Abuse-deterrent opioid formulations: Proceed with caution

Americans are in the throes of a deadly controlled substance epidemic – from misuse of both prescribed and illicit opioid drugs. It’s headline news daily, as it should be. In 2015, the Centers for Disease Control and Prevention (CDC) reported some 22,500 people died from opioid addiction or misuse. Medical and prescription costs associated with the crisis are soaring, at roughly $75.8 billion per year. The death toll from prescription opioids is roughly four times what it was in 1999. Clearly, we need an effective response to the crisis from leaders across the health care system, and this is why policy leaders are intensely focused on the issue.

To date 10 abuse-deterrent formulations (ADFs), using varying extended-release methods and designed to be harder to crush, inject or inhale, have been approved by the U.S. Food and Drug Administration (FDA). Five states have enacted laws promoting ADF opioids of which the full extent of their effectiveness remains to be seen. In those states, insurers can’t require step therapy and must cover ADFs as they do standard versions of the drug, even though ADFs are far more expensive. . Massachusetts law (not yet implemented) requires pharmacies automatically substitute standard opioid prescriptions with ADFs.

{mosads}Debate has unfolded in pharmacy and policy circles over the efficacy of ADFs. On July 20, an independent committee of medical experts met to consider research on ADFs from one of the most influential bodies advising the field: the non-profit Institute for Clinical and Economic Review (ICER). The ICER research report found at present-day prices, ADFs increase costs to the health system significantly more than the benefit they provide. Additionally, given limited evidence for both positive and negative outcomes, ICER found there is not adequate evidence to demonstrate an overall public health impact of substituting ADFs for non ADFs.

My organization, Prime Therapeutics, a pharmacy benefit manager for 17 Blue Cross and Blue Shield plans and serving more than 20 million people nationally, agrees ADFs are promising, but we must remain cautious as they can still be used in excess quantities and for illegitimate means, leading to death. They are not the silver bullet solution to end the current crisis. And while we support using all means necessary to combat this issue, more research is needed so we’re aware of ADF’s potential harm before mandating their use.

We know from our decade-long experience in controlled substance (CS) management, it takes working on multiple fronts – with prescribers, pharmacists, members, health plans and manufacturers – to make a difference. Prime has made significant headway against the problem and uses both medical and pharmacy data to identify members at risk of CS misuse then targets programs to reduce their risk.

Our Controlled Substance Management Program, grounded in our “CS score,” identifies individuals at high risk for harm, intervenes along the chain of events leading to a CS prescription for a high-CS scoring member. We alert both prescribers and pharmacists, conduct prior authorization and limit fills for certain medicines, as well as detect and correct CS fraud, waste and abuse by providers and pharmacies. And we continue to make enhancements. We now refer high-risk people to case managers who can connect to treatment options. We help people find a single “pharmacy home” for their prescriber and CS prescriptions, to limit inappropriate access to opioids. Next year we’ll deploy “predictive modeling” to take what we’ve learned from current high-risk members and compare patterns with new opioid users so we can prevent abuse before it starts.

Over the past five years, our opioid claims have decreased 16 percent among our members in commercial (non-government) plans. Recent studies showed our programs were linked to a 6.4 percent drop in emergency room visits and reduced healthcare costs of up to $1,500 per member per year. We’re striving for further reductions.

So while ADFs may be a part of attacking the problem, they’re not a panacea. They don’t change the addictive properties of these drugs, are not abuse-proof, may increase the likelihood of the use of alternative non-prescription narcotics and will add billions of dollars in costs with no clear evidence they will save lives. This is a very complicated problem that demands a comprehensive and aggressive solution. Let’s continue the research and continue to pull many levers at once with stakeholders across the pharmacy and medical fields to accelerate our efforts. That’s what it will take to tame the epidemic killing our loved ones at such an alarming pace.

Jonathan Gavras, M.D. is chief medical officer Prime Therapeutics

The views expressed by this author are their own and are not the views of The Hill.