Zeposia (ozanimod)
Indications for Prior Authorization
Zeposia (ozanimod)
-
For diagnosis of Relapsing forms of MS
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. -
For diagnosis of Ulcerative Colitis (UC)
Indicated for the treatment of moderately to severely active ulcerative colitis in adults.
Criteria
Zeposia
Prior Authorization (Initial Authorization)
Length of Approval: 12 Month(s)
For diagnosis of Multiple Sclerosis
- Diagnosis of a relapsing form of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions) [A] AND
- Not used in combination with another disease-modifying therapy for MS AND
- Prescribed by or in consultation with a neurologist
Zeposia
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Multiple Sclerosis
- Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression) AND
- Not used in combination with another disease-modifying therapy for MS AND
- Prescribed by or in consultation with a neurologist
Zeposia
* For review process only: Refer to the table in the Background section for carrier-specific formulary products
Prior Authorization (Initial Authorization)
Length of Approval: 6 Month(s)
For diagnosis of Ulcerative Colitis
- Diagnosis of moderately to severely active ulcerative colitis AND
- One of the following [4, 5]:
- Greater than 6 stools per day
- Frequent blood in the stools
- Frequent urgency
- Presence of ulcers
- Abnormal lab values (e.g., hemoglobin, ESR, CRP)
- Dependent on, or refractory to, corticosteroids
- Trial and failure, contraindication, or intolerance to one of the following conventional therapies [4, 5]:
- 6-mercaptopurine
- Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
- Azathioprine
- Corticosteroids (e.g., prednisone)
- One of the following:
- Trial and failure, contraindication, or intolerance to TWO of the following:
- One formulary adalimumab product*
- Simponi (golimumab)
- One formulary ustekinumab product*
- Omvoh (mirikizumab-mrkz)
- Skyrizi (risankizumab-rzaa)
- Tremfya (guselkumab)
- Rinvoq (upadacitinib)
- Xeljanz/XR (tofacitinib/ER)
- For continuation of prior therapy, defined as no more than a 45-day gap in therapy
- Prescribed by or in consultation with a gastroenterologist
Zeposia
Prior Authorization (Reauthorization)
Length of Approval: 12 Month(s)
For diagnosis of Ulcerative Colitis
- Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following [3-5]:
- Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline
- Reversal of high fecal output state
P & T Revisions
2024-12-13, 2024-12-11, 2024-12-11, 2024-12-01, 2024-11-27, 2024-09-08, 2024-07-30, 2024-06-24, 2024-05-31, 2024-04-24, 2024-03-07, 2023-12-11, 2023-10-04, 2023-08-30, 2023-07-26, 2023-06-30, 2023-02-01, 2022-10-24, 2022-09-13, 2022-07-05, 2022-04-07, 2022-01-05, 2021-09-27, 2021-08-03
References
- Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788.
- National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019.
- Zeposia Prescribing Information. Celgene Corporation. Summit, NJ. June 2023.
- Rubin DT, Ananthakrishnan AN, Siegel CA, et al. 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. Gastroenterol. 2020;158:1450-1461.
End Notes
- According to the National MS Society, of the four disease courses that have been identified in MS, relapsing-remitting MS (RRMS) is characterized primarily by relapses, and secondary-progressive MS (SPMS) has both relapsing and progressive characteristics. These two constitute “relapsing forms of MS” if they describe a disease course that is characterized by the occurrence of relapses. [2] The effectiveness of interferon beta in SPMS patients without relapses is uncertain. [1]
Revision History
- 2024-12-13: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
- 2024-12-11: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
- 2024-12-11: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
- 2024-12-01: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
- 2024-11-27: Added Tremfya and Omvoh as additional preferred alternatives for UC; updated Stelara to "one formulary ustekinumab product"; removed manufacturers from "one formulary adalimumab product".
- 2024-09-08: Removed bypass verbiage for UC
- 2024-07-30: Addition of Skyrizi as an additional trial option for UC indication.
- 2024-06-24: No criteria changes; updated background table to specify BI manufacturer for adalimumab-adbm
- 2024-05-31: Updated background table to include CalPERS formulary; no criteria changes
- 2024-04-24: Updated verbiage in the UC step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
- 2024-03-07: Updated verbiage in the UC step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
- 2023-12-11: Updated initial UC reauthorization duration to 6 months. Program update to standard reauthorization language; no changes to clinical intent.
- 2023-10-04: Program update to standard reauthorization language. No changes to clinical intent
- 2023-08-30: 2023 UM Annual Review. No criteria changes. Updated references and cleaned up GPIs
- 2023-07-26: Added new Zeposia starter kit and removed drug specific NF guidelines
- 2023-06-30: Addition of Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred step options for UC
- 2023-02-01: Addition of Amjevita as another preferred step option for UC
- 2022-10-24: Further clinical detail and criteria added for UC
- 2022-09-13: 2022 Annual Review
- 2022-07-05: Addition of drug specific NF criteria
- 2022-04-07: Addition of Rinvoq and Xeljanz/XR as preferred step options for UC
- 2022-01-05: Per formulary strategy, for indication of ulcerative colitis, add trial and failure requirement to two preferred biologics.
- 2021-09-27: Per formulary strategy, revised Ulcerative Colitis criteria to remove trial and failure requirement through a biologic agent.
- 2021-08-03: Added criteria for new indication of ulcerative colitis.
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