Telaprevir
Treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment naïve or have previously been treated with interferon based therapies.
Decisions on record
- Meeting Jul 2012 Recommended Hepatitis C
- Meeting Mar 2012 Deferred Hepatitis C
- Meeting Nov 2011 Not recommended Hepatitis C
Access path
- Nov 2011Not recommended
vs peginterferon alfa and ribavirin (PR) without a direct…
- ↻ resubmittedMar 2012Recommended · restricted
Comparator changed: peginterferon alfa and ribavirin (PR) without a direct acting…
- Mar 2012Recommended · restricted
Comparator changed: peginterferon alfa and ribavirin (PR) without a direct acting…
- Jul 2012Recommended · restricted
Comparator changed: peginterferon alfa and ribavirin alone → peginterferon alfa and…
- PBS listing
From the public summary
The submission stated that the changes to the economic model were: Re-infection with Hepatitis C was included in the base case – assumed 1.8% of patients with an SVR are re-infected at two years; (At its March 2012 meeting the PBAC suggested that for treatment experienced CHC patients, the possiblility of reinfection among patients who achieve a SVR should be included in the economic evaluation) Incorporated a week 24 PR stopping rule (based on the …PSD · Jul 2012
The submission presented revised base case cost-effectiveness results over 60 years for treatment naïve between $15,000 - $45,000/QALY and for treatment experienced between $15,000 - $45,000/QALY. No change was made to the 60 year lifetime horizon of the model. For PBAC’s view, see Recommendation and Reasons.PSD · Jul 2012
Cost-effectiveness
ICER not stated in the provided text. Economic analysis section begins but is incomplete in the excerpt provided.
The PBAC considered that the appropriateness of the requested restriction was uncertain noting that evaluation by the TGA was still in process and the final indication, recommended treatment duration with peg/interferon and ribavirin, and the number of quantitative hepatitis C virus (HCV) RNA assays required were all factors that will inform the appropriateness of the requested restriction. PBAC · 2011
Decision context
PopulationTreatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including cirrhosis, who are treatment naïve or have previously been treated with interferon based therapies.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2012 | Recommended · restricted | peginterferon alfa and ribavirin alone for 48 weeks | — | RCT · SVR24 |
| Mar 2012 | Recommended · restricted | peginterferon alfa and ribavirin alone for 48 weeks | — | RCT · SVR24 |
| Mar 2012 | Recommended · restricted | peginterferon alfa and ribavirin alone | — | RCT · SVR |
| Nov 2011 | Not recommended | peginterferon alfa and ribavirin (PR) without a direct acting antiviral agent; placebo or no active treatment for patien | $15k–45k | RCT · SVR24 |
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both specify genotype 1 chronic hepatitis C in compensated liver disease, treatment naïve or interferon-pretreated adults.