Dificid – Enhanced & Essential Formularies

• Dificid® (fidaxomicin) tablets
• Dificid® (fidaxomicin) suspension

• For the treatment of Clostridium difficile infection in adults and pediatric patients ≥ 6 months of age

1. The patient has a diagnosis of Clostridium difficile infection confirmed by laboratory testing (medical documentation required); AND
2. ONE of the following: 
   1. The patient is ≥ 18 years of age; OR
   2. The patient is 6 months to < 18 years of age; AND
      1. The patient has had a trial and failure of vancomycin within the past 30 days; OR
      2. The patient has a clinical contraindication/intolerance to vancomycin; AND
3. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 10 days 

Quantity limitations apply to brand and associated generic products.

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: 30 days 

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

Johnson S, Lavergne V, Skinner AM, et al. Clinical Practice Guideline by the Infectious Diseases Society of America (IDSA) and Society for Healthcare Epidemiology of America (SHEA): 2021 Focused Update Guidelines on Management of Clostridioides difficile Infection in Adults. Clin Infect Dis 2021; 73:e1029. 

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.

December 2023: Criteria update: Formatting updates only.

November 2022: Criteria update: Annual criteria review. Formatting changes only.

September 2021: Criteria change: Removed step through oral vancomycin for adults 18 years of age and older.

December 2020: Criteria update: Added new to market Dificid suspension to the policy.

February 2020: Criteria update: Indication expanded to include children aged 6 months and older.

June 2017: FDA labeling review; duration of approval limited to 30 days; formatting updated

August 2014: Original utilization management criteria issued