Brady & Rodgers: Biden’s Unprecedented Overreach Harms Alzheimer’s Patients, Chills Lifesaving Cures

After the Biden Administration’s Center for Medicare and Medicaid Services announced its decision to severely restrict coverage of an FDA-approved Alzheimer’s drug – despite repeated and numerous warnings from members of Congress – Energy and Commerce Republican Leader Rep. Cathy McMorris Rodgers (R-WA) and I issued the following joint statement:  

The Biden Administration’s unprecedented decision to restrict coverage of an FDA-approved drug is terrible news for the families suffering from Alzheimer’s and their caregivers, who are desperate for new breakthrough drugs.

This decision sends a discouraging message to millions of patients and families who are suffering with Alzheimer’s and seeking critical treatments. With this decision, CMS is putting itself between Alzheimer’s patients and their doctors while undermining FDA’s gold standard of approval. 

This overreach means an entire class of cures may never make it to market. Worse, it will have a chilling effect on innovation and future cures. American families and caregivers were obviously ignored – they deserve better.

Background: 

Ways and Means Republicans held a meeting in March with experts to examine the devastating decision by Democrats to deny coverage for cures and treatments, and how to promote innovation to bring more cures to Americans at lower costs.

• Rep. Brady noted that we can lower costs for patients without sacrificing cures: “Now that Medicare coverage has been restricted so severely, these lifesaving cures may never make it to market, which is a big worry for many of us. In fact, we’re already seeing the real-world consequences of this overreach. One innovator company has already slowed its timeline to complete application for accelerated approval of its experimental Alzheimer’s drug."

• Ways and Means Subcommittee on Health Republican Leader Rep. Vern Buchanan (R-FL) warned that innovation in life-saving cures is under threat from CMS: “Instead of promoting American innovation and helping the nearly 6 million Americans suffering from Alzheimer’s utilizing the newest available treatments, CMS effectively prohibited access through their overly prescriptive Coverage with Evidence Determination. We should be making it easier for these patients to access available treatments, not unreasonably restricting our nation’s seniors from a potentially life changing treatment."

Read: Wrap-Up: Democrats’ ‘Fewer Cures’ Agenda Limits Access to Alzheimer’s Treatments

House Republican Leaders on Health wrote to Health and Human Services Secretary Xavier Becerra in February urging the Administration not to deny Alzheimer’s patients the treatments they deserve:

• “We have significant concerns about what this decision, if finalized, could mean for the more than 6 million American families suffering from AD, including those with other neurological or medical conditions such as Down Syndrome, who may be effectively prohibited from receiving the drug under the proposed process.”
• “…[f]inalizing a decision to prohibit Medicare coverage for FDA- approved AD treatments outside of government sanctioned randomized controlled trials could unnecessarily deny to patients and their families the hope of breakthrough AD treatments and further eroding Americans’ trust in their public health institutions.”
• “Preventing potentially millions of seniors suffering from a deadly disease from accessing an FDA-approved treatment without a reasonable policy and explanation will send mixed signals about the respective agencies’ roles and sow greater confusion.”
• “[i]t is extremely concerning and unacceptable that the proposed NCD appears entirely to exclude Americans with Down Syndrome from any form of coverage through these trials for Aduhelm and any future amyloid-related treatments. …This effectively excludes patients with intellectual and developmental disabilities like Down Syndrome. This is a startling exclusion of a significant population that might otherwise benefit from coverage of Aduhelm.”