PBAC's latest decision on Telbivudine: Recommended with restriction (2008). Considered for Treatment of chronic hepatitis B in patients who are nucleoside analogue naïve and hepatitis B antigen (HBeAg)-positive with compensated liver disease, evidence of viral replication, and active liver inflammation.
PBAC outcome
Recommended with restriction
Authority Required
ICER (AUD/QALY)
$45k/QALY
Range: $15k/QALY–$45k/QALY
Submissions
2
first 2007
Submissions
2
2007 → 2008
Eligible population
Patients aged 16 years or older with HBeAg-positive chronic hepatitis B who are nucleoside analogue naïve, with histological evidence of chronic hepatitis, abnormal serum ALT or elevated HBV DNA levels, and compensated liver disease.
Therapy area
Hepatology
Line of therapy
First-line
Evidence base
RCT
Primary endpoint
Therapeutic response
Key trials
NV-02B-007, NV-02B-015
Comparator
lamivudine
Economic model
CUA
Submission history
2007: Not recommended
Mar 2008: Recommended with restriction · Authority Required — ICER $45k/QALY