Tenofovir Disoproxil Fumarate With Emtricitabine And Efavirenz; Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine; Tenofovir Disoproxil Fumarate With Emtricitabine, Elvitegravir And Cobicistat
Treatment of HIV-1 infection in adults. These are fixed-dose combination products containing tenofovir with emtricitabine and various third agents (efavirenz, rilpivirine, or elvitegravir/cobicistat).
From the public summary
3.1 The PBAC considered each of the issues raised in the sponsor’s submission datedPSD · Mar 2019
7 March 2019, as well as correspondence from the Department to the sponsor datedPSD · Mar 2019
Cost-effectiveness
Not applicable — this is a delisting review, not a health economic evaluation of a new indication or formulation. No ICER was calculated.
The PBAC advised there were no reasons why the Delegate should not revoke the declarations that Atripla, Eviplera and Stribild are drugs to which Part VII of the Act applies. PBAC · 2019
Decision context
PopulationAdults with HIV-1 infection currently treated with Atripla, Eviplera, or Stribild who have demonstrated reluctance to switch to alternative therapies, particularly newer PBS-listed therapies containing tenofovir alafenamide.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2019 | Deferred | — | — | Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to adults currently treated with these agents showing reluctance to switch, versus TGA's broader treatment indication for all HIV-1 adults.