PBAC's latest decision on Ribavirin and peginterferon alfa-2b: Recommended with restriction (2011). Considered for treatment of chronic hepatitis C in children and adolescents with a bodyweight of greater than or equal to 27 kg with compensated liver disease and who have not received previous interferon treatment.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
—
ICER not stated
Submissions
1
first 2011
Submissions
1
2011 → 2011
Eligible population
patients under the age of 18 years who have not received previous interferon treatment and weighing at least 27 kg with compensated liver disease
Therapy area
Hepatology
Evidence base
Single-arm
Primary endpoint
Sustained virological response (SVR)
Pivotal trial size
107 patients
Key trials
P02538
Comparator
standard of care (no treatment)
Economic model
CUA | Cost-minimisation
ICER note
Submission calculated an ICER of less than $15,000 but this was not incorporated as a formal band. PBAC noted uncertainty in the economic model regarding the comparator assumption.