By Ahmed Aboulenein
WASHINGTON (Reuters) – The Alzheimer’s Association has dispatched 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 push Medicare for early access to a new class of drugs , starting with lecanemab, which promises 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 of the association’s national and local officials.
The effort is aimed at persuading the Medicare health program for people age 65 and older to provide “full and unlimited coverage” for the drugs once they reach the US market under accelerated approval from the US Food and Drug Administration (FDA).
Broad coverage of the medicines would mean significantly more income for the drug manufacturers. Some analysts expect sales of lecanemab, also known as Leqembi, to reach between $26 million and $70 million in 2023. Other analysts have predicted sales as high as $5 billion by 2030 if the drug gains widespread coverage this summer.
The Alzheimer’s Association and the pharmaceutical industry say that the pharmaceutical companies are not directly involved in the campaign.
Broader Medicare coverage will become available once the drugs receive full commercial approval from the FDA, a process that requires more data from drugmakers and could take several months.
But the Alzheimer’s Association says that patients simply do not have time to spare. It estimates that hundreds of thousands of older 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 will give people more time to participate in daily life, remain independent and make health decisions for their future,” said Alzheimer’s Association president Joanne Pike.
CMS said its framework includes a broader coverage pathway if the drugs receive standard FDA approval.
“CMS is committed to being flexible 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,” said a agency spokesman to Reuters.
The agency did not process 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 progression of early-stage Alzheimer’s 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.
Eisai and Biogen said this week that the US Department of Veteran Affairs (VA) will provide coverage for Leqembi, provided veterans request it, receive prior approval and meet strict inclusion criteria.
Leqembi belongs to a new generation of treatments designed to slow the progression of the disease by removing sticky clumps of the toxic protein beta-amyloid from the brain.
An estimated 6.5 million Americans are living with Alzheimer’s disease, according to data from the US Centers for Disease Control and Prevention (CDC). 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 with congressional staffers and lawmakers, urging them to pressure the US Department of Health (HHS) to expand drug coverage.
The association’s Southeast Florida chapter launched its lobbying efforts 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, said Ryan Schiff, the department’s public policy manager.
In California, Myra Garcia, 64, whose career as a fundraiser was cut short by her diagnosis in 2020, said she met with staff 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 they would not sign the request,” Garcia told Reuters. “There was one day when I think I hit five meets.”
Nearly 100 lawmakers from both parties, including Republican Sen. Susan Collins of Maine, a founding member 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 staff 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 they would not sign the request,” Garcia told Reuters. “There was one day when I think I hit five meets.”
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 total revenue of $425 million and that the donations do not influence decision-making.
Spokesmen for all three companies said they are not cooperating with the association on its campaign to expand Medicare coverage of the drugs.
Although there is no direct link between drug company support for the association and its activities, the campaign “falls into a gray area,” said Edward Walker, a sociologist at the University of California at Los Angeles (UCLA) who studies how corporations mobilize grassroots campaigns.
“Sometimes it’s part of a long game strategy,” Walker said. “They fund a lot of these patient groups because they know that in the long term the support will come back and help them.”
GRAPHIC: Money Spent Lobbying Medicare’s Decision to Limit Coverage – https://www.reuters.com/graphics/HEALTH-ALZHEIMERS/GRASSROOTS/gdpzqmladvw/chart.png
(Reporting by Ahmed Aboulenein; Editing by Caroline Humer and Suzanne Goldenberg)
