Grazoprevir / Elbasvir

7.1 The PBAC recommended the listing of GRZ/EBR +/- RBV for the treatment of treatment-naïve and treatment experienced genotypes 1, 4 and 6 CHC on a cost minimisation basis with LDV/SOF for GT1 disease and on a cost-minimisation basis with SOF+PR for GT 4 and 6 disease.PSD · Jul 2016

7.2 The PBAC rejected the requested listing of GRZ/EBR and SOF for treatment-naïve genotype 3 CHC as it considered there was insufficient data to support recommending listing for this group.PSD · Jul 2016

6.37 The submission took a cost-minimisation approach. The equi-effective doses presented in the submission and based on the requested PBS listings for GRZ/EBR and clinical studies presented in Section B(i), are: o GRZ/EBR (100 mg/50 mg) once daily for 12 weeks is equivalent to LDV/SOF (90 mg/400 mg) once daily for 8 weeks in genotype 1 treatment-naïve non- cirrhotic patients; o GRZ/EBR (100 mg/50 mg) once daily for 12 weeks is equivalent to LDV/SOF (90 …PSD · Jul 2016

6.38 The submission claimed that GRZ/EBR12 (for relapsers) or GRZ/EBR16+RBV16 (for on-treatment virologic failures) has superior effectiveness and non-inferior safety versus no treatment in genotype 4 or 6 treatment-experienced patients. No cost- effectiveness analysis was presented in the submission on basis of this clinical claim.PSD · Jul 2016

6.34 The submission described: o GRZ/EBR12 as non-inferior to LDV/SOF8 in terms of comparative effectiveness and safety in genotype 1 treatment-naïve non-cirrhotic patients (GRZ/EBR8 could be considered in subjects with genotype 1b with minimal fibrosis (F0-F2)); o GRZ/EBR12 as non-inferior to LDV/SOF12 in terms of comparative effectiveness and safety in genotype 1 treatment-naïve cirrhotic patients, genotype 1 treatment- experienced relapsers and …PSD · Jul 2016

6.35 The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable for genotypes 1, 4 and 6, albeit noting the small patient numbers for genotypes 4 and 6. The PBAC considered the claim of non-inferior comparative effectiveness was not adequately supported by the data for genotype 3.PSD · Jul 2016

6.2 The PBAC noted and welcomed the input from individuals (6), health care professionals (1) and organisations (11) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with grazoprevir and elbasvir including increasing the range of direct acting antiviral treatments for hepatitis C and offering the first interferon-free treatment regimens for genotypes 4 and 6.PSD · Jul 2016

6.3 The PBAC noted the advice received from the following clinical groups:  Hepatitis Australia, supported by state based hepatitis groups in Victoria, South Australia and the Australian Capital Territory;  Hepatitis New South Wales, supported by Positive Life NSW, the NSW Users and AIDS Association (NUAA), the Network of Alcohol and other Drugs Agencies NSW (NADA) and ACON NSW;  The Australian Hepatology Association; and  Haemophilia Foundation …PSD · Jul 2016