Fentanyl CitrateAbstral sublingual tablets
Initial treatment for dose titration of cancer patients with breakthrough pain (BTP) attributable to cancer, in patients already receiving maintenance opioid therapy for chronic pain.
Decisions on record
- Meeting Mar 2010 Not recommended Cancer pain no PSD
- Meeting Nov 2007 Recommended Severe pain
Access path
- TGA registered · Abstral sublingual tablets
TGA label narrower than the PBS population
- Mar 2006Recommended
vs placebo
- Mar 2006Recommended
- Nov 2007Recommended · restricted
- Nov 2007Recommended · restricted
- Mar 2013Not recommended
poor quality of clinical data, uncertainty regarding non-inferiority in comparative safety, uncertain equi-effective…
- Jul 2015Not recommended
Comparator changed: oral transmucosal fentanyl citrate (OTF) → fentanyl lozenges
- ↻ resubmittedJul 2015Recommended · restricted
Comparator changed: oral transmucosal fentanyl citrate (OTF) → fentanyl lozenges
- Nov 2015Recommended · restricted
Comparator changed: fentanyl lozenges; immediate-release oral opioids (morphine)…
- Jul 2017Recommended · restricted
Listing: Authority Required → Restricted
- PBS listing · Restricted
From the public summary
6.1 The PBAC recommended the changes to the current Authority Required listing of fentanyl citrate (Abstral®) on the Palliative Care Schedule of the PBS by increasing the maximum quantity of the 100 mcg and 200 mcg presentations from 10 to 20 tablets per prescription for dose titration in the initiation of treatment of cancer patients with breakthrough pain. 3PSD · Jul 2017
6.2 The PBAC advised that the recommended changes to the listing would not be expected to increase the gross amount dispensed to patients however, it would incur additional costs to the PBS.PSD · Jul 2017
6.4 In the previous major submission considered by PBAC in July 2015, the submission presented a cost-minimisation analysis against fentanyl lozenges.PSD · Nov 2015
6.18 The submission described fentanyl buccal tablets as non-inferior in terms of efficacy and non-inferior in terms of safety compared to fentanyl lozenges.PSD · Jul 2015
6.19 The PBAC noted the weak body of evidence for comparison of fentanyl buccal tablets with fentanyl lozenge. However, noting the challenges in developing high- quality data in this clinical context the PBAC considered that the claims of non- inferior comparative effectiveness and non-inferior comparative safety were adequately supported.PSD · Jul 2015
5.2 The PBAC noted and welcomed the input from health care professionals (1) via the Consumer Comments facility on the PBS website. The comments described difficulty for these patients to see a doctor easily and indicated that the proposed increase in the maximum quantity would aid in the correct treatment of these terminally ill patients with fentanyl.PSD · Jul 2017
The PBAC considered that the size of the eligible population remains uncertain given the wide ranges in the published literature. The PBAC considered that a risk share arrangement would be needed to address this uncertainty as well as manage thePSD · Nov 2015
Cost-effectiveness
Minor submission; no economic evaluation or ICER calculated.
The PBAC considered that the reduction in MBS items as proposed by the sponsor were unlikely to be realised in actuality and that the recommended changes in the maximum quantity of fentanyl 100 mcg and 200 mcg presentations would result in a cost to the PBS and the Government health budgets. PBAC · 2017
Decision context
PopulationAdult cancer patients with breakthrough pain who are already receiving maintenance opioid therapy for chronic pain, during the initial dose titration phase of treatment.
Submission history
| Decided | Outcome | Comparator | ICER | Evidence |
|---|---|---|---|---|
| Jul 2017 | Recommended · restricted | — | — | Cost-minimisation · Cost-minimisation |
| Nov 2015 | Recommended · restricted | fentanyl citrate sublingual tablets; fentanyl lozenges; immediate-release opioids | — | Cost-minimisation · Cost-minimisation |
| Jul 2015 | Not recommended | fentanyl lozenges | — | RCT · Surrogate |
| Jul 2015 | Recommended · restricted | fentanyl lozenges; immediate-release oral opioids (morphine); subcutaneous morphine | — | RCT · Pain intensity difference, pain relief |
| Mar 2013 | Not recommended | oral transmucosal fentanyl citrate (OTF) | — | RCT · Time to onset of meaningful pain relief |
| Nov 2007 | Recommended · restricted | placebo | $45k–75k | RCT · Relative risk of responder (pain intensity difference of ≥33% at 30 mins) |
| Nov 2007 | Recommended · restricted | placebo | $45k–75k | RCT · PID |
| Mar 2006 | Recommended | placebo | — | — |
| Mar 2006 | Recommended | placebo | — | RCT |
Consumer voice
One health care professional provided input via the PBS website Consumer Comments facility, describing difficulty for terminally ill patients to see a doctor easily and indicating that the proposed increase in maximum quantity would aid in correct treatment of these patients with fentanyl.
The comments described difficulty for these patients to see a doctor easily and indicated that the proposed increase in the maximum quantity would aid in the correct treatment of these terminally ill patients with fentanyl. Consumer comments · PSD
Similar precedents
Regulatory · TGA
Label narrower than PBS population — PBAC restricted subsidy to initial dose titration phase only; TGA label permits ongoing management throughout treatment.