MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 Drug Name Steps Steps Part B and Part D Step-through through through Drugs by Indication Part B Part D (*prior authorization required) Abatacept (Orencia) Yes Yes PART B STEP: • Rheumatoid arthritis (if request is for IV): TNF inhibitor* (e.g. infliximab) • Psoriatic arthritis (if request is for SC): TNF inhibitor* PART D STEP: • Rheumatoid arthritis: methotrexate, sulfasalazine, hydroxychloroquine, d-penicillamine, azathioprine, or auranofin • Rheumatoid arthritis (if request is for IV): TNF inhibitor* (e.g., infliximab, Humira, Enbrel) • Psoriatic arthritis (if request is for SC): TNF inhibitor* (e.g., Humira, Enbrel) Aflibercept (Eylea) Yes No PART B STEP: • Intravitreal bevacizumab PART D STEP: Not applicable Atezolizumab Yes Yes PART B STEP: (Tecentriq) • Urothelial carcinoma, non-small cell lung cancer: prior platinum-containing chemotherapy* (note some IV chemo may not require prior authorization) PART D STEP: • Non-small cell lung cancer: if positive for mutation, ALK-mutation therapy (e.g., Xalkori, Alecensa, Zykadia), EGFR-mutation therapy (e.g., Tarceva, Gilotrif, Iressa) Bevacizumab Yes Yes PART B STEP: (Avastin, Mvasi, • If request is for Avastin: Mvasi* or Zirabev* Zirabev) PART D STEP: • If request is for Avastin: Mvasi* or Zirabev* Brolucizumab-dbll Yes No PART B STEP: (Beovu) • Intravitreal bevacizumab Last revised: July 22, 2020 MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 PART D STEP: Not applicable Buprenorphine No Yes PART B STEP: implant/injection Not applicable (Probuphine, Sublocade) PART D STEP: • Oral buprenorphine or buprenorphine/naloxone sublingual tablet or film Certolizumab No Yes PART B STEP: (Cimzia) Not applicable PART D STEP: • Rheumatoid arthritis: methotrexate, sulfasalazine, hydroxychloroquine, d-penicillamine, azathioprine, or auranofin • Plaque psoriasis: methotrexate, cyclosporine, or acitretin Corticotropin Yes Yes PART B STEP: (H.P. Acthar) • Multiple sclerosis: corticosteroid PART D STEP: • Multiple sclerosis: corticosteroid, multiple sclerosis treatment* (e.g., Avonex, Betaseron, Copaxone, Gilenya) Daratumumab Yes Yes PART B STEP: (Darzalex) Multiple myeloma, systemic light chain amyloidosis: prior lines of systemic therapy* (IV chemotherapy)(note some IV chemo may not require prior authorization) PART D STEP: • Multiple myeloma, systemic light chain amyloidosis: prior lines of systemic therapy* (e.g., Ninlaro, Revlimid, Thalomid) Denosumab Yes Yes PART B STEP: (Prolia, Xgeva) • Prolia: o Postmenopausal osteoporosis: IV bisphosphonate • Xgeva: Last revised: July 22, 2020 MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 o Skeletal-related events in multiple myeloma, bone metastases from solid tumors, systemic mastocytosis: zoledronic acid o Hypercalcemia of malignancy: IV bisphosphonate PART D STEP: • Prolia, postmenopausal osteoporosis: oral bisphosphonate • Xgeva, skeletal-related events in multiple myeloma, bone metastases from solid tumors, systemic mastocytosis: zoledronic acid Durvalumab Yes No PART B STEP: (Imfinzi) • Urothelial carcinoma, non-small cell lung cancer: platinum-containing chemotherapy* (note some IV chemo may not require prior authorization) PART D STEP: Not applicable Eculizumab (Soliris) Yes Yes PART B STEP: • Generalized myasthenia gravis: one corticosteroid, one cholinesterase inhibitor (e.g., neostigmine), and two immunosuppressive therapies (e.g., rituximab*) • Neuromyelitis optica spectrum disorder: rituximab* PART D STEP: • Generalized myasthenia gravis: one corticosteroid, one cholinesterase inhibitor (e.g., pyridostigmine), and two immunosuppressive therapies (e.g., azathioprine, mycophenolate, cyclosporine, rituximab*) • Neuromyelitis optica spectrum disorder: rituximab* Elotuzumab Yes Yes PART B STEP: (Empliciti) • Multiple myeloma: prior lines of systemic therapy* (IV chemotherapy) (note some IV chemo may not require prior authorization) PART D STEP: • Multiple myeloma: prior lines of systemic therapy* (e.g., Revlimid, Pomalyst) Last revised: July 22, 2020 MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 Emapalumab-lzsg Yes Yes PART B STEP: (Gamifant) • Primary HLH: prior lines of systemic therapy* (IV chemotherapy including etoposide) and dexamethasone (note some IV chemo may not require prior authorization) PART D STEP: • Primary HLH: dexamethasone Eteplirsen No Yes PART B STEP: (Exondys 51) Not applicable PART D STEP: • Oral corticosteroid Golimumab No Yes PART B STEP: (Simponi, Simponi Not applicable Aria) PART D STEP: • Rheumatoid arthritis: methotrexate, sulfasalazine, hydroxychloroquine, d-penicillamine, azathioprine or auranofin Hyaluronate Yes Yes PART B STEP: derivatives • Intra-articular glucocorticoid injection, Synvisc/Synvisc One* or Euflexxa* PART D STEP: • Simple analgesics (e.g., celecoxib, naproxen) Immune globulins Yes Yes PART B STEP: • All indications except viral prophylaxis: Gammagard* • Dermatomyositis, polymyositis: corticosteroids • Idiopathic thrombocytopenic purpura: corticosteroids or Rho(D) immune globulin* • Multiple sclerosis: three* FDA-approved disease- modifying MS therapies (e.g., Lemtrada, Tysabri, Ocrevus) • Myasthenia gravis/Lambert Eaton myasthenic syndrome: cholinesterase inhibitor (e.g., neostigmine) and systemic corticosteroid • Opsoclonus-myoclonus syndrome: corticosteroids Last revised: July 22, 2020 MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 • Pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid (a.k.a. cicatricial pemphigoid), epidermolysis bullosa acquisita: corticosteroid, one immunosuppressive agent (e.g., cyclophosphamide), and rituximab* • ADA-SCID: Adagen or Revcovi PART D STEP: • Dermatomyositis, polymyositis: corticosteroids in combination with one of the following immunosuppressive agents: methotrexate, azathioprine, cyclophosphamide, mycophenolate mofetil, tacrolimus, cyclosporine • Idiopathic thrombocytopenic purpura: corticosteroids • Multiple sclerosis: three* FDA-approved disease- modifying MS therapies (e.g., Aubagio, Tecfidera, Gilenya, Avonex, Betaseron, Plegridy, glatiramer, Copaxone, Glatopa, Extavia, Rebif) • Myasthenia gravis/Lambert Eaton myasthenic syndrome: amifampridine* or cholinesterase inhibitor (e.g., pyridostigmine), and systemic corticosteroid or immunosuppressant (e.g., azathioprine) • Opsoclonus-myoclonus syndrome: corticosteroids • Pemphigus vulgaris, pemphigus foliaceus, bullous pemphigoid, mucous membrane pemphigoid (a.k.a. cicatricial pemphigoid), epidermolysis bullosa acquisita: corticosteroid, one immunosuppressive agent (e.g., azathioprine, mycophenolate mofetil), rituximab* • Stiff person syndrome: benzodiazepine or baclofen Infliximab No Yes PART B STEP: (Remicade, Not applicable Renflexis, Inflectra) PART D STEP: • Rheumatoid arthritis: methotrexate, sulfasalazine, hydroxychloroquine, d-penicillamine, azathioprine, or auranofin • Plaque psoriasis: methotrexate, cyclosporine, or acitretin Lanreotide Yes No PART B STEP: (Somatuline Depot) • Acromegaly: pituitary irradiation Last revised: July 22, 2020 MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 PART D STEP: Not applicable Natalizumab Yes Yes PART B STEP: (Tysabri) • Crohn’s disease: infliximab* PART D STEP: • Crohn’s disease: adalimumab* or infliximab* • Relapsing-remitting multiple sclerosis: one* of the following: Aubagio, Tecfidera, Gilenya, Avonex, Betaseron, Plegridy, glatiramer, Copaxone, Glatopa, Extavia, or Rebif Ocrelizumab No Yes PART B STEP: (Ocrevus) Not applicable PART D STEP: • Relapsing-remitting multiple sclerosis: one* of the following: Aubagio, Tecfidera, Gilenya, Avonex, Betaseron, Plegridy, glatiramer, Copaxone, Glatopa, Extavia, or Rebif Octreotide Yes No PART B STEP: (Sandostatin, • Acromegaly, meningioma: radiation Sandostatin LAR) • Thymoma and thymic carcinoma: prior lines of systemic therapy* (IV chemotherapy) (note some IV chemo may not require prior authorization) PART D STEP: Not applicable Omalizumab (Xolair) No Yes PART B STEP: Not applicable PART D STEP: • Asthma: inhaled corticosteroid (e.g., beclomethasone, budesonide, flunisolide, fluticasone, mometasone, ciclesonide) • Chronic idiopathic urticaria: H1 antihistamine (e.g., levocetirizine, desloratadine) OnabotulinumtoxinA No Yes PART B STEP: (Botox) Not applicable PART D STEP: Last revised: July 22, 2020 MEDICARE PART B STEP THERAPY REQUIREMENTS CY2020 • Chronic migraine: one migraine preventative therapy (an anticonvulsant, beta blocker, or antidepressant [e.g., divalproex, topiramate, or propranolol]) and one abortive therapy (sumatriptan, rizatriptan, zolmitriptan, naratriptan, almotriptan, frovatriptan, eletriptan, ergotamine/caffeine, or dihydroergotamine) Pegaptanib Yes No PART B STEP: (Macugen) • Intravitreal bevacizumab PART D STEP: Not applicable Ramucirumab Yes Yes PART B STEP: (Cyramza) • Esophageal, esophagogastric junction, and gastric cancer, non-small cell lung cancer, colorectal cancer: prior lines of systemic therapy* (IV chemotherapy) (note some IV chemo may not require prior authorization) PART D STEP: • Hepatocellular carcinoma: Nexavar* Ranibizumab Yes No PART B STEP: (Lucentis) • Intravitreal bevacizumab PART D STEP: Not applicable Rituximab (Rituxan, Yes Yes PART B STEP: Truxima, Ruxience), • If request is for Rituxan Hycela: Rituxan*, rituximab/ Ruxience*, or Truxima* (at least 1 prior dose) hyaluronidase • Rheumatoid arthritis: TNF inhibitor* (Rituxan Hycela) PART D STEP: • If request is for Rituxan Hycela: Rituxan*, Ruxience*, or Truxima* (at least 1 prior dose) • Rheumatoid arthritis: TNF inhibitor*