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Darunavir Ethanolate

Recommended · restricted Infectious diseaseAuthority RequiredLater-line line

Treatment of HIV-1 infection in antiretroviral treatment-experienced patients with evidence of viral replication and/or CD4 cell counts <500 cells/mm³, who have failed previous treatment with or have resistance to at least 3 different antiretroviral regimens.

1
Submissions
2007–07
On the record
$15k–45k
ICER range
1 sourced ICER · 2007
ICER stated
Cost basis

Access path

1 submission · public record
  1. Jul 2007
    Recommended · restricted

    vs tipranavir/ritonavir (primary); standard care protease…

  2. PBS listing · Authority Required
RecommendedDeferredNot recommended

Cost-effectiveness

1 sourced ICER · 2007
The PBAC noted that the submission calculated the base case modelled incremental discounted cost/extra discounted QALY for darunavir versus tipranavir to be between $15,000 - $45,000 per/QALY, which was considered acceptable by the PBAC. PBAC · 2007

Decision context

PopulationAntiretroviral treatment-experienced patients with HIV-1 infection, evidence of viral replication (viral load >10,000 copies/mL) and/or CD4 <500 cells/mm³, who have failed or are resistant to at least 3 different antiretroviral regimens including at least 2 protease inhibitors.

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Jul 2007 Recommended · restricted tipranavir/ritonavir (primary); standard care protease inhibitors (secondary) $15k–45k RCT · Virological_response