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Navigate the naloxone economy

August 2, 2016
by Brian Albright
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In June, North Carolina joined the short list of states to issue a standing order for any pharmacy to provide the overdose reversal drug naloxone without a prescription. The order was signed by Gov. Pat McCrory as part of an effort address the state’s growing opioid overdose problem. That same week, drug store chain Walgreens announced it was making naloxone available without a prescription in all of its pharmacies in several large states.

Those are just the latest among efforts to increase access to the drug, which can revive an overdose victim in seconds. However, the rising cost of the drug in some forms might make it more difficult for those efforts to be successful.

The drug and the delivery

Naloxone was initially approved by the Food and Drug Administration (FDA) in 1971, and the molecular entity has long since lost its patent. However, new patented delivery mechanisms are changing the proposition for its use.

For decades, naloxone was administered by using a hypodermic needle. However, naloxone in self-contained, nasal-spray delivery packaging (branded as Narcan from Adapt Pharma) was approved by FDA late last year. The new mechanism makes it easier for users without medical training to administer the drug—an important innovation, as the drug is increasingly being provided to laypeople.

In addition to the Narcan nasal spray product and the traditional injectable version, there is also an auto-injector version approved in 2014 (Evzio, from Kaléo) as well as kits that combine the syringe with a twist-on atomizer to create a nasal spray (from several manufacturers) that have been used by first responders for years but are not specifically FDA approved.

Ease of use

Simpler delivery mechanisms are making it easier for laypeople to administer the medication in an emergency. Seabrook House, a treatment provider based in Seabrook, N.J., is providing Evzio prescriptions to all of its patients with opiate use disorder histories upon discharge. According to medical director Joseph Ranieri, ease of use was critical.

“Even at our own facility, I’ve seen staff struggle or fumble with the generic syringe version,” Ranieri says. “You have to screw the vial on the syringe. If you use the intranasal version, you have to get [the patient] on their back and attach the applicator. It’s difficult even for medial professionals. With the injector, you open it up and put it on their leg.”

Efforts to increase access to naloxone are having an impact. In June, New Mexico’s State Department of Health announced that the number of drug overdose deaths had decreased by 9% over the past year, thanks in part to legislation that made it easier for community-based programs and first responders to obtain the drug.

The good news is just about anyone can administer naloxone today. A recent study conducted by researchers from the National Institute on Drug Abuse (NIDA) and the National Institutes of Health (NIH) compared the efficacy of intranasal naloxone to the higher dose delivered with the intramuscular injection, and found that not only was the nasal spray version potentially more effective, but that it was easier to administer with no prior training.

However, price increases have community organizations, first responders, healthcare providers and state governments up in arms.

The Harm Reduction Coalition says that generic naloxone in a syringe cost roughly $1 per injection 10 years ago, but that has increased to up to $30 per dose today. Amphastar’s prices for its naloxone kit doubled to about $50 in 2015, while the Evzio auto-injector can cost as much as several hundred dollars per dose or more. The Narcan nasal spray is new to the market without historical cost data, but lists for $125 for two doses.

Challenge for state programs

Price increases across the market are proving to be a challenge for states and organizations trying to expand access to the drug in the communities where it’s most needed. And demand is rising.

“We’ve heard that some providers have seen a 17-times increase in the past two years as the drug increases in popularity,” says Kent Runyon, vice president of community relations and chief strategist and compliance officer for Novus Medical Detox Center. “Prices have not gone down as production has increased. That is disappointing given the nature of the medication and the importance of it to the overdose problem.”

Few doubt the usefulness of the drug and its newest delivery mechanisms, but some wish the pharmaceutical manufacturers would reconsider pricing structures.

“The industry as a whole is not acting in bad faith or exploitatively, but I do think there are some members of the pharmaceutical industry that are making bad commercial decisions, and they should consider the public interest and, frankly, their own public relations,” says Michael Barnes, executive director for the Center for Lawful Access and Abuse Deterrence (CLAAD).

Complicating matters, he says, are the number of third-party repackagers creating what are essentially unapproved kits with the naloxone syringes.

Barnes adds that some manufacturers are scaling their prices up to match the price of new delivery systems. For example, after the introduction of the Evzio auto-injector (which includes an electronic audio system that provides step-by-step instructions), Amphastar increased its prices for a 10-pack of 2mL syringes by nearly 60%.