VoriconazoleVfend
Prophylaxis of invasive fungal infections, including yeasts and moulds, in patients at high risk of developing such infections (specifically in AML/MDS patients with anticipated neutropenia, GVHD patients with acute or extensive chronic disease, and high-risk allogeneic haematopoietic stem cell transplant recipients).
Decisions on record
- Meeting Mar 2014 Recommended Vfend® Pfizer Australia Pty Ltd Fungal Infection To request an Authority Required listing for prophylaxis of invasive fungal infections, including both yeasts and moulds, in a patient who is at high risk of developing these infections. In the AML/MDS high risk patient population, the PBAC recommende
- Meeting Jul 2009 Recommended Antifungal no PSD
Access path
- TGA registered · Vfend
TGA label narrower than the PBS population
- Mar 2014Recommended · restricted
vs posaconazole
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended an extension to the listing of voriconazole to include an Authority required listing for prophylaxis against invasive fungal infections in the high risk patients groups of acute myeloid leukaemia (AML); high-risk myelodysplastic syndrome (MDS); Graft versus host disease (GVHD); and high risk allogeneic haematopoietic stem cell transplant (AlloHSCT) recipients.PSD · Mar 2014
7.2 The PBAC’s recommendation was on a cost minimisation basis against a weighted mixed comparator of posaconazole, fluconazole and itraconazole in the GVHD and 10PSD · Mar 2014
The submission presented a cost-minimisation analysis. The analysis included the main comparator, posaconazole, and the secondary comparators, fluconazole and itraconazole.PSD · Mar 2014
The equi-effective doses were estimated as voriconazole 200 mg twice a day is equal to: posaconazole 200 mg three times a day; fluconazole 400 mg once daily; and itraconazole 200 mg twice a day.PSD · Mar 2014
6.12 The submission claimed non-inferiority between voriconazole and posaconazole in terms of comparative effectiveness (incidence of proven or probable invasive fungal infection and all-cause mortality) and safety in high-risk patient populations (AML/MDS, GVHD, high-risk AlloHSCT).PSD · Mar 2014
6.13 The PBAC considered that despite the various factors that made the comparison of the clinical trials difficult to interpret, the submission’s clinical claim was likely to be reasonable.PSD · Mar 2014
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The submission presented a cost-minimisation analysis. PSD · 2014
Decision context
PopulationPatients at high risk of invasive fungal infections: (1) acute myeloid leukaemia or high-risk myelodysplastic syndrome patients with anticipated neutropenia (absolute neutrophil count <500 cells/mm³) for ≥10 days receiving chemotherapy; (2) patients with acute GVHD grades II–IV or extensive chronic GVHD receiving intensive immunosuppressive therapy after allogeneic haematopoietic stem cell transplant; (3) high-risk AlloHSCT recipients (cord blood, unrelated donor transplant with bone marrow source, or likely delayed engraftment).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Recommended · restricted | posaconazole | — | Meta-analysis · Incidence of proven or probable invasive fungal infection; all-cause mortality |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific haematologic malignancies and transplant populations; TGA label covers all patients at high risk of invasive fungal infections.