RifampicinRifadin
Recommended Infectious diseaseAuthority Required
Treatment of Mycobacterium ulcerans infection (Buruli ulcer) in combination with another antibiotic.
1
Submissions
2020–20
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Sep 2020 Recommended Mycobacterium ulcerans infections (Buruli ulcer)
- Meeting Jul 2020 Deferred For the treatment of Mycobacterium ulcerans infections (Buruli ulcer) no PSD
Access path
- TGA registered · Rifadin
TGA label equal than the PBS population
- Sep 2020Recommended · restricted
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC deferred making a recommendation to change the listing of rifampicin on the PBS as the TGA Delegate’s Overview was not available at the time of consideration.PSD · Sep 2020
However, the PBAC was of a mind to recommend the Authority Required (Telephone/Electronic/Emergency) listing of rifampicin for the treatment of Mycobacterium ulcerans infection (Buruli ulcer) if the TGA approves the new indication.PSD · Sep 2020
Consumer comments
4.3 The minor submission presented a Clinical Review that was written by an infectious diseases physician. The report was completed on 29 October 2019 and provided to Alphapharm Pty Ltd to facilitate that sponsor’s development of a submission to the TGA to extend the indication of rifampicin to include treatment of patients with Buruli ulcer.PSD · Sep 2020
Cost-effectiveness
No economic evaluation or ICER calculated. This is a minor submission (extension of indication to an already-listed drug with no new economic model).
Decision context
PopulationPatients with Mycobacterium ulcerans infection (Buruli ulcer) requiring treatment in combination with another antibiotic.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Sep 2020 | Recommended · restricted | — | — | Single-arm |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify rifampicin for Buruli ulcer in combination with another antibiotic; PBAC recommendation directly aligns with TGA label requirement.