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Tipranavir

Recommended Infectious diseaseRestrictedLater-line line

Treatment, in combination with other antiretroviral agents and co-administered with 200 mg ritonavir twice daily, of HIV infection in antiretroviral experienced adults with: (a) Evidence of HIV replication (viral load greater than 10,000 copies per mL); or (b) CD4 cell counts of less than 500 per cubic millimetre. Patients must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included: i) at least 1 non-nucleoside reverse transcriptase inhibitor; and ii) at least 1 nucleoside reverse transcriptase inhibitor; and iii) at least 2 protease inhibitors.

3
Submissions
2 resub
2006–07
On the record
$15k–75k
ICER range
3 sourced ICERs · 2006–2007
ICER stated
Cost basis

Decisions on record

2 decisions
  • Meeting Mar 2010 Recommended HIV infection no PSD
  • Meeting Mar 2007 Recommended HIV-AIDS

Access path

3 submissions · public record
  1. Jul 2006
    Not recommended

    high and uncertain cost-effectiveness ratio, concerns with the model including lack of modelling of the cost of…

  2. Jul 2006
    Not recommended

    high and uncertain cost-effectiveness ratio, concerns with economic model including lack of modelling of toxicity…

  3. ↻ resubmitted
    Mar 2007
    Recommended · restricted

    ICER dropped $75,000 → $45,000 (-40%)

  4. PBS listing · Restricted
RecommendedDeferredNot recommended

Cost-effectiveness

3 sourced ICERs · 2006–2007
Both the base case modelled incremental discounted cost per extra discounted QALY and the base case incremental discounted cost per extra discounted life year gained were in the range of $45,000 - $ 75,000. PSD · 2006
Surrogate endpoint

Decision context

Populationantiretroviral experienced adults with: (a) Evidence of HIV replication (viral load greater than 10,000 copies per mL); or (b) CD4 cell counts of less than 500 per cubic millimetre. Patients must have failed previous treatment with, or have resistance to, 3 different antiretroviral regimens which have included: i) at least 1 non-nucleoside reverse transcriptase inhibitor; and ii) at least 1 nucleoside reverse transcriptase inhibitor; and iii) at least 2 protease inhibitors.

Submission history

3 entries
DecidedOutcomeComparatorICEREvidence
Mar 2007 Recommended · restricted ritonavir-boosted protease inhibitor aggregate, which includes amprenavir, indinavir, lopinavir and saquinavir $15k–45k RCT · Other
Jul 2006 Not recommended ritonavir-boosted aggregate of amprenavir, indinavir, lopinavir and saquinavir $45k–75k RCT · Treatment response and time to treatment failure
Jul 2006 Not recommended ritonavir-boosted aggregate of amprenavir, indinavir, lopinavir and saquinavir $45k–75k RCT

Similar precedents

By decision profile
Tenofovir Disoproxil Fumarate With Emtricitabine73%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride73%Darunavir72%Etravirine71%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine71%Tenofovir Alafenamide / Emtricitabine / Rilpivirine70%Abacavir Sulfate With Lamivudine70%Raltegravir69%

Regulatory · TGA

Label narrower than PBS population — PBAC specifies viral load >10,000 copies/mL or CD4 <500/mm³, plus failure of 3 specific regimen classes; TGA label is broader.