FentanylAbstral sublingual tablets
Management of breakthrough pain in patients with cancer who are already receiving maintenance opioid therapy for chronic pain and are unable to tolerate further escalation of morphine for breakthrough pain.
Decisions on record
- Meeting Jul 2017 Recommended Breakthrough pain
- Meeting Mar 2014 Not recommended Abstral® A.Menarini Australia Pty Ltd Palliative Care To request Authority Required listing on the palliative care schedule for the management of breakthrough pain in patients with cancer who are already receiving maintenance opioid therapy for chronic pain and are unable to tolerate further escalat
- Meeting Mar 2014 Not recommended PecFent® AstraZeneca Pty Ltd Palliative Care To request Authority Required listing on the palliative care schedule for the management of breakthrough pain in adults with cancer who are already receiving maintenance opioid therapy for chronic pain and are unable to tolerate further escalation of morp
- Meeting Mar 2012 Recommended Analgesic no PSD
- Meeting Jul 2011 Recommended Analgesic for use in palliative care no PSD
- Meeting Mar 2011 Recommended Severe pain no PSD
- Meeting Nov 2009 Recommended Opioid analgesic no PSD
Access path
- TGA registered · Abstral sublingual tablets
TGA label narrower than the PBS population
- Mar 2006Recommended · restricted
vs oral slow release morphine (OSRM)
- Mar 2014Not recommended
Inadequate evidence of comparative efficacy versus fentanyl lozenges; clinical trials did not show clinically important…
- Mar 2014Not recommended
inadequate evidence for comparative efficacy, safety concerns specific to sublingual tablet formulation (rapid delivery…
Cost-effectiveness
Cost-minimisation analysis was presented but the PBAC considered it fundamentally inappropriate given that the clinical claim of non-inferiority was not accepted.
Given that the PBAC did not accept the clinical claim of non-inferiority, the Committee considered the cost-minimisation analysis presented in the submission was fundamentally not appropriate. PBAC · 2014
Decision context
PopulationAdult cancer patients with breakthrough pain who are already receiving maintenance opioid therapy and are unable to tolerate further escalation of morphine for breakthrough pain.
Why it was knocked back
- inadequate evidence for comparative efficacy, safety concerns specific to sublingual tablet formulation (rapid delivery with potential for overdose/narcosis versus lozenges which take 15 minutes to dissolve), high risk of diversion and misuse, unclear clinical place in therapy, inadequate dose titration options compared to fentanyl lozenges, poor quality of indirect comparison evidence, episode-level data analysis considered inappropriate
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Mar 2014 | Not recommended | fentanyl lozenges | — | RCT · Pain intensity difference and pain relief |
| Mar 2014 | Not recommended | fentanyl lozenge (oral transmucosal fentanyl citrate) | — | Single-arm · Pain intensity difference and pain relief at 30 and 60 minutes |
| Mar 2006 | Recommended · restricted | oral slow release morphine (OSRM) | — | RCT |
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricts to patients unable to tolerate morphine escalation; TGA label has no such intolerance requirement.