Cobicistat
Not recommended Infectious diseaseNot applicableNot applicable line
Treatment of HIV-infected patients as a pharmacokinetic enhancer of atazanavir.
1
Submissions
2013–13
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
Comparative effectiveness
The PBAC considered that as cobicistat has no intrinsic anti-retroviral activity and is only clinically indicated as a component in a combination product for which there is a separate application regimen. The clinical need for cobicistat as a single-ingredient was not established.PSD · Jul 2013
Furthermore, the PBAC noted that cobicistat has no current place in published recommended treatment guidelines outside of its use in the combination product Stribild (cobicistat+elvitegravir+emtricitabine+tenofovir).PSD · Jul 2013
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated as submission was based on non-inferiority claim.
The submission presented a cost-minimisation analysis based on a claim of non-inferiority for virological outcome. PSD · 2013
Surrogate endpoint
Decision context
PopulationHIV-infected patients as a pharmacokinetic enhancer of atazanavir, proposed without restriction on treatment experience.
Why it was knocked back
- Unclear clinical need for cobicistat as a single-ingredient product, inadequate evidence to support non-inferior comparative effectiveness and safety claim, no current place in published treatment guidelines outside of combination product Stribild, trial population not consistent with proposed PBS population (all treatment-naïve), small trial size, limited duration (48 weeks), partial support for safety non-inferiority claim, viral load as sole outcome not appropriate for a pharmacokinetic enhancer with no intrinsic antiretroviral activity
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2013 | Not recommended | ritonavir | — | RCT · Virological response (HIV-1 RNA < 50 copies/mL at Week 48) |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to atazanavir specifically, while TGA label permits any appropriate HIV-1 protease inhibitor.