Boceprevir and ribavirin and peginterferon alfa-2b
PBAC's latest decision on Boceprevir and ribavirin and peginterferon alfa-2b: Not recommended (2012). Considered for treatment of chronic hepatitis C in treatment naïve and treatment experienced patients aged 18 years and older who meet certain criteria.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2012
Submissions
1
2012 → 2012
Eligible population
patients naïve to interferon based therapies (non-pegylated or pegylated) or who have failed prior attempts at interferon based therapies, aged 18 years and older with compensated liver disease and genotype 1 chronic hepatitis C
Therapy area
Hepatology
Line of therapy
Second-line | Later-line
Evidence base
RCT
Primary endpoint
Sustained virological response
Key trials
Trial 216, Trial 101
Comparator
boceprevir plus Pegatron given as the two individual component packs
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis presented but not valid due to lack of supporting clinical evidence for non-inferiority claim
Why PBAC said no
Reasons cited in the latest PSD: no demonstrated clinical benefit, unmet clinical need not established, inadequate comparative clinical evidence to support cost-minimisation claim, potential for suboptimal ribavirin dose titration, unnecessary proliferation of dose forms