Subject: Litfulo SGM 6064-A P2025

Drug

LITFULO  (ritlecitinib)

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 Indication¹

Litfulo is indicated for the treatment of severe alopecia areata in adults and adolescents 12 years and older.

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:

Initial requests

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).

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 a dermatologist.

Coverage Criteria

Alopecia areata^1,2

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

Authorization of 12 months may be granted for members 12 years of age or older 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

Alopecia areata^1,2

Authorization of 12 months may be granted for all members 12 years of age or older (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^1,3

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.

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. Litfulo [package insert]. New York, NY: Pfizer Labs; June 2023.
2. King B, Zhang X, Harcha WG, et al. Efficacy and safety of ritlecitinib in adults and adolescents with alopecia areata: a randomized, double-blind, multicentre, phase 2b-3 trial. Lancet. 2023;401:1518-1529.
3. Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 4, 2024 from: https://www.cdc.gov/tb/testing/index.html.

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, 2025