Tenofovir Alafenamide / Emtricitabine

7.1 The PBAC deferred making a recommendation on whether tenofovir alafenamide with emtricitabine 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. The PBAC noted that the Department is progressing its view about those matters, and that they are 11PSD · Jul 2016

6.23 Given the recommended dose of tenofovir alafenamide is based on the concomitant administration of a pharmacokinetic booster in the anti-retroviral therapy regimen, the equi-effective doses are estimated as:  Descovy® (emtricitabine 200 mg / tenofovir alafenamide 10 mg) in a pharmacokinetic boosted regimen;  Descovy® (emtricitabine 200 mg / tenofovir alafenamide 25 mg) in an un-boosted pharmacokinetic regimen;  Truvada® (emtricitabine 200 mg / …PSD · Jul 2016

6.24 The submission presented a cost-minimisation analysis based on drug cost only. No differences were assumed in the utilisation of other healthcare resources.PSD · Jul 2016

6.19 The submission described Descovy® as non-inferior in terms of comparative effectiveness and “favourable” in terms of comparative safety over Truvada® on the basis of renal and bone related toxicity.PSD · Jul 2016

6.20 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Jul 2016