Implementation of Class-Wide REMS for Opioids; is the FDA Creating a Financial Burden on the Healthcare System?

Introduction:

The FDA recently approved class-wide REMS for extended release and long acting opioids.  Although, the FDA frequently establishes REMS for single drugs, increased class-wide REMS are being introduced.  Through the establishment of REMS, drugs that are deemed high risk may require additional training and certification for manufacturing and dispensing.  With the classification and additional requirements of certain drugs, the question of financial burden must be raised.  Will the addition of class-wide REMS, affecting a large portion of the population, such as opioids, create a financial burden on an already struggling healthcare system?

Background:

Risk Evaluation and Mitigation Strategies (REMS) were established in response to the Food and Drug Administrations’ (FDA) Amendments Act of 2007.    REMS were developed as a means to monitor drug effects and to make a long term evaluation of the benefits versus risk, to ensure patient safety.   Currently, there are numerous parameters to evaluate a drugs benefits versus risks, some of these include: the size of the patient population being treated; the severity of the disorder/disease; proposed drug benefits and treatment length; and the severity of the risks associated with the proposed drug.

Extended release (ER) and long acting (LA) opioids are routinely used for the treatment and management of pain, and often used in the course of treatment for chronic disease and disorders.  In-part, because of the potent nature of opioids, the occurrence of drug abuse leading to addiction, dependency and in some cases death is a growing socioeconomic concern.  In response, the FDA implemented ER/LA REMS to allow for the continued assessment of the drug class with the goal of reducing risks and increasing overall drug safety.

Issue:

Should the FDA Continue Impose Class-Wide ER/LA REMS for Opioids?

Rules:

The FDA should not impose class-wide ER/LA REMS for Opioids if

1)    The class-wide ER/LA REMS for opioids cause a financial burden to the healthcare provider and

2)    The additional requirements from the ER/LA REMS limits therapies available to patients

Analysis:

Will the class-wide ER/LA REMS cause a direct financial burden to the healthcare provider?  The newly enacted REMS affect approximately 20 drug companies and 30 name brand and generic drugs. As part of the REMS requirement, manufacturers of the identified ER/LA opioids will be mandated to offer additional educational and training resources.  However, attendance by the healthcare provider to any additional training remains strictly voluntary.   With no mandated healthcare provider training or certification, the healthcare provider will not experience any direct financial burden as a result of the new class-wide ER/LA REMS.

Will the additional requirements from the ER/LA REMS limit therapies available to patients? In April 2011, The Obama Administration, in an effort to address prescription drug abuse, mandated healthcare provider training in the responsible conduct of prescribing opioids.  However, the FDA does not mandate any training in prescribing opioids and the ER/LA REMS do not impose any healthcare provider limitations or conditions in prescribing opioids.  Because no pre-conditions for opioids prescriptions are imposed by the ER/LA REMS, therapies to patients will not be limited or hindered.

Conclusion:

Because no financial burden associated with mandatory training or certification and no pre-conditions to prescribing opioids are included in the ER/LA REMS, the FDA should continue to impose a class-wide ER/LA REMS for opioids.  The ER/LA REMS are not creating a financial burden on the healthcare system.