December 9, 2016 / 8:38 PM / 10 months ago

Big price hikes seen in drug that prevents overdose deaths

(Reuters Health) - Two of the largest suppliers of the life-saving drug naloxone have dramatically increased their prices in recent years, threatening to make it less likely that someone can be saved from a potentially-fatal opioid overdose.

The warning published by the New England Journal of Medicine comes in the wake of recent of drug price gouging, most notably for Turing Pharmaceuticals’ anti-parasite drug Daraprim and Mylan’s EpiPens, designed to prevent death following a severe allergic reaction.

“It’s certainly part of the larger trend in brand name drugs and old off-patent generics” that have been subject to large price hikes in recent years, said Ravi Gupta, coauthor of the opinion piece and a fourth-year medical student at the Yale University School of Medicine in New Haven, Connecticut.

He and his colleagues from Yale and the Mayo Clinic in Rochester, Minnesota found that a 10-pack of naloxone sold by the Pfizer company Hospira had more than doubled in price from $62.29 in 2012 to $142.49 this year.

But that increase is dwarfed by Kaleo’s naloxone auto-injector system, which went from $690 for two injections in 2014 to $4,500 in 2016, an increase of more than 500 percent in just two years.

Other manufacturers have not increased their prices, but Kaleo and Hospira represent most of the sales, the Gupta team writes.

“Here are drugs that are lifesaving in an acute situation, and both the EpiPen and naloxone prices have skyrocketed,” Gupta told Reuters Health. “The lack of attention to naloxone’s price increases may be associated with the stigma of people who use opioids, whereas the EpiPen is for children.”

Pfizer spokeswoman Rachel Hooper countered that ”Hospira has responsibly priced naloxone,” in an email.

“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 told Reuters Health.

Kaleo’s vice president of corporate affairs, Mark Herzog, said in an email that the company has special programs that allow patients and caregivers to get naloxone at no cost if they have a prescription and commercial insurance. “To cover the cost of this program for patients, we increased the list price,” he said.

“Drug pricing is a complex issue that involves multiple stakeholders, including insurers, payers and pharmacies,” Herzog said.

But, Gupta said, “patient discount programs are not necessarily a sustainable solution, and even if they’re offering the autoinjector for a significantly reduced price, it’s often put back on the patients themselves through an increase in insurance premiums.”

Naloxone has been available in generic form since 1985. In recent years there has been a push to make naloxone widely available to people without medical training in hopes of preventing both heroin overdoses and deaths from overuse of opioid-based prescription drugs, which have been twice as common as heroin overdose deaths. All but four states have at least one law designed to expand access to naloxone.

Kaleo’s special pen designed for untrained people was approved in 2014. A nasal spray formulation was approved in 2015. While Kaleo increased its price more than sixfold since 2014, Adapt has kept its Narcan nasal spray at $150 for two doses.

Gupta and his colleagues said Kaleo raised its price “significantly and without explanation the month before the Centers for Disease Control and Prevention released new guidelines encouraging doctors to prescribe naloxone as a precaution to patients at risk for an overdose.”

To solve the problem, they said the federal government might want to bring down the price by purchasing in bulk, creating a stable demand that might encourage other companies to compete, a strategy that keeps vaccine costs low. The government also has the right to manufacture Kaleo’s auto-injector at a lower price and simply pay a royalty for use of the patent.

The government could also allow importation of a comparable product from overseas, a strategy that has been proposed for combating the hefty price increases imposed for U.S.-produced generic drugs.

“When governments promote naloxone use, they have a responsibility to ensure the drug’s affordability,” the Gupta team writes. “Taking action now is essential to ensuring that this lifesaving drug is available to patients and communities.”

SOURCE: bit.ly/2hkIXd2 New England Journal of Medicine, online December 7, 2016.

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