Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide
Recommended · restricted Infectious diseaseAuthority RequiredFirst-line line
Treatment of HIV-1 infection in treatment-naïve patients and treatment-experienced patients with a clinical indication to switch components of therapy.
1
Submissions
2015–15
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Nov 2015Recommended · restricted
vs elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil…
- 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 elvitegravir with cobicistat, emtricitabine and tenofovir alafenamide (EVG/c/FTC/tenofovir alafenamide) fixed dose combination for the treatment of HIV.PSD · Nov 2015
The PBAC recommended the special arrangements under the HSD Community Access, Authority Required (STREAMLINED).PSD · Nov 2015
Economic analysis
6.21 The equi-effective doses were estimated as: elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg (EVG/c/FTC/tenofovir alafenamide) in a FDC product, once daily; and elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EVG/c/FTC/tenofovir DF) in a FDC product, once daily.PSD · Nov 2015
6.22 The cost-minimisation analysis only included the cost of drug acquisition. The submission considered there would be no additional cost consequences of listing EVG/c/FTC/tenofovir alafenamide. This was reasonable.PSD · Nov 2015
Clinical claim
6.15 The submission described EVG/c/FTC/tenofovir alafenamide as non-inferior in terms of comparative effectiveness and favourable in terms of comparative safety over EVG/c/FTC/tenofovir DF in treatment-naïve patients and non-inferior in terms of comparative effectiveness and safety over FTC/tenofovir DF plus third agent regimens in treatment-experienced patients.PSD · Nov 2015
6.16 The claims of non-inferiority in terms of comparative effectiveness in treatment-naïve and treatment-experienced patients were adequately supported.PSD · Nov 2015
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated.
Decision context
PopulationTreatment-naïve HIV-1 positive adults and paediatric patients 12 years and older without any known mutation associated with resistance to the individual components; also treatment-experienced virologically suppressed HIV-1 positive patients.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended · restricted | elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (Stribild) | — | RCT · Proportion of patients with HIV RNA < 50 copies/mL |
Similar precedents
Tenofovir Alafenamide / Emtricitabine83%Emtricitabine + Tenofovir Alafenamide82%Bictegravir + Emtricitabine + Tenofovir Alafenamide81%Cobicistat + Elvitegravir + Emtricitabine + Tenofovir81%Tenofovir Alafenamide / Emtricitabine / Rilpivirine81%Tenofovir Alafenamide, Emtricitabine, And Rilpivirine80%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride79%Atazanavir/Cobicistat77%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naïve patients and virologically suppressed treatment-experienced patients; TGA label permits all patients without resistance mutations.