Subject: Zeposia 3747-A SGM P2021
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. 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) when Zeposia will not be used concomitantly with other disease
modifying multiple sclerosis agents (Note: Ampyra and Nuedexta are not disease modifying).
B. Clinically Isolated Syndrome
Authorization of 12 months may be granted to members for the treatment of clinically isolated syndrome
of multiple sclerosis when Zeposia will not be used concomitantly with other disease modifying multiple
sclerosis agents (Note: Ampyra and Nuedexta are not disease modifying).
C. Moderately to Severely Active Ulcerative Colitis
Authorization of 12 months may be granted for the treatment of moderately severely active ulcerative
colitis when both of the following are met:
1. The member meets one of the following:
a. Member has previously received a biologic or targeted synthetic drug (e.g., Xeljanz) indicated
for moderately to severely active ulcerative colitis.
b. Member has had an inadequate response, intolerance or contraindication to at least one conventional
therapy option (See Appendix).
2. Zeposia will not be used concomitantly with immunomodulators, biologic therapy, or targeted synthetic drugs.
IV. CONTINUATION OF THERAPY
A. Relapsing Forms of Multiple Sclerosis and Clinically Isolated Syndrome
Authorization of 12 months may be granted when both of the following are met:
1. The member is experiencing disease stability or improvement while receiving Zeposia.
2. Zeposia will not be used concomitantly with other disease modifying multiple sclerosis agents
(Note: Ampyra and Nuedexta are not disease modifying).
B. Moderately to Severely Active Ulcerative Colitis
Authorization of 12 months may be granted for all members (including new members) who are
using the requested medication for moderately to severely active ulcerative colitis when both of
the following are met:
1. The member meets one of the following:
a. The member has achieved or maintained remission.
b. The member has achieved or maintained 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)
2. Zeposia will not be used concomitantly with immunomodulators, biologic therapy, or targeted synthetic drugs.
Special Notes:
V. 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, ercaptopurine, 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; May 2021.
- 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.
- Lichtenstein GR, Loftus Jr EV, Isaacs KI, et al. ACG Clinical Guideline: Management of Crohn’s Disease in Adults. Am J Gastroenterol. 2018;113:481-517.
- 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.
January 20, 2022
