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Canadian Drug Review Reimbursement Decision


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  BuTrans
Generic buprenorphine transdermal patch
Company Purdue Pharma
Indication pain
Condition Nervous system
Submission Type
Patient Population Buprenorphine transdermal patch has Health Canada indication for the management of persistent pain of moderate intensity in adults requiring continuous opioid analgesia for an extended period of time. Buprenorphine is an opioid receptor agonist and antagonist analgesic. Three strengths of buprenorphine transdermal patch are available in Canada: 5 mg, 10 mg, and 20 mg per patch, delivering 5 mcg per hour, 10 mcg per hour, and 20 mcg per hour of buprenorphine, respectively, for seven days. Health Canada recommends that treatment be initiated at the lowest available dose (5 mcg per hour), particularly in opioid-naive patients. Opioid-experienced patients may initiate treatment at 10 mcg per hour. The maximum recommended buprenorphine transdermal patch dose is 20 mcg per hour.
Status Complete
Date of Recommendation 2011-09-28
Recommendation Summary Do not list
Recommendation Details The Canadian Expert Drug Advisory Committee (CEDAC) recommends that buprenorphine transdermal patch not be listed.
Reason for Recommendation In the three randomized controlled trials (RCTs) included in the systematic review considered by CEDAC, buprenorphine transdermal patch did not provide statistically significantly greater reductions in pain compared with oral opioid formulations, and buprenorphine transdermal patch is more costly than many available opioid formulations. Of Note: The committee noted that the frequency of gastrointestinal adverse events was similar between buprenorphine transdermal patch and the oral opioid comparators in the systematic review.
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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