For Americans younger than 50, the leading cause of death used to be injuries caused by accidents. Now, the biggest killer isn't car crashes or ladder falls—it's drug overdoses.
Overdose deaths surged by 15% from 2015 to 2016, the largest annual increase in American history. Overdoses have pushed up death rates among all racial and ethnic groups.
Policymakers and researchers are trying to make sense of this strange new reality. Some have pointed to rising rates of unemployment and disability. Others have blamed an increase in opioid prescriptions.
One overlooked culprit worsening the epidemic, however, comes straight from our healthcare system: pharmacy benefit managers (PBMs). To improve their bottom line, they're blocking access to prescriptions that can help prevent overdoses.
For years, the Food and Drug Administration has encouraged the development and use of "abuse-deterrent formulations" of prescription opioids. ADFs are more difficult to physically alter—i.e. crush for snorting or dissolve for injecting—than traditional pills.
As a result, ADFs help curb abuse and overdoses. The ADF version of OxyContin, for instance, led to a 65% decrease in snorting, a 56% decrease in smoking and a 51% decrease in injection among patients with a history of abusing the drug, according to a report (PDF) by the Institute for Clinical and Economic Review.
Decreasing the availability of easily abused drugs leads to fewer overdoses. In the first three years after the introduction of ADF OxyContin, overdose deaths reported with a "mention of abuse-related behavior" decreased by 86%.
PBMs, however, refuse to cover the vast majority of ADFs. Their decision impacts more than 266 million Americans insured by employers, unions or government programs like Medicare Part D.
The three biggest PBMs in the country cover no more than three of the 10 ADF opioids approved by the FDA. CVS Caremark, which has nearly 90 million members, doesn't cover a single one. These pharmacies do, however, cover the cheaper, generic forms of opioids—exactly the ones that don't have ADF properties and are readily diverted to abuse. As a result, 96% of all opioid products prescribed in 2015 were non-ADF, according to a new study by the Tufts Center for the Study of Drug Development.
No patient with legitimate medical need would pay extra out-of-pocket for an ADF opioid that the patient has no intention of abusing. But would-be abusers will flock to PBMs where they can be sure they'll be able to convert pills for snorting or injection. By keeping abuse-deterrent medications out of reach, PBMs essentially put out the welcome mat for abusers.
Opioid abuse is often a gateway to even more dangerous substances, like heroin. Those who are dependent on or abuse prescription opioids have a 40-fold increased risk of using heroin, according to a report (PDF) from the National Institute on Drug Abuse.
Unfortunately, PBMs don't seem concerned by the consequences of refusing to cover ADFs and other specialty medicines. They often seem more interested in covering as few medications as possible.
In 2017, for instance, CVS Caremark removed 130 drugs from its formulary, while Express Scripts removed 85. Tasigna, a drug used to treat leukemia; Zepatier, a two-drug medication that treats hepatitis C; and Xtandi, a treatment for prostate cancer, were among the 200-plus drugs cut by the nation's leading PBMs.
PBMs say that they exclude drugs from their formularies to save patients money. But these short-term savings come with a big cost. When patients can't access the medicine prescribed by their doctor, they get sicker, and the care they require in the long run can be much more expensive. A significant chunk of the cost of the opioid epidemic is a product of exclusion of ADFs from coverage.
In fact, one study (PDF) found that the ADF version of OxyContin could prevent 4,300 cases of abuse and save $300 million in medical costs over a five-year period. But PBMs aren't concerned about long-term savings. They'd rather offer cheaper drugs—non-ADFs, in the case of opioids—and save money for themselves.
The Institute for Clinical and Economic Review, a private organization that suggests drug coverage and pricing, has recommended that PBMs do as much. Despite confirming the savings that ADFs could yield, ICER decided that ADFs did not provide any financial benefit. PBMs since have gladly accepted ICER's mistaken judgment.
CVS Caremark, among other PBMs, claims to understand the nation's drug crisis and to be "doing everything we can to help stop it." But until it starts covering all approved ADFs in its formularies, that's just not true.
Peter J. Pitts, a former FDA associate commissioner, is president of the Center for Medicine in the Public Interest. Follow him @PeterPitts.