VOWST (fecal microbiota spores, live-brpk)

VOWST (fecal microbiota spores, live-brpk)

Self-Administration – Oral

Diagnosis considered for coverage:

• Indicated to prevent the recurrence of clostridioides difficile infection (CDI) in adults who have had CDI within 12 months

Coverage Criteria:

For diagnosis of recurrent clostridioides difficile infection (CDI):

• Patient is 18 years of age or older, AND 
• Presence of diarrhea defined as a passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days, AND  
• A positive stool test for C. difficile toxin or toxigenic C. Difficile, AND
• Patient has a history of 2 or more recurrent episodes of CDI within 12 months, AND
• Patient has completed at least 10 consecutive days of one of the following antibiotic therapies 2 to 4 days prior to initiating Vowst:
  • Oral vancomycin
  • Dificid (fidaxomicin), AND
• Patient will complete the recommended course of Magnesium (Mg) citrate the day before and at least 8 hours prior to initiating Vowst verified with documentation or attestation of the doctor, AND 
• Previous episode of CDI is under control (e.g., less than 3 unformed/loose [i.e., Bristol Stool Scale type 6-7] stools/day for 2 consecutive days), AND
• Prescribed by or in consultation with one of the following: 
  • Gastroenterologist 
  • Infectious Disease Specialist 

Coverage Duration: 

Initial: 14 days

Dosing: 

• 4 capsules taken orally once daily for 3 consecutive days
• Take each dose (4 capsules) on an empty stomach prior to the first meal of the day
• Drink 296 mL (10oz) of Mg citrate on the day before and at least 8 hours prior to taking 1st dose of Vowst 
• Do not eat or drink, except for small amount of water, for at least 8 hours prior to taking the first dose.
• 12 capsules total in one course

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: 

• Patients are required to take Mg Citrate 25 hours prior to the first dose of Vowst per prescribing information. No current efficacy data regarding the use of Vowst without Mg Citrate. Mg Citrate is thought to help clear out antibiotics prior to administration of Vowst. (1,2)
• Vowst is not for treatment for CDI (1)
• In clinical studies, participants with impaired kidney function received polyethylene glycol electrolyte solution (250 mL GoLYTELY- not approved for this use)
• Manufactured from human fecal matter and may contain food allergens and contain glycerol in saline (w/w)

Policy Updates:

• 12/1/2023 – New policy approved by P&T

References:

• Vowst Prescribing Information. Aimmune Therapeutics, Inc. Brisbane, CA. April 2023. 
• Vowst. IBM Micromedex Solution. Truven Health Analytics, Inc. Ann Arbor, MI. Accessed August 29, 2023. http://www.micromedexsolutions.com.