Adefovir DipivoxilAPO-ADEFOVIR
Chronic hepatitis B in patients who have failed antihepadnaviral therapy, now with the addition of concurrent use with lamivudine in lamivudine-resistant patients.
Decisions on record
- Meeting Nov 2007 Recommended Hepatitis B
- Meeting Nov 2007 Recommended Hepatitis B
- Meeting Nov 2006 Recommended Chronic hepatitis B. no PSD
- Meeting Jul 2004 Recommended Used for the treatment of Hepatitis B no PSD
Access path
- TGA registered · APO-ADEFOVIR
TGA label narrower than the PBS population
- Jul 2006Not recommended
Trial population not representative of requested PBS population (advanced liver disease and post-transplant patients)…
- Jul 2006Not recommended
Trial population not representative of PBS listing population (HBeAg-positive, compensated, nucleos(t)ide-naïve only…
- Jul 2006Not recommended
patients in key trial not representative of population for whom PBS listing sought, comparator in clinical trial not…
- ↻ resubmittedMar 2007Recommended
Comparator changed: lamivudine monotherapy and sequential adefovir → lamivudine…
- Mar 2007Recommended
Comparator changed: lamivudine monotherapy and sequential adefovir → lamivudine…
- Nov 2007Recommended · restricted
Comparator changed: lamivudine monotherapy followed by adefovir dipivoxil monotherapy…
- Nov 2007Recommended · restricted
Comparator changed: lamivudine monotherapy followed by adefovir dipivoxil monotherapy…
- PBS listing · Restricted
From the public summary
3. Registration Status Adefovir dipivoxil tablet 10 mg was registered on 16 September 2003 by the TGA for the treatment of chronic hepatitis B in adults with evidence of active viral replication and either evidence of persistent elevations in serum aminotransferases or histologically active disease. 4.PSD · Mar 2007
(greater than 1.2 times the upper limit of normal) serum ALT levels. Patients must have received concurrent antihepadnaviral therapy of greater than or equal to 6 months. Patients may receive PBS subsidised treatment of lamivudine in combination with adefovir for the initial 3 months only of PBS subsidised adefovir, unless patients have advanced liver disease (evidence of cirrhosis on liver biopsy or a Child Pugh Turcotte score greater than 5), in which …PSD · Mar 2007
Cost-effectiveness
Cost-minimisation analysis based on cost offsets; no formal ICER calculated.
The PBAC noted that the cost offsets presented in the submission remained uncertain despite two cost offsets models being presented. PBAC · 2007
Decision context
PopulationAdult patients with chronic hepatitis B who have failed antihepadnaviral therapy (specifically lamivudine-resistant patients), with repeatedly elevated HBV DNA levels or elevated serum ALT levels, excluding pregnant/breastfeeding women of child-bearing age.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2007 | Recommended · restricted | adefovir monotherapy | — | RCT · Other |
| Nov 2007 | Recommended · restricted | adefovir monotherapy | — | Meta-analysis |
| Mar 2007 | Recommended | lamivudine monotherapy followed by adefovir dipivoxil monotherapy (for lamivudine-sensitive HBV) and adefovir dipivoxil | $45k–75k | RCT |
| Mar 2007 | Recommended | lamivudine monotherapy followed by adefovir dipivoxil monotherapy (for lamivudine-sensitive HBV); adefovir dipivoxil mon | $15k–75k | Registry |
| Jul 2006 | Not recommended | Lamivudine monotherapy and lamivudine and sequential adefovir | $45k–75k | RCT, Registry · surrogate (HBV DNA) |
| Jul 2006 | Not recommended | Lamivudine monotherapy and lamivudine and sequential adefovir | $45k–75k | RCT, Registry · surrogate (HBV DNA) |
| Jul 2006 | Not recommended | lamivudine monotherapy and sequential adefovir | — | RCT · HBV DNA change |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to treatment-experienced patients (failed prior antihepadnaviral therapy), whereas TGA label includes all treatment-naive adults with active replication.