VELSIPITY (etrasimod)

Self-Administration – oral

Diagnosis considered for coverage:
  • UC: indicated for the treatment of moderately to severely active ulcerative colitis (UC) in adults
Coverage Criteria:

For diagnosis of Ulcerative Colitis (UC):

  • Diagnosis of moderately to severely active ulcerative colitis; AND
  • Prescribed by or in consultation with a gastroenterologist; AND
  • One of the following:
    • 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
  • Trial and failure, contraindication, or intolerance to one of the following conventional therapies:
    • 6-mercaptopurine 
    • Aminosalicylate (e.g., mesalamine, olsalazine, sulfasalazine) 
    • Azathioprine 
    • Corticosteroids (e.g., prednisone); AND
  • 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, or attestation demonstrating a trial may be inappropriate:
        • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz, or Brand Adalimumab-adaz 
        • Simponi (golimumab) 
        • Skyrizi (risankizumab-rzaa) 
        • Stelara (ustekinumab) 
        • 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 Velsipity therapy, defined as no more than a 45-day gap in therapy
      • Documentation of positive clinical response to therapy as evidenced by at least one of the following
        • 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
Reauthorization Criteria:

For diagnosis of UC:

  • Patient demonstrates positive clinical response to therapy as evidenced by at least one of the following:
    • 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
Dosing:

UC: 

  • 2 mg orally once daily 
Coverage Duration:
  • Initial: 6 months
  • Reauthorization: 1 year
Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 
  • VELSIPITY is contraindicated in patients who:
    • In the last 6 months, have experienced a myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure
    • Have a history or presence of Mobitz type II second-degree or third-degree AV block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker
Policy Updates:
  • 3/1/2024 – New policy approved by WHA P&T Committee. (P&T, 2/20/2024)
  • 10/1/2024 – Addition of Skyrizi as an additional trial option for UC indication. Addition of step through Zeposia.
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.

Last review date: September 30, 2024

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