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. In addition, CMS said it was creating a new care model to care for pregnant and postpartum Medicaid beneficiaries with opioid use disorder.
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.
Standard Criteria for Loss of Ambulation Needed in DMD
April 19th 2024A recent study suggests the differences between ambulation definitions for patients with Duchenne muscular dystrophy (DMD) can impact the identification of ambulant vs nonambulant individuals, and standard criteria across settings are needed.
Read More
Overcoming Employment Barriers for Lasting Social Impact: Freedom House 2.0 and Pathways to Work
April 16th 2024To help celebrate and recognize National Minority Health Month, we are bringing you a special month-long podcast series with our Strategic Alliance Partner, UPMC Health Plan. Welcome to our second episode, in which we learn all about Freedom House 2.0 and the Pathways to Work program.
Listen
Early Involvement Critical in Treating Immunotherapy-Induced Overlap Syndrome
April 19th 2024A series of case studies reveals the importance of early diagnosis and involvement of special teams of clinicians when dealing with potential cases of overlap syndrome, which encompasses myocarditis, myasthenia gravis, and immune checkpoint inhibitor–related myositis.
Read More
Making Giant Strides in Maternity Health Through Baby Steps
April 9th 2024To help celebrate and recognize National Minority Health Month, we are kicking off a special month-long podcast series with our strategic alliance partner, UPMC Health Plan. Welcome to our first episode, which is all about the Baby Steps Maternity Program and its mission to support women throughout every step of their pregnancy journey.
Listen