According to the U.S. Food & Drug Administration (FDA), opioid formulations with abuse-deterrent properties are meant to target expected routes of abuse, such as crushing in order to snort or dissolving in order to inject. However, the FDA fully acknowledges that these products are not abuse proof.
Over the last two years, approximately 50 pieces of legislation requiring coverage of Abuse-Deterrent Formulations (ADF) of opioid products have been introduced in more than 30 different states.
Although the bills around ADF varied, the legislation generally seeks to address common objectives:
- Mandate preferential formulary placement for ADF products, and/or
- Prohibit utilization management tools like step therapy and prior authorization for ADF products.
The proffered goal of these bills – to reduced opioid abuse – is laudable in light of our nation’s crisis of opioid misuse and abuse. However, this type of legislation presents several problems:
- The FDA fully acknowledges that these products are not abuse proof. Last week, the agency held a public workshop to gather data and methods for evaluating the impact of ADF.
- A legitimate worry is that ADF opioids will lead prescribers into thinking the products are less addictive and overprescribing patterns will continue.
- While ADF opioids make tampering more difficult, these products cost a lot more than their non-ADF counterparts. Required ADF legislation has been estimated to cost the state of California $4.5 million, with another $3.2 million borne by plans sponsors and patients in the state. By enacting these bills, states deprive plan sponsors from exercising some of their control over formulary design.
Instead of mandating first-line coverage for ADF opioids, we must remain committed to reducing opioid misuse through comprehensive, well-coordinated efforts among providers, payers, state and federal governments and law enforcement – with an emphasis on drug safety, counseling and patient support.
Author: Express Scripts Lab team—a diverse group of dedicated and passionate healthcare professionals. Some of us are behavioral scientists, some pharmacists, some statisticians, and some doctors. Together, we’re committed to the Express Scripts mission to make the use of prescription drugs safer and more affordable for the tens of millions of patients who rely on us.
About: Express Scripts Advanced Opioid ManagementSM solution works across the care continuum from safe disposal, to tools for physicians at the point of care and safety checks for dispensing pharmacies. This solution helps to significantly reduce unnecessary prescribing, dispensing and use to help avoid unnecessary hospitalization, ER and drug treatment costs, while ensuring access to medication patients need.
