The Alzheimer’s Association slammed the Centers for Medicare and Medicaid Services for its decision last week to restrict coverage of Aduhelm, the Food and Drug Administration-approved drug to treat Alheimer’s disease.
“People living with MCI, Alzheimer’s disease and other dementia deserve the same access to therapies given to those living with other conditions like cancer, heart disease and HIV/AIDS,” Azheimer’s Association President Joanne Pike, Dr.P.H., said in a statement. “They deserve the opportunity to assess if an FDA-approved treatment is right for them.”
On Thursday, CMS announced that Medicare will cover the controversial Aduhelm drug only for patients participating in clinical trials, despite the FDA approving it for approximately 1.5 million Americans.
Although the Alzheimer’s Association acknowledged that CMS has expanded the number of locations for clinical trials, it argued requiring patients to take part in a trial is an unnecessary barrier that patients seeking other FDA-approved drugs don’t encounter. Alzheimer’s Association Chief Science Officer Maria Carillo, PhD, called the decision a “step backward for families facing Alzheimer’s Disease and expressed concern about future research into the disease.
“Years of increased research funding has led to more progress and innovation than ever before, but today’s decision may halt this progress as developers question if there is a pathway forward to coverage,” Carillo said in a statement.
CMS said it based its decision on 10,000 stakeholder comments and more than 250 peer-reviewed documents. It also said the decision was consistent with use outlined on the FDA label.
“Alzheimer’s disease is a highly destructive illness that affects millions of Americans and their families,” CMS Administrator Chiquita Brooks-LaSure said in a press release. “CMS has a responsibility to ensure that people with Medicare have equitable and appropriate access to therapies that are reasonable and necessary for use in the Medicare population.”
The FDA approved Aduhelm last year amid a flurry of controversy. Many physicians argued there was not enough persuasive evidence to support its approval. Cost could have also played a role in CMS’ recent decision. Several other Alzheimer’s drugs are in the FDA pipeline as well and Medicare has indicated it will cover them the same way it covers Aduhelm. Medicare raised premiums and deductibles this year to cover rising healthcare costs for seniors and to increase reserves to pay for Aduhelm.