Pharmacy Prior Authorization Criteria

Fecal Microbiota Agents - PA, NF

Indications for Prior Authorization

Rebyota (fecal microbiota, live-jslm) suspension

• For diagnosis of Recurrent Clostridioides difficile infection (CDI)
  Indicated for the prevention of recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibiotic treatment for recurrent CDI.

  Limitations of use: Rebyota is not indicated for treatment of CDI.

Vowst (fecal microbiota spores, live-brpk) capsule

• For diagnosis of Recurrent Clostridioides difficile infection (CDI)
  Indicated to prevent the recurrence of Clostridioides difficile infection (CDI) in individuals 18 years of age and older following antibacterial treatment for recurrent CDI (rCDI).

  Limitations of use: Vowst is not indicated for treatment of CDI.

Zinplava (bezlotoxumab) injection

• For diagnosis of Recurrent Clostridioides difficile infection (CDI)
  Indicated to reduce recurrence of Clostridioides difficile infection (CDI) in adults and pediatric patients 1 year of age and older who are receiving antibacterial drug treatment for CDI and are at high risk for CDI recurrence. Limitations of use: Zinplava is not indicated for the treatment of CDI.

Criteria

Rebyota

Prior Authorization

Length of Approval: 14 Day(s)

• Diagnosis of recurrent clostridioides difficile infection (CDI) as defined by both of the following:
• Presence of diarrhea defined as a passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days
• A positive stool test for C.difficile toxin or toxigenic C.difficile
AND
• Patient is 18 years of age or older
AND
• Patient has a history of one or more recurrent episodes of CDI
AND
• Both of the following:
• Patient has completed at least 10 consecutive days of one of the following antibiotic therapies between 24 to 72 hours prior to initiating Rebyota:
• oral vancomycin
• Dificid (fidaxomicin)
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

Rebyota

Non Formulary

Length of Approval: 14 Day(s)

• Diagnosis of recurrent clostridioides difficile infection (CDI) as defined by both of the following:
• Presence of diarrhea defined as a passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days
• A positive stool test for C.difficile toxin or toxigenic C.difficile
AND
• Patient is 18 years of age or older
AND
• Patient has a history of one or more recurrent episodes of CDI
AND
• Both of the following:
• Paid claims or submission of medical records (e.g., chart notes) confirming patient has completed at least 10 consecutive days of one of the following antibiotic therapies between 24 to 72 hours prior to initiating Rebyota:
• oral vancomycin
• Dificid (fidaxomicin)
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

Vowst

Prior Authorization

Length of Approval: 14 Day(s)

• Diagnosis of recurrent clostridioides difficile infection (CDI) as defined by both of the following:
• Presence of diarrhea defined as a passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days
• A positive stool test for C.difficile toxin or toxigenic C.difficile
AND
• Patient is 18 years of age or older
AND
• Patient has a history of two or more recurrent episodes of CDI within 12 months
AND
• All of the following:
• Patient has completed at least 10 consecutive days of one of the following antibiotic therapies 2-4 days prior to initiating Vowst:
• oral vancomycin
• Dificid (fidaxomicin)
AND
• Patient has completed the recommended course of magnesium citrate the day before and at least 8 hours prior to initiating Vowst [A]
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
AND
• Trial and failure, contraindication or intolerance to Rebyota

Vowst

Non Formulary

Length of Approval: 14 Day(s)

• Diagnosis of recurrent clostridioides difficile infection (CDI) as defined by both of the following:
• Presence of diarrhea defined as a passage of 3 or more loose bowel movements within a 24-hour period for 2 consecutive days
• A positive stool test for C.difficile toxin or toxigenic C.difficile
AND
• Patient is 18 years of age or older
AND
• Patient has a history of two or more recurrent episodes of CDI within 12 months
AND
• All of the following:
• Patient has completed at least 10 consecutive days of one of the following antibiotic therapies 2-4 days prior to initiating Vowst:
• oral vancomycin
• Dificid (fidaxomicin)
AND
• Patient has completed the recommended course of magnesium citrate the day before and at least 8 hours prior to initiating Vowst [A]
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
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure, contraindication or intolerance to Rebyota

Zinplava

Prior Authorization

Length of Approval: 14 Day(s)

• Diagnosis of recurrent clostridioides difficile infection (CDI) as defined by both of the following:
• Presence of diarrhea defined as a passage of 3 or more loose bowel movements in less than or equal to 24 hours
• A positive stool test for C.difficile toxin or toxigenic C.difficile
AND
• Used for the reduction of the recurrence of CDI
AND
• Used in combination with antibacterial drug treatment for CDI [e.g., oral Vancocin (vancomycin), Flagyl (metronidazole), or Dificid (fidaxomicin)]
AND
• Patient is 1 year of age or older
AND
• Patient has one or more of the following risk factors associated with CDI recurrence: [5-8, B]
• One or more prior episodes of CDI in the previous 6 months
• Immunocompromised
• Chronic dialysis
• Inflammatory bowel disease
• Continued use of non-CDI antimicrobials after diagnosis of CDI and/or after CDI treatment
AND
• Prescribed by or in consultation with one of the following:
• Gastroenterologist
• Infectious disease specialist

P & T Revisions

2024-05-06, 2024-02-01, 2023-12-08, 2023-11-03, 2023-06-28, 2023-05-03, 2023-04-04, 2023-02-16

References

1. Rebyota Prescribing Information. Ferring Pharmaceuticals, Inc. Parsippany, NJ. November 2022.
2. Vowst Prescribing Information. Aimmune Therapeutics, Inc. Brisbane, CA. April 2023.
3. Per clinical consult with gastroenterologist, May 3, 2023.
4. Zinplava Prescribing Information. Merck Sharp & Dohme LLC. Rahway, NJ. May 2023.
5. Cohen SH, Gerding DN, Johnson S, et al. Clinical practice guidelines for Clostridium difficile infection in adults: 2010 update by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA). Infect Control Hosp Epidemiol. 2010;31(5):431-55.
6. Debast SB, Bauer MP, Kuijper EJ. European Society of Clinical Microbiology and Infectious Diseases: update of the treatment guidance document for Clostridium difficile infection. Clin Microbiol Infect. 2014;20 Suppl 2:1-26.
7. Zinplava Product Dossier. Merck and Co., Inc. November 2016.
8. Vincent Y, Manji A, Grgory-Miller K, et al. A review or management of Clostridium difficile infection: Primary and recurrence. Antibiotics. 2015;4(4):411-423.
9. Kelsen JR, Kim J, Latta D, et al. Recurrence rate of Clostridium difficile infection in hospitalized patients with inflammatory bowel disease. Inflamm Bowel Disease. 2011;17:50-55.
10. Kelly CP. Can we identify patients at high risk of recurrent Clostridium difficile infection? Clin Microbiol Infect. 2012;18 Suppl 6:21-27.
11. Per clinical consult with gastroenterologist, December 28, 2016.

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End Notes

1. Patients are required to take magnesium citrate 24 hours prior to the first dose of Vowst per the prescribing information. There is currently no efficacy data regarding the use of Vowst without magnesium citrate and the thought is that it helps to clear the antibiotics prior to administration of Vowst. [2,3]
2. Risk factors for CDI recurrence: There is no specific guidance in regards to which patients should be considered high risk for CDI recurrence. There are a multitude of risk factors that increase patients' risk for recurrent CDI. Risk factors reported in one or more previously published studies and confirmed by consultant feedback include: one or more prior episodes of CDI in the previous 6 months, immunocompromised state, renal failure, inflammatory bowel disease, and continued use of non-CDI antimicrobials. Although patients greater than or equal to 65 years of age are at greater risk of recurrent CDI than younger patients, per consultant feedback, not all patients over 65 should be treated with Zinplava, only those with the highest risk. [5-11]

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Revision History

• 2024-05-06: Addition of new target, Zinplava.
• 2024-02-01: 2024 Annual Review. No changes to clinical criteria. No overutilization seen of Rebyota and Vowst and such no QL required.
• 2023-12-08: Addition of EHB formulary. No changes to criteria.
• 2023-11-03: Drug specific NF criteria added for Vowst, modified PA for Vowst to add "trial and failure, contraindication or intolerance to Rebyota" to both initial and reauth criteria"
• 2023-06-28: Add criteria for Vowst. Updated background and references.
• 2023-05-03: Added NF criteria for Rebyota.
• 2023-04-04: Added oral vancomycin and Dificid as embedded ST options.
• 2023-02-16: New program for Rebyota.

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