Subject: Litfulo 6064-A SGM P2024
Policy:
I. 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 Indications
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.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization
review:
A. Initial requests: Chart notes or medical record documentation supporting more
than 50% scalp hair loss (e.g., Severity of Alopecia Tool [SALT] score of 50 or
higher).
B. 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]).
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a dermatologist.
IV. CRITERIA FOR INITIAL APPROVAL
Alopecia areata
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:
A. Member has more than 50% scalp hair loss (e.g., Severity of Alopecia Tool [SALT]
score of 50 or higher).
B. Other forms of alopecia have been ruled out (e.g., androgenetic alopecia,
trichotillomania, telogen effluvium, chemotherapy-induced hair loss, tinea capitis).
V. CONTINUATION OF THERAPY
Alopecia areata
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]).
VI. OTHER
Member has had a documented negative tuberculosis (TB) test (which can include a
tuberculosis skin test [TST] or an interferon-release assay [IGRA])* within 6 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.
VII. 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:
- Litfulo [package insert]. New York, NY: Pfizer Inc.; June 2023.
- 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.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 6, 2023 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
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.
May 14, 2024
