Tapentadol
Chronic severe disabling pain not responding to non-narcotic analgesics.
Decisions on record
- Meeting Nov 2013 Recommended 50 mg, 100 mg, 150 mg, 200 mg and 250 mg, tablet, sustained release Palexia® SR BioCSL (Australia) Pty Ltd Major submission Chronic, severe, disabling pain Resubmission to request a restricted benefit listing for the treatment of chronic, severe, disabling pain not responding to non-narcotic analges
- Meeting Nov 2012 Not recommended The management of moderate to severe chronic pain un-responsive to non-narcotic analgesia. There is currently no clinical trial data available regarding the safety and efficacy of tapentadol SR in patients with pain due to malignancy. no PSD
- Meeting Jul 2012 Not recommended The management of moderate to severe chronic pain un-responsive to non-narcotic analgesia. There is currently no clinical data available regarding the safety and efficacy of tapentadol SR in patients with pain due to malignancy. no PSD
- Meeting Mar 2012 Not recommended The management of moderate to severe chronic pain un-responsive to non-narcotic analgesia. There is currently no clinical trial data available regarding the safety and efficacy of tapentadol SR in patients with pain due to malignancy.
- Meeting Mar 2011 Not recommended Severe pain
Access path
- Mar 2011Not recommended
uncertain clinical benefit, uncertain cost effectiveness, small differences in pain reduction unlikely to be clinically…
- Mar 2012Not recommended
uncertain clinical benefit, uncertain cost-effectiveness, methodological concerns with economic model (over-simplified…
- Mar 2012Not recommended
uncertain clinical benefit, uncertain cost-effectiveness, uncertain basis for pricing; PAC-SYM results difficult to…
- ↻ resubmittedNov 2013Recommended · restricted
Comparator changed: oxycodone CR (primary); tramadol SR (secondary) → oxycodone CR and…
- PBS listing · Restricted
From the public summary
The submission presented the results of multivariate sensitivity analyses combining a lower disutility for constipation and a risk ratio of constipation of 1.3 for oxycodone CR over tapentadol SR with an ICER of less than $15,000.PSD · Mar 2012
The equi-effective doses of tapentadol SR and tramadol SR, for the cost-minimised component of the tapentadol SR price, were unchanged from the March 2012 resubmission.PSD · Mar 2012
Cost-effectiveness
Cost-minimisation analysis; no ICER calculated by design.
The PBAC considered the updated weighted cost minimisation analysis approach based on the primary and secondary comparators as reasonable and accepted the proposed weighting of oxycodone CR and tramadol SR. PBAC · 2013
Decision context
PopulationAdults with chronic severe disabling pain not responding to non-narcotic analgesics.
Risk sharingA revised Risk Share Arrangement (RSA) was agreed to be needed due to uncertainties in usage estimates and financial implications.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Nov 2013 | Recommended · restricted | oxycodone CR and tramadol SR | — | RCT · Pain efficacy; gastrointestinal safety |
| Mar 2012 | Not recommended | oxycodone CR (main); tramadol SR (secondary) | $15k–45k | RCT |
| Mar 2012 | Not recommended | oxycodone CR (primary); tramadol SR (secondary) | $15k–45k | RCT · Pain intensity |
| Mar 2011 | Not recommended | oxycodone hydrochloride controlled release | — | RCT · Change from baseline in average pain intensity at Week 12 of the maintenance period (US regulatory outcome) and 12 week maintenance period (non-US regulatory outcome) |
Clinical evidence
| Trial | Phase | N | Primary outcome | Status |
|---|---|---|---|---|
| KF11 | Ph 3 | 1,030 | Change From Baseline of the Average Pain Intensity Based on an 11-point Numerical Rating S… | completed |
Consumer voice
Pain Australia submitted correspondence supporting access to analgesic medications on the PBS, and the PBAC noted this input regarding the Safety Net 20 Day Rule.
The PBAC also noted the correspondence received from Pain Australia supporting access to analgesic medications on the PBS. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC adds 'disabling' descriptor and explicitly limits to adults, narrowing the TGA's broader moderate-to-severe chronic pain population.