FDA Recommends Co-Prescribing Naloxone with Opioids
A PPM Brief
In a near-tie vote, an FDA advisory panel1 recommended the prescribing of naloxone along with opioids, voting 12-11 in favor of labeling changes that encourage this co-prescribing. The panel discussion touched on more ways to make the potentially life-saving opioid overdose reversal drug more readily available to providers and patients.
Naloxone is currently available through prescription programs in pain clinics and “take-home” programs among high-risk patients. Branded versions include Narcan nasal spray (Adapt Pharma, Radnor, PA) and the Evzio auto-injector (Kaleo Inc, Richmond, VA).
One member in favor of the decision, Maryann E. Amirshahi, PharmD, MD, MPH, an emergency medicine physician at MedStar Washington Hospital Center in Washington, DC, said that the co-prescription of naloxone could facilitate a healthy dialogue between patients and healthcare providers, while detractors such as Mary Ellen McCann, MD, MPH, associate professor of anesthesia at Harvard Medical School, noted its expense. “I think co-prescribing is an expensive way to saturate the population with naloxone,” she said.2 “The at-risk population is not necessarily the ones that are being prescribed new narcotics. I’m concerned about a person going in with a broken arm and ending up with $30 of a codeine product and a (naloxone) autoinjector at $4,000 plus,” she said. Others noted, however, that FDA’s cost estimates may be “inflated” due to the inclusion of Narcan and Kaleo’s Evzio, an over $4,000 markup.
Previous FDA studies have determined that co-prescribing naloxone to opioid patients could increase annual healthcare costs by $63.9 billion to $580.8 billion.2 Currently, Narcan lists at $125, while generic versions of naloxone list at around $40 per dose. In addition, Kaleo recently announced a less expensive generic version of their Evzio auto-injector.3
