Updated May 27 with FDA decision and new pricing details — The Food and Drug Administration approved Thursday the buprenorphine implant Probuphine for use treating addictions to prescription painkillers and heroin.
The implant received a lot of attention in the addiction medicine field in anticipation of its approval as a potential game changer in the fight against opioid addiction. It could also have a $5,000 plus price tag every six months.
“It’s an amazing drug. It totally blocks those urges or desires to use. So it’s a nice protector,” said a St. Louis woman named Donna, who took part in the implant’s latest clinical trial.
St. Louis Public Radio agreed to only use her first name to protect her identity.
The Probuphine implant delivers a constant stream of the opioid addiction medication buprenorphine through tiny rods inserted in the upper arm.
Each implant lasts six months, which means people recovering from addiction would no longer have to make a daily decision to take a medication that reduces their ability to get high.
The implant could also reduce the amount of buprenorphine that gets misused or sold; because it contains opioids it has street value.
Donna had been successfully using the oral form of buprenorphine known as Suboxone for four years prior to the study. She doesn’t know whether the implant or the oral tablets she used during the clinical trial were a placebo.
“Before Suboxone I literally felt suicidal. It was very hard to have any connection with my loved ones,” said Donna. She detoxed from an addiction to pain pills without medical supervision and didn’t have access to buprenorphine at the time.
Later she went to CenterPointe Hospital for intensive behavioral therapy and started using buprenorphine.
“One thing that you start striving for is just to feel normal. You want your life back. Being on Suboxone, it tricks my brain,” said Donna. “Your life is more manageable.”
Her doctor, CenterPointe President Azfar Malik oversaw Donna and eight other participants in the Probuphine trial.
“What we found was the implants had less drug use over the course of time than those who were doing pills. So not only did it prove that it’s as good as taking the pills, which are fairly effective treatment at this time, but also that implants had a little better outcome,” said Malik, who plans on adding the implant to the options available at CenterPointe if it gets FDA approval.
Luis Giuffra, another St. Louis addiction medicine specialist not affiliated with the clinical trial, said he might use the implant with his patients at Clayton Behavioral if it gets approval but also expressed reservations.
“It’s a welcome addition, but it’s far from being a homerun,” Giuffra said. “The way the product is being brought to the market makes its use limited to a small proportion of patients who paradoxically may be the ones less likely to need it.”
“Right now the product will be FDA approved only for use in stable patients who need a low dose of daily buprenorphine,” Giuffra said. “More severe cases of opioid dependence are less likely to be compliant and are more likely to skip buprenorphine in order to use — sort of timing their use of buprenorphine to allow them to relapse as they see fit and are also the ones who are more likely to divert (sell or give away) the product.”
Giuffra said limiting the implant to stable patients also makes it difficult to convince insurance companies to pay for it.
“You can imagine the payers will say ‘well if a patient is already very stable on an inexpensive treatment, why should we pay for a very expensive treatment?’ ” Giuffra said.
Probuphine manufacturer Braeburn pharmaceuticals has said it will charge less than $1,000 a month for it's implant — a lower price point than the only other long-acting opioid addiction treatment option, Vivitrol. The market rate for a Vivitrol shot is around $1,000. Each shot lasts about a month.
That means the six-month implant could cost over $5,900.
Braeburn said it will offer rebates to insurers and co-pay assistance to patients to help make it more affordable.
Donna, the clinical trial patient, is hoping the implant will end up saving her money through fewer doctor co-pays.
“I just ran into this last night,” Donna said. “If I would have had to pay last night out of pocket for the (monthly prescription of) oral medication the pharmacy was telling me it was like $386. So it is expensive. But with my insurance I think I pay $25 a month. So for somebody who didn’t have insurance, yes, it’s huge. But then again if you’re using (prescription pain pills) you’re spending more than that a month on drugs easily.”
The high cost of maintaining an addiction to pain pills is one reason researchers say people misusing prescription opioids often also use heroin.
Follow Camille Phillips on Twitter: @cmpcamille.