Darunavir + CobicistatPREZCOBIX

7.1 The PBAC recommended the Section 100 Highly Specialised Drugs Program (HSD) listing of darunavir with cobicistat fixed dose combination for the treatment of HIV.PSD · Mar 2016

The PBAC recommended the special arrangements under the HSD Community Access Program, Authority Required (STREAMLINED).PSD · Mar 2016

6.12 The submission presented a cost-minimisation analysis (CMA). Prices used in the cost minimisation have been updated to reflect the S100 HSD Community Access prices for HIV medicines. 6.13 The equi-effective doses were estimated as:PSD · Mar 2016

For treatment experienced patients:  darunavir 800 mg (with cobicistat 150 mg in the FDC) once daily is equivalent to darunavir 800 mg (with ritonavir 100 mg taken concomitantly) once daily; and  cobicistat 150 mg (in the FDC) once daily is equivalent to ritonavir 100 mg (with darunavir 800 mg) once daily.PSD · Mar 2016

6.9 Based from the pharmacokinetic evidence presented in November 2015, the PBAC considered that the claim of non-inferior comparative effectiveness and safety against darunavir and cobicistat taken concomitantly was reasonable.PSD · Mar 2016

6.10 Based from the pharmacokinetic evidence presented above in November 2015, the PBAC considered that the claim of non-inferior comparative effectiveness and safety against darunavir and ritonavir taken concomitantly was reasonable.PSD · Mar 2016

6.2 The PBAC noted and welcomed the input from organisations (2) via the Consumer Comments facility on the PBS website. The comments described benefits of treatment with darunavir/cobicistat including improvement in adherence, some savings on co-payment and possibility of fewer side-effects compared to ritonavir boosted darunavir.PSD · Nov 2015