Subject: Omvoh 6239-A SGM P2023
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 Indications1
Omvoh is indicated for the treatment of moderately to severely
active ulcerative colitis in adults.
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:
Continuation requests: Chart notes or medical record
documentation supporting positive clinical response to therapy
or remission.
III. PRESCRIBER SPECIALTIES
This medication must be prescribed by or in consultation with a
gastroenterologist.
IV. CRITERIA FOR INITIAL APPROVAL
Ulcerative colitis (UC)1,3,4,5,
Authorization of 12 months may be granted for adult members
for treatment of moderately to severely active ulcerative colitis.
V. CONTINUATION OF THERAPY
Ulcerative colitis (UC)1,3,4,5,
A. 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
ulcerative colitis and who achieve or maintain remission.
B. 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
ulcerative colitis and who achieve or maintain a positive
clinical response as evidenced by low disease activity or
improvement in signs and symptoms of the condition when
there is improvement in any of the following from baseline:
1. Stool frequency
2. Rectal bleeding
3. Urgency of defecation
4. C-reactive protein (CRP)
5. Fecal calprotectin (FC)
6. Appearance of the mucosa on endoscopy, computed
tomography enterography (CTE), magnetic resonance
enterography (MRE), or intestinal ultrasound
7. Improvement on a disease activity scoring tool (e.g.,
Ulcerative Colitis Endoscopic Index of Severity [UCEIS],
Mayo score)
VI. OTHER1,2
Member has had a documented negative tuberculosis (TB) test
(which can include a tuberculosis skin test [TST], 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.
Member cannot use the requested medication concomitantly
with any other biologic drug or targeted synthetic drug for the
same indication.
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:
- Omvoh [package insert]. Indianapolis, IN: Eli Lilly and Company.; October 2023.
- Testing for TB Infection. Centers for Disease Control and Prevention. Retrieved on November 5, 2023 from: https://www.cdc.gov/tb/topic/basics/risk.htm.
- Talley NJ, Abreu MT, Achkar J, et al. An evidence-based systematic review on medical therapies for inflammatory bowel disease. Am J Gastroenterol. 2011;106(Suppl 1):S2-S25.
- Rubin DT, Ananthakrishnan AN, et al. 2019 ACG Clinical Guideline: Ulcerative Colitis in Adults. Am J Gastroenterol. 2019;114:384-413.
- Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA Clinical Practice Guidelines on the Management of Moderate to Severe Ulcerative Colitis. 2020; 158:1450.
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 31, 2023
