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Pharmacy Medical Necessity Guidelines Orencia® (abatacept)

Document ID#: Subject: Effective Date:

2099271 Orencia (abatacept) September 11, 2012

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

MED / RX

Type of Review - Case Management Type of Review ­ Clinical Review Administrative Process (Internal Use Only)

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

Overview

FDA-APPROVED INDICATIONS Orencia (abatacept) is a selective T cell costimulation modulator indicated for: Adult Rheumatoid Arthritis (RA)

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Reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Orencia may be used as monotherapy or concomitantly with diseasemodifying antirheumatic drugs (DMARDs) other than tumor necrosis factor (TNF) antagonists.

Juvenile Idiopathic Arthritis

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Reducing signs and symptoms in pediatric patients 6 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis. Orencia may be used as monotherapy or concomitantly with methotrexate (MTX).

Important Limitations of Use: Orencia should not be administered concomitantly with TNF antagonists. Orencia is not recommended for use concomitantly with other biologic rheumatoid arthritis (RA) therapy, such as anakinra.

Pharmacy Coverage Guidelines

Tufts Health Plan may authorize coverage of Orencia (abatacept) for Members, when the following criteria are met: 1. The Member has a documented diagnosis of rheumatoid arthritis or juvenile idiopathic arthritis. AND 2. The prescription is written by a rheumatologist. AND 3. For rheumatoid arthritis, the Member has a documented inadequate response or inability to tolerate ® ® ® at least one tumor necrosis factor antagonist: Cimzia (certolizumab), Enbrel (etanercept), Humira ® TM (adalimumab), Remicade (infliximab), Simponi (golimumab). OR

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For juvenile idiopathic arthritis, the Member has a documented inadequate response or inability to tolerate Enbrel (etanercept) or Humira (adalimumab). Dosing Guidelines Intravenous

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Dosage is based on weight. Following the initial administration, Orencia (abatacept) should be given at 2 and 4 weeks after the first infusion, then every 4 weeks thereafter. Orencia (abatacept) dosing in adults with rheumatoid arthritis: Body weight < 60 kg: 500 mg Body weight 60 to 100 kg: 750 mg Body weight > 100 kg: 1000 mg Orencia (abatacept) dosing in patients 6 to 17 years of age for juvenile idiopathic arthritis: Usual dosage: Dosage is based on weight. Following the initial administration, abatacept should be given at 2 and 4 weeks after the first infusion, then every 4 weeks thereafter. Body weight < 75 kg: 10 mg/kg IV calculated based on the patient's body weight at each administration. Body weight 75 kg: Administer Orencia (abatacept) following the adult IV dosing regimen. Maximum dose: Do not exceed a maximum dose of 1,000 mg IV.

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Subcutaneous Administration

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Following a single intravenous (IV) loading dose (as per body weight categories listed in the previous table), the first 125 mg subcutaneous injection of Orencia (abatacept) should be given within a day, followed by 125 mg subcutaneously once weekly. Patients who are unable to receive an infusion may initiate weekly injections of subcutaneous Orencia (abatacept) without an IV loading dose. Patients transitioning from Orencia (abatacept) IV therapy to subcutaneous administration should administer the first subcutaneous dose instead of the next scheduled IV dose.

Limitations

1. Orencia will not be approved if administered concomitantly with another tumor necrosis factor antagonist or Kineret (anakinra). 2. Coverage of Orencia prefilled syringe after an initial intravenous loading dose is limited to 28-day supplies as follows:

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Orencia 125 mg/mL prefilled syringe ­ 4 syringes per 28 days

Codes

The following HCPCS/CPT code(s) for Orencia apply only to the lyophilized powder (vials): Code J0129 Description Injection, abatacept, per 10 mg

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

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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 2012 August 23. 2. Genovese MC, Becker JC, Schiff M, et al. Abatacept for rheumatoid arthritis refractory to tumor necrosis factor alpha inhibition. N Engl J Med. 2005;353(11):1114-23. 3. Kaine J, Gladstein G, Strusberg I et al. Evaluation of abatacept administered subcutaneously in adults with active rheumatoid arthritis: impact of withdrawal and reintroduction on immunogenicity, efficacy and safety (phase Iiib ALLOW study). Ann Rheum Dis. 2012 Jan; 71(1):38-44. 4. Kremer JM, Genant HK, Moreland LW et al. Effects of abatacept in patients with methotrexateresistant active rheumatoid arthritis: a randomized trial. Ann Intern Med. 2006 Jun 20;144(12):865-76. 5. Kremer JM, Russell AS, Emery P et al. Long-term safety, efficacy and inhibition of radiographic progression with abatacept treatment in patients with rheumatoid arthritis and an inadequate response to methotrexate: 3-year results from the AIM trial. Ann Rheum Dis. 2011 Oct; 70(10):182630. 6. McEvoy GK, ed. AHFS 2012 Drug Information. Bethesda, MD: American Society of Health-Systems Pharmacists, Inc. 2012. 7. Orencia (abatacept) [package insert]. Princeton, NJ: Bristol-Myers Squibb; December 2011. 8. Ruperto N, Lovell DJ, Quartier P et al. Abatacept in children with juvenile idiopathic arthritis: a randomised, double-blind, placebo-controlled withdrawal trial. Lancet. 2008 Aug 2;372(9636):383-91. 9. Saag KG, Teng GG, Patkar NM, et al. American College of Rheumatology 2008 Recommendations for the Use of Nonbiologic and Biologic Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis. Arthritis Rheum 2008 Jun 15; 59(6):762-84. 10. Schiff M, Pritchard C, Huffstutter JE et al. The 6-month safety and efficacy of abatacept in patients with rheumatoid arthritis who underwent a washout after anti-tumour necrosis factor therapy or were directly switched to abatacept: the ARRIVE trial. Ann Rheum Dis. 2009 Nov;68(11):1708-14. 11. 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 & Research. Vol. 64, No. 5, May 2012, pp 625­639. 12. 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. 13. Wells AF, Westhovens R, Reed DM et al. Abatacept plus methotrexate provides incremental clinical benefits versus methotrexate alone in methotrexate-naive patients with early rheumatoid arthritis who achieve radiographic nonprogression. J Rheumatol. 2011 Nov;38(11):2362-8.

Approval History

Reviewed by the Pharmacy and Therapeutics Committee on May 9, 2006. Subsequent Endorsement Date(s) and Changes Made: 1. March 13, 2007: No Changes. 2. March 4, 2008: No Changes. 3. July 8, 2008: Added new indication of juvenile idiopathic arthritis to criteria #1 and #3. Criteria within #3 are specific with respect to diagnosis of rheumatoid arthritis or juvenile idiopathic arthritis. 4. July 14, 2009: No changes. 5. January 1, 2010:

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Removal of Tufts Medicare Preferred language (separate criteria have been created specifically for Tufts Medicare Preferred).

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6. July 13, 2010:

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Added Cimzia (certolizumab) and Simponi (golimumab) to prerequisite options for rheumatoid arthritis.

· Added Enbrel (etanercept) to prerequisite options for juvenile idiopathic arthritis. 7. July 12, 2011: No changes. 8. November 15, 2011: · · ·

Added note that medical billing codes may not be used for Orencia prefilled syringe. formulation must be obtained via the Member's pharmacy benefit. Added dosing guidelines for intravenous and subcutaneous administration. This

Added quantity limitation for Orencia prefilled syringe. 9. September 11, 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. For Tufts Medicare Preferred, please refer to Tufts 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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