Subject: Specialty Quantity Limit Actemra-Tofidence 1736-H P2023b
|
ACTEMRA
(tocilizumab)
|
|
TOFIDENCE
(tocilizumab-bavi)
|
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
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Medication
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Standard Limit
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FDA-recommended dosing*
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|
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
|
80 mL (20 vials)
per 28 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, up to 600 mg per
infusion
|
|
Actemra (tocilizumab)
200 mg per 10 mL
single-use vial
|
80 mL (8 vials)
per 28 days
|
|
Actemra (tocilizumab)
400 mg per 20 mL
single-use vial
|
80 mL (4 vials) per 28 days
|
|
Tofidence
(tocilizumab-bavi)
80 mg per 4 mL
single-use vial
|
80 mL (20 vials)
per 28 days
|
|
Tofidence
(tocilizumab-bavi)
200 mg per 10 mL
single-use vial
|
80 mL (8 vials)
per 28 days
|
|
Tofidence
(tocilizumab-bavi)
400 mg per 20 mL
single-use vial
|
80 mL (4 vials) per 28 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
*The criteria outlined in this policy is only applicable to coverage in the outpatient setting. Hospitalized members receiving treatment for
coronavirus disease 2019 (COVID-19) will be managed according to the member’s inpatient benefit.
Place of Service:
Outpatient
The above policy is based on the following references:
- Actemra [package insert]. South San Francisco, CA: Genentech, Inc.; December 2022.
- Tofidence [package insert]. Cambridge, MA: Biogen MA Inc.; September 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 31, 2023
