Vowst - NC Standard

Restricted Product(s)

• Vowst™ (fecal microbiota spores, live-brpk)

FDA Approved Use

• Indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI. 
• Limitation of use: Not indicated for treatment of CDI

Criteria for Approval of Restricted Product(s)

1. The patient is 18 years of age or older; AND 
2. The patient has a diagnosis of recurrent Clostridioides difficile infection (CDI), as confirmed by BOTH of the following: 
   1. Passage of three or more loose stools within a 24-hour period for two consecutive days; AND 
   2. Positive stool test for Clostridioides difficile toxin or toxigenic Clostridioides difficile from a stool sample collected within the past 30 days (medical record documentation required); AND 
3. The patient has had at least two episodes of CDI recurrence after a primary episode (medical record documentation required); AND 
4. The patient has completed at least one round of standard-of-care oral antibiotic therapy for recurrent CDI 2 to 4 days before beginning treatment with Vowst; AND 
5. The patient’s CDI is under control after completing antibiotic therapy (e.g., less than 3 unformed/loose stools per day for two consecutive days); AND 
6. The patient will be receiving the requested agent to prevent recurrence of CDI; AND 
7. The patient has NOT previously received treatment with Vowst therapy; AND 
8. The medication is prescribed by or in consultation with a specialist in the area of the patient’s diagnosis (i.e., gastroenterologist or infectious disease specialist); AND 
9. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 30 days (one-time approval for one 3-day treatment course)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90-day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

January 2024: Criteria change: Added requirement that positive stool test for Clostridioides difficile infection (CDI) must be within past 30 days.

July 2023: Criteria update: Updated quantity limit for intent of one treatment course (12 capsules) per 365 days.

May 2023: Original utilization management criteria issued.