WASHINGTON, D.C. — In January, the Centers for Medicare and Medicaid Services (CMS) released a draft National Coverage Determination (NCD) that proposes to restrict coverage of a new class of Alzheimer’s treatments, monoclonal antibodies that target amyloid plaque, to Alzheimer’s patients who are enrolled in qualifying clinical trials.
In response to this coverage decision, U.S. Senators Shelley Moore Capito (R-W.Va.), co-chair of the Assisting Caregivers Today (ACT) Caucus, and Susan Collins (R-Maine), a founder and co-chair of the Congressional Task Force on Alzheimer's Disease, wrote to CMS Administrator Chiquita Brooks-LaSure, urging her to carefully consider stakeholder feedback as her agency works to finalize coverage for this product class. They emphasized the importance of ensuring that CMS’ action does not inappropriately threaten patient access to treatment, including for those living in rural areas, or thwart advances in research and development in Alzheimer’s disease treatments.
“There are a wide range of coverage decisions CMS might propose through an NCD process, but in this case, CMS proposed a particularly burdensome and restrictive approach that could sharply curtail access not just to one approved product, but to an entire class of potential future products still in the development pipeline,” Senators Capito and Collins wrote. “It is highly unusual…if not precedent setting, for CMS to attempt to evaluate a drug’s clinical benefit. Congress has reserved this task for the [Food and Drug Administration], which said that Aduhelm’s effect on cognition was enough to merit accelerated approval pending confirmation of the clinical benefit.”
“Approval of a new treatment – the first in nearly 20 years – was a landmark moment in the fight against Alzheimer’s that brought significant hope to the more than six million Americans with Alzheimer’s disease and their families. For patients with Alzheimer’s and their families, it might mean more time with improved cognition to spend together while research continues on this and other therapies,” Senators Capito and Collins continued. “As CMS evaluates public comment, we urge you to take these considerations into account and to ensure that agency decision-making does not impede research and development in this field or restrict patient access in a manner that is inappropriate or avoidable and thus deprives some Medicare beneficiaries with Alzheimer’s of access to an FDA-approved medication.”
The Food and Drug Administration (FDA) determined that the drug that motivated this class-wide coverage decision, Aduhelm, demonstrated a meaningful effect on the reduction of beta amyloid plaque, which is expected, although not established, to predict a clinical benefit. FDA thus granted the drug accelerated approval, a regulatory pathway that allows drugs for serious or life-threatening illnesses that provide a meaningful therapeutic advantage over existing treatments to be marketed while the predicted clinical benefit—which can often take years to manifest—is confirmed.
CMS’ proposed NCD would dramatically restrict access to the entire class of therapies to only those patients who are able to participate in a CMS-approved clinical trial or those who can afford to pay out-of-pocket. CMS has provided limited information on clinical trial criteria, but inclusion criteria presented thus far are narrow and difficult to satisfy, which may exacerbate challenges that patients have already experienced finding providers that administer Aduhelm. In particular, a proposed requirement that patients obtain drugs only through hospital outpatient settings could push patients towards one of the most expensive sites of infusion care and removes a significant number of access points from consideration. Trials are also likely to occur only in well-resourced major medical centers, which could complicate, if not revoke, access for rural seniors.
Senators Capito and Collins’ letter was supported by UsAgainstAlzheimer’s and the Alzheimer’s Association.
“The draft Medicare coverage decision is unprecedented and dangerous because it not only applies to one drug, but an entire class of medications aimed at slowing the progression of Alzheimer’s,” George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s, said. “Every day, 1,000 people slip from mild Alzheimer’s to moderate Alzheimer’s. Since these treatments are most effective in the early stages of Alzheimer’s, every day it takes CMS to do the right thing is another day lost for patients and their families who don’t have time to spare.”
“This draft decision from CMS would not only drastically limit access to treatment for people living with Alzheimer's disease, particularly those in rural and underserved communities, but it would also essentially block coverage of an entire class of potential future treatments,” Robert Egge, Alzheimer's Association chief public policy officer and Alzheimer's Impact Movement executive director, said. “Thank you to Senators Susan Collins and Shelley Moore Capito for standing up for people living with this disease and for your longstanding commitment to the fight to end Alzheimer's.”
Click here to read Senators Capito and Collins’ letter.
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