Dificid (fidaxomicin) tablets — Highmark

Preferred products

• generic fidaxomicin tablets

Initial criteria

• Diagnosis of CDAD (ICD-10: A04.7) confirmed by all of the following (1 and 2):
• 1. Member has ≥ 3 unexplained and new-onset loose bowel movements in < 24 hours;
• 2. Member has one of the following (a–d):
• a. Positive nucleic acid amplification test (NAAT) or polymerase chain reaction (PCR) result for C. difficile;
• b. Positive glutamate dehydrogenase (GDH) test result;
• c. Positive enzyme immunoassay (EIA) for C. difficile toxin;
• d. Positive stool culture for C. difficile;
• If request is for brand Dificid tablets, member has experienced therapeutic failure or intolerance to generic fidaxomicin tablets;
• If request is for Dificid oral suspension, member meets one of the following (1 or 2):
• 1. Inability to swallow capsules/tablets;
• 2. Experienced therapeutic failure or intolerance to generic plan‑preferred fidaxomicin tablets.

Reauthorization criteria

• Diagnosis of recurrent CDAD (ICD-10: A04.71, A04.72) confirmed by all of the following (1 and 2):
• 1. Member has experienced an episode of symptom onset (for example, unexplained or new onset loose bowel movements);
• 2. Member has one of the following (a–d):
• a. Positive nucleic acid amplification test (NAAT) or polymerase chain reaction (PCR) result for C. difficile;
• b. Positive glutamate dehydrogenase (GDH) test result;
• c. Positive enzyme immunoassay (EIA) for C. difficile toxin;
• d. Positive stool culture for C. difficile;
• If request is for brand Dificid tablets, member has experienced therapeutic failure or intolerance to generic fidaxomicin tablets;
• If request is for Dificid oral suspension, member meets one of the following (1 or 2):
• 1. Inability to swallow capsules/tablets;
• 2. Experienced therapeutic failure or intolerance to generic plan‑preferred fidaxomicin tablets.

Approval duration

Initial: up to 10 days; Reauthorization: up to 1 month