Posted by Michael Wonder on 21 Aug 2019
PTAC continues to find new ways to reject funding applications (part 1)
21 August 2019 - The minutes from the May 2019 PTAC meeting provide some interesting, some might say startling, insights.
The Committee reviewed correspondence requesting reconsideration of an application for buprenorphine transdermal patches for the treatment of chronic moderate/severe non-malignant pain.
"The Committee recommended that the application for buprenorphine transdermal patches for persistent moderate/severe chronic non-malignant pain be declined, based on insufficient evidence of long-term analgesic benefit, lack of evidence regarding functional improvements and improvements in health-related quality of life, and concerns regarding diversion and possible societal harm."
Buprenorphine is hardly a new medicine with little or no data on its long-term use. It was first approved by the US FDA in 1953 (albeit not as transdermal patches). Buprenorphine is an old, out of (compound) patent medicine.
The PTAC considered an application to list buprenorphine transdermal patches in 2009 for essentially the same patient population. "The Committee recommended that buprenorphine transdermal patches be listed in the Pharmaceutical Schedule, subject to Special Authority criteria restricting its use to patients who have not responded to other opioid analgesics, with a low priority."
How can the PTAC come to a justifiable conclusion that in 2019 buprenorphine (a 60+ year old medicine) does not have sufficient evidence of a long-term benefit ten years after it recommended its use with no apparent concerns about its long-term treatment effect?
