ItraconazoleAPO-ITRACONAZOLE
Treatment of systemic mycoses including systemic aspergillosis, systemic sporotrichosis, systemic histoplasmosis, disseminated pulmonary histoplasmosis infection, chronic pulmonary histoplasmosis infection, oropharyngeal candidiasis, and oesophageal candidiasis.
Decisions on record
- Meeting Nov 2015 Recommended Systemic fungal infections
- Meeting Nov 2014 Not recommended 50 mg capsule, 60 Lozanoc® Mayne Pharma International Ltd New listing (Minor submission) Systemic fungal infections Authority Required (STREAMLINED) listing of a 50 mg capsule for the same indications as the currently PBS listed 100 mg capsule. Sponsor Comment: The sponsor strongly disagrees with th
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- TGA registered · APO-ITRACONAZOLE
TGA label narrower than the PBS population
- Nov 2014Not recommended
Data demonstrating comparative efficacy and safety not provided, lack of bioequivalence statement, risk of prescriber…
- ↻ resubmittedNov 2015Recommended · restricted
Comparator changed: itraconazole 100 mg → itraconazole 100 mg capsule
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the Authority Required (Streamlined) listing of itraconazole 50mg capsule for the same indications (systemic aspergillosis, systemic sporotrichosis, systemic histoplasmosis, disseminated pulmonary histoplasmosis infection, chronic pulmonary histoplasmosis infection, oropharyngeal candidiasis, and oesophageal candidiasis) and with same restriction rules as they currently apply to the PBS-listed itraconazole 100mg capsule.PSD · Nov 2015
7.2 The PBAC noted that the submission partially addressed the issues raised by the Committee from previous submission considered at the November 2014 meeting.PSD · Nov 2015
6.13 No economic comparison was presented. In the spreadsheet with the submission, the sponsor requested an equivalent pack price to itraconazole 100 mg.PSD · Nov 2015
6.11 The submission claimed non-inferiority to itraconazole 100 mg at a dose of 200 mg daily for the treatment of moderate to severe onychomycosis of the toenail for the three primary endpoints at week 24 and superior to placebo for each of the three primary endpoints at week 24.PSD · Nov 2015
6.12 The submission states that ‘the only clinical study available is in superficial mycoses and not systemic mycoses’ (pg 18 of the re-submission) and …and in order for an orally administered drug to be effective for a superficial infection there must be systemic absorption at least equivalent to itraconazole 100 mg, thus further supporting the therapeutic equivalence statement’ (pg 22 of the re-submission).PSD · Nov 2015
6.2 The PBAC noted and welcomed the input from health care professionals (3) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with itraconazole 50 mg including better absorption and less variability in measured blood concentrations.PSD · Nov 2015
Cost-effectiveness
Minor submission with no economic evaluation; cost-minimisation analysis not applicable as this is a therapeutic equivalence submission.
Decision context
PopulationPatients with systemic mycoses including aspergillosis, sporotrichosis, histoplasmosis, candidiasis (oropharyngeal and oesophageal in immunosuppressed patients, and pulmonary/disseminated forms in AIDS patients).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended · restricted | itraconazole 100 mg capsule | — | RCT · Mycological cure, clinical cure, therapeutic cure |
| Nov 2014 | Not recommended | itraconazole 100 mg | — | Cost-minimisation |
Consumer voice
Three healthcare professionals submitted comments describing benefits of itraconazole 50 mg treatment, including better absorption, less variability in blood concentrations, and improved patient outcomes in both serious invasive fungal disease and superficial fungal infections across hospital and primary care settings.
The comments described a range of benefits of treatment with itraconazole 50 mg including better absorption and less variability in measured blood concentrations. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to systemic mycoses only, excluding superficial dermatomycoses and Pityriasis versicolour covered by TGA label.