Immune Modulating Drugs Prior Authorization Request Form

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1 Patient: HPHC member ID #: Requesting provider: Phone: Servicing provider: Diagnosis: Contact for questions (name and phone #): Projected start and end date for requested Requesting provider NPI: Fax: Servicing provider NPI: ICD 10 code: Actemra (tocilizumab) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): For the subcutaneous formulation of this drug FAX: For Buy and Bill Physician Administered Drugs Only Rheumatoid Arthritis (RA) Systemic juvenile idiopathic arthritis (SJIA) Polyarticular Juvenile Idiopathic Arthritis (PJIA) Immune Modulating Drugs Prior Authorization Request Form Concurrent treatment with traditional DMARD agent (e.g., azathioprine, cyclosporine, d-penicillamine, gold sodium, thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, and sulfasalazine) Treatment failure with traditional DMARD agent Contraindication to traditional DMARD agent Treatment failure with Enbrel (etanercept) or Humira (adalimumab) Contraindication to Enbrel or Humira Cimzia (certolizumab pegol) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): reauthorization For the subcutaneous formulation of this drug Ankylosing Spondylitis Crohn s Disease Psoriatic Arthritis Rheumatoid Arthritis Treatment failure with, or contraindication to: Corticosteroids (e.g. prednisone, prednisolone, methylprednisolone, budesonide) 5-Aminosalicylates (e.g. sulfasalazine, mesalamine, olsalazine, balsalazide) Immunosupressants/immunomodulators (e.g. 6-mercaptopurine, azathioprine, methotrexate) Previous treatment failure with Humira Previous treatment failure with Enbrel Treatment failure with prescription NSAID Harvard Pilgrim Health Care Provider Manual D.69 April 2016

2 Entyvio (vedolizumab) Chron s Disease Ulcerative Colitis Treatment failure with, or contraindication to two or more: Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g., balsalazide disodium, sulfasalazine, Azulfidine, Apriso, Delzicol,Pentasa, Rowasa, Dipentum, Colazal) 6-mercaptopurine (6-MP, Purinethol) and or azathioprine, (Imuran) Methotrexate And Treatment failure or contraindication to tumor necrosis factor (tnf) blocker (e.g., Remicade, Humira) Ilaris (canakinumab) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): If obtaining through Accredo Specialty Pharmacy, Cryopyrin-associated periodic syndromes (CAPS) including familial cold auto-inflammatory syndrome (FCAS) and Muckle-Wells syndrome Systemic Juvenile Idiopathic Arthritis (SJIA) Treatment failure with, or contraindication to: One or more Corticosteriods or NSAIDs Required Dose and Dosing Interval: Harvard Pilgrim Health Care Provider Manual D.70 April 2016

3 Orencia (abatcept) Diagnosis (Check all that apply): Clinical and Dosing Information (Check all that apply): For the subcutaneous formulation of this drug Rheumatoid Arthritis Active polyarticular juvenile idiopathic arthritis Treatment failure with traditional DMARD agent (azathioprine, cyclosporine, d-penicillamine, gold sodium, thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, sulfasalazine) Contraindication to traditional DMARD agent Treatment failure with biological DMARD agent (e.g., Cimzia [certolizumab], Kineret [anakinra], Orencia [abatacept], Remicade [infliximab], Simponi [golimumab]). Contraindication to biological DMARD agent Previous treatment failure with Enbrel or Humira. Harvard Pilgrim Health Care Provider Manual D.71 April 2016

4 Remicade (imfliximab ) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Moderately to severely active rheumatoid arthritis Active psoriatic arthritis Moderately to severely active Crohn s Disease Fistulizing Crohn s Disease Moderately to severely active ulcerative colitis Active ankylosing spondylitis Severe (extensive, disabling) plaque psoriasis Treatment failure with oral or injectable DMARD agent (e.g., azathioprine, cyclosporine, d-penicillamine, gold sodium thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, sulfasalazine) Contraindication to one oral or injectable DMARD agent Treatment failure with: Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g. sulfasalazine, mesalamine, olsalazine, balsalazide) Immunosupressants/immunomodulators (e.g., 6-mercaptopurine, azathioprine, methotrexate) Prescription NSAID Systemic therapy for psoriasis (e.g., acitretin, azathioprine, cyclosporine, hydroxyurea, methotrexate, Mycophenolate mofetil, oral methoxsalen plus UVA light [PUVA], propylthiouracil, sulfasalazine, tacrolimus, 6-thioguanine) Previous treatment failure with Humira Previous treatment failure with Enbrel Harvard Pilgrim Health Care Provider Manual D.72 April 2016

5 Rituxan (rituximab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Acute Lymphoblastic Leukemia (ALL) Central Nervous System Cancers (CNS) Chronic Lymphocytic Leukemia (CLL) Neuromyelitis Optica Non-Hodgkin s Lymphoma (NHL)* Post-transplant B-lymphoproliferative disorder Bullous Pemphigoid (refractory) Chronic Graft Versus Host Disease (GVHD Dermatomyositis Granulomatosis with Polyangiitis (GPA/Wegener s Granulomatosis) Bullous Pemphigoid (refractory) Idiopathic thrombocytopenic purpura (ITP) Microscopic Polyangiitis (MPA) in adult patients in combination with glucocorticoids Authorized when documentation confirms diagnosis. Documentation of prior treatment failure is not required. Must have all: Treatment failure with or contraindication to, corticosteroids (e.g., prednisone) Treatment failure with, or contraindication to, a calcineurin inhibitor (e.g., cyclosporine, tacrolimus) Treatment failure with, or contraindication to, glucocorticoid therapy. Treatment failure with, or contraindication to, methotrexate and/or cyclophosphamide in combination with glucocorticoids, or Documented concerns about fertility, high risk of malignancy, relapsing disease or cyclophosphamide resistance. Treatment failure or contraindication to: Systemic, or high-dose topical steroids, or Immunosuppressive glucocorticoid-sparing agent (e.g., mycophenolate mofetil, azathioprine, or methotrexate) Treatment failure or contraindication to steroid therapy: Corticosteroids High-dose topical steroids Systemic steroids Treatment failure with or contraindication to methotrexate and/or cyclophosphamide in combination with glucocorticoids. Documented concerns about fertility, high risk of malignancy, relapsing disease or cyclophosphamide resistance. Harvard Pilgrim Health Care Provider Manual D.73 April 2016

6 Rituxan (rituximab) continued Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Multiple Sclerosis (MS) Primary Progressive Relapse remitting Secondary Progressive Member is < 50 years of age, or Documentation shows enhancement on MRI Positive serology to JC virus, or History of previous immunosuppressant therapy, or History of treatment failure with, or contraindication to, Tysabri (natalizumab History of previous immunosuppressant therapy, or History of treatment failure with, or contraindication to, at least one second-line or oral MS drug (e.g. Aubagio [teriflunomide], Tecfidera [dimethylfumarate], or Gilenya [fingolimod]) Polymyositis Treatment failure with, or contraindication to, glucocorticoid therapy. Refractory Pemphigus Vulgaris Confirmed diagnosis in members 18 or older and all of the following: Failed first-line therapy Treatment failure with or contraindication to, corticosteroids Rheumatoid Arthritis (RA) Must have all: Treatment failure with, or contraindication to, one traditional DMARD agent Treatment failure with or contraindication to Enbrel (etanercept) OR Humira (adalimumab), and at least one other biological DMARD3 Inadequate response to one or more tumor necrosis factor Solid Organ Transplant Recipients Documented need to reduce anti-hla antibodies in member at high risk of antibody-mediated rejection (e.g., highly sensitized patients, patients receiving an ABO incompatible organ). Harvard Pilgrim Health Care Provider Manual D.74 April 2016

7 Simponi -Aria (Golimumab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): For the subcutaneous formulation of this drug Moderately to severely active rheumatoid arthritis Treatment failure with or contraindication to oral or injectable traditional DMARD agent (e.g., azathioprine, cyclosporine, d-penicillamine, gold sodium, thiomalate, methotrexate, auranofin, aurothioglucose, hydroxychloroquine, leflunomide, and sulfasalazine) Treatment failure with or contraindication to Enbrel or Humira Stelara (ustekinumab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): If obtaining through Accredo Specialty Pharmacy, Moderate to severe plaque psoriasis Active psoriatic arthritis Other: Treatment failure or contraindication to one course of systemic therapy for psoriasis (e.g., methotrexate, azathioprine, acitretin, tacrolimus, cyclosporine, mycophenolate mofetil, 6-thioguanine, sulfasalazine, hydroxyurea, propylthiouracil, oral methoxsalen plus UVA light (PUVA). Previous treatment failure with Enbrel or Humira Treatment failure with oral or injectable DMARD agent (e.g., Hydroxychloroquine (Plaquenil), Leflunomide (Arava), Cyclosporine (Neoral), Sulfasalzine (Azulfidine), Methotrexate (Rheumatrex, Trexall), Azathioprine (Imuran), Cyclophosphamide (Cytoxan), Biologics (Actemra, Cimzia, Kineret, Orencia, Remicade, Rituxan, Simponi) Contraindication to oral or injectable DMARD agent Required Dose and Dosing Interval: Harvard Pilgrim Health Care Provider Manual D.75 April 2016

8 Tysabri (natalizumab) Diagnosis (Check all that apply): Clinical and dosing information (Check all that apply): Multiple sclerosis Moderately to severely active Crohn s Disease Relapsing Multiple Sclerosis Documentation of anti-jcv antibody testing (include date) Treatment failure with, or contraindication to at least 2 within the past 6 months Avonex, Betaseron, Copaxone, Rebif, Plegridy, Aubagio, Gilenya, Tecfidera Crohn s Disease Treatment failure with two (or more) of the following: Documentation of anti-jcv antibody testing (include date) Corticosteroids (e.g., Prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g., Sulfasalazine, Azulfidine, Delzicol, Pentasa, Rowasa, Dipentum, Colazal ) 6-Mercaptopurine (6-mp, Purinethol ) and/or azathioprine (Imuran ) Methotrexate (MTX), and treatment failure with, or contraindication to tumor necrosis factor (TNF) blocking agent (e.g., Cimzia, Humira or Remicade ) symptom improvement(s) and documentation of anti-jcv antibody testing (include date) Harvard Pilgrim Health Care Provider Manual D.76 April 2016

subcutaneous initially every 4 weeks then every 12 weeks Coverage Criteria: Express Scripts, Inc. monograph dated 02/24/2010

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