Tenofovir disoproxil fumarate

PBAC's latest decision on Tenofovir disoproxil fumarate: Recommended with restriction (2009). Considered for Treatment of chronic hepatitis B in nucleoside analogue naïve and treatment-experienced patients, as per the TGA indication.

Eligible population

Treatment-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.

Therapy area

Gastroenterology

Line of therapy

Second-line | Later-line

Evidence base

RCT

Primary endpoint

Other

Key trials

0102, Lai 2006, Dakin 2008

Comparator

entecavir 0.5 mg (treatment-naïve patients); adefovir 10 mg (treatment-experienced patients)

Economic model

Cost-minimisation

ICER note

Cost-minimisation analysis performed; no ICER calculated by design

Submission history

• Nov 2008: Recommended with restriction · Restricted
• Jul 2009: Recommended with restriction · Private hospital authority required

Similar precedents

• Tenofovir alafenamide
  similarity 0.80
• Telbivudine
  similarity 0.70
• Adefovir dipivoxil
  similarity 0.69
• Sofosbuvir
  similarity 0.68
• Tenofovir alafenamide, emtricitabine, and rilpivirine
  similarity 0.68
• Ledipasvir/sofosbuvir
  similarity 0.68