PBAC's latest decision on Adefovir dipivoxil: Recommended with restriction (2007). Considered for Chronic hepatitis B in patients who have failed antihepadnaviral therapy, with the ability to use adefovir in combination with lamivudine in lamivudine-resistant patients.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
4
first 2006
Submissions
4
2006 → 2007
Eligible population
Adults with chronic hepatitis B who have failed antihepadnaviral therapy, including lamivudine-resistant patients who can receive adefovir in combination with lamivudine.
Therapy area
Hepatology
Line of therapy
Second-line
Evidence base
RCT
Primary endpoint
Other
Key trials
Lampertico et al (2007), Schiff et al (2007), Thiebault et al (2005), Fung et al (2005), Yeon et al (2006), Lee et al (2006), Chen et al (2006), Van der Poorten et al (2006), Rapti et al (2007), Colonno et al (2007), Jardi et al (2006)
Comparator
adefovir monotherapy
Economic model
Cost-minimisation
Budget impact
$10M
Eligible patients/year
6,000
ICER note
Cost-minimisation analysis based on cost offsets; no formal ICER calculated. PBAC noted cost offsets remained uncertain despite two models being presented.
ICER (historical)
$45k/QALY–$75k/QALY across 3 submissions (2006–2007) — the latest submission carried no numeric base case. No single PSD states this combined range; see source PSDs.
Submission history
Jul 2006: Not recommended — ICER $75k/QALY
Jul 2006: Not recommended — ICER $75k/QALY
Mar 2007: Not recommended — ICER $75k/QALY
Nov 2007: Recommended with restriction · Restricted