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States Address Opioid Epidemic with Abuse Deterrent Formulation Legislation

By Andy Wagner | May 12, 2016

UPDATED: An newer post on this topic is available here.

The increasing awareness of America's opioid epidemic has put many state legislatures under pressure to pass comprehensive drug reform during their 2016 legislative sessions. According the American Society of Addiction Medicine (ASAM), 1.9 million Americans in 2014 suffered from substance abuse disorders involving prescription pain relievers. The ASAM also found that four in five new heroin users started out misusing prescription pain relievers. In addition to creating opioid treatment and prescription drug monitoring programs, some state legislators have directed their focus toward more preventative measures as a way to tackle the ballooning problems associated with prescription drug abuse.

One popular policy tool being utilized by lawmakers is the incorporation of new medical technologies, such as abuse deterrent formulation (ADF) drugs, into healthcare and insurance-related legislation. ADF drugs use unique extended release methods or controlled delivery systems to provide pain relief to patients, while also “meaningfully deterring” at risk patients from abusing the opioids by crushing, snorting, or injecting them. [1] So far, only a handful of ADF drugs have been approved by the FDA, and their use as a possible solution to opioid abuse has become a contested issue in an increasing number of state legislatures.

In August 2014, Massachusetts became the first state to pass ADF legislation when it adopted Chapter 258 of Massachusetts’ Session Law, which requires ADF medications to be covered by insurers and limits cost-sharing requirements for patients. In 2015 Maryland with Chapter 372 and Maine with Chapter 371 followed suit and passed similar ADF legislation. In 2016, state responses have ranged from adopting legislation requiring insurance coverage of ADF drugs to establishing commissions to study the effects of providing abuse deterrent opioids. Roughly 30 bills relating to ADF drugs have been introduced in about 20 states across the country during this 2016 session. Thus far, only two additional states—Florida (S.B. 422) and West Virginia (H.B. 4146)—have passed ADF legislation this year. An additional four states have passed study resolutions, including Delaware, New Hampshire, Oklahoma, and Virginia. See the map below for a survey of ADF drug bills introduced in 2016.

UPDATED ADF MAP
Many of the ADF bills being introduced in 2016 are very similar in terms of their language and legislative intent. The overarching theme in the legislation is making ADF drugs, which can be significantly more expensive than traditional opiods, more accessible to the public regardless of cost or insurance plan. In order to accomplish this goal, most bills include provisions which require health insurers to provide coverage for ADF drug and prohibit them from imposing cost-sharing requirements that would discourage the use ADF drugs compared to normal (non-ADF) prescription opioid drugs.

Although there has been an uptick in the number of ADF bills introduced in the 2016 legislation session, the rate of adoption remains fairly low (only two counting West Virginia and Florida). In the current atmosphere, the mostly likely outcome for ADF bills at the state level is for them to be referred to a health or insurance committee, receive consideration during hearings, but not make it to a vote. Governors in New York, New Jersey, and Maine vetoed ADF bills due to budget concerns, but lawmakers on both sides of the aisle are showing interest in ADF drugs due to their potential to prevent substance abuse problems in at-risk patients. In conjunction with Prescription Drug Monitoring Programs and opioid treatment bills, ADF drugs can be in an important policy tool in the growing battle against opioid addiction.


[1] The guidance from the FDA states that ADF drugs do not fully prevent abuse, just meaningfully deter abuse. Abuse-Deterrent Opioids — Evaluation and Labeling. U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) page 5.

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