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he implant promises to treat opioid addiction without the hassle of a daily pill. And the company marketing the drug is so confident it’ll work, it’s planning to offer insurers a twist on a money-back guarantee: If the new device doesn’t save them money, they’ll get a refund.

The implant, branded as Probuphine, relies on four tiny rods implanted under the skin to dispense the drug buprenorphine for six months at a time. The Food and Drug Administration is expected to decide on Friday whether to approve it.

The decision comes amid an opioid crisis that’s devastating communities. An estimated 1.9 million Americans are addicted to prescription painkillers, and 600,000 are believed to be addicted to heroin. The implant, though, is aimed at a much narrower population: Addicts who are in recovery and considered stable, and who are already taking a low dose of the same medication in the form of pills or a thin film that dissolve under the tongue.

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Braeburn Pharmaceuticals, a New Jersey company that has commercial rights to the implant in the United States and Canada, plans to price the implant “competitively” with other injectable drugs for neuropsychological conditions that cost between $1,000 and $1,500 per month. That’s significantly more expensive than existing forms of buprenorphine.

Some doctors are skeptical it’ll make much difference.

“I just don’t see how this is going to help fight the opioid epidemic at all,” said Dr. Carl “Rolly” Sullivan, director of addiction services at West Virginia University Medicine, in a region hard-hit by the opioid crisis.

Sullivan said he worries opportunistic clinics will market the implant as a quick solution to addiction, rather than as part of the broader treatment program, including counseling, that he sees as essential to recovery. “My fear is that these kind of clinics will just use this medicine as another part of their arsenal to treat addicts who come through their door,” Sullivan said.

A novel deal for insurers

But Braeburn is so confident in the product, it’s planning to offer insurers a novel deal: If patients taking Probuphine ring up higher total medical bills — over a period of, say, six months — than comparable patients taking other forms of buprenorphine or other available opioid addiction medication, Braeburn will give them a rebate for the difference.

It’s a bet, in other words, that patients on Probuphine won’t relapse and end up doing a costly stint in rehab or develop expensive conditions like hepatitis C or HIV that disproportionately affect people addicted to opioids.

“We are going to put our money where our mouth is,” said Braeburn CEO Behshad Sheldon. “We believe that when you guarantee compliance with a medicine, it is going to save money in the long run.”

Dr. Steven Pearson, president of the nonprofit research group the Institute for Clinical and Economic Review, called Braeburn’s plan “ingenious” but cautioned that it won’t be easy to implement.

Medical spending will have to be painstakingly tracked for each patient. The deal will inevitably come to an end, potentially leaving in limbo patients who are often dependent on opioid addiction medication for years, or even decades. And what happens if patients switch insurers while still on treatment?

Sheldon said Braeburn is still in the early stages of talking to insurers. But she said some insurers maintain sophisticated databases of patient data (often stripped of patient names) that could help such deals run smoothly.

If it goes ahead with the deal, Braeburn would join a handful of other drug makers experimenting with unusual payment models.

The drug maker Novartis, for instance, has a deal with the insurer Cigna that brings it more money for its heart drug Entresto if the medication keeps patients out the hospital. And the pharmacy benefits manager Express Scripts has begun adjusting the price it’ll pay for certain drugs based on how well they treat different types of cancer. Best-selling anti-inflammatory drugs are slated to be added to the program beginning next year.

A tough sell to doctors

Originally developed by the San Francisco specialty pharma company Titan Pharmaceuticals, the new implant works by continuously dispensing a drug that acts on opioid receptors in the brain, reducing cravings and preventing withdrawal symptoms.

The medication it dispenses, buprenorphine, is addictive in and of itself. (It’s regularly dealt on the black market and increasingly seized by law enforcement.) But unlike traditional opioids, there’s a limit to how much action buprenorphine exerts. This so-called ceiling effect makes users feel normal instead of high and makes it nearly impossible to overdose on the drug alone.

opioid implant gif
Alex Hogan/STAT

That’s made the drug a heralded tool in combating the opioid epidemic. It’s been tightly controlled, however; doctors must be certified to dispense the drug and can only prescribe it to a limited number of patients. The Obama administration unveiled a plan earlier this spring to lift some of those restrictions.

But it’s unclear whether physicians will warm to the new implant form of the drug, particularly at its high price point.

For patients able and committed to taking the drug by tablet or film, “I’d probably still err on the side of prescribing it that way,” and reserve the implant for those who will have trouble sticking with a daily medication, said Dr. Sarah Wakeman, medical director for substance use disorders at Massachusetts General Hospital, which sees many patients from New England, one of the epicenters of the crisis.

The FDA rejected the implant the first time it came before the agency in 2013, requesting more data demonstrating its efficacy. An advisory panel to the FDA recommended the drug for approval in January on the back of a new, 176-patient study showing that the implant was not inferior to another form of the medication. (Twelve percent of patients with the implant relapsed, compared to 28 percent taking the pill form of the drug.)

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But some critics remained convinced that the implant still isn’t ready for prime time.

“We don’t need another product on the market that’s not been tested very well to see how safe it is and how effective it is,” said Diana Zuckerman, president of the National Center for Health Research, a nonprofit think tank. A representative for the organization testified before the FDA advisory panel, expressing concern about the risk that patients would relapse in the few weeks after the implant is placed, while therapeutic levels of the medication are still stabilizing.

Braeburn, though, is moving full-steam ahead in anticipation of an approval on Friday.

Beginning this weekend, it’s scheduled training sessions across the country for physicians, in large part general practitioners and psychiatrists, who want to learn to insert and remove the implant. (They practice on a pork tenderloin.) More than 2,200 clinicians have already signed up.

15 years of overdose deaths in the US

Explore the interactive visualization below to learn more about overdose deaths caused by narcotics and hallucinogens from 1999 to 2014. The vertical axis shows the number of people who died from a drug-related overdose in a year. The colored bands represent different types of drugs. "Other opioids" include morphine, oxycodone, and hydrocodone. The "other synthetic narcotics" category includes fentanyl, propoxyphene, and meperidine. Click on the colored bands to see the data broken down by drug type. Click on the arrows above the chart or the age groups at the bottom to see the data broken down by age.

Cannabis (derivatives)
Other and unspecified narcotics
Cocaine
Other synthetic narcotics
Methadone
Other opioids
Heroin
all ages
< 15
15-24
25-34
35-44
45-54
55-64
65-74
75+

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