Oxycodone Hydrochloride + Naloxone HydrochlorideARX-Oxycodone/Naloxone
Recommended PainRestrictedNot applicable line
Chronic severe disabling pain unresponsive to non-narcotic analgesics. Three additional modified-release tablet strengths (2.5 mg/1.25 mg, 15 mg/7.5 mg, and 30 mg/15 mg) are sought for listing under the same conditions as existing strengths.
2
Submissions
2 resub
2015–15
On the record
—
ICER range
Not modelled
Cost basis
Access path
- TGA registered · ARX-Oxycodone/Naloxone
- Mar 2015Deferred
- Nov 2015Recommended
Evidence: Cost-minimisation → Other
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
5.1 The PBAC recommended the general schedule listing of oxycodone 2.5mg + naloxone 1.25mg, oxycodone 15mg + naloxone 7.5mg, and oxycodone 30mg + naloxone 15mg under the same conditions as the currently listed strengths, noting that oxycodone (oral) was subject to a 16% statutory price reduction on 1 December 2014.PSD · Nov 2015
5.2 The PBAC reaffirmed its advice under section 101 (4AC) of the National Health Act 1953 for the additional strengths of oxycodone + naloxone.PSD · Nov 2015
Economic analysis
6.3 The price proposed for the new strengths was partially calculated using the Pricing Manual pricing derivation approach. The methodology outlines that a half strength presentation would be priced at 70% of the double strength. This was applied to thePSD · Mar 2015
2.5 mg/1.25 mg strength, which is half that of the existing 5 mg/2.5 mg presentation.PSD · Mar 2015
Cost-effectiveness
This is a minor submission for additional strengths of an already-listed product; no economic evaluation or ICER was conducted.
Decision context
PopulationPatients with chronic severe disabling pain unresponsive to non-narcotic analgesics, including those with malignant neoplasia and elderly patients with musculoskeletal pain.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2015 | Recommended | — | — | Other |
| Mar 2015 | Deferred | — | — | Cost-minimisation · Cost-minimisation |
Similar precedents
Oxycodone With Naloxone92%Oxycodone Hydrochloride With Naloxone Hydrochloride Dihydrate90%Oxycodone Hydrochloride And Naloxone Hydrochloride Dihydrate82%Buprenorphine; Oxycodone + Naloxone78%Oxycodone, Tramadol, Codeine, Hydromorphone, Morphine, Tapentadol, Buprenorphine, Fentanyl76%Oxycodone74%Oxycodone Hydrochloride71%Morphine Hydrochloride70%