Darunavir With Cobicistat With Emtricitabine And Tenofovir AlafenamideSYMTUZA

7.1 The PBAC recommended the Authority Required (STREAMLINED) listing of the combination drug darunavir with cobicistat with emtricitabine and tenofovir alafenamide (DRV/c/FTC/TAF, Symtuza) for the treatment of HIV infection, on the 15PSD · Nov 2019

7.2 The PBAC’s recommendation for listing was based on, among other matters, it’s assessment that the cost-effectiveness of Symtuza would be acceptable if it were cost- minimised against the following:  Prezcobix (DRV/c ); with  A mixed comparator of Truvada (FTC/TDF) and Descovy (FTC/TAF) at a relative weighting of 94:6, the latter accounting for a small patient population (6% of the total population) who are ineligible to receive a TDF-based regimen …PSD · Nov 2019

6.23 Table 8 presents a summary of the submission’s approach to the cost minimisation analysis (CMA). 11PSD · Nov 2019

Based on evidence presented in Section 2, effectiveness is assumed to be non-inferior effectiveness Therapeutic claim: safety Based on evidence presented in Section 2, safety is assumed to be non-inferior Direct comparison of Symtuza and CAR in EMERALD or Prezcobix +Truvada in AMBER and Evidence base Mills 2015 trials Symtuza (800mg darunavir/150mg cobicistat/ 200mg emtricitabine and 10mg Tenofovir alafenamide) =  1 x Prezcobix (DRV/c 800mg/150mg) …PSD · Nov 2019

boosted darunavir (DRV/c or DRV+r) co-administered with FTC/tenofovir (TAF or TDF) regimens Source: Table 1.1, p13 of the submission.PSD · Nov 2019

6.18 The submission claimed that the efficacy of Symtuza is non-inferior to boosted darunavir co-administered with FTC/tenofovir (both TDF and TAF), as assessed by the clinically relevant outcomes of viral rebound, virologic response and change in CD4+ cell count. Additionally, Symtuza is bioequivalent to concomitant administration of its components, and therefore is non-inferior in efficacy and safety.PSD · Nov 2019