PBAC's latest decision on Tenofovir alafenamide: Recommended with restriction (2017). Considered for Treatment of chronic hepatitis B infections in adults, including treatment-naïve and treatment-experienced patients with or without cirrhosis.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
1
first 2017
Submissions
1
2017 → 2017
Eligible population
Adult patients with treatment-naïve and treatment-experienced chronic hepatitis B infections, with or without cirrhosis (HBeAg negative and HBeAg positive populations).
Therapy area
Hepatology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
ORR
Pivotal trial size
1,301 patients
Key trials
Study 108, Study 110, Study 1249
Comparator
tenofovir disoproxil fumarate (TDF)
Economic model
Cost-minimisation
ICER note
Cost minimisation analysis performed; no ICER calculated as TAF compared to TDF in cost-minimisation evaluation.