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Diagnosis and other medications tried for the diagnosis provided. Patients 18 years of age and older. For ankylosing spondylitis (AS) must be prescribed by or in consultation with a rheumatologist. For Psoriatic arthritis (PA), must be prescribed by or in consultation with a rheumatologist or dermatologist. For plaque psoriasis (PP), must be prescribed by or in consultation with a dermatologist. Authorization will be for 12 months. For PA and PP, patient has tried at least 2 of the following biologic or target synthetic DMARDs: adalimumab, etanercept, infliximab, and apremilast for at least 3 months unless the patient experienced intolerance. For AS, the patient must have a trial with etanercept or adalimumab for at least 3 months unless the patient experienced intolerance. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 22

28 Cotellic COTELLIC Details All FDA-approved indications not otherwise excluded from Part D. Plus patients using Cotellic for a covered use. Melanoma initial - must have BRAF V600 mutation Other Authorization for 3 years. Melanoma, Unresectble or Metastatic: Approve in patients who meet the following criteria: The patient has a BRAF V600 mutation AND Cotellic is being prescribed in combination with Zelboraf (vemurafenib tabletszelboraf. 23

29 Crysvita CRYSVITA Details All FDA-approved indications not otherwise excluded from Part D. Chronic Kidney Disease (CKD), Severe Renal Impairment or End Stage Renal Disease Diagnosis, lab values Other Prescribed by or in consultation with a endocrinologist or nephrologist Approval for 3 years Approve if the patient has had a baseline (i.e., prior to any XLH treatment [e.g., Crysvita, oral phosphate/vitamin D therapy]) serum phosphorus level that was below the normal range for age. 24

30 Daraprim DARAPRIM Details All FDA-approved indications not otherwise excluded. Medication history, patient's immune status Toxoplasma gondii Encephalitis, Cystoisosporiasis, PCP, Chronic Maintenance and Prophylaxis (Primary)-prescribed by or in consultation with an infectious diseases specialist. Toxoplasmosis Treatmentprescribed by or in consultation with an infectious diseases specialist, a maternal-fetal medicine specialist, or an ophthalmologist. Authorization will be for 12 months 25

31 Other Details Malaria Prophylaxis, approve if the patient has tried at least two other antimalarials (eg, atovaquone-proguanil, chloroquine phosphate, hydroxychloroquine sulfate, doxycycline, mefloquine, and primaquine). Malaria Treatment, approve if the patient has tried at least two other antimalarials (eg, Coartem [artemetherlumefantrine tablets], quinine sulfate or quinidine gluconate in combination with doxycycline, tetracycline, or clindamycin, quinine sulfate in combination with primaquine and either doxycycline or tetracycline, or the following medications as monotherapy or in combination with primaquine: atovaquone-proguanil, mefloquine, chloroquine phosphate, and hydroxychloroquine). Toxoplasma gondii Encephalitis, Chronic Maintenance, approve if the patient is immunosuppressed. Toxoplasma gondii Encephalitis Prophylaxis(Primary), approve if the patient is immunosuppressed and the patient has tried one other recommended therapy, unless contraindicated (eg, trimethoprim-sulfamethoxazole [TMP-SMX], atovaquone). Cystoisosporiasis pt is immunosuppressed AND has tried 1 other recommended therapy unless contraindicated (e.g., trimethoprim-sulfamethoxazole [TMP-SMX], ciprofloxacin). PCP patient is immunosuppressed AND B)The patient has tried one other recommended therapy, unless contraindicated (e.g., trimethoprimsulfamethoxazole [TMP-SMX], dapsone, atovaquone, aerosolized pentamidine). 26

32 DDAVP desmopressin injection Details All FDA-approved indications not otherwise excluded. For Primary nocturnal enuresis - greater than or equal to 6 years of age. Other Authorization will be for 12 months. For diagnosis of primary nocturnal enuresis less than 18 years of age, only tablets are covered. 27

33 DUPIXENT DUPIXENT SUBCUTANEOUS SYRINGE 300 MG/2 ML Details All FDA-approved indications not otherwise excluded. Diagnosis, prescriber specialty, other medications tried and length of trials Atopic Dermatitis (AD) - 18 years of age and older (initial and continuation). Moderate to Severe Asthma - 12 years of age or older (initial and continuation) Atopic Dermatitis - Prescribed by or in consultation with an allergist, immunologist or dermatologist (initial and continuation). Moderate to Severe Asthma - prescribed by or in consultation with an allergist, immunologist, or pulmonologist (initial and continuation). AD Initial-16 weeks, Asthma Initial- 6 months, Continuation for all-1 year 28

34 Other Details Atopic Dermatitis Initial Therapy- Patient meets all both of the following criteria: Patient has used at least one medium-, medium-high, high-, and/or super-high-potency prescription topical corticosteroid for at least 28 consecutive days OR patient has atopic dermatitis affecting ONLY the face, eyes/eyelids, skin folds, and/or genitalia and has tried tacrolimus ointment for at least 28 consecutive days, AND Inadequate efficacy was demonstrated with these previously tried topical prescription therapies, according to the prescribing physician. Atopic Dermatitis Continuation- Approve if the patient has responded to Dupixent therapy as determined by the prescribing physician (e.g., marked improvements erythema, induration/papulation/edema, excoriations, and lichenification, reduced pruritus, decreased requirement for other topical or systemic therapies, reduced body surface area (BSA) affected with atopic dermatitis, or other responses observed). Moderate to Severe Asthma Initial Therapy - Patient has a blood eosinophil level of greater than or equal 150 cells per microliter within the previous 6 weeks or within 6 weeks prior to treatment with any anti-interleukin (IL) therapy OR Patient has oral (systemic) corticosteroid-dependent asthma (e.g., has received greater than or equal to 5 mg oral prednisone or equivalent per day for greater than or equal to 6 months), per the prescribing physician. Patient has received at least 3 consecutive months of combination therapy with BOTH an inhaled corticosteroid (ICS) and one of the following: Inhaled long-acting betaagonist (LABA), Inhaled long-acting muscarinic antagonist (LAMA), Leukotriene receptor antagonist (LTRA), or Theophylline. Patient's asthma is uncontrolled or was uncontrolled prior to starting any anti-il therapy as defined by ONE of the following: The patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year, OR The patient experienced one or more asthma exacerbation requiring hospitalization or an Emergency Department (ED) visit in the previous year, OR Patient has a forced expiratory volume in 1 second (FEV1) less than 80% predicted, OR Patient has an FEV1/forced vital capacity (FVC) less than 0.80, OR The patient's asthma worsens upon tapering of oral corticosteroid therapy. Moderate to Severe Asthma Continuation - Patient continues to receive therapy with one inhaled corticosteroid (ICS) or one ICS-containing combination inhaler. The patient has responded to Dupixent therapy as determined by the prescribing physician. 29

35 Elelyso ELELYSO Details All medically accepted indications not otherwise excluded Diagnosis Authorization will be for 1 year Other 30

36 Emgality EMGALITY PEN EMGALITY SYRINGE Details All FDA-approved indications not otherwise excluded from Part D. Diagnosis, number of migraine headaches per month, prior therapies tried 18 years of age and older Other Approval duration of 1 year Patient has greater than or equal to 4 migraine headache days per month (prior to initiating a migraine-preventative medication), AND patient has tried at least two standard prophylactic pharmacologic therapies, at least one drug each from a different pharmacologic class (e.g., anticonvulsant, beta-blocker), and has had inadequate responses to those therapies or the patient has a contraindication to other prophylactic pharmacologic therapies according to the prescribing physician. 31

37 Enbrel ENBREL MINI ENBREL SUBCUTANEOUS RECON SOLN ENBREL SUBCUTANEOUS SYRINGE 25 MG/0.5ML (0.51), 50 MG/ML (0.98 ML) ENBREL SURECLICK Details All FDA-approved indications not otherwise excluded plus patient already started on etanercept for a covered use. Graft versus host disease (GVHD). Behcet's disease. Autoimmune mucocutaneous blistering diseases (pemphigus vulgaris, mucous membrane pemphigoid [cicatricial pemphigoid]) (AMBD). Uveitis. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Moderate or severe heart failure (NYHA Class III or IV). History of treated lymphoproliferative disease. Multiple sclerosis or other demyelinating disorder. Diagnosis and other medications tried for the diagnosis provided. Rheumatoid arthritis (RA), Psoriatic arthritis (PA), and Ankylosing spondylitis (AS), patients 18 years of age and older. Plaque psoriasis (PP), patients 4 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (JIA)/ Juvenile Rheumatoid Arthritix (JRA) in patients 2 years of age and older. All other conditions, patients 18 years of age or older. RA/AS/JIA/JRA, prescribed by or in consult with rheumatologist. PA, prescribed by or in consultation with rheumatologist or dermatologist. PP/Cic Pemphigoid AMBD, prescribed by or in consult with a dermatologist. GVHD, prescribed by or in consult with an oncologist, hematologist, or physician affiliated with a transplant center. Behcets disease, prescribed by or in consult with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist. Authorization will be for 12 months. 32

38 Other Details For RA, the patient must have had a trial with a conventional DMARD regimen (eg, methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide) including concurrent use of two or three of the conventional DMARDs for 3 months unless the patient experienced intolerance, or the patient has tried and failed at least one biologic DMARD for 3 months unless the patient experienced intolerance. For JIA/JRA, tried another agent (eg, MTX, sulfasalazine, leflunomide, NSAID, or biologic DMARD (eg, etanercept, abatacept, infliximab, anakinra, tocilizumab) or will be starting on adalimumab concurrently with MTX, sulfasalazine, or leflunomide. Approve without trying another agent if the patient has absolute contraindication to MTX, sulfasalazine, or leflunomide or if the patient has aggressive disease. For PP, the patient has tried a systemic therapy (eg, MTX, CSA, acitretin, adalimumab, infliximab, or apremilast) for 3 months unless the patient experienced intolerance or PUVA for 3 months. For PA, the patient must have had a trial with a conventional DMARD (eg, methotrexate, sulfasalazine, and leflunomide) for at least 3 months unless the patient experienced intolerance or has severe disease activity. For AS, must have active disease despite treatment with one or more NSAIDs. For GVHD, has tried or currently is receiving one conventional GVHD treatment (high-dose SC, CSA, tacrolimus, MM, thalidomide, antithymocyte globulin, etc.). For Behcet's, have not responded to at least one conventional treatment (eg, CS, immunosuppressant, interferon alfa, MM, etc) or adalimumab or infliximab. For Cic Pemp AMBD, tried 2 conventional treatments (eg, systemic corticosteroids, azathioprine, cyclophosphamide, dapsone, MTX, cyclosporine, mycophenolate mofetil). For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 33

39 Epogen/Procrit EPOGEN INJECTION SOLUTION 10,000 UNIT/ML, 2,000 UNIT/ML, 20,000 UNIT/2 ML, 20,000 UNIT/ML, 3,000 UNIT/ML, 4,000 UNIT/ML PROCRIT Details All FDA-approved indications not otherwise excluded worded as anemia associated with chronic renal failure (CRF), including patients on dialysis and not on dialysis, and worded as anemia secondary to myelosuppressive anticancer chemotherapy in solid tumors, multiple myeloma, lymphoma, and lymphocytic leukemia. Anemia due to myelodysplastic syndrome (MDS). Plus anemia in patients with HIV(with or without zidovudine). Patients using for perisurgical adjuvant therapy. CKD and MDS - Authorization will be for 6 months, Perisurgical - 1 month, Other - 4 months 34

40 Other Details Confirmation of adequate iron stores at initiation of therapy (eg, prescribing information recommends supplemental iron therapy when serum ferritin is less than 100 mcg/l or when serum transferrin saturation is less than 20%). CRF anemia in patients on and not on dialysis. Hemoglobin (Hb) of less than 10.0 g/dl for adults or less than or equal to 11 g/dl for children to start. Hb less than or equal to 11.5 g/dl for adults or 12 g/dl or less for children if currently on epoetin alfa or Aranesp. Anemia w/myelosuppressive chemotx. pt must be currently receiving myelosuppressive chemo and Hb 10.0 g/dl or less to start. Hb less than or equal to 12.0 g/dl if currently on epoetin alfa or Aranesp. MDS, approve if Hb is 10 g/dl or less or serum erythropoietin level is 500 mu/ml or less to start. Currently receiving Aranesp or EA, approve if Hb is 12.0 g/dl or less. Anemia in HIV (with or without zidovudine), Hb is 10.0 g/dl or less or endogenous erythropoetin levels are 500 munits/ml or less at tx start. Currently on EA approve if Hb is 12.0 g/dl or less. Perisurgical adjuvant therapy, patient is undergoing hip or knee surgery, has Hgb between 10 and 13 g/dl, is not a candidate for autologous blood transfusion. 35

41 Erivedge ERIVEDGE Details All FDA-approved indications not otherwise excluded. BCC (La or Met) - must not have had disease progression while on Odomzo. Other Authorization will be for 3 years. Basal Cell Carcinoma (BCC), Locally Advanced - Approve if the patients meets ONE of the following conditions: The patient's basal cell carcinoma has recurred following surgery or radiation therapy OR The patient is not a candidate for surgery AND the patient is not a candidate for radiation therapy, according to the prescribing physician 36

42 Erleada ERLEADA Details All medically accepted and FDA-approved indications not otherwise excluded. Diagnosis Authorization will be for 3 years Other 37

43 Esbriet ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET 267 MG, 801 MG Details All FDA-approved indications not otherwise excluded. Concomitant use with Ofev. Other The patient is aged greater than or equal to 40 years old. The agent has been prescribed by, or in consultation with, a pulmonologist. Authorization will be for 3 years Idiopathic Pulmonary Fibrosis - At baseline (before therapy initiation), patients have an FVC greater than or equal to 50% of the predicted value AND The diagnosis of IPF is confirmed by one of the following (i or ii) i. Findings on high-resolution computed tomography (HRCT) indicates usual interstitial pneumonia (UIP), OR ii.a surgical lung biopsy demonstrates usual interstitial pneumonia (UIP). 38

44 Exjade EXJADE Details All medically accepted indications not otherwise excluded Serum ferritin level Other Prescribed by or in consultation with a hematologist Authorization will be for 1 year Transfusion-related chronic iron overload, initial therapy - approve if the patient is receiving blood transfusions at regular intervals for various conditions (eg, thalassemia syndromes, myelodysplastic syndrome, chronic anemia, sickle cell disease) AND prior to starting therapy, the serum ferritin level is greater than 1,000 mcg/l. Non-transfusiondependent thalassemia syndromes chronic iron overload, initial therapy - approve if prior to starting therapy the serum ferritin level is greater than 300 mcg/l. Continuation therapy - approve is the patient is benefiting from therapy as confirmed by the prescribing physician. 39

45 Fabrazyme FABRAZYME Details All medically accepted indications not otherwise excluded Diagnosis Authorization will be for 1 year Other 40

46 Farydak FARYDAK Details All FDA-approved indications not otherwise excluded. Other Authorization is for 12 months MM - must be used in combination with Velcade and dexamethasone AND previously tried Velcade and one immunomodulatory drug (i.e., Thalomid, Revlimid, or Pomalyst). 41

47 Fasenra FASENRA Details All medically-accepted and FDA-approved indications not otherwise excluded from coverage. Concurrent use with Xolair or another IL Antagonist Monoclonal Antibody. Diagnosis, severity of disease, peripheral blood eosinophil count, previous therapies tried and current therapies, FEV1/FVC. 12 years of age and older Prescribed by or in consultation with an allergist, immunologist, or pulmonologist Authorization will be for 6 months initial, 12 months continuation. 42

48 Other Details Initial - must have peripheral blood eosinophil count of greater than or equal to 300 cells per microliter within the previous 6 weeks (prior to treatment with an IL-5 antagonist monoclonal antibody) AND meet both of the following criteria: 1) Patient has received at least 3 consecutive months of combination therapy with an inhaled corticosteroid AND one of the following: inhaled LABA, inhaled long-acting muscarinic antagonist, Leukotriene receptor antagonist, or Theophylline, AND 2) Patient's asthma is uncontrolled or was uncontrolled prior to starting any ILantagonist therapy as defined by ONE of the following: a) patient experienced two or more asthma exacerbations requiring treatment with systemic corticosteroids in the previous year, OR b) patient experienced one or more asthma exacerbation requiring hospitalization or an Emergency Department (ED) visit in the previous year, OR c) patient has a FEV1 less than 80 percent predicted, OR d) Patient has an FEV1/FVC less than 0.80, OR e) Patient's asthma worsens upon tapering of oral corticosteroid therapy. Continuation - The patient has responded to Fasenra therapy as determined by the prescribing physician (e.g., decreased asthma exacerbations, decreased asthma symptoms, decreased hospitalizations, emergency department (ED)/urgent care, or physician visits due to asthma, decreased requirement for oral corticosteroid therapy) AND patient continues to receive therapy with an inhaled corticosteroid. 43

49 Ferriprox FERRIPROX ORAL TABLET Details All medically accepted indications not otherwise excluded Serum ferritin level Other Prescribed by or in consultation with a hematologist Authorization will be for 1 year Initial therapy - approve if prior to starting therapy the serum ferritin level was greater than 2,500 mcg/l. Continuation therapy - approve is the patient is benefiting from therapy as confirmed by the prescribing physician. 44

50 Firazyr FIRAZYR Details All FDA-approved indications not otherwise excluded Diagnosis Authorization will be for 1 year Other 45

51 Gilenya GILENYA ORAL CAPSULE 0.5 MG Details All FDA-approved indications not otherwise excluded. Must not be given in combination with Avonex, Betaseron, Extavia, Copaxone, Rebif or Tysabri. Other Authorization will be for 12 months. Must have tried one of the following injectable medications: Avonex (interferon beta-1a IM), Rebif (interferon beta-1a SC), Betaseron or Extavia (interferon beta 1b) or Copaxone (glatiramer acetate), or that the patient is unable to administer injections such as these due to dexterity issues or visual impairment, or has tried Tysabri. 46

52 Gilotrif GILOTRIF Details All FDA-approved indications not otherwise excluded. Diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) Authorization will be for 12 months. Other Patient must have epidermal growth factor receptor (EGFR) exon 19 deletion as detected by a Food and Drug Administration (FDA)-approved test OR the patient does not have exon 21 (L858R) substitution as detected by an FDA-approved test. 47

53 Gleevec/imatinib imatinib oral tablet 100 mg, 400 mg Details All FDA approved indications not otherwise excluded. Plus chordoma, advanced or unresectable fibromatosis (desmoid tumors), ckit positive advanced/recurrent or metastatic melamona, and pigmented Villonodular Synovitis/Tenosynovial Giant Cell Tumor, Graft Versus Host Disease (Chronic) and patients continuing treatment for an approved use. Diagnosis. For indications of CML and ALL, the Philadelphia chromosome (Ph) status of the leukemia must be reported. Other Authorization will be for 3 years. GVHD approve for 1 year. For ALL/CML, new patient must have Ph-positive for approval of imatinib.mds/mpd condition is associated with platelet derived growth factor receptor gene rearrangements. GVHD approve if patient has tried one conventional systemic treatment for graft versus host disease (e.g., corticosteroids [methylprednisolone, prednisone], cyclosporine, tacrolimus, mycophenolate mofetil, Imbruvica [ibrutinib capsules]). 48

54 Glucagon-like Peptide-1 Agonists BYDUREON BCISE BYDUREON SUBCUTANEOUS PEN INJECTOR BYETTA SUBCUTANEOUS PEN INJECTOR 10 MCG/DOSE(250 MCG/ML) 2.4 ML, 5 MCG/DOSE (250 MCG/ML) 1.2 ML VICTOZA 2-PAK 49

55 VICTOZA 3-PAK Details All FDA-approved indications not otherwise excluded. Authorization will be for 3 years. Other 50

56 Growth Hormones NUTROPIN AQ NUSPIN Details All FDA-approved indications not otherwise excluded. Growth hormone (GH) deficiency (DF). Non-GH deficient short stature (idiopathic short stature, ISS). Turner's syndrome (TS). SHOX (short stature homeoboxcontaining gene) deficiency. Chronic kidney disease (CKD) Prader-Willi syndrome (PW). Noonan syndrome (NS). Short bowel syndrome (SBS) Use in the management of acute critical illness due to complications of surgery, trauma, or with acute respiratory failure, as antiaging therapy, to improve functional status in elderly, somatopause, enhancement of athletic ability, bone marrow transplant (BMT) without total body irradiation, bony dysplasias, burn injury, cardiac transplantation, central precocius puberty, chronic fatigue syndrome, congenital adrenal hyperplasia, constitutional delay of growth and puberty, corticosteroidinduced short stature including a variety of chronic glucocorticoiddependent conditions, such as asthma, juvenile rheumatoid arthritis, after renal, heart, liver, or BMT, Crohn's disease, cystic fibrosis, dilated cardiomyopathy/heart failure, end-stage renal disease in adults undergoing hemodialysis, Down's syndrome, familial dysautonomia, fibromyalgia, HIV-infected patients with alterations in body fat distribution, infertility, kidney transplant patients (children) with a functional renal allograft, liver transplantation, multiple system atrophy, myelomeningocele, obesity, osteogenesis imperfecta, osteoporosis (postmenopausal, idiopathic in men, glucocorticoid-induced), thalassemia, and X-linked hypophosphatemic rickets (familial hypophosphatemia, hypophosphatemic rickets). Child/adolesc w/gh DF (initial tx), adolescent is less than or equal to 18 years of age.ts, children. SHOX/CRI/NS, children/adolescents. HIV infection w/wasting or cachexia, less than or equal to 18 years of age. SBS/HIV cachexia/wasting, adults. For adults, the endocrinologist must certify that the somatropin is not being prescribed for anti-aging therapy or to enhance athletic ability. All conditions - prescribed by or in consultation with an endocrinologist. 51

57 Other Details GH DF 12 mos.sbs 4-8wks/yr.Non-GH DF ISS 6 mos.hiv wast/cach 24 wks. Child/adol GH DF initial tx, documented GH stimulation test w/gh response less than 10 ng/ml AND base Ht less than the 10th pct for gender/age + pretx Ht growth rate (GR) child less than 3 yrs of less than 7 cm/yr and child greater than or equal to 3 yrs of less than 4 cm/yr OR child/adol less than 18 yrs of age GR less than the 10th pct for age/gender based on min 6 mo data. Child w/brain radiation does not have to meet base Ht criteria above but growth rate criteria does apply. Congenital hypopituitarism does not have to meet Ht or growth rate crit. Child w/hypophysectomy, approve. Child/adol GH DF cont tx, GR increased by 4 cm/yr or more in most recent yr (MRY) + epiphyses open (between 12 and 18 yrs),both crit exclude adol w/hypopituit. Review GR annually. Adoles/yng adult w/completed linear growth (GR less than 2 cm/yr), review for adult GH DF.Greater than 18 yrs,gr increased by 4 cm/yr or more in MRY AND epiphyses open, auth not allowed if midparental ht attained.iss child w/open epiphyses,6 mo trial if base Ht less than 5th pct + pretx GR child greater than or equal to 7 yrs of less than 4 cm/yr and child 3 or more yrs of less than 4 cm/yr OR child any age GR less than the 10th pct for age/gender based on min 6 mo of data and has condition which GH effective + endocrinol certifies via bone-age x-ray, + the pt doesn t have constitutional delay of growth and puberty (CDGP).Auth after initial tx based on adequate clinical response (annualized GR doubles).cont tx, at least 7 yrs and received somatropin on 6 mo trial, if GR has doubled in comparison to previous yr. At least 7 and less than 12 yrs, GR increased by 4 cm/yr or more in MRY. At least 12 and less than or equal to 18 yrs), GR increased by 4 cm/yr or more in MRY AND epiphyses open).greater than 18 yrs, GR increased by 4 cm/yr or more in MRY,+ epiphyses open auth not allowed if midparental ht attained.adult GH DF or PW/trans adoles, eval by endocrinol (start and annually).ns/shox/child PW, eval by an endocrinol, CKD, eval by an endocrin or nephrologist. 52

58 Hemlibra HEMLIBRA Details All medically accepted and FDA-approved indications not otherwise excluded. specialty, patient medical history. Other Prescribed by or in consultation with a hemophilia specialist Authorization will be for 12 months Patient is using Hemlibra for routine prophylaxis 53

59 Humira HUMIRA HUMIRA PEDIATRIC CROHNS START HUMIRA PEN HUMIRA PEN CROHNS-UC-HS START HUMIRA PEN PSOR-UVEITS-ADOL HS HUMIRA(CF) HUMIRA(CF) PEDI CROHNS STARTER HUMIRA(CF) PEN HUMIRA(CF) PEN CROHNS-UC-HS HUMIRA(CF) PEN PSOR-UV-ADOL HS Details All FDA-approved indications not otherwise excluded plus patients already started on adalimumab for a covered use. Other covered uses: Behcet's disease, pyoderma gangrenosum, undifferentiated spondylarthritis (undifferentiated arthritis), sarcoidosis, scleritis or sterile corneal ulxeration. Concurrent use with a biologic DMARD or targeted synthetic DMARD (e.g., Xeljanz, Otezla). Moderate or severe heart failure (NYHA Class III or IV). History of treated lymphoproliferative disease. Multiple sclerosis or other demyelinating disorder. Diagnosis and other medications tried for the diagnosis provided. Rheumatoid arthritis (RA), Psoriatic arthritis (PA), Ankylosing spondylitis (AS), Ulcerative colitis (UC), and Plaque psoriasis (PP), patients 18 years of age and older. Polyarticular Juvenile Idiopathic Arthritis (JIA) and Uveitis in patients aged 2 years and older. Hidradenitis suppurativa for patients 12 years of age and older. Crohn's disease (CD), patients 6 years of age and older. All other conditions, patients 18 years of age and older. RA/JIA/JRA/AS, prescribed by or in consultation with rheumatologist. PA, prescribed by or in consultation with a rheumatologist or dermatologist. PP, prescribed by or in consultation with a dermatologist. UC/CD, prescribed by or in consultation with a gastroenterologist. Authorization will be for 12 months 54

60 Other Details For RA, the patient must have had a trial with a conventional DMARD regimen (eg, methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide) including concurrent use of two or three of the conventional DMARDs for 3 months unless the patient experienced intolerance, or the patient has tried and failed at least one biologic DMARD for 3 months unless the patient experienced intolerance. For JIA/JRA, tried another agent (eg, MTX, sulfasalazine, leflunomide, NSAID, or biologic DMARD (eg, etanercept, abatacept, infliximab, anakinra, tocilizumab) or will be starting on adalimumab concurrently with MTX, sulfasalazine, or leflunomide. Approve without trying another agent if the patient has absolute contraindication to MTX, sulfasalazine, or leflunomide or if the patient has aggressive disease. For PP, the patient has tried a systemic therapy (eg, MTX, CSA, acitretin, etanercept, infliximab, or apremilast) for 3 months unless the patient experienced intolerance or PUVA for 3 months. For PA, the patient must have had a trial with a conventional DMARD (eg, methotrexate, sulfasalazine, and leflunomide) for at least 3 months unless the patient experienced intolerance or has severe disease activity. For AS, must have active disease despite treatment with one or more NSAIDs. For CD, the patient has failed corticosteroid (CS) or if CS contraindicated or if currently on CS and unable to taper off or if the patient has tried one other agent for CD for 3 months (eg, azathioprine, 6- MP, MTX, certolizumab, infliximab, ustekinumab, vedolizumab) or the patient has enterocutaneous (perianal or abdominal) or rectovaginal fistulas or the patient has had ileocolonic resection. For UC, the patient has tried a systemic therapy (eg, 6-mercaptopurine, azathioprine, CSA, tacrolimus, infliximab, vedolizumab, golimumab, or a corticosteroid such as prednisone or methylprednisolone) for 3 months or was intolerant to one of these agents, or the patient has pouchitis and has tried therapy with an antibiotic, probiotic, corticosteroid enema, or mesalamine (Rowasa) enema. For continuation of therapy for all conditions, prescriber attests the patient has had a response to treatment. 55

61 Ibrance IBRANCE Details All-FDA approved indications not otherwise excluded. Plus breast cancer in men and liposarcoma. Other Authorization for 12 months Breast cancer in women - approve in advanced (metastatic) ER positive disease and HER2-negative breast cancer. Ibrance will be used in combination with letrozole as initial endocrine-based therapy in postmenopausal women OR in combination with Faslodex in women with disease progression following endocrine therapy. Breast Cancer in men - approve in advanced (metastatic) ER positive disease and HER2- negative breast cancer. The patient is receiving a leutinizing hormonereleasing hormone (LHRH) agonist (e.g., Lupron [leuprolide], Trelstar [triptorelin], Zoladex (goserelin]) AND Ibrance will be used as first-line endocrine therapy in combination with anastrozole, exemestane, or letrozole. Liposarcoma - approve is the patient has welldifferentiated/dedifferentiated liposarcoma. 56

62 Iclusig ICLUSIG ORAL TABLET 15 MG, 45 MG Details All FDA-approved indications not otherwise excluded from Part D. plus patients already started on Iclusig for a covered use. Other Authorization will be for 3 years. For Chronic Myeloid Leukemia (CML) That is Philadelphia Chromosome Positive. Approve if the patient meets ONE of the following criteria: the patient is T315I-positive, OR the patient has tried two other tyrosine kinase inhibitors indicated for use in Philadelphia chromosome positive CML (e.g., Gleevec [imatinib tablets], Sprycel [dasatinib tablets], Tasigna [nilotinib capsules]). For Acute Lymphoblastic Leukemia (ALL) That is Philadelphia Chromosome Positive (Ph+). Approve if the patient meets ONE of the following criteria: the patient is T315I-positive, OR the patient has tried two other tyrosine kinase inhibitors that are used for Philadelphia chromosome positive ALL (e.g., Gleevec [imatinib tablets], Sprycel [dasatinib tablets]). 57

63 Idhifa IDHIFA Details All FDA-approved indications not otherwise excluded from Part D. Plus patients started on Idhifa for a Covered Use. IDH2-mutation status 18 years old and older Other Authorization will be for 3 years AML - approve if relapsed or refractory AND the patient is IDH2-mutation status positive as detected by an approved test. 58

64 Imbruvica IMBRUVICA Details All FDA-approved indications not otherwise excluded. Other Acceptable Uses: Relapsed or refractory CNS lymphoma, Diffuse Large B-Cell Lymphoma (e.g., follicular lymphoma, gastric MALT lymphoma, nongastric MALT lymphoma, primary DLBCL of the central nervous system [CNS]), Relapsed or refractory Hairy Cell Leukemia. Diagnosis Other Authorization will be for 3 years, GVHD authorization will be for 1 year. Marginal Zone Lymphoma pt has tried Rituxan (rituximab for IV infusion) or according to the prescribing physician, Rituxan is contraindicated for use in this patient. GVHD the patient has tried one conventional systemic treatment for graft versus host disease (e.g., corticosteroids [methylprednisolone, prednisone], cyclosporine, tacrolimus, mycophenolate mofetil, imatinib).for Diffuse Large B-Cell Lymphoma approve if according to the prescribing physician, the patient is using as a second-line or subsequent therapy. 59

65 Inlyta INLYTA Details All FDA-approved indications not otherwise excluded. Plus, Differentiated (i.e., papillary, follicular, and Hurthle) Thyroid Carcinoma. Other Authorization will be for 3 years. Advanced renal cell carcinoma, approve. Differentiated thyroid cancer, approve if patient is refractory to radioactive iodine therapy. 60