Subject: Zeposia 3747-A SGM P2022
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. Zeposia is indicated for the treatment of relapsing forms of
multiple sclerosis (MS), to include clinically isolated
syndrome, relapsing-remitting disease, and active secondary
progressive disease, in adults.
B. Zeposia is indicated for the treatment of moderately to
severely active ulcerative colitis (UC) 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:
Ulcerative colitis (UC):
A. Initial requests: Chart notes, medical record documentation,
or claims history supporting previous medications tried (if
applicable), including response to therapy. If therapy is not
advisable, documentation of clinical reason to avoid therapy.
B. Continuation requests: Chart notes or medical record
documentation supporting positive clinical response to
therapy or remission.
III. PRESCRIBER SPECIALTIES
The medication must be prescribed by or in consultation with
one of the following:
A. Ulcerative colitis: gastroenterologist
B. Multiple sclerosis: neurologist
IV. CRITERIA FOR INITIAL APPROVAL
A. Relapsing Forms of Multiple Sclerosis
Authorization of 12 months may be granted to members
who have been diagnosed with a relapsing form of multiple
sclerosis (including relapsing-remitting and secondary
progressive disease for those who continue to experience
relapse).
B. Clinically Isolated Syndrome
Authorization of 12 months may be granted to members for
the treatment of clinically isolated syndrome of multiple
sclerosis.
C. Ulcerative Colitis
1. Authorization of 12 months may be granted for adult
members who have previously received a biologic or
targeted synthetic drug (e.g., Xeljanz) indicated for
moderately to severely active ulcerative colitis.
2. Authorization of 12 months may be granted for adult
members for the treatment of moderately to severely
active UC when the member has had an inadequate
response, intolerance or contraindication to at least one
conventional therapy option (See Appendix).
V. CONTINUATION OF THERAPY
A. Relapsing Forms of Multiple Sclerosis and Clinically
Isolated Syndrome
Authorization of 12 months may be granted when the
member is experiencing disease stability or improvement
while receiving Zeposia.
B. Ulcerative Colitis
1. 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.
2. 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 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:
i. Stool frequency
ii. Rectal bleeding
iii. Urgency of defecation
iv. C-reactive protein (CRP)
v. Fecal calprotectin (FC)
vi. Endoscopic appearance of the mucosa
vii. Improvement on a disease activity scoring tool
(e.g., Ulcerative Colitis Endoscopic Index of Severity
[UCEIS], Mayo score)
VI. OTHER
A. For all indications: Zeposia will not be used concomitantly
with immunomodulators, biologic drugs, targeted synthetic
drugs, or disease modifying multiple sclerosis agents (Note:
Ampyra and Nuedexta are not disease modifying).
B. For multiple sclerosis: authorization may be granted for
pediatric members less than 18 years of age when benefits
outweigh risks.
VII. APPENDIX
Examples of Conventional Therapy Options for Ulcerative
Colitis
1. Mild to moderate disease – induction of remission:
a. Oral mesalamine (e.g., Asacol, Asacol HD, Lialda,
Pentasa), balsalazide, olsalazine
b. Rectal mesalamine (e.g., Canasa, Rowasa)
c. Rectal hydrocortisone (e.g., Colocort, Cortifoam)
d. Alternatives: prednisone, azathioprine, mercaptopurine,
sulfasalazine
2. Mild to moderate disease – maintenance of remission:
a. Oral mesalamine, balsalazide, olsalazine, rectal
mesalamine
b. Alternatives: azathioprine, mercaptopurine, sulfasalazine
3. Severe disease – induction of remission:
a. Prednisone, hydrocortisone IV, methylprednisolone IV
b. Alternatives: cyclosporine IV, tacrolimus, sulfasalazine
4. Severe disease – maintenance of remission:
a. Azathioprine, mercaptopurine
b. Alternative: sulfasalazine
Place of Service:
Outpatient
The above policy is based on the following references:
- Zeposia [package insert]. Summit, NJ: Celgene Corporation; April 2022.
- 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 Gastroentrol. 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. Gastroenterology 2020; 158:1450-1461.
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.
March 28, 2023
