Atazanavir/CobicistatEvotaz
Recommended · restricted Infectious diseaseAuthority Required
Treatment of HIV-1 infection in combination with other antiretroviral agents in treatment-naïve and treatment-experienced patients.
1
Submissions
2015–15
On the record
—
ICER range
Cost-min
Cost basis
Access path
- TGA registered · Evotaz
TGA label equal than the PBS population
- Nov 2015Recommended · restricted
vs atazanavir plus ritonavir taken concomitantly
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC recommended Section 100 Highly Specialised Drugs Program (HSD) listing of atazanavir/cobicistat fixed dose combination for the treatment of HIV. The PBAC recommended the special arrangements under the HSD Community Access Program, Authority Required (STREAMLINED).PSD · Nov 2015
7.2 The PBAC recommended the listing of atazanavir/cobicistat on a cost-minimisation basis with atazanavir plus ritonavir provided concomitantly. The equi-effective doses are atazanavir 300 mg (one capsule) plus cobicistat 150 mg (one tablet) once daily over 48 weeks is equal to atazanavir 300 mg (one capsule) plus ritonavir 100 mg (one tablet) once daily over 48 weeks.PSD · Nov 2015
Economic analysis
6.17 The submission presented a cost-minimisation analysis. The submission did not provide the equi-effective dose of atazanavir/cobicistat FDC and atazanavir plus ritonavir taken concomitantly. Rather it provided the equi-effective doses for atazanavir plus cobicistat taken concomitantly and atazanavir plus ritonavir taken concomitantly, derived from the efficacy and safety trials 114 and 105. 6.18 The equi-effective doses were estimated as:PSD · Nov 2015
- Atazanavir 300 mg (one capsule) plus cobicistat 150 mg (one tablet) once daily over 48 weeks,PSD · Nov 2015
Clinical claim
6.12 The submission described atazanavir/cobicistat FDC as bioequivalent to atazanavir plus cobicistat and described atazanavir plus cobicistat as non-inferior in terms of comparative effectiveness to atazanavir plus ritonavir taken concomitantly.PSD · Nov 2015
6.13 The submission did not provide direct clinical evidence comparing atazanavir/cobicistat FDC and atazanavir plus ritonavir taken concomitantly, rather it provided bridging evidence:PSD · Nov 2015
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC recommended the listing of atazanavir/cobicistat on a cost-minimisation basis with atazanavir plus ritonavir provided concomitantly. PBAC · 2015
Cost-effectiveness accepted
Decision context
PopulationAdults with HIV-1 infection, treatment-naïve and treatment-experienced patients, in combination with other antiretroviral agents.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended · restricted | atazanavir plus ritonavir taken concomitantly | — | RCT · Virologic_success |
Similar precedents
Darunavir + Cobicistat77%Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide77%Emtricitabine + Tenofovir Alafenamide75%Bictegravir + Emtricitabine + Tenofovir Alafenamide75%Cobicistat75%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine74%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride73%Tenofovir Alafenamide / Emtricitabine74%
Regulatory · TGA
Label equal than PBS population — Both TGA label and PBAC recommendation cover all adults with HIV-1 infection in combination with other antiretrovirals, regardless of treatment history.