Scoping Document for ICER Review of Abuse-Deterrent Opioid Formulations Open for Public Comment

September 8, 2016- The 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 FDA 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 Wednesday, September 28, 2016 at 5pm ET.

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.

A tentative list of drugs to be reviewed is included below. This list is preliminary in nature and is subject to change based on feedback received through public comment and continued discussion with subject matter experts.

Currently Approved Drugs

  • Oxycontin® (oxycodone extended release, Purdue Pharmaceuticals)
  • Hysingla® ER (hydrocodone extended release, Purdue Pharmaceuticals)
  • Morphabond™ (morphine extended release, Inspirion Delivery Technologies)
  • Xtampza™ ER (oxycodone extended release, Collegium Pharmaceutical)
  • Embeda® (morphine + naltrexone extended release, by Pfizer)
  • Troxyca® ER (oxycodone + naltrexone extended release, Pfizer)
Drugs Pending Approval
  • Vantrela™ ER (hydrocodone extended release, Teva Pharmaceuticals)
  • Remoxy™(oxycodone extended release, Pain Therapeutics)
  • Arymo™ ER (morphine extended release, Egalet Corporation)

All interested stakeholders, including patients, providers, payers, and manufacturers, are encouraged to submit comments and suggested refinements to the scope to ensure all perspectives are adequately considered. All comments must be received by Wednesday, September 28, 2016 at 5pm ET. Comments can be submitted by email to publiccomments@icer-review.org. More information about submitting a public comment, including formatting specifications, is available on our website. Following the public comment period, a revised scoping document will be posted on or about October 6, 2016.

The New England Comparative Effectiveness Public Advisory Council (New England CEPAC) will evaluate the report assessing abuse-deterrent opioids at a public meeting on March 23, 2017. The New England CEPAC is an independent, regional body of practicing physicians, methodological experts, and leaders in patient advocacy and engagement that provide objective, independent guidance on the application of medical evidence to clinical practice and payer policy decisions.

During the March 2017 public meeting, the Council will vote on key questions raised in the report, and a policy roundtable of patient, clinical, payer, and policy experts will discuss recommendations for how best to apply the evidence to policy and practice.

Additional information regarding the report and meeting are available on ICER’s website.

ICER’s call for proposed improvements to its value assessment framework will close on Monday, September 12, 2016.  All input should be emailed to publiccomments@icer-review.org. For more information, visit our website