2019 PRIOR AUTHORIZATION CRITERIA UCare Individual & Family Plans UCare Individual & Family Plans with Fairview

Transcription

1 2019 PRIOR AUTHORIZATION CRITERIA UCare Individual & Family Plans UCare Individual & Family Plans with Fairview 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. IFP_IFPFV_IA ( ) Updated 09/2018 U6497 (10/18)

2 Notice of Nondiscrimination UCare complies with applicable Federal civil rights laws and does not discriminate on the basis of race, color, national origin, age, disability or sex. UCare does not exclude people or treat them differently because of race, color, national origin, age, disability or sex. We provide aids and services at no charge to people with disabilities to communicate effectively with us, such as TTY line, or written information in other formats, such as large print. If you need these services, contact us at (voice) or toll free at (voice), (TTY), or (TTY). We provide language services at no charge to people whose primary language is not English, such as qualified interpreters or information written in other languages. If you need these services, contact us at the number on the back of your membership card or or toll free at (voice); or toll free at (TTY). If you believe that UCare has failed to provide these services or discriminated in another way on the basis of race, color, national origin, age, disability or sex, you can file an oral or written grievance. Oral grievance If you are a current UCare member, please call the number on the back of your membership card. Otherwise please call or toll free at (voice); or toll free at (TTY). You can also use these numbers if you need assistance filing a grievance. Written grievance Mailing Address UCare Attn: Appeals and Grievances PO Box 52 Minneapolis, MN cag@ucare.org Fax: You can also file a civil rights complaint with the U.S. Department of Health and Human Services, Office for Civil Rights, electronically through the Office for Civil Rights Complaint Portal, available at or by mail or phone at: U.S. Department of Health and Human Services 200 Independence Avenue SW Room 509F, HHH Building Washington, D.C , (TDD) Complaint forms are available at

3 ATENCIÓN: si habla español, tiene a su disposición servicios gratuitos de asistencia lingüística. Llame al / (TTY: / ). LUS CEEV: Yog tias koj hais lus Hmoob, cov kev pab txog lus, muaj kev pab dawb rau koj. Hu rau / (TTY: / ). XIYYEEFFANNAA: Afaan dubbattu Oroomiffa, tajaajila gargaarsa afaanii, kanfaltiidhaan ala, ni argama. Bilbilaa / (TTY: / ). CHÚ Ý: Nếu bạn nói Tiếng Việt, có các dịch vụ hỗ trợ ngôn ngữ miễn phí dành cho bạn. Gọi số / (TTY: / ). 注意 : 如果您使用繁體中文, 您可以免費獲得語言援助服務 請致電 / (TTY: / ) ВНИМАНИЕ: Если вы говорите на русском языке, то вам доступны бесплатные услуги перевода. Звоните / (телетайп: / ). ໂປດຊາບ: ຖ າວ າ ທ ານເວ າພາສາ ລາວ, ການບ ລ ການຊ ວຍເຫ ອດ ານພາສາ, ໂດຍບ ເສ ຽຄ າ, ແມ ນມ ພ ອມໃຫ ທ ານ. ໂທຣ / (TTY: / ). ማስታወሻ: የሚናገሩት ቋንቋ ኣማርኛ ከሆነ የትርጉም እርዳታ ድርጅቶች በነጻ ሊያግዝዎት ተዘጋጀተዋል ወደ ሚከተለው ቁጥር ይደውሉ / (መስማት ለተሳናቸው: / ). ymol.ymo;=erh>uwdraundausdmtcd<aerrm>ausdmtw>rrpxrvxawvxmbl.vxmphraedwrhrb.ohm.vdria ud; / (TTY: / ). ACHTUNG: Wenn Sie Deutsch sprechen, stehen Ihnen kostenlos sprachliche Hilfsdienstleistungen zur Verfügung. Rufnummer: / (TTY: / ). របយ ក ប ស នជ អ កន យ ភ ស រ ខ រ, រសវ ជ ន យរ ផ កភ ស ដ យម នគ តឈ ល គ ឤចម នស រ ប ប ររ អ ក ច រ ទ រស ព / (TTY: / ) ملحوظة :إذا كنت تتحدث اذكر اللغة فا ن خدمات المساعدة اللغویة تتوافر لك بالمجان.اتصل برقم / (رقم ھاتف الصم والبكم: / ). ATTENTION : Si vous parlez français, des services d'aide linguistique vous sont proposés gratuitement. Appelez le / (ATS : / ). 주의 : 한국어를사용하시는경우, 언어지원서비스를무료로이용하실수있습니다 / (TTY: / ) 번으로전화해주십시오. PAUNAWA: Kung nagsasalita ka ng Tagalog, maaari kang gumamit ng mga serbisyo ng tulong sa wika nang walang bayad. Tumawag sa / (TTY: / ).

4 ACTEMRA ACTEMRA SUBCUTANEOUS All FDA-approved indications not otherwise excluded. Plus Polymyalgia Rheumatica (PMR)and patients already started on tocilizumab for a Covered Use. Concurrent Use with a Biologic Disease-Modifying Antirheumatic Drug (DMARD) or Targeted Synthetic DMARD. Age RA, PJIA, SJIA, PMR, GCA - Prescribed by or in consultation with a rheumatologist. GCA, PMR 6 mo RA, SJIA 3 mo PJIA 4 mo. Cont - RA, PJIA, SJIA, GCA - 3 years PMR - 1 year 1

5 Other RA, approve if the patient has tried ONE conventional synthetic diseasemodifying antirheumatic drug (DMARD) for at least 3 months (e.g., methotrexate, leflunomide, hydroxychloroquine, and sulfasalazine)or patient has already had a 3-month trial of at least one biologic [e.g., Enbrel {etanercept SC injection}, Humira {adalimumab SC injection}, Remicade {infliximab IV infusion}, Simponi {golimumab SC injection}, Simponi Aria {golimumab IV infusion}, Kineret {anakinra SC injection}, Orencia {abatacept IV infusion abatacept SC injection}, or Rituxan {rituximab IV infusion}]. PJIA, approve if the patient has tried ONE other agent for this condition (e.g., methotrexate, sulfasalazine, leflunomide, a nonsteroidal anti-inflammatory drug (NSAID), or a biologic [e.g., Enbrel {etanercept}, Humira {adalimumab}, Orencia {abatacept}, Remicade {infliximab}, or Kineret {anakinra}]) OR patient will be starting on Actemra SC concurrently with methotrexate, sulfasalazine, or leflunomide, OR patient has an absolute contraindication to methotrexate (e.g., pregnancy, breast feeding, alcoholic liver disease, immunodeficiency syndrome, blood dyscrasias), sulfasalazine, or leflunomide OR patient has aggressive disease as determined by the prescribing physician. SJIA, approve if the patient has tried ONE other systemic agent for this condition (e.g., a corticosteroid, a conventional synthetic diseasemodifying antirheumatic drug [DMARD e.g., methotrexate, leflunomide, sulfasalazine], or a 1-month trial of a nonsteroidal anti-inflammatory drug [NSAID]), OR patient had a previous trial of a biologic (e.g., Kineret [anakinra], a tumor necrosis factor inhibitor [e.g., Enbrel {etanercept}, Humira {adalimumab}, or Remicade {infliximab}] GCA approve if member has tried one systemic corticosteroid (e.g. Prednisone). PMR approve if the patient has tried one systemic corticosteroid (e.g., prednisone)and the patient has evidence of large vessel vasculitis by angiography or imaging (e.g., magnetic resonance imaging [MRI], computed tomography angiography [CTA], positron emission tomography/computed tomography [PET/CT]). Cont tx RA, PJIA, SJIA - pt must have had a response(e.g., less joint pain, morning stiffness, or fatigue, improved function or ADLs, decreased soft tissue swelling in joints or tendon sheaths, improved lab values, reduced dosage of corticosteroids), as determined by the prescriber. Cont tx GCA - patient has had a response (e.g., reduced corticosteroid dose, normalization of acute phase reactants [e.g., erythrocyte sedimentation rate {ESR}, C-reactive protein {CRP}], reduction or resolution of signs or symptoms of GCA), as determined by the prescriber. Cont tx PMR approve if patient has had a response (e.g., reduced corticosteroid dose, normalization of acute phase reactants [e.g., erythrocyte sedimentation rate {ESR}, C-reactive protein {CRP}], reduction or resolution of signs or symptoms of PMR), as determined by the prescriber 2

6 Afinitor AFINITOR All FDA-approved indications not otherwise excluded from Part D. 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 Age 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. 3

7 Other 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. 4

8 Aimovig AIMOVIG AUTOINJECTOR AIMOVIG AUTOINJECTOR (2 PACK) All FDA-approved indications not otherwise excluded. Age Diagnosis, number of migraine headaches per month, prior therapiestried 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 hastried 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. 5

9 Alecensa ALECENSA All FDA-approved indications not otherwise excluded from Part D. Age 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

10 Alunbrig ALUNBRIG ORAL TABLET 180 MG, 30 MG, 90 MG ALUNBRIG ORAL TABLETS,DOSE PACK All FDA-approved indication not otherwise excluded. ALK status, treatment history and results Age 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

11 AMPYRA AMPYRA All FDA-approved indications not otherwise excluded. Age 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

12 ANABOLIC STEROIDS oxandrolone 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. Age Authorization will be for 12 months, unless otherwise specified. Other 9

13 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 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) Age 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

14 ARCALYST ARCALYST All FDA-approved indications not otherwise excluded. 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 biologic therapy (e.g.tumor necrosis factor (TNF) blocking agents (eg, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab), anakinra, or canakinumab). Age Other Initial tx CAPS-Greater than or equal to 12 years of age. Initial tx CAPS-prescribed by, or in consultation with, a rheumatologist, geneticist, or dermatologist. Initial approval of 3 months. Subsequent authorization for 3 years if patient had a response. CAPS renewal - approve if they have had a response and are continuing therapy to maintain response/remission. 11

15 Austedo AUSTEDO All FDA-approved indications not otherwise excluded Diagnosis and previous medications tried Age Other Prescribed by or in consultation with a neurologist or psychiatrist Authorization 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

16 AVONEX AVONEX (WITH ALBUMIN) AVONEX INTRAMUSCULAR PEN INJECTOR KIT AVONEX INTRAMUSCULAR SYRINGE KIT 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. Age Prescribed by or after consultation with a neurologist or an MS specialist. Authorization will be for 3 years. Other 13

17 BOSULIF BOSULIF ORAL TABLET 100 MG, 400 MG, 500 MG 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. Age 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]). 14

18 CABOMETYX CABOMETYX 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 Age 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 15

19 Calquence CALQUENCE All medically-accepted and FDA-approved indications not otherwise excluded. Previous medications/therapies tried. Age 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. 16

20 Caprelsa CAPRELSA ORAL TABLET 100 MG, 300 MG All FDA-approved indications not otherwise excluded from Part D. All FDA-approved indications not otherwise excluded. Plus Differentiated (i.e., papillary, follicular, and Hurthle) Thyroid Carcinoma and NSCLC with RET Gene Rearrangements. Age Other Authorization will be for 3 years. MTC - approve. DTC - approve if refractory to radioactive iodine therapy. 17

21 Chenodal CHENODAL All FDA-approved indications not otherwise excluded from Part D. All FDA-approved indications not otherwise excluded Age Other Authorization will be for 1 year For the treatment of gallstones, approve if the patient has tried or is currently using an ursodiol product. 18

22 COMETRIQ COMETRIQ All medically-accepted indications not otherwise excluded worded as NSCLC with RET gene Rearrangements. Age Authorization will be for 3 years Other 19

23 COPAXONE glatiramer subcutaneous syringe 20 mg/ml, 40 mg/ml glatopa subcutaneous syringe 20 mg/ml, 40 mg/ml All FDA-approved indications not otherwise excluded. Given in combination with another disease-modifying agent used for MS(such as, Rebif, Betaseron, Tysabri, Gilenya, Aubagio, and Tecfidera) Diagnosis of Multiple Sclerosis(MS) or patient has experienced an attack and is at risk for MS. Age Prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis. Authorization will be for 3 years Other 20

24 Corlanor CORLANOR All FDA-approved indications not otherwise excluded Previous use of a Beta-blocker, LVEF, sinus rhythm, and resting HR Age 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

25 COSENTYX COSENTYX COSENTYX (2 SYRINGES) COSENTYX PEN COSENTYX PEN (2 PENS) Age Other All FDA-approved indications not otherwise excluded. Concurrent Use with other Biologics or Targeted Synthetic Disease- Modifying Antirheumatic Drugs (DMARDs) Diagnosis, previous medication use 18 years of age and older AS prescribed by or in consultation with a rheumatologist. PP prescribed by or in consultation with a dermatologist. PsA prescribed by or in consultation with a rheumatologist or a dermatologist. Intial AS, PP, PsA 3 mo Con AS, PP, PsA 3 years Initial PP - approve if patient meets ONE of the following conditions: Patient has tried at least at least one traditional systemic agent for psoriasis (e.g., methotrexate [MTX], cyclosporine, acitretin tablets, or psoralen plus ultraviolet A light [PUVA]) for at least 3 months, unless intolerant OR patient has already has a 3-month trial or previous intolerance to at least one biologic (e.g., Enbrel [etanercept for SC injection], Humira [adalimumab for SC injection], an infliximab product [e.g., Remicade, Inflectra], Stelara [ustekinumab for SC injection], or Taltz [ixekizumab for SC injection]) OR b)patient has a contraindication to methotrexate (MTX), as determined by the prescribing physician. Cont tx PP - patient has responded, as determined by the prescriber Cont tx AS - approve if patient has had a response (e.g., decreased pain or stiffness, improved function or activities of daily living), as determined by the prescriber. Cont tx PsA - approve if the patient has responded (e.g., less joint pain, morning stiffness, or fatigue improved function or activities of daily living decreased soft tissue swelling in joints or tendon sheaths improvements in acute phase reactants [for example, C-reactive protein]), as determined by the prescriber. 22

26 Cotellic COTELLIC 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. Age 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 tablets Zelboraf.) 23

27 Crysvita CRYSVITA Age Other All FDA-approved indications not otherwise excluded Chronic Kidney Disease (CKD), Severe Renal Impairment or End Stage Renal Disease Diagnosis, lab values none Prescribed by or in consultation with a endocrinologist or nephrologist 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

28 Daliresp DALIRESP All FDA-approved indications not otherwise excluded Medications tried Age Other Authorization will be for 3 years COPD, approve in patients who meet all of the following conditions: Patients has severe COPD or very severe COPD, AND Patient has chronic bronchitis, AND Patient has a history of exacerbations, AND Patient has tried a medication from ALL three of the following drug categories: long-acting beta2-agonist (LABA) [eg, salmeterol, formoterol], long-acting anticholinergic (eg, tiotropium), inhaled corticosteroid (eg, fluticasone). 25

29 Doptelet DOPTELET All FDA-approved indications not otherwise excluded Diagnosis, platelet count, date of procedure Age 18 years and older 5 days Other Approve if the patient has a current platelet count less than 50 x 109/L AND the patient is scheduled to undergo a procedure within 10 to 13 days after starting Doptelet therapy. 26

30 DUPIXENT DUPIXENT All FDA-approved indications not otherwise excluded from Part D. Age Other Diagnosis, prescriber specialty, other medications tried and length of trials 18 years of age and older (initial and continuation) Prescribed by or in consultation with a an allergist, immunologist or dermatologist (initial and continuation) Initial-16 weeks, Continuation-1 year Initial Therapy- Patient meets all both of the following criteria: Patient has used at least one medium-, medium-high, high-, and/or super-highpotency 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. 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). 27

31 DYSPORT DYSPORT All FDA-approved indications not otherwise excluded. Plus Spasticity and anal fissures. Use in the management of cosmetic uses. Age Authorization for 12 months Other 28

32 ENBREL ENBREL MINI ENBREL SUBCUTANEOUS RECON SOLN ENBREL SUBCUTANEOUS SYRINGE 25 MG/0.5ML (0.51), 50 MG/ML (0.98 ML) ENBREL SURECLICK All FDA-approved indications not otherwise excluded from Part D. Plus Behcet's Disease, Graft-Versus-Host Disease, Pyoderma Gangrenosum, Scleritis (sterile corneal ulceration), Spondylarthritis, Still's Disease, and Uveitis. Concurrent Use with a Biologic DMARD or Targeted Synthetic DMARD Age RA, AS, JIA/JRA, SpA, SD - prescribed by or in consultation with a rheumatologist. PP, PG - prescribed by or in consultation with a dermatologist. PsA - prescribed by or in consultation with a rheumatologist or a dermatologist. Behcet's prescribed by or in consultation with a rheumatologist, dermatologist, ophthalmologist, gastroenterologist, or neurologist. GVHD prescribed by or in consultation with an oncologist, hematologist, or a physician in a transplant center. Scleritis, Uveit - ophthalm. Intial RA, AS, JIA, PP, PsA 3 mo Behcet's, GVHD, PG, SpA, Uv 1 year Cont RA, AS, JIA, PP, PsA 3 yrs 29

33 Other Initial RA - approve if The patient has tried ONE conventional synthetic disease-modifying antirheumatic drug (DMARD) for at least 3 months OR patient has tried a 3-month trial at least one biologic disease-modifying antirheumatic drug (DMARD). JIA/JRA - approve if patients meets the following: Patient has tried one other agent for this condition or a biologic disease-modifying antirheumatic drug OR Patient will be starting on Enbrel concurrently with methotrexate (MTX), sulfasalazine, or leflunomide OR Patient has an absolute contraindication to methotrexate (MTX), sulfasalazine, or leflunomide OR Patient has aggressive disease, as determined by the prescribing physician. PP initial - approve if The patient has tried at least at least one traditional systemic agent for psoriasis (e.g., methotrexate [MTX], cyclosporine, acitretin tablets, or psoralen plus ultraviolet A light [PUVA]) for at least 3 months, unless intolerant OR the patient has already has a 3-month trial or previous intolerance to at least one biologic. Behcet's tried at least one conventional therapy. GVHD approve if Patient has tried one conventional treatment or is currently receiving one of these medications. PG approve if patient has tried one systemic corticosteroid OR one other immunosuppressant for at least 2 mo or was intolerant. Scleritis - pt has tried 1 other therapy (NSAID, IV corticosteroid, or immunosuppressant). SpA - The patient has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet AND has tried at least ONE conventional synthetic disease-modifying antirheumatic drug (DMARD) OR The patient has axial spondyloarthritis. Still's Disease - Patient has tried one corticosteroid AND Patient has tried one conventional synthetic diseasemodifying antirheumatic drug (DMARD) such as methotrexate (MTX) given for at least 2 months or was intolerant. Uveitis - The patient has tried one of the following therapies: periocular, intraocular, or systemic corticosteroids [for example, triamcinolone, betamethasone, methylprednisolone, prednisone] immunosuppressives (e.g., methotrexate [MTX], mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide) Humira or Remicade for this condition. Cont tx approve if the patient has had a response as determined by the prescriber. 30

34 EPOGEN AND 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 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. Age CKD and MDS - Authorization will be for 6 months, Perisurgical - 1 month, Other - 4 months 31

35 Other 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. 32

36 Erivedge ERIVEDGE All FDA-approved indications not otherwise excluded from Part D. All FDA-approved indications not otherwise excluded BCC (La or Met) - must not have had disease progression while on Odomzo. Age Other Authorization will be for 12 months Locally advanced basal cell carcinoma (LABCC), approve if 1. the patient's BCC has recurred following surgery or radiation, OR 2. the patient is not a candidate for surgery and radiation therapy. 33

37 Erleada ERLEADA All medically accepted and FDA-approved indications not otherwiseexcluded. Age Authorization will be for 3 years. Other 34

38 ESBRIET ESBRIET ORAL CAPSULE ESBRIET ORAL TABLET 267 MG, 801 MG All FDA-approved indications not otherwise excluded. Used with Ofev(nintedanib) Age 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). 35

39 Exjade/Jadenu EXJADE JADENU JADENU SPRINKLE All FDA-approved indications not otherwise excluded worded as transfusion-related chronic iron overload and nontransfusion-dependent thalassemia syndromes chronic ironoverload Serum ferritin level Age Other Prescribed by or in consultation with a hematologist 1 year Transfusion-related chronic iron overload, initial therapy - approve ifthe patient is receiving blood transfusions at regular intervals forvarious conditions (eg, thalassemia syndromes, myelodysplasticsyndrome, chronic anemia, sickle cell disease) AND prior tostarting therapy, the serum ferritin level is greater than 1,000mcg/L. Non-transfusiondependent thalassemia syndromes chroniciron overload, initial therapy - approve if prior to starting therapy theserum ferritin level is greater than 300 mcg/l. Continuation therapy- approve is the patient is benefiting from therapy as confirmed bythe prescribing physician. 36

40 FARYDAK FARYDAK ORAL CAPSULE 10 MG, 15 MG, 20 MG All FDA-approved indications not otherwise excluded. Age Other Authorization 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). 37

41 Fasenra FASENRA Age All medically-accepted and FDA-approved indications not otherwiseexcluded from coverage. Concurrent use with Xolair or another IL Antagonist MonoclonalAntibody. 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, orpulmonologist Authorization will be for 6 months initial, 12 months continuation. 38

42 Other Initial - must have peripheral blood eosinophil count of greater thanor 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 inhaledcorticosteroid. 39

43 Ferripirox FERRIPROX ORAL TABLET All FDA-approved indications not otherwise excluded worded as transfusion-related due to thalassemia syndromeschronic iron overload Serum ferritin level Age Other Prescribed by or in consultation with a hematologist 1 year Initial therapy - approve if prior to starting therapy the serum ferritinlevel was greater than 2,500 mcg/l. Continuation therapy -approve is the patient is benefiting from therapy as confirmed bythe prescribing physician.42 40

44 Firazyr FIRAZYR All FDA-approved indications not otherwise excluded from Part D. All FDA-approved indications not otherwise excluded Age 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 1 year Other 41

45 GILENYA GILENYA ORAL CAPSULE 0.5 MG All FDA-approved indications not otherwise excluded. Must not be given in combination with Avonex, Betaseron, Extavia, Copaxone, Rebif or Tysabri. Age 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. 42

46 GILOTRIF GILOTRIF ORAL TABLET 20 MG, 30 MG, 40 MG All FDA-approved indications not otherwise excluded. Diagnosis of metastatic Non-Small Cell Lung Cancer (NSCLC) Age 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. 43

47 Gleevec imatinib oral tablet 100 mg, 400 mg All FDA-approved indications not otherwise excluded from Part D. 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. Age 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]). 44

48 GLUCAGON-LIKE PEPTIDE -1 AGONISTS BYDUREON BCISE BYDUREON SUBCUTANEOUS PEN INJECTOR BYDUREON SUBCUTANEOUS BYETTA SUBCUTANEOUS PEN INJECTOR 10 MCG/DOSE(250 MCG/ML) 2.4 ML, 5 MCG/DOSE (250 MCG/ML) 1.2 ML OZEMPIC All FDA-approved indications not otherwise excluded. Age Authorization will be for 3 years Other 45

49 GROWTH HORMONE GENOTROPIN GENOTROPIN MINIQUICK HUMATROPE NORDITROPIN FLEXPRO NUTROPIN AQ NUSPIN OMNITROPE SAIZEN CLICK.EASY SAIZEN SUBCUTANEOUS RECON SOLN 5 MG SEROSTIM SUBCUTANEOUS RECON SOLN 4 MG, 5 MG, 6 MG ZORBTIVE 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). 46

50 Child/adol GH DF initial tx, eval by an endocrin, documented GH stim test w/gh response less than 10 ng/ml AND base Ht less than the 10th pct for gender/age + pretx Ht growth rate (GR) child less than 3 yrs of less than 7 cm/yr and child greater than or equal to 3 yrs of less than 4 cm/yr OR child/adol less than 18 yrs of age GR less than the 10th pct for age/gender based on min 6 mo data.child w/brain radiation does not have to meet bas Ht crit.congenital hypopituit does not have to meet Ht or GR crit.child w/hypophysectomy,approve.child/adol GH DF cont tx, GR increased by 4 cm/yr or more in most recent yr (MRY) + epiphyses open (between 12 and 18 yrs),both crit exclude adol w/hypopituit.review GR annually.adoles/yng adult w/completed linear growth (GR less than 2 cm/yr), review for adult GH DF.Greater than 18 yrs,gr increased by 4 cm/yr or more in MRY AND epiphyses open, auth not allowed if midparental ht attained.iss child w/open epiphyses,6 mo trial if base Ht less than 5th pct + pretx GR child greater than or equal to 7 yrs of less than 4 cm/yr and child 3 or more yrs of less than 4 cm/yr OR child any age GR less than the 10th pct for age/gender based on min 6 mo of data and has condition which GH effective + endocrinol certifies via bone-age x-ray, + the pt doesnt 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. Age Child/adolesc w/gh DF (initial tx), adolescent is less than or equal to 18 years of age.ts, children. SHOX/CRI/NS, children/adolescents.hiv infection w/wasting or cachexia, less than or equal to 18 years of age.sbs/hiv cachexia/wasting, adults. For adults, the endocrinologist must certify that the somatropin is not being prescribed for anti-aging therapy or to enhance athletic ability. GH DF 12 mos.sbs 4-8wks/yr.Non-GH DF ISS 6 mos.hiv wast/cach 24 wks. Other 47

51 Hemlibra HEMLIBRA All medically accepted and FDA-approved indications not otherwiseexcluded. specialty, patient medical history. Age Other Prescribed by or in consultation with a hemophilia specialist Authorization will be for 12 months The patient has factor VIII inhibitors or a history of factor VIIIinhibitors. 48

52 HUMIRA HUMIRA HUMIRA PEDIATRIC CROHN'S START HUMIRA PEN HUMIRA PEN CROHN'S-UC-HS START HUMIRA PEN PSORIASIS-UVEITIS Age All ly accepted indications not otherwise excluded including Behcet's Disease, Pyoderma Grangrenosum, Sarcoidosis, Scleritis (Sterile Conreal Ulceration), Spondyloarthritis plus patients already started on adalimumab for a Covered Use. Concurrent use with biologic DMARD or targeted synthetic DMARD (does not include methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide). Moderate or severe heart failure (NYHA Class III or IV). History of treated lymphoproliferative disease. Multiple sclerosis or other demyelinating disorder. None Crohn's Disease 6 years old or older. RA/JIA/JRA/AS/SpA, prescribed by or in consultation with rheumatologist. Psoriatic arthritis (PsA), prescribed by or in consultation with a rheumatologist or dermatologist. PP or PG - prescribed by or in consultation with a dermatologist. UC/ CD, prescribed by or in consultation with a gastroenterologist. Uveitis/Scleritis prescribed by or in consultation with a ophthalmologist. Sarcoidosis prescribed by or in consultation with a pulmonologist, ophthalmologist, or dermatologist Initial RA/AS/CD/JIA/JRA/HS/PP/PsA/UC 3 months Cont RA/AS/CD/JIA/JRA/HS/PP/PsA/UC 3 yr others 1yr 49

53 Other For RA, the patient must have had a trial with a conventional DMARD regimen (eg, methotrexate, hydroxychloroquine, sulfasalazine, and leflunomide) 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 (ie, patients not required to "step back" after trying a biologic). 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 plaque psoriasis (PP), the patient has tried a systemic therapy (eg, MTX, CSA, acitretin, etanercept, infliximab, or ustekinumab) for 3 months or PUVA for 3 months, or the patient experienced an intolerance to a trial of at least one systemic therapy (oral or biologic therapy), or the patient has a contraindication to one oral agent for psoriasis. For CD, the patient has tried corticosteroid (CS) or if CS contraindicated or if currently on CS or if the patient has tried one other agent for CD (eg, azathioprine, 6-MP, MTX, certolizumab, adalimumab, 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, or a corticosteroid for 2 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. HS approve if the patient has tried ONE other therapy (e.g., intralesional or oral corticosteroids [such as triamcinolone, prednisone], systemic antibiotics [for example, clindamycin, dicloxacillin, erythromycin], isotretinoin). UV approve if patient has tried ONE of the following therapies: periocular, intraocular, or systemic corticosteroids, immunosuppressives (e.g., methotrexate [MTX], mycophenolate mofetil, cyclosporine, azathioprine, cyclophosphamide) Enbrel (etanercept SC injection), or Remicade. PG approved if patient has tried one systemic corticosteroid () OR Patient has tried one other immunosuppressant for at least 2 months or was intolerant to one of these agents. Sarcoidosis - approve if pt has tried at least 1 corticosteroid for this condition AND has tried at least one immunosuppressive agent. Scleritis approve if pt has tried 1 therapy (NSAID, IV corticosteroid, or immunosuppressive agent). SpA approve if pt has arthritis primarily in the knees, ankles, elbows, wrists, hands, and/or feet AND has tried at least ONE conventional drug DMARD. Cont - pt has had a response, as determined by prescriber 50

54 Hyqvia HYQVIA All FDA-approved indications not otherwise excluded from Part D. Age Authorization will be for 1 year. Other 51

55 Ibandronate ibandronate intravenous All FDA-approved indications not otherwise excluded from Part D. All FDA-approved indications not otherwise excluded Age Authorization will be for 12 months. Other Treatment of postmenopausal osteoporosis, must meet ONE of the following 1. T-score (current or at any time in the past) at or below -2.5 at the lumbar spine, femoral neck, or total hip, 2. has had osteoporotic fracture, 3. had a T-score (current or at any time in the past) at or below at the lumbar spine, femoral neck, or total hip and the physician believes the patient is at high risk for fracture AND has had an inadequate response to oral bisphosphonate therapy after a trial duration of 12 months as determined by the prescribing physician (e.g., ongoing and significant loss of bone mineral density (BMD), lack of BMD increase), had an osteoporotic fracture while receiving oral bisphosphonate therapy, or experienced intolerability to an oral bisphosphonate (e.g., severe GI-related adverse effects) OR pt cannot take an oral bisphosphonate because the pt cannot swallow or has difficulty swallowing or the pt cannot remain in an upright position post oral bisphosphonate administration or pt has a pre-existing GI medical condition (eg, patient with esophageal lesions, esophageal ulcers, or abnormalities of the esophagus that delay esophageal emptying [stricture, achalasia]), OR pt has tried an IV bisphosphonate (ibandronate or zoledronic acid). 52

56 IBRANCE IBRANCE All FDA approved indications not otherwise excluded. Age Other Authorization for 12 months Breast cancer - approve in postmenopausal women with advanced (metastatic) ER positive disease, and HER2-negative breast cancer when used in combination with letrozole. 53

57 Idhifa IDHIFA All FDA-approved indications not otherwise excluded from coverage. Plus patients started on Idhifa for a Covered Use. Age 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. 54