As the number of opiate overdoses among IV drug users has continued to climb across the U.S., so has the demand for naloxone, the medication first-responders can use to reverse overdose effects before they become fatal. Meeting the need for injectable naloxone at an affordable price has become a challenge, in some areas.
Miranda Gottlieb, an overdose prevention specialist for the state of Florida, recently proposed three strategies the President’s Commission on Combating Drug Addiction and the Opioid Crisis should consider to make naloxone more accessible. implementing.
Gottlieb notes that the cost of naloxone, even generic naloxone, has spiked in recent years. According to the New England Journal of Medicine, the generic injectable naloxone has increased 129 percent since 2012 and now costs roughly $40 per kit, while the auto-injector has increased by approximately 552 percent since 2014 and is listed at $4,500 per kit (though it is often covered by insurance).
The first step to make naloxone more affordable would to increase the number of new drug applications for generic versions of naloxone. The Food and Drug Administration could consider waiving fees for Abbreviated New Drug Applications filed by generic drug-makers, Gottlieb says, writing in the blog of the Institute for Research, Education and Training in Addictions (IRETA).
By prompting an increase in new drug applications, the government could stimulate competition among drug-makers, leading to lower consumer prices.
Second, Gottlieb suggests, the Department of Health and Human Services could rule that a government patent use is required in the effort to reduce opioid overdoses.
“Invoking this policy would allow the federal government to pay reasonable royalties to patent holders of brand name naloxone (Evzio and NARCAN) and direct the increased utilization of generic naloxone,” Gottlieb says. Enabling bulk purchases of generic naloxone by the government will lead to lower prices for laypeople.
A number of states already purchase other prescription drugs in bulk; naloxone should be added to the list, Gottlieb contends.
Third, the FDA should relabel naloxone to allow over-the-counter access. This will attract more manufacturers to the market, and likely reduce prices, Gottlieb says. Relabeling will likely reduce the cost of naloxone, as additional manufacturers will be attracted to the market.
“Relabeling of naloxone as an OTC drug would clear up the legal ambiguities that remain in some states for layperson- and community-based distribution of naloxone,” Gottlieb adds.
In Italy, Naloxone has been sold as an OTC drug for more than 20 years. Australia approved it for OTC status in 2015.
Higher Naloxone prices have been straining the budgets of local first responders across the U.S., according to a National Public Radio report.
Concerned about the rapidly increasing use of naloxone by first responders, and the impact on local government budgets, Sen. Claire McCaskill, D-Mo., recently sent letters to four pharmaceutical companies that make naloxone, asking them to provide details about the discount programs they offer to emergency management and public health agencies.
“The rise in costs associated with acquiring naloxone has caused significant accessibility issues for those on the front lines of this epidemic,” she wrote in the letters. The letters followed an earlier request about naloxone costs by McCaskill, in which the companies responded by saying they had donated doses and offered discounts on naloxone to first responders.
The prices of some brands of naloxone have risen in recent years, according to an analysis by the investment research firm SSR Health for NPR. The price of a vial of generic naloxone made by the company Amphastar rose from about $4 in 2009 to about $16 this year, according to SSR. )
On October 26, President Trump declared the opioid epidemic a national emergency. The emergency declaration gives the Department of Health and Human Services the power to negotiate lower prices for naloxone. The day before the president’s announcement, Sen. Debbie Stabenow (D-MI) and 19 other Democratic senators on called on President Trump to allow the government to negotiate lower prices for naloxone.
That same day, the Energy & Commerce Committee questioned HHS officials about the rising price of naloxone.