KU-led research shows drug critical to fighting opioid addiction remains underused
December 19, 2018
By Kristi Birch
It will take many weapons to fight the epidemic of opioid addiction, but one medication critical to fighting the worst drug crisis in U.S. history remains woefully underprescribed and underutilized, according to research from the University of Kansas Medical Center.
The number of Americans with an opioid addiction has more than doubled in the last 10 years. Meanwhile, drug overdoses have become the leading cause death in the United States for people under 50 years of age and the overall leading cause of death by injury (overdoses are categorized as unintentional injuries by the Centers for Disease Control and Prevention).
Yet there remains a huge gap in the number of prescriptions for buprenorphine, a medication effective in treating opioid addiction, and the skyrocketing number of people who have that addiction, according to research led by Andrew Roberts, Pharm.D., Ph.D., assistant professor in the Department of Preventive Medicine and Public Health at the University of Kansas School of Medicine.
First approved by the Food and Drug Administration in 2002 to treat opioid use disorder, buprenorphine is a partial opioid itself. Also known by its brand name, Suboxone, buprenorphine reduces cravings and relieves withdrawal symptoms but does not produce a high at typical doses. People in recovery from addiction can take buprenorphine to stay physically comfortable while stopping their abuse of riskier prescriptions such as oxycodone or street opioids such as heroin.
Methadone, the better known, older opioid replacement therapy, does the same thing, but is often harder for people to access: in the United States, methadone must be administered to the patient at a clinic certified by the Substance Abuse and Mental Health Services Administration; the methadone clinic system was developed in the 1960s and then carved into law in the Narcotic Addict Treatment Act in 1974. But patients can take buprenorphine at home on a schedule, as they would for any other chronic condition. "It can be prescribed by any physician trained to prescribe it, and you just pick it up at the pharmacy," said Roberts. "It's much easier for people to obtain."
There's the irony. Of the more than 2 million Americans with opioid addiction, just one in five obtain any treatment. Studies show that the most effective therapy for opioid addiction is medication-assisted treatment: behavioral therapy combined with a medication such as buprenorphine or methadone. In 2016, the same year that more Americans-more than 40,000-died from opioid overdoses than from car accidents, Congress passed the Comprehensive Addiction and Recovery Act to increase treatment access. One provision of the law is an increase the number of people for whom a doctor can prescribe buprenorphine, from 100 to 275 patients per year. Expanding access to the drug has become a major federal priority.
Meanwhile, Roberts and his colleagues were thinking ahead. "Assuming that the provider supply issue could be addressed, we were wondering what other barriers there might be to getting and adhering to treatment."
They immediately thought of cost, a known treatment barrier with other chronic conditions such as asthma and diabetes. When the price of a medication for those diseases goes up, the less likely people are to take it and the worse their clinical outcomes are.
Roberts also points to the risk of price gouging. The obvious headline-making example is the price of the EpiPen-the life-saving injection device used by millions of Americans to treat lethal allergic reactions-which rose 500 percent over a decade. There's already some evidence of price gouging happening in the opioid treatment arena. The cost of a twin-pack of injector device to administer naloxone, a drug that can reverse an opioid overdose, has risen to $4,500 in 2018, from $690 in 2014. "We wanted to see if we needed to be worried about the cost of buprenorphine as we try to connect people with treatment," Roberts said.
Working with researchers from Vanderbilt and Johns Hopkins, Roberts analyzed outpatient prescription claims data from 2003 to 2015, looking at buprenorphine utilization and expenditures for both health plans and insured patients. The database captured 20 million people annually during those years who were in a commercial health insurance plan provided by a large or medium-sized U.S. employer. They wanted to look at privately insured people in particular because these people are more likely to be affected by higher out-of-pocket prescription costs than are Medicare and Medicaid patients.
What they found, Roberts calls a "pleasant surprise": the median amount paid by private payers (health plans) for a 30-day supply of buprenorphine has remained relatively stable since 2003, and the out-of-pocket median expenditure for privately insured adults has actually steadily decreased over time, from $67 to $32 for a 30-day prescription. Buprenorphine appears to be insulated from the large spending increases that have affected life-saving drugs for other chronic diseases.
But they also saw something worrisome in the data. The number of people taking buprenorphine for treatment increased until 2013, but then the number of people initiating treatment declined from 2013 through 2015. "This is in the face of a massive treatment gap," said Roberts. "We would have hoped to have seen an exponential increase in the number of people starting treatment-we know they are out there."
If cost isn't the barrier to buprenorphine being more widely used, then the question becomes, what is?
One issue, Roberts said, is that although it's less complicated than methadone, prescribing buprenorphine is more regulated than for other medications. Physicians must take a short training course to get permission to prescribe it. "So there's that hoop to jump through, and sometimes physicians are leery into wading into that territory [of addiction] clinically. There's a fear it might invite scrutiny from authorities," he said. "And then there's the whole stigma around addiction."
Brendan Saloner, Ph.D., assistant professor in the Department of Health Policy and Management at the Johns Hopkins Bloomberg School of Public Health and a co-author on the study, also cites stigma as a barrier. "Many patients and doctors still harbor antiquated ideas about how addiction medication works, and there is a pervasive and untrue myth that medication substitutes one form of addiction for another," he said.
Roberts notes that their data go only through 2015, and the jury is still out on how much of a difference the 2016 regulations, including increasing the number of people doctors can treat with buprenorphine, will make. "But according to our data, the uphill battle to close these treatment gaps is getting providers to participate in this fight," said Roberts. "And one of the easiest ways to fight it is to get trained and treat patients with this drug."