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).

In a close vote, panel members were divided over co-prescribing opioids and naloxone. (Source: 123RF)

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