MethadoneASPEN METHADONE SYRUP
Chronic severe disabling pain and severe disabling pain in palliative care patients where alternative pain management therapies have failed.
Decision on record
- Meeting Jul 2025 Recommended Chronic severe disabling pain and severe disabling pain
Access path
- TGA registered · ASPEN METHADONE SYRUP
TGA label narrower than the PBS population
- Jul 2025Recommended · restricted
vs methadone 10 mg tablet (Physeptone)
- PBS listing · Authority Required
From the public summary
6.1 The PBAC recommended the listing of methadone 5 mg tablet as a General Schedule (STREAMLINED) and Palliative Care (Telephone/Online) listing under the same 9PSD · Jul 2025
6.2 The PBAC noted that the TGA established 2 x 5 mg methadone tablet is bioequivalent to 1 x methadone 10 mg tablet.PSD · Jul 2025
5.5 The submission proposed methadone 5 mg tablets be cost-minimised to methadone 10 mg tablets.PSD · Jul 2025
5.6 The submission requested an approved ex-manufacturer price (AEMP) of $3.70 for a quantity of 20 tablets. The proposed price was not consistent with a cost-minimisation approach to methadone 10 mg tablets. No justification was provided by the sponsor.PSD · Jul 2025
5.3 The submission did not explicitly state a clinical claim for Methadone-AFT 5 mg. 6PSD · Jul 2025
5.4 The PBAC considered that a claim of non-inferior efficacy and non-inferior safety compared to methadone 10 mg tablets is reasonable where two 5 mg tablets are used in place of one 10 mg tablet. The PBAC noted this aligns with the TGA’s bioequivalence statement.PSD · Jul 2025
5.2 The PBAC noted and welcomed the input from individuals (3) via the Consumer Comments facility on the PBS website. The comments described the effects of chronic pain as debilitating and the impacts on quality of life included limited ability to work and interact with family and friends. The comments supported the availability of methadone 5 mg for chronic severe disabling pain.PSD · Jul 2025
Cost-effectiveness
Cost-minimisation analysis proposed; no ICER calculated.
The submission proposed methadone 5 mg tablets be cost-minimised to methadone 10 mg tablets. PSD · 2025
Decision context
PopulationAdults with chronic severe disabling pain or severe disabling pain in palliative care who are not opioid-naïve and have had inadequate pain management with maximum tolerated doses of non-opioid and other opioid analgesics, or are unable to use such analgesics due to contraindications or intolerance.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2025 | Recommended · restricted | methadone 10 mg tablet (Physeptone) | — | Cost-minimisation · Cost-minimisation |
Consumer voice
Three individuals provided input describing chronic pain as debilitating with significant impacts on quality of life, including limited ability to work and interact with family and friends. They supported the availability of methadone 5 mg for chronic severe disabling pain.
The comments described the effects of chronic pain as debilitating and the impacts on quality of life included limited ability to work and interact with family and friends. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to palliative care patients with failed alternative therapies and non-opioid-naïve status; TGA label includes all chronic severe disabling pain indications.