Democratic and Republican attorneys general in nearly half of U.S. states are calling on Medicare to provide unlimited coverage for antibody treatments for Alzheimer’s disease, according to a letter released Monday.
The push by attorneys general from 23 states, the District of Columbia and two U.S. territories adds to growing pressure on the federal Centers for Medicare and Medicaid Services, or CMS, to end a controversial policy that severely restricts access to new drugs such as Eisai and biogenicit’s Leqembi.
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Fortnightly infusions of Leqembi have shown promise in slowing the progression of early Alzheimer’s disease to more advanced stages of the mind-losing disease. Medicare’s decision to restrict coverage means only wealthy seniors can afford to pay $26,500 a year out of pocket.
“We call on CMS to provide full, unrestricted Medicare coverage for FDA-approved Alzheimer’s disease treatments, consistent with its decades-long practice of providing FDA-approved prescription drug coverage for beneficiaries of Medicare,” the attorneys general, led by Oklahoma’s Gentner Drummond, wrote to CMS. Administrator Chiquita Brooks-LaSure and Secretary of Health Xavier Becerra.
Attorneys general have acknowledged that Leqembi is associated with some side effects, such as brain swelling and bleeding, but said families and their doctors can weigh those risks against the benefit of patients being able to recognize loved ones during a longer period.
In a country where political divisions run deep, the drive to provide broad access to treatments for Alzheimer’s disease is one of the few issues around which both sides of the aisle can rally. More than 70 House lawmakers and 18 senators called on Medicare to provide unlimited coverage for Alzheimer’s treatments in February.
The push from members of Congress and state attorneys general comes after Medicare rejected a request from the Alzheimer’s Association to cover Leqembi without any conditions.
“After careful consideration of the claim and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence that meets the criteria for reconsideration,” CMS said in February.
Unlike Medicare, the Veterans Health Administration has agreed to cover Leqembi for veterans age 65 and older who meet certain eligibility criteria.
Leqembi received accelerated approval from the Food and Drug Administration in January. Under its current policy, Medicare will only cover antibody treatments that receive expedited approval for patients in clinical trials. Eisai’s trial is over, which means the overwhelming majority of seniors don’t have access to the drug.
Attorneys general said the decision disadvantages older Americans living in rural areas because clinical trials are typically held in large cities far from small towns.
“It is an enormous physical and financial burden for Medicare beneficiaries to travel to the few research institutes that host the trials,” the attorneys general said. “Patients, families and caregivers living in rural and underserved areas should have equal opportunities to access treatment.”
The language of the letter is similar to letters sent by House lawmakers and senators to Medicare in February.
Medicare has agreed to provide broader coverage of Leqembi if the treatment receives full FDA approval on July 6. But the program for the elderly will still require patients to participate in so-called “registries” that collect data about treatment. Brooks-LaSure promised Congress last week that these registries would not restrict access to treatment.
But Robert Egge, director of policy for the Alzheimer’s Association, told CNBC that registries would restrict access despite Medicare promises. He said the association was unaware of any substantive work that had been done to set up the registers.
Brooks-LaSure said private sector entities can start setting up the registers now.
Attorneys general said Alzheimer’s disease and other forms of dementia cost US$321 billion in 2022, placing a significant financial burden on federal health insurance programs. Medicare and Medicaid paid for about 67% of health care costs, or $239 billion, for the disease in 2021, attorneys general said.
“Unless a treatment to slow, stop, or prevent the disease is approved and available to people, by 2050 Alzheimer’s disease is expected to reach a total cost of $1 trillion (in 2022 dollars) “said the attorneys general.
The letter was signed by the attorneys general of Arizona, Arkansas, Connecticut, District of Columbia, Florida, Idaho, Indiana, Maine, Michigan, New Hampshire , New Jersey, New Mexico, North Dakota, Northern Mariana Islands, Minnesota, Ohio, Oklahoma, Oregon, Pennsylvania, Puerto Rico, South Carolina, Texas, Utah, Vermont, Virginia and West Virginia.
Correction: This story has been updated to correctly reflect the following quotes from the attorneys general’s letter: “We call on CMS to provide full, unrestricted Medicare coverage for FDA-approved Alzheimer’s disease treatments, in accordance with its longstanding practice of FDA coverage. prescription drugs approved for Medicare beneficiaries. “It’s a huge physical and financial burden for Medicare beneficiaries to travel to the few research institutes that host the trials.” “Patients, families and caregivers living in rural and underserved areas should have equal opportunities to access treatment.” “Unless a treatment to slow, stop, or prevent the disease is approved and available to people, by 2050 Alzheimer’s disease is expected to reach a total cost of $1 trillion (in 2022 dollars) .” A previous version inadvertently omitted parts of the quotation marks.