Velsipity (etrasimod) - PA, NF
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
* 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 [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
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one of the following conventional therapies [2, 3]:
- 6-mercaptopurine
- Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
- Azathioprine
- Corticosteroids (e.g., prednisone)
- One of the following:
- Both of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming 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)
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Zeposia (ozanimod)
- Both of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy AND
- Documentation of 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
- 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
Velsipity
* For review process only: Refer to the table in the Background section for carrier-specific formulary products
Non Formulary
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
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to one of the following conventional therapies [2, 3]:
- 6-mercaptopurine
- Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine)
- Azathioprine
- Corticosteroids (e.g., prednisone)
- One of the following:
- Both of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming 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)
- Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication, or intolerance to Zeposia (ozanimod)
- Both of the following:
- Paid claims or submission of medical records (e.g., chart notes) confirming continuation of prior therapy, defined as no more than a 45-day gap in therapy AND
- Documentation of 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
- Prescribed by or in consultation with a gastroenterologist
P & T Revisions
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
- Velsipity Prescribing Information. Pfizer Labs. New York, NY. October 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.
Revision History
- 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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