Subject: Specialty Quantity Limit Orencia 1977-H P2023
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If member’s plan allows a quantity limit exception review for the requested medication, coverage of an additional quantity may be provided up to the exception limit with prior authorization.
II. COVERED QUANTITIES
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Medication
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Standard Limit
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Exception Limit*
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FDA-recommended dosing
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Orencia (abatacept) subcutaneous injection: 50 mg per 0.4 mL syringe
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4 syringes per 28 days
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N/A
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• RA and PsA (adult): 125 mg once weekly (for RA only: optional loading dose as a single IV infusion as per body weight categories for RA listed below) • PJIA and PsA (2 years of age and older) º Weight 10 kg to < 25 kg: 50 mg once weekly º Weight 25 kg to < 50 kg: 87.5 mg once weekly º Weight ≥ 50 kg: 125 mg once weekly
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Orencia (abatacept) subcutaneous injection: 87.5 mg per 0.7 mL syringe
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4 syringes per 28 days
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N/A
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Orencia (abatacept) subcutaneous injection: 125 mg per mL syringe/autoinjector
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4 syringes per 28 days
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N/A
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Orencia (abatacept) intravenous: 250 mg single-use vial
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4 vials every 28 days
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16 vials per 28 days
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• RA and PsA (adult) at week 0, 2, and 4, then every 4 weeks º Weight < 60 kg: 500 mg º Weight 60 kg to 100 kg: 750 mg º Weight > 100 kg: 1000 mg
• PJIA (6 years of age and older) at week 0, 2, and 4 then every 4 weeks º Weight < 75 kg: 10 mg per kg º Weight ≥ 75 kg: following the RA/PsA dosing above
• Prophylaxis of aGVHD º 2 years to less than 6 years of age: 15 mg/kg on the day before transplantation (Day -1), followed by 12 mg/kg on Days 5, 14, and 28 after transplantation º 6 years of age and older: 10 mg/kg (max 1000 mg) on the day before transplantation (Day -1), followed by administration on Days 5, 14, and 28 after transplantation
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Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; PJIA = polyarticular juvenile idiopathic arthritis; aGVHD = acute graft versus host
disease; IV = intravenous
*Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity
Exception Criteria for approval.
Place of Service:
Outpatient
The above policy is based on the following references:
- Orencia [package insert]. Princeton, NJ: Bristol-Myers Squibb Co.; October 2023.
Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
December 09, 2023