Elvitegravir
Not recommended Infectious diseaseNot applicableLater-line line
Continuing treatment of HIV-1 infection in antiretroviral treatment-experienced adults and adolescents in combination with a ritonavir-boosted protease inhibitor and other antiretroviral therapy.
1
Submissions
2013–13
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
Comparative effectiveness
The PBAC noted the safety outcomes reported in Trial GS-0145 and considered that the long- term safety of elvitegravir, beyond the 96 weeks of the trial, was uncertain. The PBAC noted that longer term post-marketing surveillance with the comparator raltegravir had identified additional safety issues, and it was unclear whether these events are integrase strand transfer inhibitor class effects.PSD · Mar 2013
Overall, the PBAC concluded that based on the available data elvitegravir is probably non- inferior to raltegravir in terms of comparative safety, albeit with a different adverse event profile.PSD · Mar 2013
Cost-effectiveness
Cost-minimisation analysis presented; no ICER calculated as the submission claimed non-inferiority and identical pricing to comparator.
The PBAC noted that elvitegravir requires boosting, with co-administration with a boosted protease inhibitor featured as a requirement of the proposed TGA indication and requested PBS listing. PBAC · 2013
Decision context
PopulationTreatment-experienced adults and adolescents with HIV-1 infection receiving a ritonavir-boosted protease inhibitor and other antiretroviral agents
Why it was knocked back
- Absence of final TGA indication at time of consideration preventing identification of clinical place and appropriate PBS restriction; uncertain utilisation estimates based on unsupported assumptions; uncertain long-term safety beyond 96 weeks; unclear whether safety events identified post-marketing are class effects; high discontinuation and loss to follow-up rates in trial
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2013 | Not recommended | raltegravir | — | RCT · Virological response (HIV-1 RNA <50 copies/mL) |
Similar precedents
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide77%Raltegravir76%Bictegravir + Emtricitabine + Tenofovir Alafenamide75%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride72%Atazanavir/Cobicistat72%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine72%Etravirine72%Emtricitabine + Tenofovir Alafenamide71%
Regulatory · TGA
Label equal than PBS population — Both specify treatment-experienced adults/adolescents with HIV-1 using ritonavir-boosted PI and other antiretroviral therapy.