← The record

Oxycodone HydrochlorideEndone

Not recommended mixed outcome Pain 💬 consumer voice

Modified release oxycodone 5 mg strength for pain management in patients unresponsive to non-opioid analgesics.

1
Submissions
2015–15
On the record
ICER range
Not modelled
Cost basis

Decisions on record

3 decisions

The committee reached more than one outcome for this medicine at its most recent sitting — different indications were decided differently. The header reflects the least favourable of them; all are listed below.

  • Meeting Mar 2015 Not recommended Pain
  • Meeting Mar 2015 Deferred Chronic pain
  • Meeting Nov 2008 Recommended Narcotic analgesic no PSD

Access path

1 submission · public record
  1. TGA registered · Endone
  2. Mar 2015
    Not recommended

    no pressing clinical need established for the strength; previous strength was de-listed after sponsor established no…

RecommendedDeferredNot recommended

From the public summary

Verbatim · PSD text · may span indications
PBAC outcome
7.1 The PBAC rejected the proposed General schedule listing of the oxycodone 5 mg strength.PSD · Mar 2015
7.2 The PBAC noted that another sponsor’s 5mg presentation of oxycodone had been removed from the PBS at the request of that sponsor. The PBAC recalled that as a standard part of a request to delist a product from the PBS, it must be established that there is no pressing clinical need for the product in question.PSD · Mar 2015
Economic analysis
6.3 The submission proposed that the 5 mg strength be priced approximately ''''''% less than the current AEMP for Targin (oxycodone + naloxone) 5mg/2.5mg.PSD · Mar 2015

Cost-effectiveness

No economic analysis performed; this was a minor submission for a strength variation of an existing product.

The PBAC noted that the submission did not provide financial estimates. PBAC · 2015

Decision context

PopulationPatients requiring modified release oxycodone 5 mg for pain management.

Why it was knocked back

  • no pressing clinical need established for the strength; previous strength was de-listed after sponsor established no clinical need; submission did not provide financial estimates; did not establish convincing argument that clinical need now existed

Submission history

1 entries
DecidedOutcomeComparatorICEREvidence
Mar 2015 Not recommended Cost-minimisation

Consumer voice

Mar 2015

No consumer comments were received for this item.

The PBAC noted that no consumer comments were received for this item. Consumer comments · PSD

Similar precedents

By decision profile

Regulatory · TGA