(Reuters) Patient groups are mounting a public pressure campaign to persuade the U.S. government to loosen proposed restrictions on new Alzheimer's treatments, spending millions of dollars on television and local advertisements that began running during the Sunday morning political shows.
The unusual ad campaign comes after a high-profile disagreement between government health agencies over who should have access to Biogen's Aduhelm, the first treatment for the mind-wasting disease to be approved in 20 years.
In January, the government's Medicare program, which provides health benefits for Americans aged 65 and older, proposed paying for Biogen's drug and similar treatments in development only for patients enrolled in years-long government studies.
The drugs are being considered to remove amyloid plaques from the brain of people with Alzheimer's. The agency has until April 11 to issue a final coverage decision.
The highly restrictive move came after Aduhelm was approved by the Food and Drug Administration last June, even though only one of two late-stage trials showed that it helped slow cognitive decline. As written, the Medicare plan would also apply to plaque-clearing drugs in advanced development by Eli Lilly (NYSE: LLY) and Co, Roche Holding AG (OTC: RHHVF), and Eisai Co (OTC: ESALY) Ltd.
USAgainstAlzheimer's, one of the largest U.S.-based groups representing patients with the disease, said it is funding ads in the Washington D.C. and Baltimore areas targeting the Centers for Medicare and Medicaid Services, the Department of Health, and Human Services (HHS), the White House and Congress.
"We want to put a face on the individuals that are affected by this Medicare decision," said USAgainstAlzheimer's Chairman George Vradenburg. "We tend to talk about big numbers. We don't talk about individual people."
He said the group is spending millions on the campaign, which will feature Alzheimer's patients, including social media outreach and print ads on bus stops and other transportation in the Washington area. Many have the tagline "Alzheimer's patients can't wait."
Thousands of patients and doctors have already pressured the Medicare agency with letters, echoing the companies' assertions that patients should not be cut off from the new drugs once they have been approved. At the same time, many comments praised Medicare for putting curbs on Aduhelm's use.
Aduhelm's price - cut in December to $28,200 from $56,000 per year - sparked concerns about Medicare's budget since Alzheimer's is an age-related disease and around 85% of people eligible for the drug are covered by the government plan.
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The number of Americans with Alzheimer's is expected to rise to 13 million by 2050 from more than 6 million currently.
Biogen (NASDAQ: BIIB) has estimated that around 1 million should be eligible for Aduhelm, approved for people in the early stages of the memory-robbing illness.
The Alliance for Aging Research said it had organized a protest for Tuesday across the street from HHS headquarters in Washington. Patients, caregivers, and others will call for Medicare to reconsider its restrictive plan.