Oxycodone, Tramadol, Codeine, Hydromorphone, Morphine, Tapentadol, Buprenorphine, Fentanyl
Recommended · restricted PainRestricted
Short-term relief of acute severe pain unresponsive to non-opioid analgesics; management of chronic severe pain in cancer and palliative care settings.
1
Submissions
1 resub
2019–19
On the record
—
ICER range
Not modelled
Cost basis
Access path
- Dec 2019Recommended · restricted
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
8.1 The PBAC recommended changes to opioids listed on the PBS as below (and detailed in section 9): implementing new Restricted Benefit listings for smaller MQs of immediate release opioids with no increased quantities or repeats (as identified in Table 2) for patients requiring short-term relief of acute severe pain that is unresponsive to non-opioid analgesics; amending the listings for immediate- and modified-release opioids (outlined in para 8.7 …PSD · Dec 2019
8.2 The PBAC noted that the TGA would be requiring sponsors to register new smaller pack sizes for some immediate-release opioid analgesics, and considered that 9PSD · Dec 2019
Cost-effectiveness
Not modelled; this is a regulatory/restrictions-change submission, not a new drug economic evaluation.
Decision context
PopulationPatients requiring short-term (2–3 days) relief of acute severe pain unresponsive to non-opioid analgesics; patients with chronic severe pain in cancer and palliative care settings where other treatment options have failed or are inappropriate.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Dec 2019 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to acute severe pain unresponsive to non-opioids and cancer/palliative care chronic pain; TGA label includes broader severe pain indications.