Alzheimer's Association lobbies for Medicare coverage of Leqembi and
other drugs
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[March 16, 2023]
By Ahmed Aboulenein
WASHINGTON(Reuters) - The Alzheimer's Association has deployed 1,000
people diagnosed with, or caring for someone with the disease, to meet
with all 535 members of Congress across the United States and urge them
to press Medicare for early access to a new class of drugs, beginning
with lecanemab, that promise to slow the disease.
The grassroots lobbying campaign, which has not been reported in detail,
is being led by state-based chapters, according to interviews with four
Association national and local officials.
The effort is aimed at persuading the Medicare health program for people
aged 65 and older to provide "full and unrestricted coverage" to the
drugs when they first reach the U.S. market under an accelerated
approval from the U.S. Food and Drug Administration (FDA).
Broad coverage of the drugs would mean substantially more revenue for
the drug makers. Some analysts project 2023 sales of lecanemab, also
known as Leqembi, could reach between $26 million and $70 million. Other
analysts have forecast sales as high as $5 billion by 2030 if the drug
gets broad coverage this summer.
![](http://archives.lincolndailynews.com/2023/Mar/16/images/031323PIX/graue_lda_preowned_031323.jpg)
The Alzheimer's Association and the pharmaceutical industry say the drug
companies are not directly involved in the campaign.
Wider Medicare coverage will become available once the drugs receive
full commercial approval from the FDA, a process that requires more data
from drugmakers and that could take several months.
But the Alzheimer's Association says patients simply don't have the time
to spare. It estimates hundreds of thousands of elderly people with mild
dementia may progress to a more advanced stage of the disease during
that time, and will no longer be eligible for the new treatments.
"Treatments taken in the early stages of Alzheimer’s would allow people
more time to participate in daily life, remain independent and make
health care decisions for their future," Alzheimer’s Association
President Joanne Pike said.
CMS said its framework includes a broader coverage pathway if the drugs
receive standard FDA approval.
"CMS is committed to being nimble when reconsidering this coverage
framework in light of any new evidence related to the clinical benefit
of this drug, and we continue to encourage clinicians, patients and
caregivers to send us relevant evidence," an agency spokesperson told
Reuters.
The agency did not address the Alzheimer's Association campaign.
The first of the new drugs, Japan's Eisai Co and Biogen Inc's drug
Leqembi, won FDA approval in January under an accelerated review
process, after the drug showed some evidence in trials that it could
slow the advance of Alzheimer's in early stages of the disease. Eisai
priced the drug at $26,500 a year.
The FDA is expected to give full approval this summer. Eli Lilly & Co's
drug donanemab is expected to be considered for full approval later this
year.
![](http://archives.lincolndailynews.com/2023/Mar/16/images/ads/current/railer_norapeters_sda_LCHSBOARD_2023.png)
Eisai and Biogen said this week that the U.S. Department of Veteran
Affairs (VA) will provide coverage of Leqembi provided veterans request
it, receive prior approval, and meet strict inclusion criteria.
Leqembi belongs to a new generation of treatments designed to slow
advance of the disease by removing sticky clumps of the toxic protein
beta amyloid from the brain.
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![](../images/031623PIX/health88.jpg)
The Alzheimer's drug Leqembi is seen in
this undated handout image obtained by Reuters on January 20, 2023.
Eisai/Handout via REUTERS
![](http://archives.lincolndailynews.com/2023/Mar/16/images/ads/current/peasley_lda_051513.png) An estimated 6.5 million Americans
are living with Alzheimer's disease, according to U.S. Centers for
Disease Control and Prevention (CDC) data. It is the fifth leading
cause of death for adults over 65.
TWEETS, LETTERS AND MEETINGS
Over the past two months, chapters have tweeted, written letters and
met congressional staffers and lawmakers, calling on them to apply
pressure on the U.S. Department of Health and Human Services (HHS)
to expand drug coverage.
The association's Southeast Florida chapter launched its lobbying
drive a few weeks before the FDA granted accelerated approval to
Leqembi. Association members have met 30 times with staffers for the
state's 20 members of Congress, Ryan Schiff, the chapter's public
policy manager, said.
In California, Myra Garcia, 64, whose career as a fundraiser was cut
short by her diagnosis in 2020, said she met with staffers for seven
members of Congress from the state.
"It was quite a flurry of meetings, one after another, and, to a
person, there is not a person who said that they would not sign on
to the ask," Garcia told Reuters. "There was one day where I think I
hit five meetings."
Nearly 100 lawmakers from both parties, including Republican Senator
Susan Collins from Maine, a founder of the congressional task force
on Alzheimer's, have signed a letter urging HHS and Medicare to
expand coverage.
Myra Garcia, 64, whose career as a fundraiser was cut short by her
diagnosis in 2020, said she met with staffers for seven members of
Congress representing California.
"It was quite a flurry of meetings, one after another, and, to a
person, there is not a person who said that they would not sign on
to the ask," Garcia told Reuters. "There was one day where I think I
hit five meetings."
![](http://archives.lincolndailynews.com/2023/Mar/16/images/ads/current/llm_lda_ANIMAL_2023.png)
The Alzheimer's Association received $4.5 million in funding from
the pharmaceutical industry in 2022, including a combined $1.34
million from Biogen, Eisai, and Eli Lilly, makers of the new drugs.
The Association says on its website that the funding represents just
over 1% of its overall revenue of $425 million and that the
donations do not impact decision making.
Spokespeople for all three companies said they do not work with the
Association on its campaign to expand Medicare coverage of the
drugs.
While there is no direct connection between drug company support for
the Association and its activities, the campaign "falls in a gray
area," said Edward Walker, University of California at Los Angeles
(UCLA) sociologist who studies how companies mobilize grassroots
campaigns.
"Sometimes it's part of a long game strategy," Walker said. "They
fund a lot of these patient advocacy groups because they know that
in the long term that support is going to come back around and help
them."
(Reporting by Ahmed Aboulenein; Editing by Caroline Humer and
Suzanne Goldenberg)
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