Aimed Alliance Says Congress Needs the Complete Facts About The Nation's Risk Evaluation and Mitigation Strategies (REMS) Program

WASHINGTON, June 15, 2017 /PRNewswire-USNewswire/ -- The Alliance for the Adoption of Innovations in Medicine ("Aimed Alliance") – a not-for-profit that works to improve access to quality health care – today refuted the findings of a generic drug industry-funded study that alleges misuse of the restricted drug distribution programs mandated by the Food and Drug Administration (FDA) through the nation's Risk Evaluation and Mitigation Strategies (REMS) program. REMS are FDA-mandated safety protocols used to manage known or potential serious risks associated with a medication.

Because REMS programs make it possible for millions of Americans with diseases like cancer, HIV, kidney disease, and multiple sclerosis access to be treated with valuable therapies that would otherwise not be on the market today, the Aimed Alliance is urging policymakers to get the complete facts so lawmakers will recognize the meaningful impact of these safeguards to patients.
Of special importance to patient advocates are overcoming misperceptions about the most restrictive type of REMS – Elements to Assure Safe Use (ETASU) – that include restricted distribution systems and are only required when therapies are associated with the most severe risks, including risk of birth defects and death.

As a step in this direction, the Aimed Alliance identified significant deficiencies in a new study by Matrix Global Advisors that claims brand drug manufacturers misuse REMS with restricted distribution to block generic drug development. By comparing the report's findings with readily available information from the FDA on 41 therapies or medicine classes marketed with restricted distribution programs, the organization documented unfounded assumptions, omissions of necessary details, and faulty estimates that resulted in misleading and inaccurate conclusions. Specifically, Aimed Alliance concluded that:

• Matrix Global Advisors conflated REMS-mandated restricted distribution programs with voluntary, non-REMS programs put into place by individual companies. Accordingly, the researchers combined sales of these two different categories of drugs, thereby doubling the estimate of possible savings to the health should the nation's REMS policies be weakened.
• When calculating the cost-savings that could be expected if generic manufacturers had access to REMS drugs with restricted distribution, the study's researchers overlooked the fact that a significant number of these drugs are actually already generics. Simply by reviewing documents about these drugs on the FDA's REMS website, the Aimed Alliance identified six classes of REMS drugs where both branded and generic versions are now distributed through a shared distribution system.  Collectively, these six shared systems cover the distribution of 61 different drug products of which more than half (33) are generics. Therefore, the conclusion of Matrix Global Advisors that medicines requiring REMS controls, with "sales totaling $11.5 billion in 2016," are limiting generic entry is a misleading overstatement.
• While estimating that seven drugs marketed with restricted distribution programs generated sales of over $1 billion in 2016, the Matrix Global Advisors study only lists the names of the four medicines requiring REMS-mandated restricted distribution programs.
• Moreover, the study failed to note that among these four $1 billion medicines requiring REMS-mandated restricted distribution, one – Suboxone – already has a generic version available and on June 9, FDA approved the second – the HIV drug Truvuda – ahead of schedule. Moreover, the cancer therapy Revalimid is expected to go generic in March 2022.
• The remaining REMS drug, Tysabri, is a biologic for which it is not possible to make a generics version. Nevertheless, biosimilars for Tysabri are currently in development, but based on pricing to date, these drugs will not cost significantly less than Tysabri when they reach the market – certainly not the 80 percent savings suggested by the report.

"When all the facts are presented about REMS-mandated restricted distribution programs, the take-away is much different than the conclusions presented in Matrix Global Advisors' report," said Stacey Worthy, Executive Director of Aimed Alliance. "In reality, REMS safeguards give patients access to innovative medicines that would otherwise not be available, including generic versions. Policymakers should be presented with a full and accurate story about REMS, not misleading math."

About the Alliance for the Adoption of Innovations in Medicine (Aimed Alliance)
Aimed Alliance is a tax-exempt, not-for-profit organization that works to improve health care in the U.S. through access to evidence-based treatments and technologies. The organization conducts policy activity with a legal focus.  Aimed Alliance's supporters are disclosed at http://www.aimedalliance.org/collaborators/. For more information, visit www.aimedalliance.org and follow @AdoptInnovation on Twitter.

SOURCE Aimed Alliance

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