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The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report that found an absence of sufficient evidence to confirm the efficacy of abuse-deterrent formulations (ADFs) of opioids in decreasing the opioid abuse levels of the greater population.
The Institute for Clinical and Economic Review (ICER) released a Final Evidence Report that found an absence of sufficient evidence to confirm the efficacy of abuse-deterrent formulations (ADFs) of opioids in decreasing the opioid abuse levels of the greater population.
The report reviewed a total of 10 ADF opioids, consisting of 9 extended release opioids and 1 immediate release. The report was intended to assess the effectiveness, safety, and economic impact of ADFs compared to other opioid treatments.
As part of the effort against opioid abuse, manufacturers have started making it more challenging to crush, snort, or inject opioids; however, the oral route was found to be most common. Therefore, ICER’s report revealed minimal evidence of the influence of ADFs and even suggest that such deterrents may encourage abusers to try other, more harmful drugs—especially if non-ADF opioids were removed from the market.
“While we would like to support widespread use of a product that may lower the abuse risk for individual patients, policies 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, MD, professor of Emergency Medicine and director of Medical Toxicology in the Department of Emergency Medicine at the Perelman School of Medicine at the University of Pennsylvania, said in a statement.
There was evidence to suggest that OxyContin, the original opioid to be manufactured in ADF form, demonstrated a decreased risk of abuse among patients and a reduced diversion of the drug into those who were not prescribed the opioid. However, the New England Comparative Effectiveness Public Advisory Council (New England CEPAC) held a public deliberation in July and voted against the significance of this finding in decreasing the overall rate of opioid abuse.
ICER’s report also considers the substantial cost increases that would result from the implementation of ADFs. It is estimated that for every 100,000 patients who are prescribed an extended release ADF opioid, there would be a net increase in cost of $533 million over 5 years, according to the report.
“We want to encourage innovation that may help to deter opioid abuse, but without significant discounts to the current prices, widespread or mandated use of ADF opioids will drive up costs for patients and the health system at an unsustainable rate,” concluded C. Bernie Good, MD, MPH, chair of the Medical Advisory Panel for Pharmacy Benefits Management in the Department of Veterans Affairs.