The Latest Weapon in the Treatment of Opioid Addiction – Will Probuphine Live Up to the Hype?

Medicare Set-Aside Blog, Rx/Pharmacy on June 6, 2016 | Posted by Erin O'Neill, PA-C, JD

On May 26, 2016, the U.S. Food and Drug Administration (FDA) approved the first implant of its kind designed to provide maintenance treatment of opioid dependence.

http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm503719.htm

Probuphine, developed by Braeburn Pharmaceuticals utilizing Titan Pharmaceuticals’ continuous drug delivery system, is a small implant that is made from a mixture of ethylene-vinyl acetate and 80mg of buprenorphine. Probuphine consists of four one inch long devices that are implanted on the inside of the upper arm. The devices deliver a low-level steady dose of buprenorphine, for a six month period of time. Probuphine is indicated for the maintenance treatment of opioid dependence in patients who are stable on 8mg or less of buprenorphine daily. Buprenorphine was previously available only in tablet or film formulas and had to be taken on a daily basis as part of an overall treatment program for opioid dependent patients. Buprenorphine, as well as other similar medications such as naltrexone and methadone, are utilized to reduce the desire to use opioids as well as decrease the withdrawal symptoms associated with discontinuation of opioids.

Proponents of this latest development cite improved patient compliance as a major benefit over the other formulations of buprenorphine. Additionally, because the devices are implanted it is noted that they will be much more difficult to abuse than the tablet or film versions; however, opponents of Probuphine indicate that the device is not without potential for abuse. The implants contain a very potent amount of the drug which could be abused if removed from the skin by the patient.

An additional concern cited by critics includes the cost of the procedure. In a press release announcing the commercialization plans for Probuphine, Braeburn Pharmaceuticals indicated that the implant will cost $4,950.00 for the six month course of treatment. Braeburn Pharmaceuticals outlined they are currently discussing a value-based reimbursement program with insurers, whereby the insurers would be eligible for a rebate if the overall cost of treatment for a group of patients provided with Probuphine, exceeded the cost of treatment for that same group of patients in a prior six month period or for a comparable group of patients who were taking another form of opioid addiction medication.

Opponents have also pointed to the fact that Probuphine can only be placed by a trained provider and that a surgical procedure is required to insert and remove the implants. All surgical procedures, regardless of how minor carry inherent risks associated with the procedure. In the press release noted above, Braeburn Pharmaceuticals has indicated that over the next six weeks, 262 training sessions will be conducted in over 55 cities, which will add additional providers to the 121 providers already certified as of the end of May.

There is also a question as to whether this latest development really provides any additional assistance in the fight to decrease opioid dependence. As noted above, Probuphine is only approved for those individuals who are already stable on low dosages of other forms of buprenorphine. In order to be considered stable, these individuals have likely already demonstrated the ability to take their medication on a daily basis.

Finally, the question arises as to what happens after six months. The Full Prescribing Information indicates that after six months, the procedure can be repeated one additional time with placement of the implants in the contralateral upper arm. Additional studies are being required before the FDA will approve additional courses of treatment.