Comment; What a GREAT solution to the exorbitant cost of Naloxone!

The pricing and availability of drugs — legal and illegal — illuminate how markets chase profits and reward innovation. A comparison of heroin (and other illicit opioids) with naloxone, the lifesaving antidote for opioid overdoses, offers a devastating peek into the overdose epidemic that is ravaging the United States.

Let’s start with the price of heroin. In the early 1980s, a gram of pure heroin cost about $2,200. Today that same amount costs less than $500, nearly an 80 percent decrease. A bag of heroin today will set you back about $5, the cost of a pumpkin spice latte. And prices continue to fall with the introduction of new and more powerful synthetic opioids, such as fentanyl.

Compared to heroin, which requires lengthy cultivation of poppy plants and cumbersome processing, fentanyl and its ilk are relatively cheap to make. Humans have been growing poppies and harvesting opium for at least 6,000 years; manufacturing has historically been constrained by the 120-day growth cycle of the opium poppy plant and the distant geography in which it grows.

Today, fentanyl and other illicit opioids are being rapidly mass produced. Much of the supply is coming from China, though Mexico and small U.S.-based labs are also creating these products. Innovation in the retail manufacturing and distribution of heroin and fentanyl is now as redundant and robust as the supply chain bringing coffee beans to your neighborhood cafe, though with far more “retail outlets.”

It’s a different story for naloxone, a drug patented in 1961. Naloxone is near miraculous in its ability to reverse an opioid overdose within minutes. Prompt access to it could prevent some or all of the 115 opioid overdose deaths that occur in the United States every day. Naloxone is cheap to make, and has been off patent since 1985.

Given the ongoing devastation of the opioid crisis, you might expect that naloxone would be widely available at a low price. Not so. A decade ago, a lifesaving dose of naloxone cost $1. Today, that same dose costs $150 for the nasal spray, a 150-fold increase. A naloxone auto-injector, approved in 2016, costs $4,500.

Pharmaceutical innovation hasn’t driven up these prices. Opportunity has.

Market forces are working from opposite directions to boost the death count from opioids. In the midst of this crisis, lethally potent street drugs are increasingly affordable and available, while their lifesaving antidote, naloxone, is increasingly expensive and difficult to obtain.

The aggressive marketing and sales of highly potent prescription opioids, combined with price-lowering innovations in the production and distribution of heroin, illicit opioids, and fentanyl, have not been matched by innovations in the legal market for naloxone. Its high price and restricted availability — despite its low production costs and excellent safety and effectiveness records — betray our collective ambivalence about the millions of Americans with opioid use disorder.

An approach taken by many states has been for a high-ranking state health official to issue a “standing order” for naloxone. This is essentially a prescription for everyone that makes it possible to obtain naloxone from a pharmacist without first having to visit your own doctor and get a prescription. While appealing in concept, this approach hasn’t worked for three reasons: most citizens are unaware of these programs, insurance companies rarely provide coverage for naloxone, and the price remains prohibitive.

We offer a different solution: Make naloxone available over the counter, in much greater quantities and at lower prices.

The FDA approved naloxone for use by prescription in 1971, and could easily transition the drug from prescription to over-the-counter status. If for-profit pharmaceutical companies are unable to see past their bottom lines to make naloxone available over the counter and at a low cost, then a nonprofit should step in and do just that, eliminating the exorbitant markups. This is what Civica, a nonprofit generic drug company launched by several hospital systems, aims to do to fight rising drug costs and chronic shortages.

FDA Commissioner Scott Gottlieb recently announced plans for a December meeting to discuss how to improve the availability of naloxone products. With a concerted national effort, this can be a solvable problem.

The opioid epidemic is a tragic consequence of multiple forces — the aggressive marketing of potent prescription opioids, increased availability and decreased costs of illicit opioids, and insufficient access to medications that can quickly reverse overdoses as well as those that can treat opioid dependence. Increased access to inexpensive naloxone alone will not solve the opioid crisis. But individuals dependent on opioids must be kept alive if they are ever to have the opportunity to recover.

The pharmacoeconomics of the opioid epidemic are not on our side. But let us hope that common sense is. In a sane world, naloxone should be at least as available and affordable as heroin.

Michael Hufford, Ph.D., is co-founder and CEO of Harm Reduction Therapeutics, a Pittsburgh-based nonprofit focused on making naloxone more available. Donald S. Burke, M.D., is dean of the Graduate School of Public Health at the University of Pittsburgh.

Dr. Raymond Oenbrink
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