PBAC's latest decision on Glecaprevir with pibrentasvir: Deferred (2020). Considered for Treatment of chronic hepatitis C (CHC) infection in patients who are treatment-naïve with compensated cirrhosis, genotypes 1-6, with a shortened 8-week treatment duration.
PBAC outcome
Deferred
Restricted
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
3
first 2017
Submissions
3
2017 → 2020
Eligible population
Adults with chronic hepatitis C genotypes 1-6 who are treatment-naïve with compensated cirrhosis
Therapy area
Hepatology
Line of therapy
First-line
Evidence base
Single-arm
Primary endpoint
SVR12
Pivotal trial size
343 patients
Key trials
EXPEDITION-8
Comparator
12-week treatment course of glecaprevir with pibrentasvir (current PBS listed regimen); alternative pan-genotypic treatments including sofosbuvir/velpatasvir
Economic model
Cost-minimisation
ICER note
This was a minor submission requesting amendment of treatment duration; no economic evaluation with ICER was required. The submission was based on cost minimisation principles with no change to cost per treatment course.
Submission history
Jul 2017: Recommended with restriction · Authority Required
Nov 2017: Recommended with restriction · Authority Required