Opioid use disorder

Medications that treat opioid use disorder (OUD) — such as methadone, buprenorphine and extended-release naltrexone — are life-saving drugs that have been proven to decrease opioid overdoses by more than half. However, 86.6% of people who have OUD are not receiving these medications, according to a study published Thursday in the International Journal of Drug Policy.

For the study, researchers at NYU Grossman School of Medicine analyzed two databases: a publicly available one that tracked the dispensing of OUD medications by licensed methadone clinics and a private one that tracked prescriptions filled for buprenorphine and extended-release naltrexone. Through their analysis, they found that although the use of medications for OUD has more than doubled over the last 10 years, the use of these medications is still far too low to keep up with the opioid overdose fatality rates that have been soaring during the past decade — a trend driven mainly by the rise of synthetic opioids like fentanyl.

When the researchers looked at the data state-by-state, they found utilization of medication for OUD varied significantly. OUD medication treatment rates were at their lowest in South Dakota and highest in Vermont. But even in states with the highest rates of use, at least half of people who could benefit from OUD medications were still not receiving them.

There are three key ways to address this problem, Noa Krawczyk, the study’s lead author, said in an interview. 

One is by relaxing tight regulations on methadone dispensing. Methadone is one of the most effective ways to treat OUD, according to Krawczyk, but the medication can only be dispensed from licensed opioid treatment programs (OTPs). She pointed out that about 80% of U.S. counties do not even have an OTP. When it comes to expanding access to methadone, providers and harm reduction advocates pretty much have their hands tied, as federal law stipulates that the medication can only be dispensed through these programs.

This is not the case in other countries, Krawczyk noted. For example, in the U.K., patients can receive a prescription for methadone from their physician and pick it up at the pharmacy, just as they would obtain any other chronic medication. Having a similar system in the U.S. would make the life-saving medication much more widely available, Krawczyk said.

Another change the U.S. healthcare system should make to increase access to OUD medication is removing the special waiver requirements physicians need to prescribe buprenorphine. In order to prescribe buprenorphine in this country, providers need the X waiver, a requirement mandated by Congress in 2000 that necessitates physicians receive a day’s training before they can prescribe the drug.

Last year, a bipartisan group of six members of Congress introduced the Mainstreaming Addiction Treatment (MAT) Act to eliminate the X-waiver. The bill cited a National Institutes of Health study that showed France’s opioid overdose deaths declined by 79 percent over a four-year period after the country took similar measures to make buprenorphine prescription possible without a waiver. Krawczyk said passing this bill would not only free up bureaucratic hurdles, but also eliminate “the sense that buprenorphine is a very complicated treatment when it’s really not.”

The final change needed to increase access to OUD medication is expanding the deployment of these medications in mobile health clinics and community-based organizations, as well as within the criminal justice system. In order to accomplish this, the medical community will have to work on decreasing stigma around OUD, Krawczyk declared. She pointed out that many providers have stigma against people with OUD because they were never trained to understand the condition in medical school.

“If you work at any hospital or community clinic, you’re going to run into patients with substance use disorders,” Krawczyk said. “So it’s really pretty disgraceful that we don’t spend more time training our doctors about this. Opioid use disorder is the only chronic disorder that’s treated in this way — no other chronic medications require a special license or have to be provided in these specific settings.”

Photo: sorbetto, Getty Images

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Digital health startup Pear Therapeutics released the first real-world data showing its digital therapeutic for opioid use disorder decreased medical costs. The company received FDA clearance for its reSET-O product in 2018 to be used as a treatment for opioid use disorder in conjunction with medication.

Until now, the company had estimated the digital therapeutic’s cost effectiveness using modeled data.

“This is the first data looking at actual claims and real-world use,” Pear CEO Dr. Corey McCann said in a phone interview. “I think that establishing the cost effectiveness is an important part of the value proposition for any therapeutic — in particular, a digital therapeutic. “

The results were published in peer-reviewed journal Expert Review of Pharmacoeconomics & Outcomes Research on Wednesday. Pear funded and conducted the retrospective study, which evaluated 351 patients’ healthcare utilization up to six months before and after using reSET-O.  The majority, 82.6%, were covered through Medicaid.

Patients used reSET-O in conjunction with medication-assisted therapy, specifically, buprenorphine. They would interact with the app for about 40 to 50 minutes per week, which features modules focused on helping them understand their reasons for use and motivations for sobriety, as well as skills for managing triggers and harm reduction.

In total, researchers saw 1,181 fewer claims after using reSET-O, resulting in a savings of about $2,150 per patient. They saw 45 fewer inpatient visits, a significant decline, and 27 fewer emergency department visits, a less significant decrease. Patients used case management and rehabilitative services more frequently.

McCann said Pear has seen “a good deal of payer interest” in its programs, and was also in advanced conversations with state Medicaid organizations. Earlier this year, a bill was also introduced into the U.S. Senate to establish a benefit category for digital therapeutics under Medicare and Medicaid.

“We absolutely are using this data for conversations with employers, payers, and also state payers like Medicaid,” he said.

In the meantime, states are grappling with the “epidemic within the pandemic,” as opioid use has increased in recent months. As of late October, more than 40 states had reported increases in opioid-related deaths, according to the American Medical Association.

For many patients, what would have been face-to-face visits has shifted to telemedicine encounters. In some states, patients still face prior authorization hurdles to accessing care.

“The pandemic has really impacted them from both sides. While they’ve experienced a decrease in access to care, they also experience an increase in depression, anxiety and other triggering events,” McCann said. “I think that’s something that has gotten worse during the Covid era.”

Photo credit: Getty Images, photo_chaz

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