WASHINGTON--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 programme 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.
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.
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.
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.
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.