Subject: Specialty Quantity Limit Actemra 1736-H P2022a
Policy:
I. PROGRAM DESCRIPTION
The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. The recommended dosing parameters for all FDA-approved indications fall within the standard limits. Coverage of an additional quantity may be reviewed on a case-by-case basis upon request.
II. COVERED QUANTITIES
|
Medication
|
Standard Limit
|
FDA-recommended dosing
|
|
Actemra (tocilizumab) 162 mg per 0.9 mL prefilled syringe for subcutaneous injection
|
4 syringes per 28 days
|
• RA (adult), weight < 100 kg: 162 mg every other
week, followed by an increase to every week based on
clinical response
• RA (adult), weight ≥ 100 kg: 162 mg every week
• PJIA, weight < 30 kg: 162 mg every 3 weeks
• PJIA, weight ≥ 30 kg: 162 mg every 2 weeks
• SJIA, weight < 30 kg: 162 mg every 2 weeks
• SJIA, weight ≥ 30 kg: 162 mg every week
• Giant cell arteritis: 162 mg every week
(can be given every other week based on clinical
considerations)
• SSc-ILD: 162 mg every week
|
|
Actemra (tocilizumab) 162 mg per 0.9 mL ACTPen autoinjector for subcutaneous injection
|
4 autoinjectors per 28 days
|
|
Actemra (tocilizumab) 80 mg per 4 mL single-use vial
|
40 mL (10 vials) per 14 days
|
• RA (adult): 4 mg per kg every 4 weeks followed by
an increase to 8 mg per kg every 4 weeks based on
clinical response, up to 800 mg per infusion
• PJIA, weight < 30 kg: 10 mg per kg every 4 weeks
• PJIA, weight ≥ 30 kg: 8 mg per kg every 4 weeks
• SJIA, weight < 30 kg: 12 mg per kg every 2 weeks
• SJIA, weight ≥ 30 kg: 8 mg per kg every 2 weeks
• CRS, weight <30 kg: 12 mg per kg once, up to
800 mg per infusion (up to 3 additional doses can
be given if no clinical improvement after the first dose)
• CRS, weight >30 kg: 8 mg per kg once, up to
800 mg per infusion (up to 3 additional doses can
be given if no clinical improvement after the first dose.
• Giant cell arteritis: 6 mg per kg every 4 weeks
|
|
Actemra (tocilizumab) 200 mg per 10 mL single-use vial
|
40 mL (4 vials) per 14 days
|
|
Actemra (tocilizumab) 400 mg per 20 mL single-use vial
|
40 mL (2 vials) per 14 days
|
Abbreviations: RA = rheumatoid arthritis; PJIA = polyarticular juvenile idiopathic arthritis; SJIA = systemic juvenile idiopathic arthritis;
CRS = cytokine release syndrome; SSc-ILD = systemic sclerosis-associated interstitial lung disease
Place of Service:
Outpatient
The above policy is based on the following references:
- Actemra [package insert]. South San Francisco, CA: Genentech, Inc.; February 2022.
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.
June 26, 2022
