Prior treatment with non-biologic Disease- Modifying Antirheumatic. Not to be used in combination with another biologic DMARD

Transcription

1 Abatacept (Orencia) 1, 2, 7, 11, 13, 14, 18, 24, 31, 44, 48, 49, 51, 53, 55, 57 J0129 Alpha 1 - Proteinase inhibitor (Prolastin-C) 5, 6, 10, 12, 40 Medically Necessary (if all the following criteria apply): Active Adult RA 1. Rheumatologi st confirmed Active Juvenile Idiopathic Arthritis 1.Rheumatologist Confirmed 2.Over 6 years of age 3.Polyarthritis ( 5 joints) Congenital alpha 1- antitrypsin deficiency (AATD) and Emphysema Confirmed by Pulmonologist Contraindications/ Exclusions: Not to be used in combination with another biologic DMARD Not to be used in combination with another biologic DMARD IgA deficiency with antibodies against IgA due to the risk of developing hypersensitivity and anaphylactic reactions Step Therapy Required: Prior with non-biologic Disease- Modifying Antirheumatic Drug (DMARD) and failure due to 1 of the following: Significant intolerance Allergic response Continued symptoms after 3 months of Prior with a biologic DMARD (i.e., a TNF alpha antagonist) and failure due to 1 of the following: Significant intolerance Allergic response Continued symptoms after 6 weeks of Additional Required Clinical Criteria: Negative TB test or TB Risks of serious infection and cancer discussed with patient Negative TB test or TB Risks of serious infection and cancer discussed with patient Alpha 1-antitrypsin (AAT) < 11 um/l FEV1 30% and 65% Nonsmoker/ smoking cessation

2 J0256, J0257 Belimumab (Benlysta) J0490 Denosumab (Prolia) 56, 59 J0897 4, 20, 21, Active Systemic Lupus Erythematosus (SLE) 1. Rheumatologi st Confirmed (Board Certified) 2. Age 18 years Osteoporosis in postmenopausal women Osteoporosis in men Severe Active Lupus Nephritis (i.e., proteinuria 6 g/24 hr or serum creatinine 2.5mg/dl) Severe Active Central Nervous System Lupus Current with intravenous cyclophospha-mide Combination therapy Pregnancy Under 18 years of age with zoledronic acid within the past year Hypocalcemia Receiving standard of care for SLE, for at least 30 days, including (alone or in combination): 1.Corticosteroids 2.Antimalarials 3.Non-biologic immunosuppress-ive medications Tried and/or failed oral bisphosphonate-nates: Intolerance to/contraindicati on to/or failure to respond to oral If oral are not tolerated due to the oral route of administration, but there is no documented contraindication or failure to respond to otherwise, intolerance to/contraindicati May be used as a steroid sparing agent; when unable to wean from steroids; ongoing disease activity that is not controlled despite optimization of immunosuppressives. Osteoporotic (defined by T- score below -2.5) by dual x-ray absorptiometry (DXA), or low impact fracture Normal phosphorus and magnesium levels Planned supplementation with calcium and Vitamin- D Routine oral exam performed

3 Golimumab (Simponi Aria) 1, 2, 22, 33, 29, 42, 44, 45, 48, 51 J1602 Natalizumab (Tysabri) 23, 27, 38, 54, 58 J2323 8, 15, 19, Rheumatoid Arthritis (RA) 1.Rheumatologist Confirmed; with 2.Ongoing disease activity (in a commonly used scoring system) 3.Age 18 years Relapsing Remitting Multiple Sclerosis (RRMS) 1.Confirmed by a Neurologist 2.Over 18 years of age Inflammatory Bowel Disease [i.e., Crohn s Disease (CD) ] 1.Moderate to severe Combination drug therapy for MS Perianal fistulizing disease on to/or failure to respond to IV must be documented Prior with non-biologic Disease- Modifying Antirheumatic Drug (DMARD) and failure due to 1 of the following: after 3 months of Previous with 1 MS disease modifying drugs (biologic or glatiramer acetate) with failure, due to one of the following: 3.Progression of disability or worsening neurologic function 4.Significant relapse or new MRI lesions after therapy 6 months Previous with biologics with failure, due to one of the following: TB testing negative or TB treated Risks of serious infection and cancer discussed with patient May be combined with Methotrexate Risk of progressive multifocal leukoencephalopathy (PML) discussed with patient or caregiver Negative JC virus testing Enrollment in TOUCH Prescribing Program Risk of progressive multifocal leukoencephalopathy (PML) discussed with

4 Romiplostin (Nplate) 39, 60 J2796 3, 25, 34, Taliglucerase alfa (Elelyso) 28, 33, 36, 37, 61 J3060 Tocilizumab (Actemra) 1, 2, 7, 14, 17, 24, 32, 42, 44, 48, 49, 51, 53, 55 J3262 disease confirmed by a Gastroenterologist 2.Over age 18 Immune Thrombocytopenia (ITP) 1.Confirmed by a specialist 2.Maintenance therapy for platelet count < 30 x10 (9)/L 3.Over age 18 Type 1 Gaucher disease (confirmed by Beta-glucosylceramidase activity or GBA gene test) Active Rheumatoid Arthritis (RA) 1.Confirmed by Rheumatologist 2.Over 18 years of age Juvenile Idiopathic Arthritis (Systemic, Polyarticular) Bleeding episode (urgent) Age 18 and 65 Type 2 Gaucher Disease Type 3 Gaucher disease 2 years of age or findings 2 months Prior therapy with: Corticosteroid and/or immune globulin with failure, due to one of the following: 2.Continued platelet count < 30 x10 (9)/L 3.Allergic response Tried and/or failed 1 Disease-Modifying Antirheumatic Drug (DMARD) with failure due to: after 3 months of Previously treated for JIA (e.g. NSAIDs, corticosteroids, or patient Negative JC virus testing Enrollment in TOUCH Prescribing Program Risk of thrombosis discussed with patient With one of the following: Anemia Thrombocytopenia Splenomegaly Hepatomegaly Bone disease Negative TB test or TB Risks of serious infection and cancer discussed with patient Negative TB test or TB Risks of serious infection and

5 Vedolizumab (Entyvio) 52, 54) C , 38, 46, Velaglucerase Alfa (VPRIV) 28, 36, 47, 61 J3385 Zoledronic Acid 9, 21, 26, (Reclast) 35, 41, 43, 56, 59 J Rheumatologist Confirmed 2.Moderate to high disease activity 3.Active in 5 joints Inflammatory Bowel Disease (i.e., Crohn s Disease, ulcerative colitis) 1.Gastroenterologist Confirmed 2.Age 18 Type 1 Gaucher disease (confirmed by Beta-glucosylceramidase activity or GBA gene test) Osteoporosis or Osteopenia in postmenopausal women Osteoporosis in men Paget s Disease 1.With consistent radiographic findings 2.Elevated serum alkaline phosphatase Glucocorticoid- Perianal fistulizing disease Age 18 and 65 Type 2 Gaucher Disease Type 3 Gaucher disease Current with similar medication (e.g., Zometa, Xgeva, or Prolia) Pregnancy Under 18 years of age with zoledronic acid within the past year Hypocalcemia methotrexate) Previous with biologics with failure, due to one of the following: or findings 6 weeks Tried and/or failed oral Patients with creatinine clearance of 35mL/min and in those with evidence of acute renal impairment cancer discussed with patient Biologic therapy failure due to: or side effects 2. Allergic response 3. Continued symptoms or findings 2 months With one of the following: 1.Anemia 2.Thrombocytopenia 3.Splenomegaly 4.Hepatomegaly 5.Bone disease Osteopenic (T-score -1.0 to - 2.5) or osteoporotic (T-score below -2.5) by dual x-ray absorptiometry (DXA), or low impact fracture Renal function evaluated and no evidence of renal impairment Normal phosphorus and magnesium levels Planned supplementation with calcium and Vitamin- D Osteoporosis (postmenopausal females, males)

6 induced osteoporosis (GIO) or with glucocorticoids for more than 3 months and GIO : 5 mg once a year Osteoporosis prevention (post-menopausal women) : 5 mg once every 2 years Paget s disease : a single 5 mg infusion