Bictegravir + Emtricitabine + Tenofovir Alafenamide

7.1 The PBAC was of a mind to recommend the Authority Required (STREAMLINED) Section 100 listing for a fixed dose combination (FDC) tablet containing tenofovir alafenamide with emtricitabine and bictegravir (BFTAF) for the treatment of patients with human immunodeficiency virus (HIV-1). However the PBAC deferred making a final recommendation pending the provision of the relevant TGA delegate’s overview.PSD · Mar 2018

7.2 The PBAC considered that the cost-effectiveness of BFTAF would be acceptable if it were cost-minimised against the lowest priced alternative FDC triple-therapy for the treatment of HIV (i.e. tenofovir disproxil-based (TDF) alternatives to the nominated secondary comparators GENVOYA® and ODEFSEY®, STRIBILD® and EVIPLERA®).PSD · Mar 2018

6.27 The submission stated that the equi-effective doses were based on Trial 1490 regimens. These doses were consistent with the draft PI of BFTAF and available dosages of DESCOVY® plus dolutegravir on the PBS.PSD · Mar 2018

6.28 The submission also stated that given recent PBAC recommendations for FTAF-based regimens were on a cost-minimisation basis, it may be appropriate to describe additional equi-effective doses for BFTAF versus other FTAF regimens (GENVOYA® and ODEFSEY®):  one tablet of BFTAF (50mg/200mg/25mg) and one tablet of GENVOYA® (10/200/150//150) are equi-effective  one tablet of BFTAF (50mg/200mg/25mg) daily and one tablet of ODEFSEY® (200/25/25) are …PSD · Mar 2018

6.20 The submission described BFTAF as non-inferior in terms of effectiveness and safety compared with tenofovir alafenamide regimens DESCOVY® + dolutegravir, GENVOYA®, ODEFSEY®.PSD · Mar 2018

6.21 The therapeutic conclusion of non-inferior effectiveness presented in the submission was supported by Trial 1490 for the comparison of BFTAF and DESCOVY® + dolutegravir in treatment-naïve patients given the trial met accepted, pre-specified non-inferiority margins.PSD · Mar 2018