Jessie Hellmann | (TNS) CQ-Roll Call
Consensus is growing around the idea that for some patients higher doses of a gold-standard opioid addiction treatment drug may be better than lower doses at keeping patients healthy and in treatment, especially for those who use fentanyl.
But whether someone can access higher doses of buprenorphine — which works by curbing cravings and withdrawal from opioids — depends on where they live.
In most states, Medicaid — the largest payer of substance use disorder treatment in the U.S. — caps the doses it will pay for at arbitrary levels, typically at no more than 24 milligrams.
In some states, like Tennessee, that level is∂ as low as 16 milligrams. With “underdosing,” patients may experience symptoms that could push a person back toward the drugs they’re trying to quit, risking overdose or even death.
Providers say higher doses, sometimes up to 32 milligrams, are necessary in the face of a drug supply dominated by highly potent fentanyl.
“It’s probably the most significant challenge that we’re facing in our community because so many patients are needing higher doses to have the desired outcome the medicine is designed to achieve,” said Ryan Alexander, addiction medicine physician and medical director for substance use programming at McNabb Center in Knoxville, Tenn.
TennCare, Tennessee’s Medicaid program, won’t pay for doses higher than 16 milligrams except in limited circumstances.
“If you’re on a limit of 16 milligrams and cravings aren’t being controlled, you’re inadequately managing their disease,” Alexander said. “That puts them at risk of relapse and overdose.”
Limitations around buprenorphine prescribing have received more attention as providers reckon with the increasing use of fentanyl and other synthetic opioids, which were responsible for 70% of drug overdose deaths in 2022.
Several recent studies have shown dosage limits may be standing in the way of better care.
A study published last month in JAMA Network Open found that adults with opioid use disorder who received buprenorphine doses higher than 24 milligrams had a lower risk of emergency department visits or inpatient visits related to behavioral health. It aligns with other recent studies reaching similar conclusions.
Still, there appears to be a misconception that “less is more,” said Melissa Weimer, medical director of the Yale Addiction Medicine Consult Service, which treats hospitalized patients with substance use disorder.
“Less is not more. For these individuals, you need to have an appropriate dose, and if they don’t have an appropriate dose, they actually do not have opioid overdose protection, and they’re more likely to have what you might call an unsuccessful treatment with buprenorphine,” Weimer said. “I think that’s the shift that has happened with fentanyl, is that you can’t have a one-size-fit-all treatment.”
Medicaid programs often cite Food and Drug Administration labeling, which says the dose should be up to 24 milligrams and “dosages higher than 24 mg have not been demonstrated to provide any clinical advantage.”
But doctors say the labeling hasn’t kept up with the science of the fast-moving opioid epidemic.
“If the drugs people are using are no longer prescription opioids or heroin but instead illicit fentanyl with a much higher potency, it seems reasonable you need something stronger to deal with that,” said Bobby Mukkamala, president-elect of the American Medical Association and the chair of the AMA’s Substance Use and Pain Care Task Force.
Earlier this year, the AMA House of Delegates, the legislative and policymaking body of the American Medical Association, adopted a resolution supporting physicians’ ability to prescribe buprenorphine doses that exceed the FDA-approved labeling when recommended by their prescriber.
It also urged federal agencies, manufacturers, medical organizations and health plans to review the evidence about dosing and revise labels and policies accordingly.
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The FDA appears to be considering changing the labeling. It held a meeting in December, along with the National Institute on Drug Abuse and the Substance Abuse and Mental Health Services Administration, to collect data on the safety and efficacy of buprenorphine doses over 24 milligrams to “inform federal guidelines and policies with the latest evidence and practice experiences.”
Some states, like Washington, as well as the District of Columbia have recently increased their limits to 32 milligrams.
The FDA did not respond to a request for comment about the next steps.
“These higher doses can improve outcomes for patients. It literally keeps people alive when you have the right dose. The barrier to that is nonscientific, bureaucratic insurance company regulations,” Mukkamala said.
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