PBAC's latest decision on Raltegravir: Deferred (2017). Considered for Treatment of HIV-1 infection in combination with other antiretroviral therapy. The submission sought listing for treatment-naïve patients, treatment-experienced patients, and patients virologically suppressed on raltegravir 400 mg twice daily.
PBAC outcome
Deferred
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2008
Submissions
2
2008 → 2017
Eligible population
HIV-1 infected patients (treatment-naïve and treatment-experienced) who weigh >40 kg, including patients virologically suppressed on raltegravir 400 mg twice daily, treated in combination with other antiretroviral therapy.
Therapy area
Infectious disease
Line of therapy
Any
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
797 patients
Key trials
PN292
Comparator
raltegravir 400 mg tablets twice daily
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis; no ICER calculated by design. The submission established equi-effective doses (raltegravir 1200 mg once daily versus 400 mg twice daily) with identical daily treatment costs ($7,978.66 per patient per year).
ICER (historical)
$45k/QALY–$75k/QALY in an earlier submission (2008) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Mar 2008: Recommended with restriction · Authority Required — ICER $75k/QALY