Oxycodone Hydrochloride With Naloxone Hydrochloride DihydrateARX-Oxycodone/Naloxone
Recommended PainRestrictedNot applicable line
Chronic severe disabling pain not responding to non-narcotic analgesics.
1
Submissions
1 resub
2010–10
On the record
$15k–45k
ICER range
1 sourced ICER · 2010
ICER stated
Cost basis
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 2010Recommended · restricted
vs oxycodone controlled release, without prophylactic laxatives
- PBS listing · Restricted
RecommendedDeferredNot recommended
Cost-effectiveness
The PBAC noted that although the price of the combination product had been reduced, there was still a price premium over oxycodone controlled release (OxyContin®). The PBAC also noted that the comparator was oxycodone controlled release, without prophylactic laxatives, the same as in the July 2010 submission. PBAC · 2010
ICER / price too high
Decision context
PopulationChronic severe disabling pain not responding to non-narcotic analgesics.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2010 | Recommended · restricted | oxycodone controlled release, without prophylactic laxatives | $15k–45k | RCT · Bowel function index (BFI) score, Pain control |
Similar precedents
Oxycodone Hydrochloride And Naloxone Hydrochloride Dihydrate91%Oxycodone Hydrochloride + Naloxone Hydrochloride90%Oxycodone With Naloxone86%Oxycodone, Tramadol, Codeine, Hydromorphone, Morphine, Tapentadol, Buprenorphine, Fentanyl75%Oxycodone75%Buprenorphine; Oxycodone + Naloxone70%Methylnaltrexone Bromide70%Morphine Hydrochloride69%
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to 'disabling' pain, adding a functional severity criterion absent from the TGA label.