Tenofovir Alafenamide / Emtricitabine / Rilpivirine
Deferred Infectious diseaseAuthority RequiredFirst-line line 💬 consumer voice
Treatment of human immunodeficiency virus (HIV) infection in treatment-naïve and treatment-experienced patients.
1
Submissions
2016–16
On the record
—
ICER range
Cost-min
Cost basis
From the public summary
PBAC outcome
7.1 The PBAC deferred making a recommendation on whether tenofovir alafenamide with emtricitabine and rilpivirine should be listed in the Pharmaceutical Benefits Schedule for the treatment of HIV infection.PSD · Jul 2016
7.2 The PBAC deferred making a recommendation, noting that before doing so it wishes to hear the Department’s views on matters relevant to the question of whether tenofovir disoproxil and tenofovir alafenamide should be declared as different drugs for the purposes of the Act, rather than as tenofovir, as currently.PSD · Jul 2016
Economic analysis
6.26 The submission presented a cost-minimisation analysis. 9PSD · Jul 2016
6.27 The submission stated that one Odefsey® tablet (rilpivirine 25mg + emtricitabine 200mg + tenofovir alafenamide 25mg) and one Eviplera® tablet (tenofovir disoproxil fumarate 300 mg + emtricitabine 200 mg + rilpivirine 25 mg) once daily are equi- effective. The PBAC accepted these equi-effective doses.PSD · Jul 2016
Clinical claim
6.23 The submission described Odefsey® as non-inferior in terms of comparative efficacy and non-inferior in terms of comparative safety versus Eviplera®, with a favourable safety profile.PSD · Jul 2016
6.24 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Jul 2016
Cost-effectiveness
Cost-minimisation analysis only; no ICER calculated as submission was based on drug cost comparison only.
Decision context
PopulationTreatment-naïve and treatment-experienced HIV-1 positive patients; for treatment-naïve patients with pre-treatment HIV RNA <100,000 copies/mL and CD4 T-lymphocyte count >200 cells/mm³.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2016 | Deferred | Eviplera® | — | RCT · HIV RNA <50 |
Consumer voice
The PBAC noted that no consumer comments were received for this item.
The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD
Similar precedents
Tenofovir Alafenamide, Emtricitabine, And Rilpivirine96%Tenofovir Disoproxil Fumarate With Emtricitabine And Rilpivirine Hydrochloride85%Emtricitabine + Tenofovir Alafenamide83%Tenofovir Alafenamide / Emtricitabine83%Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide81%Tenofovir Disoproxil Fumarate With Emtricitabine79%Bictegravir + Emtricitabine + Tenofovir Alafenamide79%Tenofovir Disoproxil Fumarate With Emtricitabine / Tenofovir Disoproxil Maleate With Emtricitabine / Tenofovir Disoproxil Phosphate With Emtricitabine75%