The Institute for Clinical and Economic Review (ICER) has published a draft scoping document about abuse-deterrent formulations (ADFs) of opioids and how they may contribute as part of integrative pain management.
ICER’s report will review the “evidence on several new and emerging opioid re-formulations to evaluate how effectively they 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 population of focus for the review will include all people who use opioids for therapeutic (as prescribed) and non-therapeutic use (abuse, addiction). ICER will look at several key subpopulations including the following:
- Patients with non-cancer chronic pain, stratified by age group where feasible
- Patients with cancer, with particular attention to cancer patients in palliative care
- Recreational drug users
- Persons addicted to opioids
The drugs of focus for the review will include:
Currently FDA 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 FDA Approval
- Vantrela™ ER (hydrocodone extended release, Teva Pharmaceuticals)
- Remoxy™(oxycodone extended release, Pain Therapeutics)
- Arymo™ ER (morphine extended release, Egalet Corporation)
ICER identified numerous stakeholders for input on its upcoming report, including some familiar organizations engaged in the CDC Guideline for Prescribing Opioids for Chronic Pain, such as:
- Physicians for Responsible Opioid Prescribing (PROP)
- US Pain Foundation
- PAINS – The Pain Action Alliance to Implement a National Strategy
A full list of stakeholder organizations can be found here.
ICER also “welcomes suggestions from the broader community on additional organizations to add to this list. ICER also receives input from independent patients and clinicians, and invites the public to submit recommendations for key stakeholders in these categories.”
The draft scoping document will be open to public comment for three weeks until Wednesday, September 28, 2016, at 5pm ET. Comments can be submitted by email to firstname.lastname@example.org. More information about submitting a public comment, including formatting specifications, is available here.
Following the public comment period, a revised scoping document will be posted on or about October 6, 2016.
According to its website, ICER is a “non-profit organization that evaluates evidence on the value of medical tests, treatments and delivery system innovations and moves that evidence into action to improve the health care system.”
ICER’s website also addresses “myths about ICER” including that it is a front to the insurance industry, ignores patient perspectives, discriminates against those with serious health conditions, restricts access to patients by making them take less effective and older medications first, among others.
You can read ICER’s positions on these topics here.