EntecavirEntecavir RBX
Treatment of chronic hepatitis B in adults 16 years and older with evidence of active liver inflammation. Listing sought for nucleoside-naive patients (500 microgram tablet) and for patients who have failed lamivudine therapy (1 mg tablet).
Decisions on record
- Meeting Nov 2007 Recommended Hepatitis B no PSD
- Meeting Nov 2006 Recommended Chronic hepatitis B no PSD
Access path
- TGA registered · Entecavir RBX
TGA label narrower than the PBS population
- 2006Recommended · restricted
vs Lamivudine 100 mg (nucleoside-naïve patients); Adefovir…
- Jul 2006Recommended · restricted
Comparator changed: Lamivudine 100 mg (nucleoside-naïve patients); Adefovir dipivoxil 10…
- PBS listing · Restricted
From the public summary
For lamivudine resistant patients, the choice of the cost-minimisation approach for these patients was considered valid.PSD · 2006
The trial-based incremental cost per extra patient achieving histological improvement at 48 weeks for both nucleos(t)ide-naïve patients - HBeAg-positive patients and HBeAg- negative/ HBV DNA-positive patients were between $15,000 and $45,000. The trial- based ICERs incorporated drug costs only.PSD · 2006
Cost-effectiveness
The base case modelled incremental discounted cost per extra discounted life year gained was for both nucleos(t)ide-naïve patients - HBeAg-positive patients and for HBeAg-negative/ HBV DNA-positive patients between $15,000 and $45,000. PSD · 2006
Decision context
PopulationAdults aged 16 years or older with chronic hepatitis B: (1) nucleoside-naive patients with histological evidence of chronic hepatitis, abnormal serum ALT, and documented HBV infection (HBeAg-positive or HBV DNA-positive); (2) lamivudine-resistant patients with abnormal serum ALT and documented chronic HBV infection (HBeAg-positive or HBV DNA-positive).
Risk sharingPBAC advised the PBPA that a risk sharing arrangement should be considered to account for potential usage outside restriction and development of resistance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2006 | Recommended · restricted | Lamivudine 100 mg (nucleoside-naive patients); adefovir dipivoxil 10 mg (lamivudine-resistant patients) | $15k–45k | RCT · histological_improvement |
| 2006 | Recommended · restricted | Lamivudine 100 mg (nucleoside-naïve patients); Adefovir dipivoxil 10 mg (lamivudine-resistant patients) | $15k–45k | RCT · OS | PFS | DFS | ORR | QoL | Surrogate |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to nucleos(t)ide naïve or lamivudine-resistant patients with histological confirmation and specific ALT/HBV DNA criteria; TGA label requires only active inflammation.