VELSIPITY (etrasimod)

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.