The increasing price of naloxone may decrease the likelihood of people being saved from an otherwise deadly opioid overdose, according to a December article published in the New England Journal of Medicine.
The warning comes after two of the largest suppliers of the drug increased prices drastically over the last few years. An injection of naloxone can revive a person who is overdosing on heroin or prescription opioid painkillers.
Amphastar, the only manufacturer of 1-mg-per-milliliter naloxone injections — the dose used off-label as a nasal spray — increased that product’s price by nearly 95 percent from $20.34 in 2009 to $39.60 in 2016. Similarly, the authors noted that a 0.4 mg-per millimeter dose of naloxone from Pfizer’s Hospira that costed $62.29 in 2012 now costs $142.49.
Rachel Hooper, a Pfizer spokeswoman, told Reuters Health that Hospira has responsibly priced naloxone.
“We believe our actions have reflected sensitivity to the need for the product and also take into account the reality and necessary investments needed to produce high-quality generic drugs,” she said.
But Hospira’s price increases pale in comparison to the rising price of a two-dose package of Evzio, a naloxone auto-injector device manufactured by Kaleo. Its price surged from $690 in 2014 to $4,500 in 2016, an increase of more than 500 percent in only two years.
Mark Herzog, Kaleo’s vice president of corporate affairs, said that the company has implemented special programs that provide free naloxone to patients and caregivers who have a prescription and commercial insurance. He justified the price increase as a means to sustain these programs.
Ravi Gupta, lead author of the article, disagrees with Herzog. He stated that discount programs are not a sustainable option because the patients typically end up paying higher insurance premiums to benefit from these low-cost medicine options.
“The challenge is as the price goes up for naloxone, it becomes less accessible for patients,” Gupta said.
Government Should Ensure Affordability of Naloxone
Gupta and his co-authors recognized the government’s efforts to expand access to naloxone and prevent overdose deaths. Laws in 42 states grant criminal or civil immunity to bystanders who possess or use drugs when they provide emergency services to overdose victims. These services include administering naloxone or calling emergency responders.
Despite several government initiatives to increase naloxone’s availability, the authors commented on the slow increase in naloxone use. The yearly number of naloxone prescriptions grew from 2.8 million in 2009 to 3.2 million in 2015.
The researchers blame this slow increase on stigmatization, lack of familiarity with the drug and the increasing prices. Gupta says the lack of attention to naloxone’s soaring prices may be associated with the stigma of addiction. No such stigma exists for children who use the EpiPen, another life-saving injectable drug that reverses allergic reactions.
Gupta and colleagues proposed a number of steps the government could take to address the spike in naloxone prices:
- Purchase naloxone in bulk, creating stable demand. This might be a good incentive for other companies to manufacture the drug.
- Invoke a federal law requiring Kaleo to manufacture cheaper versions of Evzio in exchange for reasonable royalties.
- Authorize imports of generic versions of naloxone from international manufacturers that have obtained approval similar to the FDA’s standards.
- Allow the FDA to provide new manufacturers with incentives such as no application fees and faster drug approval times.
“When governments promote naloxone use, they have a responsibility to ensure the drug’s affordability,” wrote the researchers. They urged the government to act now to make sure that overdose patients and the community have access to the life-saving drug.
Naloxone, the Life-Saving Drug
Throughout the opioid overdose epidemic, naloxone has gained in popularity among medical professionals and the community alike.
Naloxone is an opioid antagonist that binds to opioid receptors, reversing or blocking the effects of opioids. An opioid overdose may cause a person to stop breathing, but naloxone quickly restores normal respiration.
There are three FDA-approved forms of naloxone:
- Injectable via syringe, requiring professional training
- Auto-injectable devices branded as Evzio
- Prepackaged nasal spray branded as Narcan
While only physicians and trained medical personnel are allowed to administer the injectable version, Evzio and Narcan are both available for friends, family and the community to use. Several cities across the United States are taking the initiative to provide naloxone training to their residents.
In February 2016, Baltimore, Maryland, introduced an online training program to teach residents how to administer naloxone and provided them with a certificate allowing them to obtain the overdose-reversal drug without a prescription.
Naloxone can be obtained in most pharmacies. While most locations require prescriptions, CVS and Walgreens pharmacies in some states provide naloxone without a prescription.