Pharmacy Prior Authorization Criteria

Velsipity (etrasimod)

Indications for Prior Authorization

Velsipity (etrasimod)

• For diagnosis of Ulcerative Colitis (UC)
  Indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

Criteria

Velsipity

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 [2, 3]:
• 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
AND
• Prescribed by or in consultation with a gastroenterologist

Velsipity

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 [1-3]:
• 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

2025-05-20, 2025-04-03, 2025-02-09, 2025-01-16, 2024-12-01, 2024-11-27, 2024-09-08, 2024-07-30, 2024-06-24, 2024-05-31, 2024-04-24, 2024-04-04, 2024-03-07, 2023-11-30, 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

1. Velsipity Prescribing Information. Pfizer Labs. New York, NY. October 2023.
2. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413.
3. 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.

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Revision History

• 2025-05-20: No criteria changes; background and operational updates
• 2025-04-03: Removed conventional step from UC criteria
• 2025-02-09: Removed step requirement through other targeted immunomodulators; removed claims requirements from conventional step; removed nonformulary criteria
• 2025-01-16: Updated background table
• 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: April 2024 - Additional step added through Zeposia; Addition of non-formulary criteria and records/claims requirements to embedded steps in PA criteria. March 2024 - Updated verbiage in the step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2024-04-04: April 2024 - Additional step added through Zeposia; Addition of non-formulary criteria and records/claims requirements to embedded steps in PA criteria. March 2024 - Updated verbiage in the 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 step to say, "One formulary adalimumab product manufactured by AbbVie, Amgen, BI, or Sandoz"; added table to background section detailing preferred adalimumab products
• 2023-11-30: New program
• 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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