The Centers for Medicare & Medicaid Services (CMS) recently released draft guidance that, in the future, proposes to only reimburse FDA approved treatments for Alzheimer’s disease in a CMS authorized randomized controlled trial. To the outside world, this likely doesn’t seem like a problem. However, this CMS proposal has ignited a firestorm across the US healthcare ecosystem.

Vital Transformation (VT) CEO Duane Schulthess is joined by VT’s US Business Director, Dr. Joseph Hammang, and VT’s Consulting Economist, Dr. Harry Bowen to discuss the core findings of their recent research and analysis which was commissioned and funded by Biogen, Inc.  The VT team found that, if implemented, CMS’ plan would have devastating impacts on the development of new treatments for Alzheimer’s disease, neurological disorders, and new therapies using accelerated approvals.

Additionally discussed are the enormous challenges and high failure rates associated with clinical developments in neurology since reaching their peak in 2009.  VT’s research finds the current failure rate for clinical developments in Alzheimer’s disease is 99.5%, meaning that if the proposed CMS guidance is implemented, it would likely drive down the number of new therapies developed for Alzheimer’s disease to nearly zero. 

The Centers for Medicare &amp; Medicaid Services (CMS) recently released draft guidance that, in the future, proposes to only reimburse FDA approved treatments for Alzheimer&rsquo;s disease in a CMS authorized randomized controlled trial. To the outside world, this likely doesn&rsquo;t seem like a problem. However, this CMS proposal has ignited a firestorm across the US healthcare ecosystem.
Vital Transformation (VT) CEO Duane Schulthess is joined by VT&rsquo;s US Business Director, Dr. Joseph Hammang, and VT&rsquo;s Consulting Economist, Dr. Harry Bowen to discuss the core findings of their recent research and analysis which was commissioned and funded by Biogen, Inc. &nbsp;The VT team found that, if implemented, CMS&rsquo; plan would have devastating impacts on the development of new treatments for Alzheimer&rsquo;s disease, neurological disorders, and new therapies using accelerated approvals.
Additionally discussed are the enormous challenges and high failure rates associated with clinical developments in neurology since reaching their peak in 2009.&nbsp; VT&rsquo;s research finds the current failure rate for clinical developments in Alzheimer&rsquo;s disease is 99.5%, meaning that if the proposed CMS guidance is implemented, it would likely drive down the number of new therapies developed for Alzheimer&rsquo;s disease to nearly zero.&nbsp;

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess is the CEO of Vital Transformation, host and producer of Vital Health Podcast.  Vital Transformation understands the implications of new medical procedures, technologies and regulations. We measure their impact upon treatment pathways and the biopharma innovation ecosystem in collaboration with health care professionals, researchers, and regulators. Through our web platform and client network, we are able to communicate our findings with international decision makers and stakeholders.

Duane Schulthess, Managing Director of Vital Tran…

Advertisement