An article published in Business Insurance says that a U.S. Food and Drug Administration committee’s vote in favor of approving a long-acting, rod-shaped drug implant to combat opioid addiction could mean added costs for workers compensation payers.
In a 12-5 vote last week, the FDA’s Psychopharmacologic Drugs Advisory Committee approved Probuphine. The implant, by South San Francisco, California-based Titan Pharmaceuticals Inc. and Princeton, New Jersey-based Braeburn Pharmaceuticals, which is surgically inserted under the skin of the arm, can help reduce opioid dependence by delivering a daily dose of buprenorphine for up to six months.
Probuphine is a version of buprenorphine, which federal law classifies as a Schedule III controlled substance. Buprenorphine is a “widely accepted tool to help people taper from opioids” that already is available in tablet and film formulations, Mark Pew, senior vice president at Duluth, Georgia-based medical management company PRIUM, said in an email. “In a perfect world, the buprenorphine is added to discontinue the opioids, and then the buprenorphine is itself discontinued,” Mr. Pew said. “However, since we don’t live in a perfect world, often the buprenorphine stays long-term.”
Titan Pharmaceuticals submitted a new drug application for Probuphine to the FDA in 2012, but the agency decided against approving the treatment since the dose provided was too low to be effective for patients new to buprenorphine treatment. This time around, the advisory committee expressed concerns about whether physicians would be sufficiently trained on surgically inserting the rod, saying “provider qualification and training should be better defined.”
Mr. Pew said the implant could become a “long-term cost consideration” for workers comp payers. “If Probuphine becomes a long-term strategy for pain management, it could be a very expensive addition,” Mr. Pew added. “If all other drugs were tapered appropriately, then the payer may be swapping one cost for another, and that may or may not be a cost-efficient swap.”
The FDA, which is scheduled to make a decision by Feb. 27, isn’t obligated to follow the committee’s recommendation.