Washington, D.C. — After the Biden Administration’s Center for Medicare and Medicaid Services announced its decision to severely restrict coverage of the first FDA-approved drug for Alzheimer’s in almost two decades – despite repeated warnings from members of Congress and patient advocates – House Energy and Commerce Republican Leader Cathy McMorris Rodgers (R-WA) and Ways and Means Republican Leader Rep. Kevin Brady (R-TX) 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.”
At an Energy and Commerce Health Subcommittee hearing in February, Republican Leader Rodgers spoke on the need to unleash innovation in healthcare and CMS’s efforts to restrict Medicare coverage for Alzheimer’s treatments:
“FDA also works with companies designing clinical trials for approval, including a number of treatments for Alzheimer’s Disease.
“I was shocked to find out that the CMS proposed National Coverage Determination (NCD) severely restricts Medicare coverage for a whole class of Alzheimer’s treatments, including the recently FDA-approved Aduhelm, to only cover these drugs in CMS-approved clinical trials.
“It also excludes those with Down Syndrome from participating in covered trials, even though Alzheimer’s may affect greater than 90 percent of those with Down Syndrome over the age of 60. This is wrong.
“We need clinical trials that more closely reflect the diversity of Americans, including those with developmental disabilities.
“Further, just because they may be excluded from trials today, that should also not hurt their access to an FDA-approved drug if their doctor determines that is the best decision for their health.
“We are committed to moving these user fee agreements through Committee on time and through regular order. Now, more than ever, we should be working together in a bipartisan way to promote innovation, to lower costs with more competition, and deliver safe and effective drugs to Americans.”
CLICK HERE to read her full remarks.
House Republican Leaders on Health also 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.”
CLICK HERE to read the letter.
Republican Leader of the Energy and Commerce Committee’s Health Subcommittee Rep. Brett Guthrie (R-KY) led a bipartisan letter pressing top Biden Administration health officials to reverse a proposal, which CMS rejected in finalizing this restricted policy today.
“I am calling on CMS to reverse their proposed national coverage decision to restrict Medicare beneficiaries’ access to Aduhelm, a recently approved Alzheimer’s treatment, and all future similar treatments being developed to treat Alzheimer’s Disease. This proposal will not only arbitrarily limit access to these breakthrough therapies for people living with Alzheimer’s, including individuals with Down Syndrome, but it will also discourage future investments in research to find a cure to Alzheimer’s Disease. CMS must reverse their decision.”
CLICK HERE to read the letter.