Hydromorphone HydrochlorideDilaudid tabs
Recommended PainRestrictedNot applicable line
Severe disabling pain. The submission requested PBS listing of a 200 mL oral liquid formulation as a replacement for the currently listed 473 mL glass bottle presentation.
3
Submissions
1 resub
2005–18
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
- Meeting Mar 2018 Recommended Severe disabling pain
- Meeting Jul 2010 Recommended Pain relief no PSD
- Meeting Nov 2009 Recommended Analgesics no PSD
- Meeting Nov 2008 Recommended Opioid pain reliever
Access path
- TGA registered · Dilaudid tabs
TGA label narrower than the PBS population
- Jul 2005Recommended · restricted
vs oxycodone controlled release tablets
- Nov 2008Recommended · restricted
Comparator changed: oxycodone controlled release tablets → oxycodone controlled release…
- Mar 2018Recommended
Evidence: RCT → Cost-minimisation
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the listing of a 200 mL PET bottle replacement, containing hydromorphone hydrochloride, for the currently listed 473 mL glass bottle Dilaudid® Oral Liquid presentation indicated for use in severe disabling pain. 4PSD · Mar 2018
5.2 The PBAC considered the listing of a 200 mL presentation of Dilaudid® Oral Liquid to be appropriate. The PBAC noted that a reduction in the volume of opioid available in the community at any one time may be a positive outcome from a quality use of medicines perspective.PSD · Mar 2018
Cost-effectiveness
Minor submission (formulation change only); no economic evaluation performed
The PBAC considered the financial implications of the proposed change in availability of hydromorphone oral liquid to be unclear, noting that the realisation of a save is highly dependent on the assumption that a second bottle of the 200 mL presentation will be required in less than '''''% of cases, and this assumption is uncertain. PBAC · 2018
Economic model disputedNo head-to-head trialIndirect comparisonCost-effectiveness accepted ×2
Decision context
PopulationPatients with severe disabling pain unresponsive to non-opioid analgesics
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2018 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2008 | Recommended · restricted | oxycodone controlled release (CR) tablets | — | RCT · Pain severity (brief pain inventory pain severity sub-score) |
| Jul 2005 | Recommended · restricted | oxycodone controlled release tablets | — | RCT · Pain intensity |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted to severe disabling pain unresponsive to non-opioid analgesics; TGA label covers moderate to severe pain broadly.