Democratic and Republican attorneys general in nearly half of U.S. states are calling on Medicare to provide unrestricted coverage of 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 mounting 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 Biogen's Leqembi.
Twice-monthly infusions of Leqembi have shown promise in slowing progression of early Alzheimer's to more advanced stages of the mind-wasting disease. Medicare's decision to restrict coverage means only wealthy seniors can afford to pay $26,500 per year out of pocket.
"We ask that CMS provide full and unrestricted Medicare coverage for FDA-approved Alzheimer's treatments, consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries," the attorneys general, led by Oklahoma's Gentner Drummond, wrote to CMS Administrator Chiquita Brooks-LaSure and Health Secretary Xavier Becerra.
The attorneys general acknowledged that Leqembi is associated with certain side effects, such as brain swelling and bleeding, but they said families and their doctors can assess these risks against the benefit of patients being able to recognize their loved ones for a longer period.
In a nation with deep political divisions, the push to provide broad access to Alzheimer's treatments is one of the few issues both sides of the aisle can rally around. More than 70 House lawmakers and 18 senators called on Medicare to provide unrestricted coverage of Alzheimer's treatments in February.
The push by members of Congress and state attorneys general comes after Medicare rejected a request by the Alzheimer's Association to cover Leqembi without any conditions.
"After careful review of the request and supporting documentation, we are making this decision because, as of the date of this letter, there is not yet evidence meeting the criteria for reconsideration,"Â CMS said in February.
Unlike Medicare, the Veterans Health Administration agreed to cover Leqembi for veterans ages 65 and older who meet certain eligibility criteria.
Leqembi received expedited 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 participating in clinical trials. Eisai's trial has concluded, which means the overwhelming majority of seniors do not have access to the drug.
The attorneys general said the decision puts older Americans living in rural areas at a disadvantage, because clinical trials are typically hosted in larger cities far from small towns.
"It is an enormous physical and financial burden for Medicare beneficiaries to travel to the few research institutions that host the trials," the attorneys general said. "Patients, families and caregivers living in rural and underserved areas should have the same opportunity for access to treatment."
The language of the letter is similar to the 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 seniors will still require patients to participate in so-called "registries" that collect data about the treatment. Brooks-LaSure promised Congress last week that these registries will not restrict access to the treatment.
But Robert Egge, the Alzheimer's Association chief policy officer, told CNBC that the registries will restrict access despite what Medicare has promised. He said the association is not aware of any substantive work that has been done to set up the registries.
Brooks-LaSure said private sector entities can start setting up the registries now.
The attorneys general said Alzheimer's disease and other forms of dementia cost the U.S. $321 billion in 2022, which is a substantial financial burden on federal health insurance programs. Medicare and Medicaid picked up an estimated 67% of the health-care costs, or $239 billion, for the disease in 2021, the attorneys general said.
"Unless a treatment to slow, stop, or prevent the disease is approved and accessible to people, by 2050, Alzheimer's is projected to reach a total cost of $1 trillion (in 2022 dollars)," the attorneys general said.
The letter was signed by the attorneys general of Arizona, Arkansas, Connecticut, the 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 letter by the attorneys general: "We ask that CMS provide full and unrestricted Medicare coverage for FDA-approved Alzheimer's treatments, consistent with its decades-long practice of covering FDA-approved prescription drugs for Medicare beneficiaries." "It is an enormous physical and financial burden for Medicare beneficiaries to travel to the few research institutions that host the trials." "Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment." "Unless a treatment to slow, stop, or prevent the disease is approved and accessible to people, by 2050, Alzheimer's is projected to reach a total cost of $1 trillion (in 2022 dollars)." A previous version inadvertently omitted parts of the quotes.