PBAC's latest decision on Darunavir: Not recommended (2010). Considered for treatment in combination with other antiretroviral agents, and co-administered with 100 mg ritonavir once daily, of HIV infection in a protease inhibitor naïve patient with: (a) evidence of HIV replication (viral load greater than 10,000 copies per mL); and/or (b) CD4 cell counts of less than 500 per cubic millimetre.
PBAC outcome
Not recommended
2010
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2007
Submissions
2
2007 → 2010
Eligible population
treatment naïve and protease inhibitor naïve patients
Cost-minimisation analysis presented, but PBAC rejected submission before economic evaluation could be completed due to inappropriate comparator choice and absence of efficacy/safety data versus the appropriate comparator (atazanavir).
ICER (historical)
$15k/QALY–$45k/QALY in an earlier submission (2007) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Why PBAC said no
Reasons cited in the latest PSD: Inappropriate choice of comparator (lopinavir instead of atazanavir); absence of clinical and cost-effectiveness data comparing darunavir versus atazanavir (the appropriate comparator per current treatment guidelines); no evidence from direct or indirect comparison of atazanavir with boosted darunavir in treatment naïve and PI naïve patients