Clinical Policy: Certolizumab (Cimzia) Reference Number: ERX.SPA.167 Effective Date:

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1 Clinical Policy: (Cimzia) Reference Number: ERX.SPA.167 Effective Date: Last Review Date: Revision Log See Important Reminder at the end of this policy for important regulatory and legal information. Description (Cimzia ) is a tumor necrosis factor (TNF) blocker. FDA Approved Indication(s) Cimzia is indicated for: 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 Treatment of adults with moderately to severely active rheumatoid arthritis () Treatment of adult patients with active psoriatic arthritis (PsA) Treatment of adults with active ankylosing spondylitis (AS) Policy/Criteria Provider must submit documentation (which may include office chart notes and lab results) supporting that member has met all approval criteria It is the policy of health plans affiliated with Envolve Pharmacy Solutions that Cimzia is medically necessary when the following criteria are met: I. Initial Approval Criteria A. Crohn s Disease (must meet all): 1. Diagnosis of moderate-to-severe ; 2. Prescribed by or in consultation with a gastroenterologist; 4. Failure of a trial of a thiopurine (6-mercaptopurine or azathiopurine) or methotrexate (MTX) used for 3 months, unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of a trial of adalimumab (Humira is preferred) for 3 consecutive months unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization is required for adalimumab 4. Dose does not exceed 400 mg SC at weeks 0, 2, and 4, followed by maintenance dose of 400 mg SC every 4 weeks. B. Rheumatoid Arthritis (must meet all): 1. Diagnosis of ; 2. Prescribed by or in consultation with a rheumatologist; 4. Member meets one of the following (a or b): a. Failure of a trial of MTX (at up to maximally indicated doses) used for 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; b. If intolerance or contraindication to MTX, failure of a trial of sulfasalazine or 1 other conventional DMARD (at up to maximally indicated doses) used for 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced (see Appendix C); 5. Failure of etanercept (Enbrel is preferred) AND adalimumab (Humira is preferred), each trialed for 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; Page 1 of 7

2 *Prior authorization is required for etanercept and adalimumab 6. Dose does not exceed 400 mg subcutaneously at weeks 0, 2, and 4, followed by maintenance dose of 400 mg every 4 weeks. C. Psoriatic Arthritis (must meet all): 1. Diagnosis of active PsA; 2. Prescribed by or in consultation with a dermatologist or rheumatologist; 4. Member meets one of the following (a or b): a. Failure of a trial of MTX f or 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; b. If MTX is contraindicated, failure of a trial of leflunomide, sulfasalazine, or cyclosporine or 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of etanercept (Enbrel is preferred) AND adalimumab (Humira is preferred), each trialed for 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization is required for etanercept and adalimumab 6. Dose does not exceed 400 mg subcutaneously at weeks 0, 2, and 4, followed by maintenance dose of 400 mg every 4 weeks. D. Ankylosing Spondylitis (must meet all): 1. Diagnosis of active AS; 2. Prescribed by or in consultation with a rheumatologist; 4. Failure of at least two non-steroidal anti-inflammatory drugs (NSAIDs), each tried for at least 1 month at maximal recommended or tolerated anti-inflammatory doses, unless contraindicated or clinically significant adverse effects are experienced; 5. Failure of etanercept (Enbrel is preferred) AND adalimumab (Humira is preferred), each trialed for 3 consecutive months, unless contraindicated or clinically significant adverse effects are experienced; *Prior authorization is required for etanercept and adalimumab 6. Dose does not exceed 400 mg subcutaneously at weeks 0, 2, and 4, followed by maintenance dose of 400 mg every 4 weeks. E. Other diagnoses/indications 1. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). II. Continued Therapy A. All Indications in Section I (must meet all): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions or member has previously met initial approval criteria; 2. Member responding positively to therapy (e.g., labs, sign/symptom reduction, no significant toxicity); 3. If request is for a dose increase, new dose does not exceed 400 mg every 4 weeks. Approval duration: 12 months B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via a health plan affiliated with Envolve Pharmacy Solutions and documentation supports positive response to therapy. Approval duration: Duration of request or 6 months (whichever is less); or Page 2 of 7

3 2. Refer to ERX.PA.01 if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized). III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off-label use policy ERX.PA.01 or evidence of coverage documents. IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key AS: ankylosing spondylitis DMARD: disease modifying antirheumatic drug FDA: Food and Drug Administration MTX: methotrexate NSAID: non-steroidal anti-inflammatory drug PsA: psoriatic arthritis : rheumatoid arthritis Appendix B: 2010 ACR Classification Criteria for Classification criteria for (score-based algorithm: add score of categories A through D; a score of 6 out of 10 is needed for classification of a patient as having definite ) A B C D Score Joint involvement 1 large joint large joints small joints (with or without involvement of large joints) small joints (with or without involvement of large joints) 3 > 10 joints (at least one small joint) 5 Serology (at least one test result is needed for classification) Negative rheumatoid factor (RF) and negative anti-citrullinated protein antibody 0 (ACPA) Low positive RF or low positive ACPA 2 High positive RF or high positive ACPA 3 Acute phase reactants (at least one test result is needed for classification) Normal C-reactive protein (CRP) and normal erythrocyte sedimentation rate (ESR) 0 Abnormal CRP or normal ESR 1 Duration of symptoms < 6 weeks 0 6 weeks 1 Appendix C: Therapeutic Alternatives Drug Name Dosing Regimen Dose Limit/ azathioprine (Imuran ) 1 mg/kg/day PO given as a QD or BID Maximum Dose 2.5 mg/kg/day PO corticosteroids cyclosporine (Sandimmune Neoral ) mg PO daily Prednisone 40 mg PO QD for 2 weeks or IV mg Q6H for 1 week budesonide (Entocort EC ) 6-9 mg PO QD mg/kg/day PO divided BID PsA mg/kg/day N/A 4 mg/kg/day Page 3 of 7

4 Drug Name Dosing Regimen Dose Limit/ Maximum Dose hydroxychloroquine (Plaquenil ) mercaptopurine (Purinethol ) methotrexate (Rheumatrex ) Initial dose: mg PO QD Maintenance dose: mg PO QD mg PO daily 7.5 mg/week PO or 2.5 mg PO Q12hr for 3 doses/week 600 mg/day (465 mg base/day) or 6.5 mg/kg/day (5 mg base/kg/day), whichever is lower 5 mg/kg/day For : 20 mg/week For PsA: 30 mg/week Pentasa (mesalamine) sulfasalazine (Azulfidine ) NSAIDs (indomethacin, ibuprofen, naproxen, celecoxib, meclofenate, etc.) adalimumab (Humira, Amjevita )* etanercept (Enbrel, Erelzi )* PsA mg/week PO 1000 mg PO QID 2 gm/day PO in divided doses PsA 2,000 mg/day PO AS varies Initial dose (Day 1): 160 mg SC Second dose two weeks later (Day 15): 80 mg SC Two weeks later (Day 29): Begin a maintenance dose of 40 mg SC every other week AS, PsA 40 mg SC every other week 40 mg SC every other week If not on concomitant methotrexate, may benefit from increasing the dosing frequency to 40 mg SC every week PsA, 50 mg SC once weekly 4 g/day For : 3 g/day For PsA: 5 g/day varies For AS,, PsA: 40 mg SC every other week For : 40 mg SC every week 50 mg once weekly AS 50 mg SC once weekly Therapeutic alternatives are listed as Brand name (generic) when the drug is available by brand name only and generic (Brand name ) when the drug is available by both brand and generic. *Requires PA V. Dosage and Administration Indication Dosing Regimen Maximum Dose Page 4 of 7

5 PsA,, AS 400 mg SC at 0, 2, and 4 weeks, then 400 mg every 4 weeks thereafter 400 mg SC at 0, 2, and 4 weeks, then 200 mg every other week Alternative maintenance dosing: 400 mg SC every 4 weeks 400 mg every 4 weeks 200 mg every other week or 400 mg every 4 weeks VI. Product Availability For injection: 200 mg lyophilized powder for reconstitution in a single-use vial, with 1 ml of sterile water for injection Injection: 200 mg/ml solution in a single-use prefilled syringe VII. References 1. Cimzia Prescribing Information. Smyrna, GA: UCB, Inc.; January Available at Accessed October 2, Lichtenstein GR, Hanauer SB, Sandborn WJ, and the Practice Parameters Committee of the American College of Gastroenterology. Management of Crohn s disease in adults. Am J Gastroenterol. 2009;104(2): Smolen JS, Landewé R, Breedveld FC, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2013 update. Ann Rheum Dis. 2014; 73: 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 the treatment of rheumatoid arthritis. Arthritis Care Res. 2012; 64(5): Menter A, Korman NJ, Elmets CA, et al. Guidelines of care for the management of psoriasis and psoriatic arthritis. Section 6: Guidelines of care for the treatment of psoriasis and psoriatic arthritis: case-based presentations and evidence-based conclusions. J Am Acad Dermatol. 2011;65(1): Menter A, Gottlieb A, Feldman SR, et al. Guidelines for the management of psoriasis and psoriatic arthritis. Section 1: Overview of psoriasis and guidelines of care for the treatment of psoriasis with biologics. J Am Acad Dermatol. 2008;58(5): Ward MM, et al. American College of Rheumatology/Spondylitis Association of America/Spondyloarthritis Research and Treatment Network 2015 recommendations for the treatment of ankylosing spondylitis and nonradiographic axial spondyloarthritis. Arthritis & Rheumatology, DOI /ART Braun J, van den berg R, et al Update of the ASAS/EULAR recommendations for the management of ankylosing spondylitis. Am Rheu Dis. 2011: 70; Sandborn WJ. Crohn s Disease Evaluation and Treatment: Clinical Decision Tool. Gastroenterology 2014; 147: Singh JA. Saag KG, Bridges SL, et al American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care and Research. 2015; DOI /acr Reviews, Revisions, and Approvals Date P&T Approval Date Policy split from USS.SPMN.24 Irritable Bowel Disease (IBD) Treatments, USS.SPMN.41 Psoriasis Treatments, and USS.SPMN.44 Rheumatoid Arthritis and Ankylosing Spondylitis Treatments. Converted to new template. Removed all safety criteria. Added dosing criteria per PI. Added requirement for trial and failure of PDL Enbrel and Humira, unless contraindicated (just Humira for ). -: removed aminosalicylate as an option for initial therapy per 2013 Gastro Clinical Decision Tool. -: added age requirement per PI; modified criteria to require trial of methotrexate, unless contraindicated; added Page 5 of 7

6 Reviews, Revisions, and Approvals Date P&T Approval Date sulfasalazine and hydroxychloroquine as an alternative to methotrexate if methotrexate is contraindicated. -AS: removed question about axial vs peripheral disease; removed requirement for trial of methotrexate or sulfasalazine. For all trial/failure requirements, indicated that member can also meet criteria if intolerant (as opposed to just contraindicated) to therapy in question. Modified the following initial criteria sets: -: indicated that disease must be moderately to severely active. -PsA: modified trial/failure requirement- instead of requiring 2 or more nonbiologic DMARDs (such as cyclosporine, sulfasalazine, azathioprine, hydoxychloroquine), criteria now requires MTX. If MTX is contraindicated, then cyclosporine, sulfasalazine, leflunomide, cyclosporine, or azathioprine may be trialed. -: removed option for trial/failure of corticosteroid 4Q17 Annual Review Converted to new template. Aligned diagnostic criteria per 3Q17 TCRs: -All indications: removed requirement of additional biologic; Specified trial of conventional and biologic DMARDs for 3 months or greater; -: modified diagnostic criteria from requirement of poor prognostic factors to appropriate diagnosis only from specialist, removed active verbiage; -PsA: listed alternatives for those not a candidate for MTX (leflunomide, sulfasalazine, or cyclosporine); -: added age requirement; removed requirement for submission of diagnostic lab since a specialist is required to prescribe or be consulted Removed UpToDate references Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. This Clinical Policy is not intended to dictate to providers how to practice medicine, nor does it constitute a contract or guarantee regarding payment or results. Providers are expected to exercise professional medical judgment in providing the most appropriate care, and are solely responsible for the medical advice and treatment of members. This policy is the property of Envolve Pharmacy Solutions. Unauthorized copying, use, and distribution of this Policy or any information contained herein is strictly prohibited. By accessing this policy, you agree to be bound by the foregoing terms and conditions, in addition to the Site Use Agreement for Health Plans associated with Envolve Pharmacy Solutions Envolve Pharmacy Solutions. All rights reserved. All materials are exclusively owned by Envolve Pharmacy Solutions and are protected by United States copyright law and international copyright law. No part of this publication may be reproduced, copied, modified, distributed, displayed, stored in a retrieval Page 6 of 7

7 system, transmitted in any form or by any means, or otherwise published without the prior written permission of Envolve Pharmacy Solutions. You may not alter or remove any trademark, copyright or other notice contained herein. Page 7 of 7