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Pharmacy Medical Necessity Guidelines Cimzia® (certolizumab pegol)

Document ID#: Subject: Effective Date:

2126739 Cimzia (certolizumab pegol) October 09, 2012

MED/ RX Type of Review - Case Management Type of Review ­ Clinical Review Administrative Process (Internal Use Only) RN

Clinical Documentation and Prior Authorization Required Not Covered Pharmacy (RX) or Medical (MED) Benefit

Note: This pharmacy medical necessity guideline applies to commercial products. For Tufts Health Plan Medicare Preferred members, please refer to the Tufts Health Plan Medicare Preferred Prior Authorization Criteria. Background, applicable product and disclaimer information can be found on the last page.

Overview

FDA-APPROVED INDICATIONS Cimzia (certolizumab pegol) is a tumor necrosis factor (TNF) blocker indicated for: 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. Rheumatoid Arthritis Treatment of adults with moderately to severely active rheumatoid arthritis.

Pharmacy Coverage Guidelines

Tufts Health Plan may authorize coverage of Cimzia (certolizumab pegol) for Members, when all of the following criteria are met: For Crohn's Disease 1. The Member has a documented diagnosis of Crohn's disease by a gastroenterologist AND 2. The Member has demonstrated an inadequate response to an appropriate trial with two or more of the following agents:

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Corticosteroids (e.g., prednisone, prednisolone, methylprednisolone)

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5-Aminosalicylates (e.g., sulfasalazine, Azulfidine , Apriso , Asacol , Pentasa , Rowasa , Dipentum , Colazal )

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TM

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6-mercaptopurine (6-MP, Purinethol ) and/or azathioprine (Imuran ) Methotrexate (MTX)

OR ® 3. Failure or intolerance to infliximab (Remicade )

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For Rheumatoid Arthritis 1. The Member has a documented diagnosis of Rheumatoid Arthritis by a rheumatologist AND 2. The Member must have an inadequate response to methotrexate after three months at optimal doses or an inability to take methotrexate. Note: Maximal doses of methotrexate are defined as 15mg to 25mg per week depending on the patient's tolerance.

Limitations

1. 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

The following HCPCS/CPT code(s) for Cimzia apply only to the lyophilized powder (vials): Code J0718 Description Injection, certolizumab pegol, 1 mg

Note: Medical billing codes may not be used for Cimzia prefilled syringe. This formulation must be obtained via the Member's pharmacy benefit.

References

1. Agency for Healthcare Research and Quality. Choosing Medications for Rheumatoid Arthritis. Available at http://effectivehealthcare.ahrq.gov/ehc/products/14/85/RheumArthritisClinicianGuide.pdf. Accessed August 26, 2011. 2. Cimzia (certolizumab pegol) [package insert]. Smyrna, GA: UCB, Inc.; April 2012. 3. 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. 4. Food and Drug Administration. FDA Approves Cimzia to Treat Crohn's Disease. URL: http://www.fda.gov/bbs/topics/NEWS/2008/NEW01821.html. Available from Internet. Accessed August 12, 2008. 5. 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. 6. 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. 7. 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. 8. 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. 9. 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. 10. 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.

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Approval History

Reviewed by the Pharmacy and Therapeutics Committee on September 9, 2008. Subsequent Endorsement Date(s) and Changes Made: 1. November 10, 2009:

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Added note to refer to Pharmacy Medical Necessity Guidelines for Rheumatoid Arthritis ­ Injectable Drugs for the diagnosis of Rheumatoid Arthritis. Added dispensing limitation for Cimzia prefilled syringes.

Added medical billing code for Cimzia lyophilized powder (vials). 2. January 1, 2010: Removal of Tufts Medicare Preferred language (separate criteria have been created specifically for Tufts Medicare Preferred). 3. February 16, 2010: Administrative Update: Removed temporary code C9249 and replaced with J0718. 4. November 9, 2010: Added Apriso to examples of 5-aminosalicylates. 5. November 15, 2011: Added coverage criteria for rheumatoid arthritis (previously included on the Medical Necessity Guideline for Rheumatoid Arthritis ­ Injectable Drugs originating in August 2002, Document ID# 1035134). 6. October 9, 2012: No changes.

Background, Product and Disclaimer Information

Pharmacy Medical Necessity Guidelines have been developed for determining coverage for Tufts Health 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). Tufts Health 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 Tufts Health Plan service area who are medical experts in the particular field, FDA and other government agency policies, and standards adopted by national accreditation organizations. Tufts Health Plan revises and updates Pharmacy Medical Necessity Guidelines annually, or more frequently if new evidence becomes available that suggests needed revisions. Pharmacy Medical Necessity Guidelines apply to all fully insured Tufts Health Plan offerings unless otherwise noted in this policy or the Member's benefit document. Check the applicable formulary in the Pharmacy section of our Web site at http://www.tuftshealthplan.com/providers to determine if the drug requires you to get prior authorization. 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, SM Pharmacy Medical Necessity Guidelines do not apply to CareLink 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.

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For Tufts Health Plan Medicare Preferred, please refer to Tufts Health Plan Medicare Preferred Prior Authorization Criteria. 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.

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