By Pat Anson, Editor

In 2013, the U.S. Food and Drug Administration put drug makers on notice that they should speed up the development of abuse deterrent formulas for opioid pain medication.

“(The) abuse and misuse of these products have resulted in too many injuries and deaths across the United States,” Douglas Throckmorton, MD, a top FDA official said at the time. “An important step towards the goal of creating safer opioids is the development of products that are specifically formulated to deter abuse.”

Acting on the FDA's guidance, pharmaceutical companies have spent hundreds of millions of dollars developing abuse deterrent formulas (ADFs) that make opioid medications harder for addicts to chew, crush, snort or inject. Several new opioids with ADF formulas have been approved by the FDA and more are still in the pipeline.

Was it worth the investment? Not according to a new study funded by insurers, pharmacy benefit managers and some drug makers.

The Institute for Clinical and Economic Review (ICER), a non-profit that recommends which medications should be covered by insurance and at what price, released a Draft Evidence Report  earlier this month that questions the effectiveness of ADF opioids, giving them a middling grade of C+ when it comes to preventing abuse.

“Without stronger real-world evidence that ADFs reduce the risk of abuse and addiction among newly prescribed patients, our judgment is that the evidence can only demonstrate a ‘comparable or better’ net health benefit (C+),” the ICER report states.

ICER also gave a lukewarm review to OxyContin, the painkiller that was reformulated by Purdue Pharma in 2010 after widespread reports that it was being abused and causing addiction.   

“Evidence on the impact of reformulated OxyContin on opioid abuse is mixed. The majority of time series studies found that after the abuse-deterrent formulation of OxyContin was introduced, there was a decline in the rate of OxyContin abuse,” the ICER report states. “However, the rate of abuse of other prescription opioids (ER oxymorphone, ER morphine, IR oxycodone) and heroin abuse may have increased during the same period.

“Furthermore, findings from direct interviews with recreational users showed that reformulated OxyContin may have limited impact on changing overall abuse patterns.”

Purdue objects to ICER’s analysis – citing another study that found reformulated OxyContin prevented 7,200 cases of abuse and $200 million in additional medical costs.

“ICER missed the opportunity to fairly evaluate the impact of these innovative technologies, recognized by the FDA, DEA, NIDA (National Institute of Drug Abuse) and other policy makers as an important component of addressing the opioid crisis,” the company said in a statement.

Purdue and other ADF makers are troubled by the ICER report because it gives cover to insurers who are already reluctant to pay for branded ADF opioids like OxyContin when generic opioids without abuse deterrent formulas are much cheaper.  According to one study, OxyContin was covered by only 33% of Medicare Part D plans in 2015. Many insurers create more hoops for patients and doctors to jump through by requiring that prior authorization be given before an OxyContin prescription is filled.  

ICER estimates the average annual cost of an ADF opioid (90mg MED) prescription at $4,234, nearly twice that of a non-ADF opioid ($2,124).  If all opioid medication was made with ADFs, ICER says the additional cost to patients and insurers would be $645 million over five years.

Are ADFs worth it, given their mixed record in preventing abuse and addiction?

According to startling cost-benefit analysis devised by ICER, preventing a single case of opioid abuse with ADFs costs $165,868. The same analysis found that preventing just one overdose death with ADFs would cost $977,119,566 – almost a billion dollars.

Survey Shows Addicts Abusing ADF Opioids

A new report from RADARS, a national drug abuse tracking system, would seem to support ICER’s analysis that ADFs are not making a significant impact on abuse. A survey of 1,775 addicts about to enter treatment in early 2017 found that ADF opioids were still being chewed, snorted, injected and smoked, but at rates "slightly lower" than those of non-ADF opioids.

“The majority of individuals who abused an ER (extended release) opioid abused an ADF opioid (58.6%), but the proportion of respondents who reported abuse via tampering was slightly lower for ADF opioids than ER opioids as a whole. Among individuals entering treatment, abuse of prescription opioids by chewing, snorting, or injecting is prevalent with oral solid dosage formulations of both IR (immediate release) and ER opioids,” the RADARS report said.

Lost in the debate over the cost and effectiveness of ADF’s is the decreasing role played by prescriptions opioids in the nation’s overdose epidemic. As PNN has reported, prescriptions for hydrocodone and other painkillers have been declining for years, yet drug overdoses continue to continue climb; fueled by heroin, illicit fentanyl and other illegal drugs, for which there are no abuse deterrent formulas other than abstinence and sobriety.