PBAC's latest decision on Paritaprevir with ritonavir and ombitasvir: Recommended with restriction (2016). Considered for Treatment of patients infected with genotype 4 chronic hepatitis C virus infection, irrespective of previous treatment history, in combination with ribavirin.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2016
Submissions
1
2016 → 2016
Eligible population
Adults aged 18 years or older with genotype 4 chronic hepatitis C infection, treatment-naïve or treatment-experienced, with or without cirrhosis, treated for 12 weeks in combination with ribavirin
Therapy area
Hepatology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
Surrogate
Pivotal trial size
624 patients
Key trials
PEARL I, AGATE I, AGATE II
Comparator
grazoprevir-elbasvir ± ribavirin
Economic model
Cost-minimisation
ICER note
Cost-minimisation analysis conducted against grazoprevir-elbasvir ± ribavirin; no ICER calculated as per cost-minimisation approach