Subject: Olumiant 2597-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
A. Olumiant is indicated for the treatment of adult patients with moderately to
severely active rheumatoid arthritis who have had an inadequate response to one
or more tumor necrosis factor (TNF) blockers.
B. Olumiant is indicated for the treatment of coronavirus disease 2019 (COVID-19)
in hospitalized adults requiring supplemental oxygen, non-invasive or invasive
mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).
C. Olumiant is indicated for the treatment of 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.
II. DOCUMENTATION
Submission of the following information is necessary to initiate the prior authorization
review:
A. Rheumatoid arthritis (RA)
1. Initial requests: Chart notes, medical record documentation, or claims history supporting previous medications tried (if applicable), including response to
therapy.
2. Continuation requests: Chart notes or medical record documentation
supporting positive clinical response.
B. Alopecia areata:
1. 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).
2. 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 one of the following:
A. Rheumatoid arthritis: rheumatologist
B. Alopecia areata: dermatologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Rheumatoid arthritis (RA)
1. Authorization of 12 months may be granted for adult members for treatment of
moderately to severely active rheumatoid arthritis (RA) when the member has
experienced an inadequate response or intolerance to at least one tumor
necrosis factor (TNF) inhibitor.
2. Authorization of 12 months may be granted for adult members who have
previously received a biologic (other than a TNF inhibitor) or targeted synthetic
drug (e.g., Rinvoq, Xeljanz) indicated for moderately to severely active RA.
B. Alopecia areata
Authorization of 12 months may be granted for adult members for treatment of
severe alopecia areata when both of the following criteria are met:
1. Member has more than 50% scalp hair loss (e.g., Severity of Alopecia Tool
[SALT] score of 50 or higher).
2. 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
A. Rheumatoid arthritis (RA)
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.
B. Alopecia areata
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]).
VI. OTHER
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 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.
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.
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:
- Olumiant [package insert]. Indianapolis, IN: Lilly USA, LLC; June 2022.
- 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.
- Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2019 update. Ann Rheum Dis. 2020;79:685-699.
- 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.
- King B, Ohyama M, Kwon O, et al. Two phase 3 trials of baricitinib for alopecia areata. NEJM. 2022;386(18):1687-1699.
- 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.
May 14, 2024
