Cobicistat + Elvitegravir + Emtricitabine + Tenofovir
Treatment of HIV infection in patients with CD4 count less than 500 per cubic millimetre or symptomatic HIV disease, in both treatment-naïve and treatment-experienced patients.
Access path
- Mar 2013Recommended · restricted
vs Atripla (tenofovir/emtricitabine/efavirenz)
- PBS listing · Authority Required
Cost-effectiveness
Cost-minimisation analysis; no numeric ICER calculated. PBAC recommended listing on a cost-minimisation basis with Atripla with a cost-offset for increased renal monitoring.
The PBAC did not accept the economic analysis, which was based on the components being administered concurrently (excepting cobicistat, which was included at no extra cost), was appropriate in view of the lack of conclusive non-inferiority with the components and that, in practice, the true comparator would be Atripla. PBAC · 2013
Decision context
PopulationTreatment-naïve and treatment-experienced HIV-1 patients with CD4 count less than 500 per cubic millimetre or symptomatic HIV disease.
Risk sharingSponsor commitment to continued monitoring of the risk of renal adverse events as part of ongoing post-marketing agreements.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2013 | Recommended · restricted | Atripla (tenofovir/emtricitabine/efavirenz) | — | RCT · Virological response |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to CD4 <500/mm³ or symptomatic disease; TGA label includes all treatment-naïve adults without CD4 threshold.