PBAC's latest decision on Fentanyl: Not recommended (2014). Considered for 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.
PBAC outcome
Not recommended
Authority Required
ICER (AUD/QALY)
Cost-min
cost-minimisation analysis
Submissions
2
first 2014
Submissions
2
2014 → 2014
Eligible population
Adult cancer patients with breakthrough pain who are already receiving maintenance opioid therapy and are unable to tolerate further escalation of morphine for breakthrough pain.
Therapy area
Pain
Line of therapy
Second-line
Evidence base
Single-arm
Primary endpoint
Pain intensity difference and pain relief at 30 and 60 minutes
Cost-minimisation analysis was presented but the PBAC considered it fundamentally inappropriate given that the clinical claim of non-inferiority was not accepted.
Why PBAC said no
Reasons cited in the latest PSD: 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