(Tocilizumab) Policy Number: 1040 Policy History Approve Date: 12/11/2015 Effective Date: 12/11/2015 Preauthorization All Plans Benefit plans vary in coverage and some plans may not provide coverage for certain service(s) listed in this policy. Decisions for authorization are subject to all terms and conditions of the applicable benefit plan, including specific exclusions and limitations as well as applicable state and/or federal laws. Please review the benefit plan descriptions for details. We utilize a combination of MCG and internally developed evidence-based clinical guidelines to support our prior authorization work. All internally developed prior authorization guidelines follow a rigorous process including, but not limited to, review by clinical pharmacist, clinical nurse manager, Chief Medical Officer, independent 3 rd party physician review agency and WEA Trust s Medical Advisory Committee. Prior authorization guidelines are reviewed at least annually, or when there are significant labeling changes made by FDA or peer-reviewed clinical outcomes (via Cochrane or Hayes). INSTRUCTIONS: Please review section I and complete sections II, III, and IV (type or print clearly). Prescribers are asked to submit this form along with supporting clinical documentation to the WEA Trust for review. Submission of form does not guarantee approval. Submit preauthorization (PA) by fax to the WEA Trust at (608) 276-9119 or by mail to WEA Trust, Pharmacy Services Prior Authorization, P.O. Box 7338, Madison, WI 53707-7338. Section I Approval Criteria I. (tocilizumab) is medically necessary for the treatment of an individual with moderately to severely active Rheumatoid Arthritis (RA) when ALL of the following criteria are met: A. Individual is 18 years of age or older AND B. May be used alone or in combination with MTX or with other non-biologic DMARDs AND C. Individual has had an inadequate response to at least one preferred tumor necrosis factor [TNF] inhibitor in the previous 180 days, (current preferred biologics include Enbrel (etanercept) and Humira (adalimumab), having been at least 80% adherent (PDC of at least 0.80)) CALCULATED BY WEA PHARMACY
Page 2 II. (tocilizumab) is medically necessary for an individual with active polyarticular juvenile idiopathic arthritis (PJIA) when all of the following criteria are met: A. Individual is two years of age or older AND B. Individual has failed to respond to a trial of at least one tumor necrosis factor [TNF] inhibitor C. Individual has been at least 80% adherent to the drug regimen over the previous 180 days ( PDC of at least 0.80) as calculated by WEA Pharmacy D. Individual is intolerant of, or has a medical contraindication to DMARD III. (tocilizumab) is medically necessary when the follow criteria are met for the treatment of an individual with active Systemic Juvenile Idiopathic Arthritis (SJIA) when ALL of the following criteria are met: A. Individual is two years of age or older AND B. Individual has failed to respond to, is intolerant of, or has a medical contraindication to one or more corticosteroids or nonsteroidal anti-inflammatory drugs (NSAIDs) IV. (tocilizumab) is not medically necessary for an individual with ANY of the following: A. Use in combination with other biologic DMARDs such as anti-cd20 monoclonal antibodies, IL-1R antagonists, Janus kinas inhibitors (for example, tofacitinib citrate), selective co- stimulation modulators, or TNF antagonists OR B. At initiation of therapy, absolute neutrophil count (ANC) less than 2,000/mm 3, platelet count less than 100,000/mm 3, or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 1.5 times the upper limit of normal (ULN) OR C. Tuberculosis, invasive fungal infection, or other active serious infections or a history of recurrent infections OR D. Individual has not had a tuberculin skin test (TST) or Centers for Disease Control (CDC) - recommended equivalent to evaluate for latent tuberculosis prior to initiating (tocilizumab) V. (tocilizumab) is considered investigational and is not medically necessary for the following when the medically necessary criteria are not met and for all other indications, including but not limited to the treatment of: A. Adult onset Still s disease (AOSD) B. Ankylosing spondylitis (AS) C. Castleman s disease D. Crohn s disease (CD) E. Large vessel vasculitis (giant cell and Takayasu s arteritis) F. Systemic lupus erythematosus (SLE) G. Tumor necrosis factor receptor-associated periodic syndrome (TRAPS) VI. (tocilizumab) has a black box warning for risk of serious infections. Individuals treated with are at increased risk for developing serious infections that may lead to hospitalization or death. Most individuals who developed these infections were taking concomitant immunosuppressants. Reported infections include: Tuberculosis, invasive fungal infections (including candidiasis, aspergillosis, and pneumocystosis), and infections (bacterial, viral, or other) due to opportunistic pathogens. The risks and benefits of treatment with should be considered prior to initiating in individuals with chronic or recurrent infection. If a serious infection develops, therapy should be interrupted until the infection is controlled. Individuals should be closely monitored for the development of signs and symptoms of infection during and after treatment with, including the possible development of tuberculosis in individuals who tested negative for latent tuberculosis infection prior to initiating therapy.
Page 3 Renewal Criteria I. All renewals will be for six months II. For rheumatoid arthritis: A. 20% improvement in the number of tender joints AND B. 20% improvement in the number of swollen joints AND C. 20% improvement in three of the following five measures: i. Pain ii. Global assessment of disease activity by the physician iii. Global assessment of disease activity by the patient iv. Patient assessment of physical function v. Levels of acute phase reactant (ESR or CRP) OR vi. Achieved an equivalent therapeutic response as indicated by scoring using the DAS28, SDAI, CDAI indice References 1. NYC Dept of Public Health Fund for Public Health- New York Medication Adherence Project 2010 http://www.nyc.gov/html/doh/downloads/pdf/cardio/cardio-map-tools-manual.pdfho PM et al. Arch Intern Med. 2006;166:1842-1847 Effect of Medication Non-adherence on Hospitalization and Mortality Among Patients With Diabetes Mellitus 2. Karen M. Stockl, PharmD, et al. Journal of Managed Care Pharmacy 2010; Vol 16;No 8:593-604 Outcomes of a Rheumatoid Arthritis Disease Therapy Management Program Focusing on Medication Adherence 3. Grant W. Cannon, et al. Arthritis Care and Research 2011;Vol 63 No 12: 1680-1690 Merging Veterans Affairs Rheumatoid Arthritis Registry and Pharmacy Data to Assess Methotrexate Adherence and Disease Activity in Clinical Practice 4. David P. Nau, RPh, PhD, CPHQ Pharmacy Quality Alliance; Proportion of Days Covered (PDC) as a Preferred Method of Measuring Medication Adherence 5. Sofia de Achaval and Maria E. Suarez-Almazor, MD, PhD J Musculoskelet Med. 2010 October 12; 27(10):Improving Treatment Adherence in Patients with Rheumatologic Disease 6. James Bluett, et al. Rheumatology 2015; Vol 54 No 53: 494-499 Impact of Inadequate Adherence on Response to Subcutaneously Administered Anti-Tumour Necrosis Factor Drugs: Results from the Biologics in Rheumatoid Arthritis Genetics and Genomics Study Syndicate cohort 7. Luca Degli Esposti et al. ClinicoEconomics and Outcomes Research 2014:6 401 407 Adherence and Resource use among Patients Treated with Biologic Drugs: Findings from BEETLE Study 8. Christian A. Waimann et al. Arthritis and Rheumatism 2013 Vol 65 No 6: 1421-1429 Electronic Monitoring in Oral Therapies in Ethnically Diverse and Economically Disadvantaged Patients with Rheumatoid Arthritis: Consequences of Low Adherence 9. Prescribing Information. Genentech, Inc. Revised: 11/2014. 10. Singh JA, Saag KG, Bridges L, et. al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. DOI 10.1002/acr.22783. 2015, American College of Rheumatology. 11. Smolen JS, Landew R, Breedveld FC, Buch M, Burmester G, Dougados M, Emery P, Gaujoux-Viala C, Gossec L, Nam J, Ramiro S, Winthrop K, de Wit M, Aletaha D, Betteridge N, Bijlsma JW, Boers M, Buttgereit F, Combe B, Cutolo M, Damjanov N, Hazes JM, Kouloumas M, Kvien TK, Mariette X, Pavelka K, van Riel PL, Rubbert-Roth A, Scholte-Voshaar M, Scott DL, Sokka-Isler T, Wong JB, van der Heijde D. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological diseasemodifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014 Mar 1;73(3):492-509. doi: 10.1136/annrheumdis-2013-204573. Epub 2013 Oct 25. 12. Beukelman T, Patkar NM, Saag KG, et al. 2011 American College of Rheumatology recommendations for
Page 4 the treatment of juvenile idiopathic arthritis: initiation and safety monitoring of therapeutic agents for the treatment of arthritis and systemic features. Arthritis Care Res (Hoboken) 2011; 63:465. 13. Ringold S, Weiss PF, et. al. 2013 Update of the 2011 American College of Rheumatology 14. 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 & RHEUMATISM. Vol. 65, No. 10, October 2013, pp 2499 2512. DOI 10.1002/art.38092 15. Unizony S, Arias-Urdaneta L, Miloslavsky E, Arvikar S, Khosroshahi A, Keroack B, Stone JR, Stone JH. Tocilizumab for the treatment of large-vessel vasculitis (giant cell arteritis, Takayasu arteritis) and polymyalgia rheumatica. Arthritis Care Res (Hoboken). 2012 Nov;64(11):1720-9. 16. Loricera J, Blanco R, Hernández JL, Castañeda S, Mera A, Pérez-Pampín E, Peiró E, Humbría A, Calvo-Alén J, Aurrecoechea E, Narváez J, Sánchez-Andrade A, Vela P, Díez E, Mata C, Lluch P, Moll C, Hernández Í, Calvo- Río V, Ortiz-Sanjuán F, González-Vela C, Pina T, González-Gay MÁ. Tocilizumab in giant cell arteritis: Multicenter open-label study of 22 patients. Semin Arthritis Rheum. 2015 Jun;44(6):717-23. doi: 10.1016/j.semarthrit.2014.12.005. Epub 2014 Dec 27. 17. Seitz M, Reichenbach S, Bonel HM, Adler S, Wermelinger F, Villiger PM. Rapid induction of remission in large vessel vasculitis by IL-6 blockade. A case series. Swiss Med Wkly. 2011;141:w13156. Salvarani C, Magnani L, Catanoso M, Pipitone N, Versari A, Dardani L, Pulsatelli L, Meliconi R, Boiardi L. Tocilizumab: a novel therapy for patients with large-vessel vasculitis. Rheumatology (Oxford). 2012 Jan;51(1):151-6. Epub 2011 Nov 10. 18. ClinicalTrials.gov
Page 5 Section II Member Information Name (Last, First, Middle Initial) Date of Birth WEA Trust Subscriber Number Diagnosis 1. MEDICATION 2. STRENGTH 3. DIRECTIONS 4. QUANTITY (tocilizumab) Specify: 5. DIAGNOSIS: 6. APPROVAL CRITERIA: CHECK ALL BOXES THAT APPLY NOTE: Any areas not filled out are considered not applicable to your patient and MAY AFFECT THE OUTCOME of this request. A RESPONSE IS REQUIRED FOR EACH OF THE FOLLOWING: Yes No Has the patient had Tuberculosis, invasive fungal infection, or other active serious infections, or a history of recurrent infections? Yes No Has the patient had a tuberculin skin test (TST), or a CDC-recommended equivalent, to evaluate for Latent Tuberculosis prior to initiating (tocilizumab)? Yes No Will the patient be using (tocilizumab) in combination with other biologic disease modifying anti-rheumatic drugs (DMARDs) such as anti-cd20 monoclonal antibodies, IL-1R antagonists, Janus kinas inhibitors (for example, tofacitinib citrate), selective co-stimulation modulators, or TNF antagonists? Yes No Does the patient have an absolute neutrophil count (ANC) less than 2000/mm, platelet count less than 100,000/mm 3 or ALT or AST above 1.5 times the upper limit of normal (ULN)? Rheumatoid Arthritis (RA): Yes No Is the patient 18 years of age or older? Yes No Does the patient have moderately to severely active rheumatoid arthritis? Yes No Has the patient had an inadequate response to a trial of at least two disease modifying anti-rheumatic drugs (DMARDs) (for example, methotrexate [MTX], sulfasalazine, hydroxychloroquine ) in combination, consistent with ACR/EULAR treat-to-target guidelines, and having been at least 80% adherent to the drug regimen (PDC of at least 0.80) AND subsequently at least two self-administered tumor necrosis factor [TNF] inhibitors. CALCULATED BY WEA PHARMACY Yes No Will the patient be using (tocilizumab) alone or in combination with MTX or with other non-biologic DMARDs? Yes No Has the patient had an inadequate response to two preferred biologic therapies in the previous 180 days? (please indicate): Enbrel (etanercept) Humira (adalimumab) Remicade (infliximab) Simponi (golimumab)
Page 6 Systemic Juvenile Idiopathic Arthritis (SJIA): Yes No Does the patient have active Systemic Juvenile Idiopathic Arthritis (SJIA)? Yes No Has the patient failed to respond to, is intolerant of, or has a medical contraindication to one or more corticosteroids or non-steroidal anti-inflammatory drugs (NSAIDs)? Polyarticular Juvenile Idiopathic Arthritis (PJIA): Yes No Is the patient two years of age or older? Yes No Does the patient have active polyarticular juvenile idiopathic arthritis (PJIA)? Yes No Has the patient failed to respond to, is intolerant of, or has a medical contraindication to one or more non-biologic DMARDs (such as MTX)?
Page 7 Section III Physician Information Physician Name National Provider Identification (NPI) Number Clinic Name Address (Street, City, State, Zip Code) Physician Telephone Number Physician Fax Number Physician Signature Date Administering Physician/Facility NPI Section IV For WEA Trust Use Only Plan: Copay Tiers: Date of Receipt: Remarks: Approve Deny More information is needed Incomplete form Submission and review of this form does not guarantee approval of this request. Unless approved, payment of the brand-name medication will be limited to the amount the Trust would have paid for the generic equivalent. Insureds and providers will be informed of the decision in writing within approximately 30 days. Fax to: Pharmacy Services (608) 276-9119 Mail to: WEA Trust Pharmacy Services Prior Authorization P.O. Box 21538 Eagan MN 551221-5038