OxycodoneEndone
Not recommended mixed outcome PainRestricted 💬 consumer voice
Acute severe disabling pain unresponsive to non-opioid analgesics for short-term use (2–3 days) in patients with severe disabling pain.
3
Submissions
2 resub
2014–19
On the record
—
ICER range
Not modelled
Cost basis
Decisions on record
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 Jul 2019 Recommended Severe disabling pain
- Meeting Jul 2019 Not recommended The management of moderate to severe chronic pain unresponsive to non- narcotic analgesia.
- Meeting Nov 2016 Recommended Chronic severe disabling pain
- Meeting Nov 2015 Recommended Pain
- Meeting Jul 2015 Deferred Pain
- Meeting Nov 2014 Not recommended 10 mg modified release tablets 15 mg modified release tablets 20 mg modified release tablets 30 mg modified release tablets 40 mg modified release tablets 80 mg modified release tablets OxyContin® MR Mundipharma Pty Ltd Change to listing (Minor submission) Chronic severe disabling pain To amend the
Access path
- TGA registered · Endone
TGA label narrower than the PBS population
- Nov 2014Noted
- Jul 2019Noted
Evidence: Other → Registry
- Jul 2019Recommended · restricted
Evidence: Other → Registry
- PBS listing · Restricted
RecommendedDeferredNot recommended
From the public summary
PBAC outcome
7.1 The PBAC is extremely concerned about prescription opioid misuse in Australia, and notes that oxycodone misuse contributes significantly to this issue.PSD · Jul 2019
7.2 The PBAC welcomes proposals for strategies to combat opioid misuse in Australia in the context of the Pharmaceutical Benefits Scheme subsidy arrangements. However, for the reasons set out below, the PBAC considered the proposal put forward in the current submission would be highly unlikely to have this effect, particularly as it relies exclusively on restricting PBS subsidised access to some, but not all, alternative opioid medicines.PSD · Jul 2019
Economic analysis
6.34 The submission presented a cost consequence analysis that examined changes in health system costs due to decreased oxycodone misuse over one year.PSD · Jul 2019
Table 10: Summary of the cost consequence analysis Component Summary Type of analysis Cost consequence analysis Perspective Healthcare system Reduced oxycodone utilisation Reduced doctor-shopping (fewer GP consultations) Outcomes Fewer ambulance attendances Fewer hospitalisations Time horizon 1 year Source: Table 3-1 to 3-2, pp226-227 of the submission; GP = general practitionerPSD · Jul 2019
Clinical claim
6.30 The submission claimed that OxyContin/Novacodone was superior in terms of safety compared with Oxycodone Sandoz based on: Reductions in oxycodone utilisation following reformulation. However, the evaluation noted there was no decrease in population-level oxycodone utilisation, rather, a reduction in the use of 20 mg, 40 mg, and 80 mg strengths of modified- release oxycodone; Reduction in oxycodone injection in high-risk groups in Australia.PSD · Jul 2019
6.31 The PBAC agreed the therapeutic conclusion presented in the submission was not adequately supported by the evidence presented the submission because: There was no change in harms due to opioid misuse or dependence in terms of hospitalisations, ED attendance, or ambulance attendance; there was no change in the proportion of Australians reporting recent oxycodone misuse in the NDSHS since the introduction of OxyContin/Novacodone in 2014; …PSD · Jul 2019
Consumer comments
5.3 The majority of the comments received described a range of potential harms in relation to treatment with non-abuse deterrent oxycodone including increased diversion and abuse, compromising patient care and safety while also placing pharmacists at risk in the workplace.PSD · Nov 2014
5.4 In contrast, other comments were received from Alphapharm and Sandoz which stated that prohibiting ‘a’ flagging threatens patient choice and timely access to affordable medication, while also removing the ability for pharmacists to exercise professional judgement.PSD · Nov 2014
Cost-effectiveness
Not applicable — minor submission for new pack size/maximum quantity with no economic comparison or ICER calculated.
The minor submission presented no economic comparison. PBAC · 2019
Decision context
PopulationPatients with acute severe disabling pain unresponsive to non-opioid analgesics requiring short-term (2–3 days) pain relief.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2019 | Noted | Oxycodone Sandoz (modified-release oxycodone without hydro-gelling and crush-deterrent properties) | — | Registry · Other |
| Jul 2019 | Recommended · restricted | oxycodone 5 mg (20 capsules, existing PBS listing) | — | Cost-minimisation · Cost-minimisation |
| Nov 2014 | Noted | — | — | Other |
Consumer voice
The PBAC noted that 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
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Regulatory · TGA
Label narrower than PBS population — PBAC restricts to acute severe disabling pain unresponsive to non-opioids for short-term use (2–3 days), narrowing the broad TGA label of moderate to severe opioid-responsive pain.