Pharmacy Medical Necessity Guidelines: Cimzia (certolizumab pegol) Effective: January 1, 2018 Prior Authorization Required Type of Review Care Management Not Covered Type of Review Clinical Review Pharmacy (RX) or Medical (MED) Benefit RX Department to Review RXUM This Pharmacy Medical Necessity Guideline applies to the following: Fax Numbers: Tufts Health Plan Commercial Plans Tufts Health Plan Commercial Plans large group plans Tufts Health Plan Commercial Plans small group and individual plans Tufts Health Public Plans RXUM: 617-673-0988 Tufts Health Direct Health Connector Tufts Health Together A MassHealth Plan Tufts Health RITogether A RIte Care + Rhody Health Partners Plan Tufts Health Freedom Plan products Tufts Health Freedom Plan - large group plans Tufts Health Freedom Plan - small group plans OVERVIEW FDA-APPROVED INDICATIONS Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated for: Ankylosing Spondylitis Treatment of adults with active ankylosing spondylitis (AS). Crohn s Disease Reducing signs and symptoms of Crohn s disease and maintaining clinical response in adult patients with moderately to severely active disease who have had an inadequate response to conventional therapy. Psoriatic Arthritis Treatment of adult patients with active psoriatic arthritis (PsA). Rheumatoid Arthritis Treatment of adults with moderately to severely active rheumatoid arthritis. COVERAGE GUIDELINES The plan may authorize coverage of Cimzia (certolizumab pegol) for members when all of the following criteria for a particular regimen are met and limitations do not apply: Ankylosing Spondylitis 1. The Member has a documented diagnosis of active ankylosing spondylitis 2. The prescription is written by a rheumatologist 3. The Member is 18 years of age or older 4. The Member has tried and failed treatment with, or the patient has a contraindication to at least one NSAID 5. Failure or intolerance to adalimumab (Humira ) and etanercept (Enbrel ) 6. Documentation of the following: b. Documentation the Member has been previously hospitalized for ankylosing spondylitis 2324478 1 Pharmacy Medical Necessity Guidelines:
Crohn s Disease 1. The Member has a documented diagnosis of Crohn s disease by a gastroenterologist 2. The Member is 18 years of age or older 3. The Member has demonstrated an inadequate response to an appropriate trial with two or more of the following agents: Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone) 5-Aminosalicylates (e.g., sulfasalazine, Azulfidine, Apriso, Delzicol, Pentasa, Rowasa, Dipentum, Colazal ) 6-mercaptopurine (6-MP, Purinethol ) and/or azathioprine (Imuran ) Methotrexate (MTX) 4. Failure or intolerance to adalimumab (Humira ) 5. Documentation of the following: b. Documentation the Member has been previously hospitalized for Crohn s disease Psoriatic Arthritis 1. The Member has a documented diagnosis of psoriatic arthritis 2. The prescription is written by a rheumatologist 3. The Member is 18 years of age or older 4. The Member has a documented inadequate response or inability to take methotrexate sulfasalazine at maximal doses for three months. 5. Failure or intolerance to adalimumab (Humira ) and etanercept (Enbrel ) 6. Documentation of the following: b. Documentation the Member has been previously hospitalized for psoriatic arthritis Note: Maximal doses of methotrexate are defined as 15mg to 25mg per week depending on the patient s tolerance. Rheumatoid Arthritis 1. The Member has a documented diagnosis of rheumatoid arthritis by a rheumatologist 2. The Member is 18 years of age or older 3. The Member tried and failed treatment with, or has a contraindication to at least one DMARD (Disease Modifying Anti-rheumatic Drugs), such as azathioprine, gold therapy, hydroxychloroquine, methotrexate, penicillamine, sulfasalazine, cyclosporine or leflunomide 4. Failure or intolerance to adalimumab (Humira ) and etanercept (Enbrel ) 5. Documentation of the following: b. Documentation the Member has been previously hospitalized for rheumatoid arthritis Note: Maximal doses of methotrexate are defined as 15mg to 25mg per week depending on the patient s tolerance. LIMITATIONS 1. Samples, free goods or similar offerings of Cimzia (certolizumab) do not qualify for an established clinical response and will not be considered for prior authorization. 2324478 2 Pharmacy Medical Necessity Guidelines:
2. Members new to the plan and stable on Cimzia (certolizumab) are not required to provide documentation of prerequisite trials with conventional (i.e., non-biologic) therapies (e.g., hydroxychloroquine, methotrexate, sulfasalazine). 3. Initial approval of Cimzia (certolizumab pegol) will be limited to 12 months. Subsequent authorizations may be approved in 12 month intervals when the provider indicates improvement with therapy. 4. Coverage of Cimzia prefilled syringe is limited to 28-day supplies as follows: Cimzia 200 mg syringe 6 syringes per 28 days (initial 4 weeks) then 2 syringes per 28 days thereafter. CODES Medical billing codes may not be used for this medication. This medication must be obtained via the Member s pharmacy benefit. REFERENCES 1. Agency for Healthcare Research and Quality. Choosing Medications for Rheumatoid Arthritis. Available at effectivehealthcare.ahrq.gov/ehc/products/14/85/rheumarthritisclinicianguide.pdf. Accessed August 26, 2011. 2. Bonafede M, Joseph GJ, Princic N, Harrison DJ. Annual acquisition and administration cost of biologic response modifiers per patient with rheumatoid arthritis, psoriasis, psoriatic arthritis, or ankylosing spondylitis. J Med Econ. 2013 Sep; 16(9):1120-8. 3. Choy E, McKenna F, Vencovsky J, et al. Certolizumab pegol plus MTX administered every 4 weeks is effective in patients with RA who are partial responders to MTX. Rheumatology (Oxford). 2012 Jul; 51(7):1226-34. 4. Cimzia (certolizumab pegol) [package insert]. Smyrna, GA: UCB, Inc.; April 2016. 5. Clark M, Colombel JF, Feagan BC, et al. American Gastroenterological Association Consensus Development Conference on the Use of Biologics in the Treatment of Inflammatory Bowel Disease, June 21-23, 2006. Gastroenterology. Jul 2007; 133(1):312-339. 6. Da W, Zhu J, Wang L, Lu Y. Efficacy and safety of certolizumab pegol for Crohn's disease: a systematic review and meta-analysis. Adv Ther. 2013 May; 30(5):541-53. 7. Enbrel prescribing information. Thousand Oaks, CA: Amgen Inc. and Pfizer Inc.; 2015 March. 8. Food and Drug Administration. FDA Approves Cimzia to Treat Crohn s Disease. URL: fda.gov/bbs/topics/news/2008/new01821.html. Available from Internet. Accessed August 12, 2008. 9. Humira prescribing information. North Chicago, IL: AbbVie Inc.; 2016 June. 10. Keystone EC, Combe B, Smolen J, et al. Sustained efficacy of certolizumab pegol added to methotrexate in the treatment of rheumatoid arthritis: 2-year results from the RAPID 1 trial. Rheumatology (Oxford). 2012 Sep; 51(9):1628-38. 11. Keystone E, Landewé R, van Vollenhoven R, et al. Long-term safety and efficacy of certolizumab pegol in combination with methotrexate in the treatment of rheumatoid arthritis: 5-year results from the RAPID 1 trial and open-label extension. Ann Rheum Dis. 2013 Aug 5. 12. Landewé R, Braun J, Deodhar A, et al. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloarthritis including ankylosing spondylitis: 24-week results of a double-blind randomised placebo-controlled Phase 3 study. Ann Rheum Dis. 2013 Sep 6. 13. Machado MA, Barbosa MM, Almeida AM, et al. Treatment of ankylosing spondylitis with TNF blockers: a meta-analysis. Rheumatol Int. 2013 Sep; 33(9):2199-213. 14. Mease PJ, Fleischmann R, Deodhar AA, et al. Effect of certolizumab pegol on signs and symptoms in patients with psoriatic arthritis: 24-week results of a Phase 3 double-blind randomised placebocontrolled study (RAPID-PsA). Ann Rheum Dis. 2013 Aug 28. 15. Saag KG, Teng GG, Patkar NM, Anuntiyo J, Finney C, Curtis JR. American College of Rheumatology 2008 recommendations for the use of nonbiologic and biologic disease-modifying antirheumatic drugs in rheumatoid arthritis. Arthritis Rheum. Jun 15 2008; 59(6):762-84. 16. Sandborn WJ, Feagan BG, Stoinov S, et al. Certolizumab pegol for the treatment of Crohn's disease. N Engl J Med. Jul 19 2007; 357(3):228-238. 17. Sandborn WJ, Schreiber S, Feagan BG, et al. Certolizumab pegol for active Crohn's disease: a placebo-controlled, randomized trial. Clin Gastroenterol Hepatol. 2011 Aug; 9(8):670-678. 18. Schreiber S, Khaliq-Kareemi M, Lawrance IC, et al. Maintenance therapy with certolizumab pegol for Crohn's disease. N Engl J Med. Jul 19 2007; 357(3):239-250. 19. Schreiber S, Rutgeerts P, Fedorak RN, et al. A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease. Gastroenterology. Sep 2005; 129(3):807-818. 20. Singh JA, Furst DE, Bharat A et al. Update of the 2008 American College of Rheumatology Recommendations for the Use of Disease-Modifying Antirheumatic Drugs and Biologic Agents in 2324478 3 Pharmacy Medical Necessity Guidelines:
the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. Vol. 64, No. 5, May 2012, pp 625 639. 21. Singh JA, Saag KG, Bridges SL Jr, et al. 2015 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthritis Rheumatol. 2016 Jan;68(1):1-26. 22. Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs. Ann Rheum Dis 2010; 69: 964 75. 23. Tosh JC, Wailoo AJ, Scott DL, Deighton CM. Cost-effectiveness of combination nonbiologic diseasemodifying antirheumatic drug strategies in patients with early rheumatoid arthritis. J Rheumatol. Aug 2011; 38(8):1593-600. 24. Vavricka SR, Schoepfer AM, Bansky G, et al. Efficacy and safety of certolizumab pegol in an unselected crohn's disease population: 26-week data of the FACTS II survey. Inflamm Bowel Dis. 2011 Jul; 17(7):1530-9. 25. Weinblatt ME, Fleischmann R, Huizinga TW, et al. Efficacy and safety of certolizumab pegol in a broad population of patients with active rheumatoid arthritis: results from the REALISTIC phase IIIb study. Rheumatology (Oxford). 2012 Dec; 51(12):2204-14. APPROVAL HISTY June 2009: Reviewed by Pharmacy & Therapeutics Committee. Subsequent endorsement date(s) and changes made: December 2, 2014: Reviewed by the Pharmacy and Therapeutics Committee. September 16, 2015: No changes January 1, 2016: Administrative change to rebranded template. September 13, 2016: Added exception language for Members new to the plan and stable on Cimzia prior to enrollment. November 18, 2016: Administrative update; clarified for the diagnosis of Crohn s disease that member must have tried and failed a nonbiologic DMARD and adalimumab (Humira). April 11, 2017: Administrative update, Adding Tufts Health RITogether to the template. July 11, 2017: Administrative update to add the following Limitation: Samples, free goods or similar offerings of Cimzia (certolizumab) do not qualify for an established clinical response and will not be considered for prior authorization. December 12, 2017: Effective January 1, 2018 updated the criteria allowing members new to the plan stable on Cimzia (certolizumab) to also require documentation of previous hospitalization for the requested indication due to new state requirements. Added the following limitation: Members new to the plan and stable on Cimzia (certolizumab) are not required to provide documentation of prerequisite trials with conventional (i.e., non-biologic) therapies (e.g., hydroxychloroquine, methotrexate, NSAID). BACKGROUND, PRODUCT DISCLAIMER INFMATION Pharmacy Medical Necessity Guidelines have been developed for determining coverage for plan benefits and are published to provide a better understanding of the basis upon which coverage decisions are made. They are used in conjunction with a Member s benefit document and in coordination with the Member s physician(s). The plan makes coverage decisions on a case-by-case basis considering the individual Member s health care needs. Pharmacy Medical Necessity Guidelines are developed for selected therapeutic classes or drugs found to be safe, but proven to be effective in a limited, defined population of patients or clinical circumstances. They include concise clinical coverage criteria based on current literature review, consultation with practicing physicians in the service area who are medical experts in the particular field, FDA and other government agency policies, and standards adopted by national accreditation organizations. The plan revises and updates Pharmacy Medical Necessity Guidelines annually, or more frequently if new evidence becomes available that suggests needed revisions. This Pharmacy Medical Necessity Guideline does not apply to Uniformed Services Family Health Plan Members or to certain delegated service arrangements. Unless otherwise noted in the Member s benefit document or applicable Pharmacy Medical Necessity Guideline, Pharmacy Medical Necessity Guidelines do not apply to CareLink SM Members. For self-insured plans, drug coverage may vary depending on the terms of the benefit document. If a discrepancy exists between a coverage guideline and a self-insured Member s benefit document, the provisions of the benefit document will govern. Applicable state or federal mandates will take precedence. For Tufts Health Plan Medicare Preferred Members, please refer to the Tufts Health Plan Medicare Preferred Prior Authorization Criteria. 2324478 4 Pharmacy Medical Necessity Guidelines:
Treating providers are solely responsible for the medical advice and treatment of Members. The use of this policy is not a guarantee of payment or a final prediction of how specific claim(s) will be adjudicated. Claims payment is subject to Member eligibility and benefits on the date of service, coordination of benefits, referral/authorization and utilization management guidelines when applicable, and adherence to plan policies and procedures and claims editing logic. Provider Services 2324478 5 Pharmacy Medical Necessity Guidelines: