Boceprevir And Ribavirin And Peginterferon Alfa-2b
Treatment of chronic hepatitis C genotype 1 infection in adult patients (18 years and older) with compensated liver disease who are previously untreated or who have failed previous therapy.
Decision on record
- Meeting Nov 2012 Not recommended Hepatitis C
Access path
- Nov 2012Not recommended
no demonstrated clinical benefit, unmet clinical need not established, inadequate comparative clinical evidence to…
- Nov 2012Not recommended
No demonstrated clinical benefit, unmet clinical need not established, inadequate comparative clinical evidence to…
Cost-effectiveness
Cost-minimisation analysis presented but not valid; no ICER calculated
The PBAC noted the cost-minimisation analysis resulted in a net cost to the PBS due to the reduced number of patient co-payments. PBAC · 2012
Decision context
PopulationAdults aged 18 years and older with chronic hepatitis C genotype 1 infection with compensated liver disease, either treatment naïve or who have failed one prior interferon-based therapy
Why it was knocked back
- No demonstrated clinical benefit, unmet clinical need not established, inadequate comparative clinical evidence to support cost-minimisation claim, no clinical data presented for the main comparator, potential for inappropriate ribavirin dose titration due to fixed monthly pack composition
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2012 | Not recommended | boceprevir plus Pegatron given as the two individual component packs | — | RCT · Sustained virological response |
| Nov 2012 | Not recommended | boceprevir plus Pegatron (ribavirin and peginterferon alfa-2b) given as the two individual component packs | — | RCT · SVR |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to interferon-naïve or interferon-experienced patients, whereas TGA label includes all previously untreated or treatment-failed patients.