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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.”
Rather than using medication-assisted treatment, Mr. Pew said he prefers the natural tapering process, where drugs are gradually decreased “until the minimum dosage for the maximum benefit is achieved … But I do believe both options should be made available, and the best choice is an individualized plan for a specific patient.”
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.”
The committee also said if Probuphine is approved, “a risk mitigation strategy (beyond professional labeling) will be required to address the risk of complications of migration, protrusion, expulsion and nerve damage resulting from improper insertion and removal of Probuphine.” It also cited “the risks of accidental overdose, misuse and abuse if an implant comes out or protrudes from the skin.”
The FDA, which is scheduled to make a decision by Feb. 27, isn't obligated to follow the committee's recommendation.
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.”
Dr. Gabriel Schonwald, San Mateo, California-based pain specialist and adjunct clinical faculty member of Stanford University's division of pain medicine, said injured workers who are addicts, not pain patients, would be the likely candidates for the implant since it uses a fixed dose of buprenorphine.
Even in the case of a “pain patient who has become addicted to opioid medications, and now is in that gray zone between pain and addiction, I still don't like the fact that you're stuck with whatever dose they put in there,” Dr. Schonwald said. “That should change over time.”
States have pursued several different approaches to restrict costly physician dispensing of medications, particularly opioids, often with mixed results.