Asunaprevir

7.1 The PBAC rejected the submission for the Authority Required (Streamlined) listing for asunaprevir (in combination with daclatasvir) for the treatment of chronic hepatitis C Genotype 1b because the treatment was clinically not non-inferior to treatment with ledipasvir and sofosbuvir (LDV/SOF) or daclatasvir + sofosbuvir (DCV+SOF) for treatment naive patients with Genotype 1b.PSD · Mar 2015

7.2 The PBAC reiterated that the Committee recognised that new treatments of HCV resulted in high rates of sustained virological response, where the HCV virus could not be detected in the blood of patients 12 weeks after treatment commenced.PSD · Mar 2015

6.23 The economic model of DCV+ASV compared with no treatment, or active HCV treatment, was the same as that used to assess DCV+SOF, except that the population in the model was only for HCV genotype 1b. The summary of model structure and rationale is presented in PBAC documents of the DCV submission (item 5.06).PSD · Mar 2015

6.24 A summary of the key drivers of the model is presented below.PSD · Mar 2015

6.18 The submission described DCV+ASV as superior in terms of both comparative effectiveness and comparative safety over TVR+PR in patients with genotype 1b HCV. This claim was not adequately supported in terms of the relative effectiveness of DCV+ASV compared to TVR+PR in treatment-naïve patients. The claim of superiority in terms of comparative safety is probably reasonable given the considerable adverse events associated with PR therapy.PSD · Mar 2015

6.19 With regard to the comparator considered appropriate by the PBAC, DCV+ASV was superior to ‘no treatment’ in terms of therapeutic effectiveness and inferior in terms of safety in both treatment-naïve and treatment-experienced patients with HCV genotype 1b.PSD · Mar 2015

6.2 The PBAC noted and welcomed the input from individuals (172), health care professionals (16) and organisations (18) via the Consumer Comments facility on the PBS website. The PBAC noted the correspondence from the Gastroenterological Society of Australia (GESA) on use of DAAs in the treatment of patients with liver cirrhosis and severe portal hypertension, decompensated liver disease, or patients post liver transplant.PSD · Mar 2015

6.3 Representatives of the PBAC met with Hepatitis Australia, Hepatitis NSW, the Australian Injecting and the Illicit Drug User’s League prior to the PBAC meeting, and reported the following key points to the PBAC in relation to the agenda items for the treatment of Hepatitis C:  The high burden of disease associated with HCV infection was noted, and the urgent need for new treatments acknowledged.PSD · Mar 2015