Alzheimer patients rally for easier access to FDA-approved treatments

Advocates gathered outside the White House on Monday.
Published: Mar. 21, 2023 at 11:52 AM CDT
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WASHINGTON (Gray DC) - Alzheimer’s patients and their families rallied outside the White House Monday to call on the President and lawmakers to make FDA-approved Alzheimer drugs easier to access.

On its website, the Alzheimer’s Association says “In April 2022, the Centers for Medicare & Medicaid Services (CMS) issued an unprecedented decision that blocks Medicare coverage of FDA-approved treatments that target amyloid for Alzheimer’s disease. This policy applies to all currently FDA-approved monoclonal antibody treatments, including lecanemab (Leqembi™) and aducanumab (Aduhelm™), and others that may receive approval in the coming months.”

In February, CMS issued a response to the group’s request for reconsideration of coverage. It said in part, “at this time, CMS is not reconsidering the national coverage determination (NCD),” adding “as defined in statute, to provide coverage nationally, CMS is required to examine whether a medication is reasonable and necessary. This standard differs from the criteria used by the FDA to assess whether medications are safe and effective.”

Currenlty, Lecanemab/Leqembi is covered by Medicare if it meets certain criteria.

Alzheimer patients Joe Montminy travelled from Massachusetts on Monday to the rally outside the White House. He was first diagnosed when he was 54-years-old. Now he’s 59-years-old. He said patients like him don’t have time to wait for the government to act. They want to see lawmakers and the President do something now.

He said his doctor told him when he was diagnosed, “there’s a chance that as this disease progresses in 3 to 5 years, you know, things are going to digress. In 5 to 7 years, you may not recognize your family. And, she gave me a ten year life expectancy, and it was totally different than what I was expecting. So, I was just devastated trying to figure out how I was going to deal with this. Because your whole life, you know, you work. I worked 30 years looking forward to spending time with my children and my retirement and all of a sudden that just gets blown up. It’s devastating.”

Robert Egge, Chief Public Policy Officer of the Alzheimer’s Association, added, “our number one goal for everybody here is to have access to these first FDA approved treatments right now. We’re the only treatments approved by the FDA that Medicare is not covering.”

Following the White House rally Monday, advocates plan to go to Capitol Hill to meet with lawmakers one-on-one.

CMS said “The Centers for Medicare & Medicaid Services (CMS) is committed to helping people get timely access to treatments and improving care for people with Alzheimer’s disease and their families.”

The National Institute on Aging provided Gray Television with the following statement:

“The National Institute on Aging (NIA), part of the National Institutes of Health, is the lead U.S. federal agency supporting and conducting Alzheimer’s disease research. NIA is currently funding more than 450 active Alzheimer’s disease and related dementias prevention, treatment, and caregiving clinical trials. Of these, approximately 200 are testing interventions for effective prevention and treatment of these diseases, and others are testing dementia care and caregiving interventions.

Alzheimer’s is now recognized as a complex disorder that involves many cellular changes, in addition to the accumulation of the amyloid beta protein. In this disease, tau, TDP43, and alpha-synuclein also accumulate in the brain; and inflammation, genetics, environmental factors, and changes to the vascular system are factors as well. Further research has shown that the clinical changes linked to dementia can result from a range of changes to cells in the brain that can occur along or in combination with one another. This complexity underscores the need for personalized (precision medicine) treatment plans.

Before biomarker tests were developed in the early 2000s, the only sure way to know whether a person had Alzheimer’s was via autopsy. Scientists have since designed diagnostics to detect biomarkers associated with dementia in living people. These include blood tests such as PrecivityAD™; brain imaging tools CT, MRI, and PET; and the first tau biomarker test, all of which enable more precise diagnoses; increased clinical trial enrollment; and advancement toward more equitable access to future treatments.

Ten years ago, we knew of only 10 genes associated with Alzheimer’s. Today, scientists know of and are researching more than 70 related genetic regions. Understanding which genes play a role — and whether they increase risk or provide protection — will help identify new drug options.

Research has also found that a combination of healthy lifestyle traits may substantially reduce Alzheimer’s disease risk. For example, intensive lowering of high blood pressure appears to reduce the risk of cognitive impairment and may slow age-related brain damage.

These efforts and many others can only happen in collaboration with the research community, industry, and importantly, public participation. NIA is grateful for the many individuals who have participated in clinical trials that helped advance knowledge, and we continue to emphasize the enormous importance of participating in research studies. We remain committed to recruiting and retaining a broad range of clinical trial participants from diverse communities, and to expanding and diversifying the dementia research workforce.

For more information, visit Alzheimer’s Disease & Related Dementias Scientific Advances.”