PBAC's latest decision on Daclatasvir: Noted (2015). Considered for Treatment of chronic hepatitis C infection (CHC) across all genotypes (1-6), irrespective of previous treatment history or cirrhosis status, in patients with compensated liver disease.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Not modelled
no economic evaluation
Submissions
2
first 2015
Submissions
2
2015 → 2015
Eligible population
Adults aged ≥18 years with chronic hepatitis C infection (all genotypes 1-6), including treatment naïve and treatment experienced patients, with or without cirrhosis, and patients co-infected with HIV, requiring compensated liver disease.
Therapy area
Hepatology
Line of therapy
Any
Evidence base
Single-arm
Primary endpoint
SVR12
Pivotal trial size
316 patients
Key trials
ALLY 1, ALLY 2
Comparator
For genotype 1: ledipasvir/sofosbuvir (LDV/SOF); for genotype 2: sofosbuvir plus ribavirin; for genotypes 4-6: no treatment
Economic model
Not modelled
ICER note
Re-submission did not present Sections A, C, D or E (economic evaluation sections). Only new clinical evidence was presented. No ICER was calculated or provided in this re-submission.