Democratic and Republican attorneys general in nearly half of US states are asking 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 is increasing pressure on the Federal Centers for Medicare and Medicaid Services (CMS) to end a controversial policy that severely restricts access to new drugs like Eisai And biogenic‘s Leqembi.
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Twice-monthly infusions of Leqembi have shown promise in slowing the progression of early Alzheimer’s disease to more advanced stages of the mind-wasting disease. Medicare’s decision to limit coverage means only affluent seniors can afford to pay $26,500 a year out of pocket.
“We require 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 attorney general wrote, led by Gentner Drummond of Oklahoma to CMS Administrator Chiquita Brooks-LaSure and Secretary of Health Xavier Becerra.
Attorneys general acknowledged that Leqembi is linked to certain side effects, such as brain swelling and bleeding, but said families and their doctors can weigh those risks against the benefit of allowing patients to recognize their loved ones over a longer period of time.
In a nation with deep political divisions, the quest to provide widespread access to Alzheimer’s treatments is one of the few issues both sides of the aisle can rally around. More than 70 members of the House of Representatives and 18 senators called on Medicare to provide full coverage for Alzheimer’s treatments in February.
The push by members of Congress and attorneys general comes after Medicare rejected a request from the Alzheimer’s Association to cover Leqembi unconditionally.
“After carefully reviewing the application and supporting documentation, we are making this decision because, as of the date of this letter, there is no evidence meeting the criteria for a re-examination,” CMS said in February.
Unlike Medicare, the Veterans Health Administration 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 only covers antibody treatments that receive accelerated approval for patients participating in clinical trials. Eisai’s study is complete, meaning the overwhelming majority of seniors do not have access to the drug.
The attorney general said the decision puts older Americans living in rural areas at a disadvantage because clinical trials typically take place in larger cities far from small towns.
“It’s a tremendous physical and financial burden for Medicare beneficiaries to travel to the few research facilities that host the studies,” the attorney general said. “Patients, families and carers living in rural and underserved areas should have an equal opportunity to access treatment.”
The language of the letter is similar to letters sent to Medicare by lawmakers and House Senators in February.
Medicare has agreed to provide broader coverage of Leqembi if the treatment receives full FDA approval on July 6. However, the program for seniors still requires patients to participate in so-called “registries” that collect data about treatment. Brooks-LaSure promised Congress last week that these registries will not restrict access to treatment.
But Robert Egge, chief policy officer of the Alzheimer’s Association, told CNBC that the registries will restrict access despite Medicare’s promises. He said the association was not aware of any significant work that had been done to set up the registers.
According to Brooks-LaSure, private sector companies can now begin setting up the registers.
The attorney general said Alzheimer’s disease and other forms of dementia would cost $321 billion in 2022, placing a significant financial burden on state health insurance programs. Medicare and Medicaid will cover an estimated 67% of healthcare 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 accessible to people, Alzheimer’s is projected to reach a total cost of $1 trillion (in 2022 dollars) by 2050,” the attorney general said.
The letter was sent 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 Attorney General’s letter: “We are asking CMS to 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 facilities that host the studies.” “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 accessible to people, Alzheimer’s is expected to cost a total of $1 trillion (in $2022).” An earlier version inadvertently omitted parts of the quotation marks.
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