FDA to Discuss Wider Naloxone Availability; CMS Launches Opioid Maternal Care Model

The FDA announced it will consider ways to make naloxone more broadly available, including the possibility of coprescribing the opioid overdose antidote with some or all opioid prescriptions, and separately, CMS announced a new care delivery model for pregnant and postpartum women on Medicaid with opioid use disorder (OUD).

The FDA discussion will happen over a 2-day public advisory committee meeting of the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee on December 17 and 18, 2018.

“With the number of overdose deaths from prescription and illicit opioids doubling from 21,089 in 2010 to 42,249 in 2016, it’s critical that we continue to tackle this human tragedy from all fronts—including, and importantly, looking at new ways to increase the availability of naloxone,” FDA Commissioner Scott Gottlieb, MD, said in a statement.

Gottlieb said the committee will “weigh logistical, economic and harm reduction aspects of different strategies. And we will consider whether naloxone should be coprescribed with all or some opioid prescriptions to reduce the risk of overdose death.” Besides the economic costs that the committee will have to weigh, Gottlieb also cited practical considerations, like manufacturing supply and the risk of drug shortages.

Last spring, Surgeon General Jerome M. Adams, MD, issued a call for more people to carry naloxone. And the American Society of Addiction Medicine supports coprescribing of naloxone for people at risk of overdose, which it said includes those receiving nonacute opioid treatment for pain and those being treated for opioid use disorder.

However, there are barriers to implementing a policy to enhance access to naloxone. A Health Affairs blog post earlier this year, coauthored by A. Mark Fendrick, director of the Center for Value-Based Insurance Design at the University of Michigan and co-editor-in-chief of The American Journal of Managed Care^®, underscored the complexity of identifying who is most likely to benefit, as well as ensuring accessibility and affordability.

The authors identified 3 groups who require distribution approaches tailored to their specific needs: prescription opioid users, illegal opioid users, and third-party witnesses of overdose.

In addition, in the wake of the opioid crisis, the FDA is stepping up its encouragement of the development of opioid abuse-deterrent formulations (ADFs). But last year, the Institute for Clinical and Economic Review (ICER) said there was a lack of evidence to show that ADFs were effective at reducing opioid abuse levels. ICER estimated that for every 100,000 patients who are prescribed an extended release ADF opioid, there would be a net increase in cost of $533 million over 5 years.

In the CMS announcement, the agency said its Maternal Opioid Misuse (MOM) model aims to align and cooordinate care. It said Medicaid pays the largest portion of hospital charges for maternal substance use, as well as a majority of the $1.5 billion annual cost of neonatal abstinence syndrome (NAS).

The Center for Medicare and Medicaid Innovation will execute up to 12 cooperative agreements with states, whose Medicaid agencies will implement the model with 1 or more community partners. The model will serve pregnant Medicaid and Children’s Health Insurance Program beneficiaries with OUD.

Under the model, Medicaid beneficiaries will have access to essential physical and behavioral health services, such as medication-assisted treatment (MAT) for OUD, maternity care, relevant primary care services, and other mental and behavioral health services beyond MAT.

In June, CMS released guidance to states about treating infants with NAS.