OUR MINDS. OUR LIVES. OUR CHOICES 

This is the Voices of Alzheimer's member newsletter.  

In this edition, we poll the membership, sit down with Jay Reinstein to discuss the quality of life and family, and plead with CMS to cover lifesaving treatments.

A Voice of Alzheimer’s: Jay Reinstein

Every day at 6:30 a.m., Jay Reinstein of Durham, N.C. receives a call from his youngest daughter on her way to her teaching job. A few hours later, he speaks separately with his parents, both in their 80s. Throughout the day, he interacts with his wife, and he cherishes video-connecting with his two children and five grandchildren who live out of state.

Reinstein’s days are all about quality of life and family. He is purposefully making up for lost time—and he doesn’t want to lose any more. “What I live for is to spend time with them,” he says.

It wasn’t always that way, he admits. In local government for 25 years, the self-described workaholic had “neglected” his loved ones, missing his daughter’s dance recitals and other family events. 

Why the dramatic change? While serving as the assistant city manager in Fayetteville, N.C., he noticed frightening gaps in his short-term memory and skills. Once, he couldn’t recall the departments under his watch; increasingly, he wrote notes to himself and worked longer hours to keep up. 

After seeing neurologists and undergoing neuropsychological testing and brain scans, in 2018, Reinstein, at 57, was diagnosed with early-onset (also called young-onset) Alzheimer’s. He carries one APOEe4 gene, which doubles to triples the risk of developing the disorder. 

Since the diagnosis, he says, “It’s about doing as much as I can in this period of time before the disease progresses.” Reinstein had no choice but to retire from his job. Today, quality of life means spending time with family, staying healthy (he recently was diagnosed with Lupus), traveling, keeping active, and hosting two radio shows. 

 Moreover, he has emerged as a staunch Alzheimer’s advocate, serving on the board of Voices of Alzheimer’s, supporting other Alzheimer’s organizations, lobbying, and raising awareness. Advocacy accounts for about 60 percent of his time these days. 

“Advocacy has been a big thing that has filled the void. I don’t mind ruffling feathers,” says Reinstein, whose upcoming engagements include addressing an important medical advisory panel, called the MEDCAC, which provides input to the Centers for Medicare and Medicaid Services. 

 He ardently researches advances in the field, noting, “There’s a sense of urgency now. The sooner I can get on a drug, the sooner they can figure out more about the disease, the better my quality of life will be, even if it is for a shorter time.” 

Reinstein is considered a good candidate for the new FDA-approved treatment lecanemab by his neurologist, but access to the treatment through Medicare is severely limited.    

 “To me, it’s outrageous,” Reinstein says of the Medicare decision to limit coverage following FDA approval. “If you look at FDA’s history of approving drugs, ensuring they are safe and effective, that the new treatments for Alzheimer’s have not gotten Medicare coverage is discriminatory.” 

 A “glass-half full-person,” he would jump at the opportunity to access a treatment, and hopefully benefiting from its effect. “Two to three more years with my family outweighs any risk of side effects to me…It’s not even close,” Reinstein says. 

What do you want people to know about you?  

“An Alzheimer’s diagnosis doesn’t mean my life is over. I can still do a lot of things…and have meaningful conversations. I can be a fun person to hang out with…It’s not all about Alzheimer’s disease.” 


Message to CMS: Coverage of New Treatments Would Be Life Changing 

Amid the recent excitement—and rightly so—about the U.S. Food and Drug Administration (FDA) approval of two new Alzheimer’s medications, people with Alzheimer’s are encountering a new barrier to medicines – access.   

 Hope came when the FDA granted accelerated approval of two disease-modifying drugs—Aduhelm (aducanumab) and Leqembi (lecanemab)—for people with mild cognitive impairment (MCI) or with early-stage Alzheimer’s. The drugs, monoclonal antibodies, attack amyloid plaque in the brain and research suggests they change the progression of the disease by slowing it down. 

 In trials, participants who received lecanemab had a 27 percent slower cognitive decline in disease progression over 18 months versus those on a placebo.  Most significantly, those on the drug had a 37 percent slower decline in Activities of Daily Living than those on the placebo, and 51 percent reported better quality of life.  For those on the drug, this slower cognitive progression could provide two or three additional years in the mild stage of the disease.  

 But a major new roadblock to access is the Centers for Medicare and Medicaid Services (CMS). Its national coverage decision on monoclonal antibodies for Alzheimer’s, which applies to everyone on Medicare, limits reimbursement for treatment to only those involved in randomized controlled trials through a mechanism called Coverage with Evidence Development (CED). Thus, the vast majority of people with Alzheimer’s, who can’t access or are excluded from a clinical trial, are out of luck. 

“CMS is using its CED approval mechanisms to limit the population that can access new treatments. Their argument that they are protecting the public from ineffective or unsafe treatments does not hold water, since that is the FDA’s job. The FDA has said these drugs are safe and effective. What Medicare is doing is actually cost control,” shared Jim Taylor, President and CEO of Voices of Alzheimer’s. 

Critics who have called the benefits of newly-developed treatments a “modest effect” are missing the bigger picture for people with Alzheimer’s. “More than the quantitative score, we care about the ability to remain independent, drive, go to the supermarket, play with our grandchildren,” said Taylor. “To get a few years longer in the mild stages is phenomenal.” 

Medicare is prohibited from considering cost as part of the decision whether or not to cover a new drug, but with a million or more Medicare beneficiaries for whom new Alzheimer’s treatments may be appropriate, the agency seems to be using all the tools it has to control its expenses. Unfortunately, examples of other costly treatments abound, however, including a rheumatoid arthritis drug that costs about $32,000 and a cancer drug at nearly $60,000 per beneficiary, both covered by Medicare Part B. 

So why discriminate against people with Alzheimer’s? Because Medicare hasn’t had to pay for treatment for this community before now.  

Widely available symptomatic treatments covered by Medicare are relatively inexpensive and often available as generic or unbranded. The overwhelming costs related to Alzheimer’s are those associated with care, and according to experts, families are often paying out of pocket for the majority of these expenses. An estimated 75 percent of Alzheimer’s care is provided by family members, who often sacrifice their own financial stability, physical and emotional health, and career opportunities to provide caregiving support. Annual out-of-pocket expenses for specialized care can be more than $100,000, with the figure increasing as the disease progresses.  

New treatments that delay the progression of Alzheimer’s can change the care that a person may need and better support their independence, as well as quality of life.  At the same time, Medicare coverage that many argue beneficiaries are entitled to, would relieve some of the financial burden that is currently a significant hardship for many families.  

VoA will address the use of CED as a way to limit access at the Feb. 13-14 meeting of the Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) during its review of requirements for clinical studies submitted for CMS’ coverage with CED program. 

VoA members are encouraged to make their voices heard by signing our petition to stop Medicare’s discrimination against people with Alzheimer’s.   

FDA Announces Expedited Approval of Lecanemab; Attention Shifts to Undoing Discriminatory Medicare Policies

Washington, DC, January 6, 2023 – Voices of Alzheimer’s, an advocacy organization led by people with lived experience with Alzheimer’s, today welcomed the decision by the U.S. Food and Drug Administration to approve the second-ever disease modifying treatment for early-stage Alzheimer’s and said the approval must refocus attention on Medicare’s discriminatory decision last year to block coverage for innovative treatments for people living with Alzheimer’s.

The FDA this afternoon granted expedited approval to Lecanemab, a drug developed by Eisai and Biogen, which has demonstrated positive results in slowing Alzheimer’s. The FDA is expected to give full approval to Lecanemab later this year.

According to published and peer reviewed research findings, Lecanemab has shown a slowing of decline of activities of daily living by 37 percent, a critical indicator of the quality of life of people living with Alzheimer’s and their care partners.  Additionally, clinical trial data showed that Lecanemab delayed progression of cognitive loss by 27 percent compared to placebo, which could equate to months or years of benefit to patients in terms of engaging with loved ones and living independently.

The company’s clinical trials enrolled 1,795 people with early Alzheimer’s who had evidence of the amyloid brain plaques believed to contribute to cognitive decline.

Voices of Alzheimer’s said that it continues to be concerned that the price of Lecanemab and future breakthrough treatments will negatively impact their accessibility. As to safety, Dr. Sharon Cohen, a member of the VOA scientific advisory committee, asserted that the drug’s safety profile is “reasonable with low risks.”

“Once again,” Dr. Cohen added, “some are trying to hold Alzheimer’s treatments to a higher standard than with other therapeutic areas.”

Jim Taylor, President of Voices of Alzheimer’s and long-time care partner, said that “The FDA’s decision represents a milestone moment in the search for an effective treatment for Alzheimer’s.”

These results, Taylor added, will add pressure on Medicare to reverse its blanket decision last year to refuse to cover the new treatments for Alzheimer’s.

“Based on the FDA’s decision and the new effectiveness data,” he said, “we will demand that the federal government change its discriminatory policies on coverage and allow for access to those who could benefit from the treatment.”

Late last year, the Alzheimer’s Association filed a formal request with the Centers for Medicare and Medicaid Services that it reconsider a blanket decision to require further evidence before approving any of the drugs like Lecanemab for coverage by Medicare. Voices of Alzheimer’s strongly supports the Association’s request.

Last year’s decision by Medicare to severely limit coverage for anti-amyloid drugs was unprecedented. Experts say they can think of no other class of drugs that has been treated in such a way by Medicare.

Rebecca Chopp, a founding Board member of Voices of Alzheimer’s, is living with early Alzheimer’s. “We have waited long enough,” she said.  “We are now seeing the fruits of decades of research into treatment for this disease.”

“We must not allow the government to continue to discriminate against people living with Alzheimer’s by blocking equitable coverage for these new treatments,” she added.

Learn more on the Voices of Alzheimer’s website, and on social media through Facebook, Twitter, Instagram, and TikTok.

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