PBAC's latest decision on Itraconazole: Recommended with restriction (2015). Considered for Treatment of systemic mycoses including systemic aspergillosis, systemic sporotrichosis, systemic histoplasmosis, disseminated pulmonary histoplasmosis infection, chronic pulmonary histoplasmosis infection, oropharyngeal candidiasis, and oesophageal candidiasis.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2014
Submissions
2
2014 → 2015
Eligible population
Patients with systemic mycoses including aspergillosis, sporotrichosis, histoplasmosis, candidiasis (oropharyngeal and oesophageal in immunosuppressed patients, and pulmonary/disseminated forms in AIDS patients).
Therapy area
Infectious disease
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Mycological cure, clinical cure, therapeutic cure
Pivotal trial size
175 patients
Key trials
HGN007, HGN008, 70850702
Comparator
itraconazole 100 mg capsule
Economic model
Cost-minimisation
ICER note
Minor submission with no economic evaluation; cost-minimisation analysis not applicable as this is a therapeutic equivalence submission.
Submission history
Nov 2014: Not recommended · Not applicable
Nov 2015: Recommended with restriction · Authority Required