MP Specialty Drugs: Drug-Specific Criteria

Transcription

1 Abatacept (Orencia) J0129 Moderate to Severe Active Adult RA 1. Rheumatologist confirmed Not to be used in combination with another biologic DMARD Prior treatment with nonbiologic Disease- Modifying Antirheumatic Drug (DMARD) and treatment failure due to 1 of the following: 2. Allergic 3. Continued symptoms after 3 months of treatment Negative TB test or TB Treatment Risks of serious infection and cancer discussed with patient or caregiver 1, 2, 7, 11, 13, 14, 18, 24, 31, 44, 48, 49, 51, 53, 55, 57 Moderate to Severe Active Juvenile Idiopathic Arthritis 1. Rheumatologist Confirmed 2. Over 6 years of age 3. Polyarthritis ( 5 Not to be used in combination with another biologic DMARD Prior treatment with a biologic DMARD (i.e., a TNF alpha antagonist) and treatment failure due to 1 of the following: Negative TB test or TB Treatment Risks of serious infection and cancer discussed with patient or caregiver 1

2 joints) 2. Allergic 3. Continued symptoms after 6 weeks of treatment Alpha 1 - Proteinase inhibitor (Prolastin-C) J0256, J0257 Denosumab (Prolia) J0897 Congenital alpha 1- antitrypsin deficiency (AATD) and Emphysema 1. Confirmed by Pulmonologist Osteoporosis in post-menopausal women Osteoporosis in men IgA deficiency with antibodies against IgA due to the risk of developing hypersensitivity and anaphylactic reactions. Combination therapy Pregnancy Under 18 years of age Treatment with zoledronic acid within the past Tried and/or failed oral bisphosphonatenates If oral bisphosphonates are not tolerated, IV Alpha 1-antitrypsin (AAT) < 11 um/l FEV1 30% and 65% Nonsmoker/ smoking cessation 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 5, 6, 10, 12, 40 4, 20, 21, 56, 59 2

3 year Hypocalcemia bisphosphonates must first be tried and failed/or contraindicated Routine oral exam performed Golimumab (Simponi Aria) J1602 Rheumatoid Arthritis (RA) 1. Rheumatologist Confirmed; with 2. Ongoing disease activity (in a commonly used scoring system) 3. Age 18 years Prior treatment with nonbiologic Disease- Modifying Antirheumatic Drug (DMARD) and treatment failure due to 1 of the following: 2. Allergic 3. Continued symptoms after 3 months of treatment TB testing negative or TB treated Risks of serious infection and cancer discussed with patient or caregiver May be combined with Methotrexate 1, 2, 22, 33, 29, 42, 44, 45, 48, 51 Natalizumab (Tysabri) Relapsing Remitting Multiple Sclerosis (RRMS) Combination drug therapy for MS Previous treatment with 1 MS disease Risk of progressive multifocal leukoencephalopathy (PML) discussed with patient or caregiver 8, 15, 19, 23, 27, 38, 3

4 J Confirmed by a Neurologist 2. Over 18 years of age modifying drugs (biologic or glatiramer acetate) with treatment failure, due to one of the following: 2. Allergic 3. Progression of disability or worsening neurologic function 4. Significant relapse or new MRI lesions after therapy 6 months Negative JC virus testing Enrollment in TOUCH Prescribing Program 54, 58 Inflammatory Bowel Disease [i.e., Crohn s Disease (CD) ] 1. Moderate to severe Perianal fistulizing disease Previous treatment with biologics with treatment failure, due to Risk of progressive multifocal leukoencephalopathy (PML) discussed with patient or caregiver Negative JC virus testing Enrollment in TOUCH Prescribing 4

5 disease confirmed by a Gastroenterologist 2. Over age 18 one of the following: 2. Allergic 3. Continued symptoms or findings 2 months Program Romiplostin (Nplate) J2796 Immune Thrombocytopenia (ITP) 1. Confirmed by a specialist 2. Maintenance therapy for platelet count < 30 x10 (9)/L 3. Over age 18 Bleeding episode (urgent) Prior therapy with: Corticosteroid and/or immune globulin with treatment failure, due to one of the following: 2. Continued platelet count < 30 x10 (9)/L 3. Allergic Risk of thrombosis discussed with patient or caregiver 3, 25, 34, 39, 60 Taliglucerase Type 1 Gaucher Age 18 and With one of the following: 28, 33, 5

6 alfa (Elelyso) J3060 disease (confirmed by Betaglucosylceramid-ase activity or GBA gene test) 65 Type 2 Gaucher Disease Type 3 Gaucher disease 1. Anemia 2. Thrombocytopenia 3. Splenomegaly 4. Hepatomegaly 5. Bone disease 36, 37, 61 Tocilizumab (Actemra) J3262 Moderate to Severe Active Rheumatoid Arthritis (RA) 1. Confirmed by Rheumatologist 2. Over 18 years of age Tried and/or failed 1 Disease- Modifying Antirheumatic Drug (DMARD) with treatment failure due to: 2. Allergic 3. Continued symptoms after 3 months of treatment Negative TB test or TB Treatment Risks of serious infection and cancer discussed with patient or caregiver 1, 2, 7, 14, 17, 24, 32, 42, 44, 48, 49, 51, 53, 55 Juvenile Idiopathic Arthritis (Systemic, Polyarticular) 1. Rheumatologist Confirmed 2 years of age Previously treated for JIA (e.g. NSAIDs, corticosteroids, or Negative TB test or TB Treatment Risks of serious infection and cancer discussed with patient or caregiver 6

7 2. Moderate to high disease activity 3. Active in 5 joints methotrexate) Vedolizumab (Entyvio) C9026 Moderate to Severe Inflammatory Bowel Disease (i.e., Crohn s Disease, ulcerative colitis) 1. Gastroenterologist Confirmed 2. Age 18 Perianal fistulizing disease Previous treatment with biologics with treatment failure, due to one of the following: 2. Allergic 3. Continued symptoms or findings 6 weeks Biologic therapy failure due to: or side effects 2. Allergic 3. Continued symptoms or findings 2 months 16, 38, 46, 52, 54 Velaglucerase Alfa (VPRIV) J3385 Type 1 Gaucher disease (confirmed by Betaglucosylceramid-ase activity or GBA gene test) Age 18 and 65 Type 2 Gaucher Disease Type 3 Gaucher disease With one of the following: 1. Anemia 2. Thrombocytopenia 3. Splenomegaly 4. Hepatomegaly 5. Bone disease 28, 36, 47, 61 Zoledronic Osteoporosis or Current Tried and/or Osteopenic (T-score -1.0 to -2.5) or 9, 21, 7

8 Acid (Reclast) J3489 Osteopenia treatment in postmenopausal women Osteoporosis in men Paget s Disease 1. With consistent radiographic findings 2. Elevated serum alkaline phosphatase Glucocorticoid-induced osteoporosis (GIO) or treatment with glucocorticoids for more than 3 months treatment with similar medication (e.g., Zometa, Xgeva, or Prolia) Pregnancy Under 18 years of age Treatment with zoledronic acid within the past year Hypocalcemia failed oral bisphosphonate s Patients with creatinine clearance of 35mL/min and in those with evidence of acute renal impairment 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 treatment (postmenopausal females, males) and GIO treatment: 5 mg once a year Osteoporosis prevention (postmenopausal women) treatment: 5 mg once every 2 years Paget s disease treatment: a single 5 mg infusion 26, 35, 41, 43, 56, 59 References 1. AHRQ. Comparative Effectiveness Review: Drug Therapy for Rheumatoid Arthritis in Adults: An Update. Rockville: Agency for Healthcare Research and Quality; Available from: [cited Aug ]. 8

9 2. Aletaha et al. Rheumatoid Arthritis classification criteria: An American College of Rheumatology/European League Against Rheumatism collaborative initiative. Arthritis Rheum 2010, 62: Amgen Manufacturing Limited. Nplate (romiplastin) prescribing information. Thousand Oaks CA: Amgen Manufacturing Limited; Available from: [cited Apr ]. 4. Amgen Manufacturing Limited. Prolia (denosumab) prescribing information. Thousand Oaks CA: Amgen Manufacturing Limited; Available from: [cited Jul ]. 5. Bals, Robert. "Alpha-1-antitrypsin deficiency." Best Practice & Research Clinical Gastroenterology 24.5 (2010): Baxalta. Aralast NP [Alpha 1 Proteinase Inhibitor (Human)] prescribing information. Westlake Village CA: Baxter Healthcare Corporation; Available from: [cited Nov ]. 7. Beukelman, Timothy, et al. "2011 American College of Rheumatology recommendations for the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features." Arthritis care & research 63.4 (2011): Biogen Idec Inc. Tysabri (natalizumab) prescribing information. Cambridge MA: Biogen Idec Inc.; 2015 Available from: [cited May ]. 9. Black, Dennis M., et al. "Once-yearly zoledronic acid for treatment of postmenopausal osteoporosis." New England Journal of Medicine (2007): Blanco, Ignacio, Beatriz Lara, and Frederick De Serres. "Efficacy of alpha1-antitrypsin augmentation therapy in conditions other than pulmonary emphysema." Orphanet journal of rare diseases 6.1 (2011): Bristol-Myers Squibb. Orencia (abatacept) prescribing information. Princeton NJ: Bristol-Myers Squibb; Available from: [cited Aug ]. 12. Chen S. Human [alpha] 1-proteinase Inhibitor for Patients with [alpha] 1-antitrypsin Deficiency. Canadian Agency for Drugs and Technology in Health, 2007 [cited Nov ]. 13. Cush, J. J., et al. "Screening for Mycobacterium tuberculosis infection: questions and answers for clinical practice." Drug Safety Quart 1.1 (2010). 9

10 14. Donahue, Katrina E., et al. "Systematic review: comparative effectiveness and harms of disease-modifying medications for rheumatoid arthritis." Annals of Internal Medicine (2008): Filippini, Graziella, et al. "Immunomodulators and immunosuppressants for multiple sclerosis: a network meta-analysis." Cochrane Database Syst Rev 6 (2013). 16. Feuerstein, Joseph D., and Adam S. Cheifetz. "Ulcerative colitis: epidemiology, diagnosis, and management." Mayo Clinic Proceedings. Vol. 89. No. 11. Elsevier, Genentech, Inc. Actemra (tocilizumab) prescribing information. South San Franciso CA: Genentech, Inc.: Available from: [cited Mar ]. 18. Goldzweig, Ofra, and Philip J. Hashkes. "Abatacept in the treatment of polyarticular JIA: development, clinical utility, and place in therapy." Drug Des Devel Ther 5 (2011): Goodin, D. S., et al. "Disease modifying therapies in multiple sclerosis." Neurology 58.2 (2002): Harris, E. D., and G. S. Firestein. "Course and complications of established rheumatoid arthritis." Firestein GS, Budd RC, HarrisEDJr, et al. Kelley s Textbook of Rheumatology, 8th ed. St. Louis, MO: WB Saunders (2008). 21. Institute for Clinical Systems Improvement (ISCI). Diagnosis and treatment of osteoporosis Available from: [cited Jan ]. 22. Janssen Biotec. Simponi Aria (golumimab) prescribing information. Horsham PA: Available from: [cited Apr ]. 23. Kalb. A clinical bulletin: overview of multiple sclerosis. National Multiple Sclerosis Society; Available from: al_bulletin_overview-of-multiple- Sclerosis.pdf [cited April 2015]. 24. Kemper, A. R., et al. "Disease-Modifying Antirheumatic Drugs (DMARDs) in Children with Juvenile Idiopathic Arthritis (JIA). Comparative Effectiveness Review No. 28. (Prepared by the Duke Evidence-based Practice Center under Contract No. HHSA ) Rockville, MD: Agency for Healthcare Research and Quality." Rockville (MD): Agency for Healthcare Research and Quality (2011). 25. Lo, Ernest, and Sean Deane. "Diagnosis and classification of immune-mediated thrombocytopenia." Autoimmunity reviews 13.4 (2014):

11 26. Lyles, Kenneth W., et al. "Zoledronic acid and clinical fractures and mortality after hip fracture." New England Journal of Medicine (2007): MacDonald, John K., and J. W. McDonald. "Natalizumab for induction of remission in Crohn s disease." Cochrane Database Syst Rev 2007(1):CD Martins, Ana Maria, et al. "Recommendations on diagnosis, treatment, and monitoring for Gaucher disease." The Journal of pediatrics (2009): S10-S Nam, Jackie L., et al. "Efficacy of biological disease-modifying antirheumatic drugs: a systematic literature review informing the 2013 update of the EULAR recommendations for the management of rheumatoid arthritis." Annals of the rheumatic diseases 73.3 (2014): National Institute for Clinical Excellence. Rheumatoid Arthritis The management of rheumatoid arthritis in adults. London: NICE; Available from: [cited Aug ]. 31. National Institute for Clinical Excellence, TA. "280: Abatacept for treating rheumatoid arthritis after the failure of conventional disease modifying antirheumatic drugs (rapid review of TA 234), April nice.org.uk." TA National Institute for Clinical Excellence. Tocilizumab for the treatment of systemic juvenile idiopathic arthritis. London: NICE; Available from: juvenile-idiopathic-arthritis National Institute of Health. Gaucher disease. Current issues in diagnosis and treatment. NIH Technology Assessment Panel on Gaucher Disease Available from: [cited Nov ]. 34. Neunert, Cindy, et al. "The American Society of Hematology 2011 evidence-based practice guideline for immune thrombocytopenia." Blood (2011): Novartis Pharmaceuticals Corporation. Reclast (zoledronic acid) prescribing information. East Hanover NJ: Novartis Pharmaceutics Corporation; Available from: [cited Jan ]. 36. Pastores and Hughes. Gaucher Disease Available from: ncbi.nlm.nih.gov/books/nbk1269/ [cited Jul ]. 11

12 37. Pfizer Labs. Elelyso (Taliglucerase alfa) prescribing information. New York NY; Pfizer Labs; Available form: [cited Nov ]. 38. Prince. Crohn s Disease Activity Index (CDAI) calculator Available from: [cited Jan ]. 39. Provan, Drew, et al. "International consensus report on the investigation and management of primary immune thrombocytopenia." Blood (2010): Rabe, Klaus F., et al. "Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary." American journal of respiratory and critical care medicine (2007): Räkel, Agnès, Andrée Boucher, and Louis-Georges Ste-Marie. "Role of zoledronic acid in the prevention and treatment of osteoporosis." Clinical interventions in aging 6 (2010): Ramiro, Sofia, et al. "Safety of synthetic and biological DMARDs: a systematic literature review informing the 2013 update of the EULAR recommendations for management of rheumatoid arthritis." Annals of the rheumatic diseases (2014): annrheumdis Reid, David M., et al. "Zoledronic acid and risedronate in the prevention and treatment of glucocorticoid- induced osteoporosis (HORIZON): a multicentre, double-blind, double-dummy, randomised controlled trial." The Lancet (2009): Ringold et al update of the 2011 American College of Rheumatology recommendations for the treatment of Juvenile Idiopathic arthritis: Recommendations for the medical therapy of children with systemic juvenile idiopathic arthritis and tuberculosis screening among children receiving biologic medications. Arthritis Rheum (10): Saag, Kenneth G., et al. "American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease modifying antirheumatic drugs in rheumatoid arthritis." Arthritis Care & Research 59.6 (2008): Sandborn, William J., et al. "Adalimumab for maintenance treatment of Crohn s disease: results of the CLASSIC II trial." Gut 56.9 (2007): Shire Human Genetic Therapies, Inc. VPRIV (velaglucerase) prescribing information. Lexington MA: Shire Human Genetic Therapies, Inc.; Available from: PI Prescribing Information [cited Nov ]. 48. Singh et al update of the 2008 American College of Rheumatology recommendations for the use of disease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis. Arthritis Care Res (Hoboken) (5):

13 49. Singh JA, Christensen R, Wells GA, et al. Biologics for Rheumatoid arthritis: An overview of Cochrane reviews. Cochrane Database Syst Rev, 2009(4): CD Singh, Siddharth, and Darrell S. Pardi. "Update on anti-tumor necrosis factor agents in Crohn disease." Gastroenterology Clinics of North America 43.3 (2014): Smolen et al. Treating spondyloarthritis, including ankylosing spondylitis and psoriatic arthritis, to target: Recommendations of an international task force. Ann Rheum Dis (1): Takeda Pharmaceuticals America. Entyvio (vedolizumab) prescribing information. Deerfield, IL: Available from: 2e821c-687d-48ff-a3c0-efe98848cc66 [cited Jan ]. 53. Turkstra et al. A mixed treatment comparison of the short-term efficacy of biologic disease modifying anti-rheumatic drugs in established rheumatoid arthritis. Curr Med Res Opin (10): Ueno, Fumiaki, et al. "Evidence-based clinical practice guidelines for Crohn s disease, integrated with formal consensus of experts in Japan." Journal of gastroenterology 48.1 (2013): Ungar, Wendy J., et al. "The use of biologic modifiers in polyarticular-course juvenile idiopathic arthritis: a systematic review." Seminars in arthritis and rheumatism. Vol. 42. No. 6. WB Saunders, US Preventive Services Task Force. "Screening for osteoporosis in postmenopausal women: recommendations and rationale." Annals of Internal Medicine (2002): Wallace, Carol A., et al. "American College of Rheumatology provisional criteria for defining clinical inactive disease in select categories of juvenile idiopathic arthritis." Arthritis care & research 63.7 (2011): Wingerchuk, Dean M., and Jonathan L. Carter. "Multiple sclerosis: current and emerging disease- modifying therapies and treatment strategies." Mayo Clinic Proceedings. Vol. 89. No. 2. Elsevier, World Health Organization Scientific Group. Assessment of osteoporosis at the primary care level. Technical Report Available from: [cited Jan ]. 60. Zeng, Yan, et al. "TPO receptor agonist for chronic idiopathic thrombocytopenic purpura." Cochrane Database Syst Rev 7 (2011). 13

14 61. Zimran et al. Pivotal trial with plant-cell expressed recombinant glucocerebrosidase, Taliglucerase alfa, a novel enzyme replacement therapy for Gaucher disease. Blood (22). Available from: [cited Nov ]. 14