PBAC's latest decision on Tipranavir: Recommended with restriction (2007). Considered for 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.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
$45k/QALY
$15k/QALY–$45k/QALY · across 2 submissions
Submissions
2
first 2006
Submissions
2
2006 → 2007
Eligible population
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.
Therapy area
Infectious disease
Line of therapy
Later-line
Evidence base
RCT
Primary endpoint
Other
Key trials
RESIST
Comparator
ritonavir-boosted protease inhibitor aggregate, which includes amprenavir, indinavir, lopinavir and saquinavir
Economic model
CUA
Budget impact
$10M
ICER basis
Range aggregates 2 submissions (2006–2007) — not a single base case.
Submission history
Jul 2006: Not recommended — ICER $75k/QALY
Mar 2007: Recommended with restriction · Restricted — ICER $45k/QALY