Oxycodone With NaloxoneARX-Oxycodone/Naloxone
Treatment of moderate to severe chronic pain unresponsive to non-opioid analgesia. Specifically, chronic severe disabling pain unresponsive to non-opioid analgesics.
Decision on record
- Meeting Nov 2010 Recommended Severe pain no PSD
Access path
- TGA registered · ARX-Oxycodone/Naloxone
TGA label narrower than the PBS population
- Nov 2016Recommended
- PBS listing · Authority Required
From the public summary
7.1 The PBAC recommended the listing of the new strengths of oxycodone with naloxone for the treatment of chronic severe disabling pain.PSD · Nov 2016
7.2 The PBAC noted the market for both oxycodone and oxycodone with naloxone is growing but did not consider that the addition of extra strengths to the PBS would add to that growth.PSD · Nov 2016
6.3 The price proposed for the two additional strengths was calculated using the Pricing Manual pricing derivation approach, based on a 20% premium over the comparable oxycodone presentation.PSD · Nov 2016
6.2 The PBAC noted and welcomed the input of health care professionals (1) via the Consumer Comments facility on the PBS website. The comment described the benefit of treatment with oxycodone hydrochloride with naloxone hydrochloride, highlighting the availability of higher strengths which would allow for the administration of fewer tablets to improve patient compliance. The PBAC noted that this advice was supportive of the claims made by the submission. 3PSD · Nov 2016
Cost-effectiveness
Not modelled — minor submission (formulation/strength extension with no new economic model)
The submission proposed there will no net change in the number of prescriptions for oxycodone and consequently no real change in the cost to the PBS/RPBS. PSD · 2016
Decision context
PopulationAdults with chronic severe disabling pain unresponsive to non-opioid analgesics, requiring the higher strengths (60 mg/30 mg and 80 mg/40 mg) for pain titration and management of opioid-induced constipation.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2016 | Recommended | — | — | Cost-minimisation · Cost-minimisation |
Consumer voice
One healthcare professional submitted input via the Consumer Comments facility supporting the benefits of oxycodone hydrochloride with naloxone hydrochloride, particularly noting that higher strengths would reduce tablet burden and improve patient compliance.
the benefit of treatment with oxycodone hydrochloride with naloxone hydrochloride, highlighting the availability of higher strengths which would allow for the administration of fewer tablets to improve patient compliance Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to chronic severe disabling pain and specifies higher strength formulations for titration and constipation management.