Findings from the Institute for Clinical and Economic Review’s final evidence report.
Last month, the Institute for Clinical and Economic Review (ICER) released its final report on the effectiveness and value of abuse-deterrent formulations (ADFs) of opioids (Institute for Clinical and Economic Review, 2017). Abuse, misuse, and overdoses attributed to opioid analgesics have detrimental effects on communities across the United States. The FDA has recognized the need for safer drugs and as one step towards improving patient safety related to opioid analgesic prescribing, released guidance in 2015 to standardize the evaluation and labeling of ADFs of extended-release/long-acting (ER/LA) opioids. Currently approved ADFs incorporate features that discourage adulteration of the product—which is done to facilitate alternate delivery methods that can enhance the high associated with the drug—but such properties fail to address the most common route of abuse: taking more pills than prescribed. Despite feeling more comfortable prescribing ADFs than non-ADFs, physicians surveyed as part of DRG’s primary research on the U.S. access and reimbursement landscape for chronic pain treatment report their prescribing of these agents are constrained by reimbursement restrictions. The ICER report attempts to quantify the perceived benefit of ADFs through the scrutiny of post-marketing studies evaluating the impact of ADFs on abuse, misuse, and overdoses as well as modeling cost-benefit and cost neutrality analyses in chronic non-cancer pain patients.
For further analysis of the ICER report and additional insights on U.S. market access in chronic pain, see DRG’s “Chronic Pain | Access and Reimbursement | US, 2017.”