EtravirineINTELENCE
Treatment of HIV-1 infection in combination with other antiretroviral agents in antiretroviral treatment-experienced adults with evidence of viral replication and/or low CD4 cell counts who have failed or developed resistance to multiple prior regimens.
Decisions on record
- Meeting Jul 2011 Recommended HIV infection no PSD
- Meeting Mar 2009 Recommended Antiretroviral agent
Access path
- TGA registered · INTELENCE
TGA label narrower than the PBS population
- Mar 2009Recommended · restricted
vs raltegravir
- PBS listing · Authority Required
Cost-effectiveness
ICER range applies to stepped economic evaluation comparing etravirine plus OBR versus OBR alone; cost-minimisation analysis used for primary comparison with raltegravir
The PBAC noted that the submission calculated the base case modelled incremental discounted cost/extra discounted QALY for etravirine plus OBR versus OBR alone to be between $45,000 - $75,000 per /QALY. PBAC · 2009
Decision context
PopulationAntiretroviral experienced adults with HIV-1 infection with evidence of viral replication (viral load greater than 10,000 copies per mL) and/or CD4 cell counts less than 500 per cubic millimetre who have failed or developed resistance to 3 different antiretroviral regimens including at least one NNRTI, one NRTI, and one PI
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2009 | Recommended · restricted | raltegravir | $45k–75k | RCT · VL |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to specific viral load threshold (>10,000 copies/mL) and CD4 count (<500/mm³) and requires failure of 3 specific regimen classes.