Telbivudine
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.
Decisions on record
- Meeting Jul 2008 Recommended Chronic hepatitis B no PSD
- Meeting Mar 2008 Recommended Hepatitis B
- Meeting Jul 2007 Not recommended Hepatitis B
Access path
- 2007Not recommended
uncertainty about cost effectiveness over lamivudine, uncertainty about efficacy in comparison with entecavir on some…
- Jul 2007Not recommended
uncertainty about cost effectiveness over lamivudine, uncertainty about efficacy in comparison with entecavir on some…
- ↻ resubmittedMar 2008Recommended · restricted
- PBS listing · Authority Required
Cost-effectiveness
However, the PBAC noted that while telbivudine was dominant in the 20 year base case compared to lamivudine, the incremental cost effectiveness ratio at 10 years also remained acceptable though somewhat uncertain at between $15,000 and $45,000 per extra QALY gained. PBAC · 2008
Decision context
PopulationPatients 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.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2008 | Recommended · restricted | lamivudine | $15k–45k | RCT · Therapeutic response |
| Jul 2007 | Not recommended | lamivudine | — | RCT |
| 2007 | Not recommended | lamivudine | — | RCT | indirect comparison via common reference · therapeutic response (serum HBV DNA <5 log copies/mL), histologic improvement, undetectable HBV DNA levels, ALT normalisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to HBeAg-positive only and adds age ≥16 years; TGA label includes both HBeAg-positive and HBeAg-negative.