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Peginterferon Alfa-2a, Ribavirin

Deferred HepatologyAuthority RequiredLater-line line

Treatment of chronic hepatitis C in patients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated).

1
Submissions
2010–10
On the record
—
ICER range
Cost-min
Cost basis

Decisions on record

3 decisions
  • Meeting Nov 2012 Deferred Chronic hepatitis C
  • Meeting Jul 2010 Recommended Hepatitis C
  • Meeting Jul 2009 Not recommended Hepatitis C no PSD

Access path

1 submission · public record
  1. Jul 2010
    Recommended · restricted

    vs peginterferon alfa-2b plus ribavirin (Pegatron CT)

  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

Cost-minimisation analysis performed; no ICER calculated

The PBAC noted that the evidence for the comparative effectiveness of Pegasys RBV versus Pegatron CT for a treatment course of 48 weeks in genotype 1, 2, 3 and 4 infection, in both non-responders and relapsers to pegylated interferon plus ribavirin, who are likely to represent the majority of re-treated patients in Australia, is derived from non-comparative studies, with considerable potential for confounding and major biases. Nonetheless, the Committee accepted that it was very unlikely that Pegasys RBV would be less effective than Pegatron CT. PBAC · 2010
No head-to-head trialCost-effectiveness accepted

Decision context

PopulationPatients who have failed one prior attempt at interferon based therapies (non-pegylated or pegylated).

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2010 Recommended · restricted peginterferon alfa-2b plus ribavirin (Pegatron CT) — RCT, non-comparative studies · SVR

Clinical evidence

Trials cited in the PSDs · ClinicalTrials.gov
TrialPhaseNPrimary outcomeStatus
HALT-C Ph 3 1,050 Progression of Liver Disease as Indicated by Death, Hepatic Decompensation, Hepatocellular… completed

Similar precedents

By decision profile
Peginterferon Alfa-2b86%Peginterferon Alfa-2a79%Ribavirin78%Boceprevir And Ribavirin And Peginterferon Alfa-2b77%Ribavirin And Peginterferon Alfa-2b75%Boceprevir73%Telaprevir73%Sofosbuvir72%

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to patients who failed one prior interferon attempt; TGA label includes both treatment-naïve and treatment-experienced patients.