PBAC's latest decision on Bulevirtide: Noted (2025). Considered for Treatment of chronic hepatitis D (CHD) in patients with detectable hepatitis D virus (HDV) RNA and elevated alanine transaminase (ALT) levels, with compensated liver disease.
PBAC outcome
Noted
Authority Required
ICER (AUD/QALY)
Redacted
commercial-in-confidence
Submissions
2
first 2024
Submissions
2
2024 → 2025
Eligible population
Adult patients with chronic hepatitis D (CHD) who are hepatitis D virus (HDV) RNA positive as detected by PCR, have elevated serum alanine transaminase (ALT) levels, and have compensated liver disease (no current or previous decompensated liver disease within last 2 years).
Therapy area
Hepatology
Line of therapy
Not applicable
Evidence base
RCT
Primary endpoint
Composite endpoint at Week 48 of undetectable HDV RNA or ≥2 log IU/mL decrease in HDV RNA from baseline AND ALT normalisation
Key trials
MYR301
Comparator
best supportive care (BSC) / symptomatic chronic hepatitis D management
Economic model
CUA
ICER note
ICER values are redacted/commercially sensitive. Document states 'The ICER estimated in the current resubmission was $ 1/QALY but increases to > $ 2/QALY in some of the multivariate analyses' with actual values shown as placeholders ($).