Subject: Olumiant SGM 2597-A P2026

Drug

OLUMIANT  (baricitinib)

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

• Adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) blockers
• Coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO)
• Adult patients with severe alopecia areata

Note: The criteria outlined in this policy is only applicable to coverage in the outpatient setting. Hospitalized members receiving Olumiant for the treatment of COVID-19 will be managed according to the member’s inpatient benefit.

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:

Rheumatoid arthritis (RA)

Initial requests

Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to therapy. If therapy is not advisable, documentation of clinical reason to avoid therapy.

Continuation requests

Chart notes or medical record documentation supporting positive clinical response.

Alopecia areata

Initial requests

• Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable).
• Chart notes or medical record documentation supporting at least 50% scalp hair loss (e.g., Severity of Alopecia Tool [SALT] score of 50 or higher) (if applicable).

Continuation requests

Chart notes or medical record documentation supporting positive clinical response (e.g., increased scalp hair coverage, 80% total scalp hair coverage [SALT score of 20 or less]).

Prescriber Specialties

This medication must be prescribed by or in consultation with one of the following:

• Rheumatoid arthritis: rheumatologist
• Alopecia areata: dermatologist

Coverage Criteria

Rheumatoid arthritis (RA)^1,3,4

Authorization of 12 months may be granted for adult members for treatment of moderately to severely active rheumatoid arthritis (RA) when the member has had an inadequate response, intolerance, or has a contraindication to at least one tumor necrosis factor (TNF) inhibitor.

Alopecia areata^1,5,6

Authorization of 12 months may be granted for adult members who have previously received a targeted synthetic drug (e.g., Leqselvi, Litfulo) indicated for treatment of severe alopecia areata in the past year.

Authorization of 12 months may be granted for adult members for treatment of severe alopecia areata when both of the following criteria are met:

• Member has at least 50% scalp hair loss (e.g., Severity of Alopecia Tool [SALT] score of 50 or higher).
• Other forms of alopecia have been ruled out (e.g., androgenetic alopecia, trichotillomania, telogen effluvium, chemotherapy-induced hair loss, tinea capitis).

Continuation of Therapy

Rheumatoid arthritis (RA)^1,3,4

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for moderately to severely active RA and who achieve or maintain a positive clinical response as evidenced by disease activity improvement of at least 20% from baseline in tender joint count, swollen joint count, pain, or disability.

Alopecia areata^1,5

Authorization of 12 months may be granted for all adult members (including new members) who are using the requested medication for severe alopecia areata and who achieve or maintain a positive clinical response as evidenced by an improvement in signs and symptoms of the condition from baseline (e.g., increased scalp hair coverage, 80% total scalp hair coverage [SALT score of 20 or less]).

Other^1,2

For all indications: Member has had a documented negative tuberculosis (TB) test (which can include a tuberculosis skin test [TST] or an interferon-release assay [IGRA]) within 12 months of initiating therapy for persons who are naïve to biologic drugs or targeted synthetic drugs associated with an increased risk of TB.

If the screening testing for TB is positive, there must be further testing to confirm there is no active disease (e.g., chest x-ray). Do not administer the requested medication to members with active TB infection. If there is latent disease, TB treatment must be started before initiation of the requested medication.

For all indications: Member cannot use the requested medication concomitantly with any other biologic drug, targeted synthetic drug, or potent immunosuppressant such as azathioprine or cyclosporine.

Dosage and Administration

Approvals may be subject to dosing limits in accordance with FDA-approved labeling, accepted compendia, and/or evidence-based practice guidelines.

Place of Service:

Outpatient

The above policy is based on the following references:

1. Olumiant [package insert]. Indianapolis, IN: Lilly USA, LLC; June 2022.
2. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 11, 2025 from: https://www.cdc.gov/tb/testing/index.html.
3. Smolen JS, Landewé RBM, Bergstra SA, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2022 update. Ann Rheum Dis. 2023;82:3-18.
4. Fraenkel L, Bathon JM, England BR, et al. 2021 American College of Rheumatology guideline for the treatment of rheumatoid arthritis. Arthrit Care Res. 2021;0:1-16.
5. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. NEJM. 2022;386(18):1687-1699.
6. King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. NEJM. 2022;386(18)(suppl):1-77.

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.

February 16, 2026