ICER review of abuse-deterrent opioid formulations open for public comment

The USA’s Institute for Clinical and Economic Review (ICER) has posted a  draft scoping document that will shape an upcoming report on abuse-deterrent opioids.

To address the ongoing national opioid epidemic, the Food and Drug Administration has issued guidance for drug manufacturers to develop abuse-deterrent opioid formulations to help patients manage pain while lowering the risk for opioid misuse. ICER’s report will review the evidence on several new and emerging opioid re-formulations to evaluate how effectively these drugs reduce opioid misuse and its many consequences. Analyses will also be performed to provide information on the long-term value of abuse-deterrent opioids for the health system and for society. The draft scoping document will be open to public comment for three weeks until September 28, 2016.

The draft scoping document was developed with input from key stakeholders, including relevant patient organizations and clinical experts. In initial discussions, patient organizations and clinical experts provided feedback on the outcomes and issues of greatest importance to patients, including the need to balance patients’ need for pain control with the risks of opioid misuse. ICER will continue to engage with patient groups and clinicians to enrich the evidence available from clinical trials.