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Canadian Drug Review Reimbursement Decision

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Generic Fentanyl citrate
Company Paladin Labs Inc.
Indication pain
Condition Nervous system
Submission Type
Patient Population Fentanyl citrate sublingual tablets have a Health Canada indication only for the management of breakthrough pain in patients with cancer, aged 18 years and older, who are already receiving, and who are tolerant to, opioid therapy for their persistent baseline cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg per day morphine equivalents for a week or longer. Fentanyl is a pure µ-opioid receptor agonist. Fentanyl citrate sublingual tablets are available in the following strengths: 100 mcg, 200 mcg, 300 mcg, 400 mcg, 600 mcg, and 800 mcg. The Health Canada–approved dose includes an initial dose of 100 mcg for all patients. If adequate analgesia is not obtained with the first 100 mcg, dose escalation in a stepwise manner over consecutive breakthrough episodes should continue until adequate analgesia with tolerable side effects is achieved. Doses higher than 800 mcg should not be used. Single doses should be separated by at least two hours and should be used only once per breakthrough cancer pain episode; i.e., fentanyl citrate sublingual tablets should not be re-dosed within an episode.
Status Complete
Date of Recommendation 2011-12-16
Recommendation Summary Do not list
Recommendation Details The Canadian Drug Expert Committee (CDEC) recommends that fentanyl citrate sublingual tablets not be listed at the submitted price.
Reason for Recommendation 1. At the submitted price, the cost of Abstral greatly exceeds that of other available oral (taken by mouth) opioids. 2. There are no well-designed medical studies comparing Abstral with other less costly opioids available for the management of breakthrough cancer pain. Of Note: Based on a review of the clinical evidence, the Committee felt that a reduced price would increase the likelihood of a recommendation to "list" or "list with criteria".
Clinical Report:
Pharmacoeconomic Report:
Final Recommendation Report: CDR clinical report  CADTH-CDR Final Recommendation report

†The information referenced on this page is compiled from publicly available documents published by CADTH and is available through the embedded links.

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