PBAC's latest decision on Ledipasvir/sofosbuvir: Recommended with restriction (2015). Considered for Treatment of patients infected with genotype 1 chronic hepatitis C (CHC), irrespective of previous treatment history.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
1
first 2015
Submissions
1
2015 → 2015
Eligible population
Adults aged 18 years or older with chronic genotype 1 hepatitis C infection, stratified by cirrhosis status and prior treatment history (treatment-naïve without cirrhosis, treatment-naïve with cirrhosis, treatment-experienced).
Therapy area
Hepatology
Line of therapy
Any
Evidence base
RCT
Primary endpoint
Surrogate
Key trials
ION-2
Comparator
no treatment
Economic model
CUA
ICER note
ICER values not stated in the public summary document; listing was sought on the basis of cost-effectiveness but specific ICER figures are not provided.