Subject: Specialty Quantity Limit Cimzia 2267-H P2025

Drug

CIMZIA  (certolizumab pegol)

Policy:

Program Description

The standard limit is designed to allow a quantity sufficient for the most common uses of the medication. If the 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.

Covered Quantities

Coverage up to the exception limits may be provided with prior authorization via the Specialty Post Limit Quantity Exception Criteria for approval.

Medication	Standard Limit	Exception Limit
Cimzia (certolizumab pegol) starter kit   (contains six 200 mg per 1 mL prefilled syringes)	N/A	1 kit (3 sets of 2 syringes) per 28 days
Cimzia (certolizumab pegol) 200 mg per 1 mL prefilled syringe kit for subcutaneous injection	2 kits (4 syringes) per 28 days	N/A
Cimzia (certolizumab pegol) 200 mg per 1 mL prefilled   syringe for subcutaneous injection	4 syringes per 28 days	N/A
Cimzia (certolizumab pegol) kit (contains two 200 mg vials)	2 kits (4 vials) per 28 days	3 kits (6 vials) per 28 days

FDA-recommended Dosing

Abbreviations: RA = rheumatoid arthritis; PsA = psoriatic arthritis; AS = ankylosing spondylitis; nr-axSpA = non-radiographic axial spondyloarthritis; pJIA = polyarticular juvenile idiopathic arthritis

RA/PsA/AS/nr-axSpA

Loading doses

400 mg (two 200 mg injections) at weeks 0, 2, and 4

Maintenance dose

200 mg every other week or 400 mg every 4 weeks

Crohn’s disease

Loading doses

400 mg (two 200 mg injections) at weeks 0, 2, and 4

Maintenance dose

400 mg every 4 weeks based on clinical response

Plaque psoriasis

400 mg (two 200 mg injections) every other week

For some patients with body weight less than or equal to 90 kg, 400 mg at weeks 0, 2, and 4, followed by 200 mg every other week may be considered.

pJIA

10 kg to less than 20 kg

100 mg at weeks 0, 2, and 4, followed by 50 mg every other week

20 kg to less than 40 kg

200 mg at weeks 0, 2, and 4, followed by 100 mg every other week

Greater than or equal to 40 kg

400 mg at weeks 0, 2, and 4, followed by 200 mg every other week

Place of Service:

Outpatient

The above policy is based on the following references:

1. Cimzia [package insert]. Smyrna, GA: UCB, Inc.; September 2024.

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.

January 01, 2026