Subject: Olumiant 2597-A SGM P2023a
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
[PPD], an interferon-release assay [IGRA], or a chest x-ray)*
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. 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 June 5, 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.
December 09, 2023
