Tenofovir AlafenamideVemlidy
Treatment of chronic hepatitis B infections in adult patients who are treatment-naïve or treatment-experienced, with or without cirrhosis.
Decisions on record
- Meeting Jul 2022 Noted Hepatitis B no PSD
- Meeting Mar 2017 Recommended Chronic hepatitis B
- Meeting Nov 2016 Recommended Human immunodeficiency
- Meeting Nov 2016 Recommended Human immunodeficiency virus (HIV)
Access path
- TGA registered · Vemlidy
TGA label equal than the PBS population
- Mar 2017Recommended · restricted
vs tenofovir disoproxil fumarate (TDF)
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of tenofovir alafenamide (TAF) as a Section 100 (Highly Specialised Drugs Program – Community Access): Authority Required (STREAMLINED) listing for the treatment of chronic hepatitis B infection (CHB). The PBAC’s recommendation for listing was based on, among other matters, its assessment, as described above, that the cost-effectiveness of TAF would be acceptable if it were cost-minimised against entecavir.PSD · Mar 2017
7.2 The PBAC recommended that the equi-effective doses to be TAF 25 mg once daily is equivalent to entecavir 0.5 mg once daily for nucleos(t)ide naïve CHB patients, and entecavir 1 mg once daily for nucleos(t)ide experienced CHB patients, with the proportions of use of the two entecavir strengths reflecting current usage under the PBS.PSD · Mar 2017
6.24 The submission presented a cost minimisation analysis between TAF and TDF.PSD · Mar 2017
6.25 The PBAC noted it could only recommend listing TAF at a higher price than an alternative therapy or therapies if it is satisfied that it provides, for some patients, a significant improvement in efficacy or reduction of toxicity over the alternative therapy or therapies. The alternative therapies in this case include entecavir.PSD · Mar 2017
6.20 The submission described TAF as non-inferior in terms of comparative effectiveness and superior in terms of comparative safety over TDF. The ESC considered that the claim was reasonable with respect to efficacy but the claim of superior safety of TAF over TDF was based on surrogate measures (BMD and renal function), and the results were not consistent at all measured time points.PSD · Mar 2017
6.21 Given the data presented, the ESC considered that treatment with TAF is likely to be at least non-inferior in terms of safety compared to treatment with TDF.PSD · Mar 2017
6.2 The PBAC noted and welcomed the input from health care professionals (1) and organisations (2) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of treatment with TAF including a perceived better safety profile of TAF compared to TDF.PSD · Mar 2017
Cost-effectiveness
Cost minimisation analysis performed; no ICER calculated as TAF was compared on a cost basis to TDF.
The basis for requesting listing of TAF was a cost minimisation analysis versus TDF. PSD · 2017
Decision context
PopulationAdult patients with treatment-naïve or treatment-experienced chronic hepatitis B infections, with or without cirrhosis (HBeAg-negative and HBeAg-positive populations).
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2017 | Recommended · restricted | tenofovir disoproxil fumarate (TDF) | — | RCT · HBV DNA suppression |
Consumer voice
Two healthcare organisations (Hepatitis NSW and the Korean Hepatitis B Education Project) provided input describing benefits of TAF treatment, particularly a better safety profile compared to TDF with fewer side effects on bone mineral density and kidney function, and potential to increase HBV treatment rates.
The comments described a range of benefits of treatment with TAF including a perceived better safety profile of TAF compared to TDF. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label equal than PBS population — Both texts cover chronic hepatitis B treatment in adults across all patient types and disease stages without meaningful restrictions.