At long last, naloxone is available over the counter.
But now comes a moment of truth for the overdose-reversal medication: Will increased access help to save lives? And more immediately, can everyone who wants to buy naloxone at a pharmacy afford it?
In the months since the first naloxone products received over-the-counter status, health insurers have remained particularly quiet. One major plan — Blue Cross Blue Shield of Massachusetts — announced this week that it would cover naloxone as an over-the-counter medication. But it’s unclear whether others will follow suit, and more generally, whether making naloxone available without a prescription will make much difference in the fight against opioid overdose deaths.
“Insurers should pay for this, whether it’s over-the-counter or not — that’s the right thing to do,” said Maya Doe-Simkins, the co-director of Remedy Alliance, a nonprofit that acquires and distributes free or low-cost naloxone to harm-reduction organizations and other community groups. “All of this is good, and I’m in favor of all of it. But it does have the impact of distracting the dialogue.”
Naloxone is a critical component of the U.S. response to the opioid overdose epidemic, which currently claims over 80,000 American lives annually. While the medication is highly effective at reversing overdoses, however, limited supplies and exorbitant prices have long prevented it from being distributed as widely as needed.
Narcan, a popular nasal spray version, typically retails for $50 or more for a two-pack. In recent years, manufacturers have also rushed to create higher-dose, mechanically complex versions that sell for far more, even as public health experts question whether they’re more effective.
The federal government has cast two new developments as a win for access: The Food and Drug Administration’s approval of Narcan for over-the-counter marketing, and the more recent approval of RiVive, a nearly identical but cheaper product manufactured by the nonprofit Harm Reduction Therapeutics.
But many questions remain. For one, many health insurers don’t reimburse for over-the-counter medications, an instant point of concern upon the FDA’s approval of relaxed status for Narcan.
Immediately following the FDA’s announcement, the American Medical Association issued a statement calling on insurers to continue to cover naloxone, citing aspirin and vitamin D as other over-the-counter medications that patients can be reimbursed for.
“Waiving out-of-pocket costs for this emergency medication aligns with our commitment to ensuring our members have access to the substance use disorder treatment they need, when they need it,” Sandhya Rao, Blue Cross’ chief medical officer, said in a statement, “especially critical as opioid-related overdose deaths in Massachusetts continue to rise.”
Héctor Hernández-Delgado, a staff attorney for the National Health Law Program, said in an interview that additional guidance is needed from the Centers for Medicare and Medicaid Services to ensure that governments, insurers, and people who wish to buy naloxone understand the new landscape.
“There really needs to be more clarification from CMS to tell states or to tell plans what they’re expected to cover, and also to provide more tools for states to cover the medication through their Medicaid programs,” he said. “I expect that to happen.”
But states already have numerous paths to force insurers to continue to cover naloxone despite its over-the-counter status, Hernández-Delgado said. Other workarounds are available, too — like insurers continuing to require a prescription for naloxone before they’re willing to pay for it.
Normally, requiring a prescription for an over-the-counter medication would be self-defeating, Hernández-Delgado acknowledged. But amid the opioid crisis, nearly every state has issued a so-called “standing order” for naloxone — effectively a blanket prescription that allows anyone to walk into a pharmacy and buy the medication without receiving individual permission from a doctor.
America’s Health Insurance Plans, the lobbying group representing commercial health insurers in Washington, did not respond to STAT’s request for comment.
Even if the thorny insurer issues are solved, most of the battle still remains, said Doe-Simkins.
The reality, she argued, is that most people using naloxone to reverse overdoses aren’t buying two-packs of Narcan at pharmacies. In fact, they’re not acquiring the medication through the health care system at all: Instead, most are using naloxone distributed by community groups, who in turn buy it at a discount or receive it for free from drug manufacturers.
Most naloxone being used in the field, in fact, is not a nasal spray like Narcan or RiVive but a generic, injectable product that laypeople and emergency responders can administer with a vial and syringe. Despite the sky-high price of naloxone sprays and auto-injectors, the simpler formulation is often available for pennies on the dollar, and one of its principal manufacturers, Pfizer, has donated over 1 million doses to community groups in recent years.
“Fundamentally, the way that naloxone is distributed in our country is completely outside of the normal medication acquisition process,” she said. “If you want to look at the naloxone that gets used in the field, a very, very tiny portion of the naloxone that’s acquired via the traditional medical acquisition way is used during overdoses.”
STAT’s coverage of chronic health issues is supported by a grant from Bloomberg Philanthropies. Our financial supporters are not involved in any decisions about our journalism.