States Have Stalled on Potential Opioid Abuse Solution: Deterrent Formulation Drugs

Last May, we reported that some states were utilizing abuse-deterrent drug legislation to address the opioid epidemic. A year later, the opioid epidemic remains a ballooning public health crisis with upwards of 91 Americans dying from opioid overdoes each day. State lawmakers continue to introduce, debate, and pass legislation to help ameliorate and hopefully solve this crisis, so here are the latest updates on abuse-deterrent legislation.

Abuse Deterrent Formulation Drugs

Abuse-deterrent formulation (ADF) drugs are specialized opioids with extended release mechanisms that prevent users from manipulating the drug’s chemical delivery systems. Although manufacturers and advocates of ADF drugs acknowledge that they are not a panacea for the opioid abuse epidemic, they contend that the drugs are an important tool in prevention because they're less susceptible to abuse than their generic alternatives. The drugs' abuse-deterrent properties prevent would-be-abusers from crushing, snorting, or cooking them to obtain a quicker, stronger high than they would feel if they swallowed the pills — a kind of abuse that can cause long-term addiction or lead to more dangerous drugs use like heroin and fentanyl.

How States Are Fighting Opioid Abuse

State lawmakers are attempting to curb the number of future addicts by passing legislation requiring health plans to provide coverage for ADF drugs, which can be prohibitively more expensive than their generic counterparts. By improving access to ADF drugs, these lawmakers aim to keep opioids out of the hands of patients at risk of addiction.

The bills vary slightly but most follow the same framework. All of the bills require health benefit plans to cover at least one ADF drug. Some bills, such as one introduced in Indiana (IN HB 1544), only apply to state-run plans. To address concerns about costs to patients, the bills often contain a provision that prohibits health insurers from increasing co-payments or cost sharing limits. The provision is usually uniform and reads like this language in Kentucky's bill (KY HB 308): “Cost sharing for abuse-deterrent opioid analgesic drug products shall not exceed the lowest cost-sharing level applied to prescription drugs covered under the same health benefit plan.”

Another common provision among the bills prohibits prior authorization, or “fail first,” agreements. These agreement force patients to first try non-ADF opioids before insurers agree to cover ADF opioids. “Fail first” policies do not make sense when “failing” translates to addiction and the goal is prevention. A pair of bills in Illinois (IL HB 2956 & IL SB 1609) removes fail first requirements but stops short of requiring ADF coverage.

Legislative Trends

To date, only five states have successfully passed legislation with abuse-deterrent insurance requirements. This year, we have identified 16 bills introduced in 10 different states, but so far none of these ADF bills have passed in 2017. This is nearly a 50 percent drop in bill introductions from 2016, when roughly 30 bills were introduced in 15 states.

This year, a bill in Kentucky (KY HB 308) saw the most action when it cleared the house, but it failed to pass the senate before the legislature adjourned at the end of March. ADF bills in other states remain in committee in their chamber of origin.

One reason ADF legislation is losing traction stems from the cost burdens they pose for state-run health plans, as Medicaid is one of the largest payers of opioid products. Last year, governors in New York, New Jersey, and Maine vetoed ADF legislation citing budgetary concerns (lawmakers in Maine later overturned the governor's veto and the bill became law). In February, New Jersey’s Mandated Health Benefits Advisory Commission published a report that estimated mandating coverage for ADF drugs would cost the state $111 million in the first year and $203 million total over the course of the decade. The high cost estimates have had a cooling effect on support for ADF legislation in New Jersey. Senator Joe Vitale, sponsor of ADF legislation (NJ SB 1313) in New Jersey, recently claimed the cost concerns raised by the report led him to believe further study is necessary.

Some lawmakers have shifted attention to new methods of preventing opioid abuse, such as limiting the supply of opioid prescriptions. In February, New Jersey passed legislation (NJ SB 3) limiting initial opioids prescriptions for outpatients to five days. Connecticut, Maine, Massachusetts, New York, Rhode Island, and Vermont passed similar legislation in 2016. This year, we've identified roughly 30 opioid prescription limit bills in at least 16 states. Generally, these laws target first-time opioid patients and minors. The limits are normally set at seven days, but some bills set it as low as three days (e.g., WA H.B. 1339) or by dosage (e.g., ME S.D. 1031).

Federal Action

The opioid epidemic is also attracting attention from the federal government. Following campaign promises to fight opioid addiction, President Donald Trump recently sign an executive order that creates a presidential commission to combat the opioid crisis. According to PBS News Hour, the commission is designed to:
Treatment advocates and critics argue that the order is too passive in its focus on further study at time when actual treatment and recovery programs are needed. Existing efforts to provide funding for programs have also stalled under the Trump Administration. Last year, as part of the 21st Century Cures Act, Congress allocated $1 billion for states to expand addiction services, but nearly four months since the funding became available, it has still not been allocated to the states.

The legislative branch is also taking steps to address the opioid crisis on the federal level. Earlier this month, Representative Morgan Griffith (R-VA) introduced the Abuse-Deterrent Opioids Plan for Tomorrow Act (US H.R.2025). The bill makes a very technical amendment to the Food, Drug, and Cosmetic Act (§ 505(c)(3)(E)) to address an exclusivity-blocking issue (additional details are available here). The intent is to increase competition among pharmaceutical companies in order to drive down the price of ADF drugs.

Last year, Congress passed the Comprehensive Addiction and Recovery Act (CARA) to address the opioid crisis. According to Senator Tim Kaine (D-VA), securing funding for CARA’s policy goals — including prevention, treatment, and recovery programs — will be a major part of the upcoming budget battle.

No Easy Solutions

Policymakers on both the state and federal levels will continue to address the opioid abuse epidemic. A recent Washington Post-Kaiser Family Foundation survey found that “one-third of Americans who have taken prescription opioids for at least two months say they became addicted to, or physically dependent on, the powerful painkillers.” But there are no easy solutions to the opioid epidemic. “This is one of those problems that society has to manage,” says Thomas McLellan, former Deputy Director of the White House Office of National Drug Control Policy. “You can’t do away with it. Not with 70 million older Americans who vote and are aging and need them. You can’t ban them.”