PosaconazoleAKM Posaconazole
Treatment of invasive aspergillosis, fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, and mycetoma in patients intolerant of or refractory to alternative therapy; and prophylaxis of invasive fungal infections in patients at high risk.
Decisions on record
- Meeting Mar 2015 Recommended Fungal infections
- Meeting Nov 2012 Not recommended Antifungal no PSD
- Meeting Mar 2010 Not recommended Anti-infective no PSD
- Meeting Mar 2008 Recommended Anti Fungal
Access path
- TGA registered · AKM Posaconazole
TGA label narrower than the PBS population
- Jul 2006Recommended · restricted
Comparator changed: other salvage therapies (caspofungin, amphotericin B lipid complex)…
- Jul 2006Recommended · restricted
Comparator changed: other salvage therapies (caspofungin, amphotericin B lipid complex)…
- Mar 2008Recommended · restricted
Comparator changed: other salvage therapies (including voriconazole, caspofungin, and…
- Mar 2015Recommended
Comparator changed: fluconazole and itraconazole → posaconazole oral liquid formulation
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of posaconazole tablets, on the basis that it should be available as an Authority Required item on the General Schedule for both prophylaxis and treatment of invasive fungal infections.PSD · Mar 2015
6.2 The PBAC is satisfied that posaconazole tablets provide the same benefits as seen with posaconazole liquid but with the potential for greater ease of administration as the tablet formulation does not need to be taken with food.PSD · Mar 2015
5.4 Due to the differing treatment regimens between the liquid and tablet preparations, it is not possible to calculate equi-effective doses or a simple comparative price per milligram.PSD · Mar 2015
5.5 The minor submission instead presented an economic evaluation based on a 10% sample of Medicare data to evaluate the proportion of use of posaconazole in prophylaxis compared to treatment, estimating a proportion of patients requiring a loading dose and calculating patient co-payments to estimate the average days of therapy per pack and price per day.PSD · Mar 2015
Cost-effectiveness
Minor submission with no formal economic evaluation or ICER calculation. Cost-neutrality was claimed based on ad hoc analysis of Medicare data.
The submission proposed that the listing of posaconazole tablets will be cost neutral. PSD · 2015
Decision context
PopulationPatients aged 13 years or older with invasive fungal infections (aspergillosis, fusariosis, zygomycosis, coccidioidomycosis, chromoblastomycosis, mycetoma) intolerant of or refractory to alternative therapy, or at high risk of invasive fungal infection due to anticipated neutropenia or acute/chronic graft versus host disease.
Risk sharingPBAC recommended that financial risks to the Commonwealth should be managed through a risk share agreement with the sponsor or through a reduction in price of the tablet formulation, due to concerns about utilisation potentially exceeding restrictions.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2015 | Recommended | posaconazole oral liquid formulation | — | Other |
| Mar 2008 | Recommended · restricted | fluconazole and itraconazole | — | RCT |
| Jul 2006 | Recommended · restricted | other salvage therapies (caspofungin, amphotericin B lipid complex); voriconazole | $15k–75k | Single-arm |
| Jul 2006 | Recommended · restricted | other salvage therapies (including voriconazole, caspofungin, and amphotericin B lipid complex) | $15k–75k | Single-arm |
Consumer voice
No consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients aged 13 years or older; TGA label contains no age restriction.