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Boceprevir

Recommended HepatologyAuthority Required | Public Hospital Authority Required (Streamlined)First-line | Later-line line 💬 consumer voice

treatment, managed by an accredited treatment centre, of chronic hepatitis C genotype 1 infection in combination with peginterferon alfa and ribavirin in patients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C

4
Submissions
3 resub
2011–12
On the record
$15k–45k
ICER range
4 sourced ICERs · 2011–2012
ICER stated
Cost basis
risk sharing

Decisions on record

3 decisions
  • Meeting Jul 2012 Recommended Hepatitis C
  • Meeting Mar 2012 Deferred Hepatitis C
  • Meeting Jul 2011 Not recommended Hepatitis C

Access path

4 submissions · public record
  1. Jul 2011
    Not recommended

    uncertain cost effectiveness, omission of hepatitis C virus complications for SVR patients in economic model, uncertain…

  2. ↻ resubmitted
    Mar 2012
    Recommended

    Comparator changed: peginterferon alfa and ribavirin → peginterferon alfa and ribavirin…

  3. Mar 2012
    Recommended · restricted

    Comparator changed: peginterferon alfa and ribavirin → peginterferon alfa and ribavirin…

  4. Jul 2012
    Recommended · restricted

    Comparator changed: peginterferon alfa and ribavirin (standard of care) for up to 48…

  5. PBS listing · Authority Required | Public Hospital Authority Required (Streamlined)
RecommendedDeferredNot recommended

Cost-effectiveness

4 sourced ICERs · 2011–2012
The PBAC noted that the only update to the economic model in this minor submission from the March 2012 submission was a reduction in price. The price reduction resulted in revised base case ICERs at a 50 year time horizon of $15,000- $45,000 per QALY for treatment naive patients and $15,000- $45,000 per QALY for treatment experienced patients (both reduced though in the same range from the March 2012 submission) The PBAC considered that the uncertainties with the economic model identified in March 2012 remained and therefore the resulting cost effectiveness of boceprevir/PR was uncertain. PBAC · 2012
ICER uncertain ×2Economic model disputed ×2Cost-effectiveness accepted

Decision context

Populationpatients 18 years or older who have compensated liver disease and who have received no prior interferon alfa or peginterferon alfa treatment for hepatitis C

Risk sharingThe PBAC recommended that the sponsors of boceprevir and telaprevir rebate to the Government 100 % of the cost of telaprevir and boceprevir above the estimates accepted by the PBAC.

Submission history

4 entries
DecidedOutcomeComparatorICEREvidence
Jul 2012 Recommended · restricted peginterferon alfa with ribavirin $15k–45k
Mar 2012 Recommended peginterferon alfa and ribavirin alone for up to 48 weeks $15k–45k RCT · Sustained virological response (SVR)
Mar 2012 Recommended · restricted peginterferon alfa and ribavirin (standard of care) for up to 48 weeks $15k–45k RCT · SVR
Jul 2011 Not recommended peginterferon alfa and ribavirin $15k–45k RCT · Sustained virological response (SVR)

Consumer voice

Jul 2012

The PBAC acknowledged and noted consumer comments on the boceprevir submission, though specific details of the consumer input were not elaborated in the document.

The PBAC acknowledged and noted the consumer comments on this item. Consumer comments · PSD

Similar precedents

By decision profile

Regulatory · TGA

Label narrower than PBS population — PBAC restricts to treatment-naïve patients (no prior interferon), compensated liver disease, age ≥18, and specific combination therapy requirement.