Advice
following a full submission:
fidaxomicin (Dificlir®) is accepted for restricted use within NHS Scotland.
Indication under review: treatment of adults with Clostridium difficile infections (CDI) also known as C. difficile-associated diarrhoea (CDAD).
SMC restriction: Treatment of adults with a first CDI recurrence on the advice of local microbiologists or specialists in infectious diseases.
Fidaxomicin demonstrated non-inferiority to another antibiotic in the clinical cure of Clostridium difficile infection and superiority in reducing recurrence.
The submitting company did not present a sufficiently robust economic analysis to gain acceptance by SMC for first-line use in adults with severe CDI.
Download detailed advice288KB (PDF)
Medicine details
- Medicine name:
- fidaxomicin (Dificlir)
- SMC ID:
- 791/12
- Indication:
- Treatment of clostridim difficile infections (CDI) also known as C. Difficile-associated diarrhoea (CDAD)
- Pharmaceutical company
- Astellas Pharma Ltd
- BNF chapter
- Infections
- Submission type
- Full
- Status
- Restricted
- Date advice published
- 09 July 2012