PBAC's latest decision on Sofosbuvir: Recommended with restriction (2015). Considered for Treatment of chronic hepatitis C (CHC) in treatment-naïve and treatment-experienced patients with genotypes 1-6, administered in combination with peginterferon alfa and ribavirin or ribavirin alone, depending on genotype and treatment experience.
PBAC outcome
Recommended with restriction
Restricted
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2014
Submissions
2
2014 → 2015
Eligible population
Adults aged 18 years or older with compensated liver disease and chronic hepatitis C (genotypes 1-6), either treatment-naïve or treatment-experienced, excluding those who are breastfeeding or have previously received oral direct-acting antiviral agents (except where intolerance requiring permanent withdrawal has been documented).
Therapy area
Hepatology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
SVR12
Economic model
Not modelled
ICER note
Pricing information is redacted (indicated by '''''''''''''''''''''''' placeholders in the text). No ICER is explicitly stated in this PSD.
Risk sharing
Risk-sharing arrangement in place — A special pricing arrangement (rebate) was proposed to cap the cost of the sofosbuvir component of a 24-week course of treatment for genotype 3 patients.
Submission history
Jul 2014: Recommended with restriction · Authority Required
Mar 2015: Recommended with restriction · Restricted