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Report: Abuse-deterrent opioids too pricey for limited benefits


By Brett Norman

An influential independent review board is casting new doubts on efforts supported by FDA and many lawmakers to push chronic pain treatment toward costly versions of opioids that are more difficult to abuse.

The Institute for Clinical and Economic Review found that the added cost of "abuse-deterrent formulations" of painkillers — which are harder for would-be abusers to crush and snort or inject — outweighs the public health benefits, even though these formulations are a promising tool for reducing abuse among some patients.

The ICER report estimates that every 100,000 chronic pain patients who are switched from traditional painkillers to an abuse-deterrent version would cost the health care system more than $500 million over five years, even accounting for reduced drug abuse and a slight decrease in overdose deaths. Because of the limited impact and expense of abuse-deterrent drugs, which can cost 10 times more than older versions, ICER estimated the cost to prevent one new case of abuse was about $232,000; the price tag to prevent an overdose was $1.36 billion.

Those numbers don't reflect the impact on diversion — a common route of abuse, in which people get the drugs from friends and family or off the street, rather than from doctors. The report acknowledged data showing that a reformulated version of OxyContin did appear to significantly reduce that.

Four states now require pharmacies to substitute abuse-deterrent products when prescriptions are written for the same drugs without those protections, starting with Massachusetts in 2014. At least 20 more states are considering legislation promoting these products. ICER concluded automatic substitution laws are premature until more data is collected about how the drugs are working in real world.

"[P]olicies that mandate replacement of non-ADF opioid prescriptions with ADFs may have the unintended consequences of opioid users shifting abuse to other opioids or heroin, which may ultimately result in increased harm. We need more evidence to fully understand the impact such policies will have," Jeanmarie Perrone, an emergency physician and professor at the Perelman School of Medicine at the University of Pennsylvania, said in a release.

The abuse-deterrent formulations are intended to mitigate the risk of abuse and addiction, but ICER is holding them to a higher bar, industry critics said.

"At its core, the report basically asked the question: Can these products do what they're not designed to do? Not surprisingly the answer is no," said Dan Cohen, forum chair of the Abuse Deterrent Coalition, who represented the industry at the ICER meetings. "They can't prevent addiction because they're not designed to prevent addiction."

FDA has encouraged manufacturers to develop the abuse-deterrent technologies — in its policy recommendations, ICER favors labeling the drugs as "tamper-resistant" as a more accurate description of their technology. The drugs can still be abused by simply taking more pills, which is the most common way people begin misusing opioids.

FDA has granted nine extended-release painkillers permission to be marketed as "abuse-deterrent" on their labels, though most have only come to market in the past year. Only one, OxyContin, which added the new anti-crush properties in 2010 and was labeled abuse-deterrent in 2013, has been available long enough to produce the data needed to judge how well it has worked, ICER said.

ICER noted studies finding that OxyContin abuse dropped between 12 percent to as high as 75 percent after the new version was released. One study found that 3 percent of OxyContin users even opted to stop abusing opioids after the reformulated pill was introduced. But in that study, a third of OxyContin users switched to other drugs, with 70 percent of those opting for heroin.

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