PBAC's latest decision on Lenacapavir: Recommended with restriction (2023). Considered for Treatment of adults with highly multidrug-resistant HIV-1 infection in combination with optimised background regimen, for patients who have no more than 2 fully active antiretrovirals remaining from the 4 main classes that can be effectively combined to form a viable regimen.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2022
Submissions
2
2022 → 2023
Eligible population
Adults with highly multidrug-resistant HIV-1 infection who have no more than 2 fully active antiretrovirals remaining from the 4 main antiretroviral classes (NRTIs, NNRTIs, INSTIs, PIs) that can be effectively combined to form a viable treatment regimen.
Therapy area
Infectious disease
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Surrogate
Pivotal trial size
72 patients
Key trials
CAPELLA
Comparator
OBR (optimised background regimen) alone
Economic model
CUA
ICER note
ICER range redacted as commercial-in-confidence. Document states base case ICER range is $75,000 to <$95,000 per QALY; alternative base case ICER is $115,000 to <$135,000 per QALY.
ICER (historical)
$75k/QALY–$95k/QALY in an earlier submission (2023) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Nov 2022: Recommended with restriction · Authority Required
Nov 2023: Recommended with restriction · Authority Required — ICER $95k/QALY