Emtricitabine + Tenofovir Alafenamide
Recommended · restricted Infectious diseaseAuthority Required
Treatment of human immunodeficiency virus (HIV) infection in treatment-naïve and treatment-experienced patients, administered in combination with other antiretroviral agents.
1
Submissions
1 resub
2016–16
On the record
—
ICER range
Cost-min
Cost basis
Access path
- Nov 2016Recommended · restricted
vs Truvada®
- PBS listing · Authority Required
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
4.1 The PBAC recommended the listing of emtricitabine + tenofovir alafenamide as a Section 100 (community access): Authority Required (STREAMLINED) listing for treatment-naïve and treatment-experienced patients with human immunodeficiency virus (HIV) on a cost-minimisation basis to Truvada®.PSD · Nov 2016
4.2 The PBAC noted the evidence presented by the sponsor that indicated tenofovir alafenamide and tenofovir disoproxil fumarate had differences in relation to dose, plasma stability, and metabolism. On this basis, the PBAC considered that tenofovir alafenamide should be considered different drug to tenofovir for the purposes of section 85(2) of the Act.PSD · Nov 2016
Cost-effectiveness
Cost-minimisation analysis conducted; no incremental ICER calculated
Cost-effectiveness accepted
Decision context
PopulationTreatment-naïve patients and treatment-experienced patients with HIV infection receiving combination antiretroviral therapy
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended · restricted | Truvada® | — | Cost-minimisation · Cost-minimisation |
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