Tenofovir Disoproxil FumarateTenofovir Sandoz
Treatment of chronic hepatitis B in nucleoside analogue naïve and treatment-experienced patients, as per the TGA indication.
Decisions on record
- Meeting Aug 2019 Noted Hepatitis B infection no PSD
- Meeting Nov 2008 Recommended Chronic hepatitis B
Access path
- TGA registered · Tenofovir Sandoz
TGA label narrower than the PBS population
- Nov 2008Recommended · restricted
vs entecavir 0.5 mg (nucleos(t)ide naïve patients); adefovir…
- Jul 2009Recommended · restricted
Comparator changed: entecavir 0.5 mg (nucleos(t)ide naïve patients); adefovir dipivoxil…
- PBS listing · Private hospital authority required
Cost-effectiveness
Cost-minimisation analysis performed; no ICER calculated by design
Decision context
PopulationTreatment-naïve chronic hepatitis B patients who satisfy all of the following criteria: (1) Histological evidence of chronic hepatitis on liver biopsy; (2) Abnormal serum ALT levels in conjunction with documented chronic hepatitis B infection; or (b) Elevated HBV DNA levels in conjunction with documented chronic hepatitis B infection. Treatment-experienced patients who have failed antihepadnaviral therapy and satisfy certain criteria.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2009 | Recommended · restricted | entecavir 0.5 mg (treatment-naïve patients); adefovir 10 mg (treatment-experienced patients) | — | RCT · Other |
| Nov 2008 | Recommended · restricted | entecavir 0.5 mg (nucleos(t)ide naïve patients); adefovir dipivoxil 10 mg (nucleos(t)ide experienced patients) | — | RCT · HBV DNA suppression |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-naïve and nucleos(t)ide-experienced patients with specific biomarkers (ALT/HBV DNA), whereas TGA label requires only active viral replication and active liver inflammation.