Subject: Otrexup SGM 2019-A P2026

Drug

OTREXUP  (methotrexate )

Policy:

Indications

The indications below including FDA-approved indications and compendial uses are considered a covered benefit provided that all the approval criteria are met and the member has no exclusions to the prescribed therapy.

FDA-approved Indications¹

Rheumatoid Arthritis (RA) including Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Otrexup is indicated in the management of selected adults with severe, active rheumatoid arthritis (RA) or children with active polyarticular juvenile idiopathic arthritis (pJIA), who have had an insufficient therapeutic response to, or are intolerant of, an adequate trial of first-line therapy including full dose non-steroidal anti-inflammatory agents (NSAIDs).

Psoriasis

Otrexup is indicated in adults for the symptomatic control of severe, recalcitrant, disabling psoriasis that is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and/or after dermatologic consultation. It is important to ensure that a psoriasis “flare” is not due to an undiagnosed concomitant disease affecting immune responses.

Limitations of use

Otrexup is not indicated for the treatment of neoplastic diseases.

Compendial Use

Microscopic polyangiitis⁶

All other indications are considered experimental/investigational and not medically necessary.

Documentation

Submission of the following information is necessary to initiate the prior authorization review:

• Chart notes, medical record documentation, or claims history supporting previous use of generic oral methotrexate and inadequate response or intolerance to therapy.
• Chart notes or medical record documentation of member’s inability to prepare and administer generic injectable methotrexate.

Coverage Criteria^2-6

Authorization of 12 months may be granted for treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), psoriasis, or microscopic polyangiitis when BOTH of the following criteria are met:

• Member has had an inadequate response or intolerance to generic oral methotrexate.
• Member has an inability to prepare and administer generic injectable methotrexate.

Continuation of Therapy

Authorization of 12 months may be granted for all members (including new members) who meet ALL requirements in the coverage criteria and achieve or maintain a positive clinical response as evidenced by low disease activity or improvement in signs and symptoms of the condition.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Otrexup [package insert]. Lake Forest, IL: Otter Pharmaceuticals, LLC; September 2024.
2. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2021;73(7):924-939.

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.

April 18, 2026