“If the FDA grants traditional approval, CMS is prepared to ensure anyone with Medicare Part B who meets the criteria is covered,” CMS administrator Chiquita Brooks-LaSure said in a statement.
Barriers to Coverage
According to the Alzheimer’s Association, nearly 7 million American seniors are living with Alzheimer’s disease, the most common form of dementia. It remains the fifth-leading cause of death among adults aged 65 and older.
Among patient advocates, the news about Medicare coverage for newer therapies is welcome. It could mean that more people will now be able to afford newer Alzheimer’s drugs as they secure full FDA approval.
One medication, Leqembi, could be fully approved by the FDA as soon as July 2023. Currently, it costs more than $26,000 annually, a price tag that keeps it far from reach for the vast majority of patients. The other FDA-approved therapy available is Aduhelm, which comes at a similarly high cost. Both have received accelerated approval by the FDA.
To be eligible to receive coverage for these Alzheimer’s treatments, patients will need the following:
- Medicare Part B,
- a diagnosis of early dementia or mild cognitive impairment caused by Alzheimer’s, and
- a health care provider and clinical team that take part in what is known as a registry, which is a health agency database where information regarding patient outcomes is tracked.
The Controversies Surrounding Alzheimer’s Treatment
Advocates, as well as some lawmakers and health care experts, are expressing concern on several fronts, however.
For example, the Alzheimer’s Association issued a statement arguing against the inclusion of registries in the coverage requirements.
“We remain concerned that the requirement of clinicians to register and enter data will create unnecessary hurdles,” the association stated.
Meanwhile, at least two lawmakers say that the CMS’ plan does not make clear how seniors who need this type of treatment will actually gain access to it. They are raising questions that CMS has not yet addressed regarding how the registry would work, including when it would go live and how patients would find out whether their doctor takes part in registries.
In their joint statement, they ask Brooks-LaSure to “either reconsider the coverage with evidence requirements for the Alzheimer’s treatments or to immediately begin preparing for a registry that is clearly defined and minimizes provider and patient burden.”
Still others point out that coverage of a drug such as Leqembi would mean increased spending for Medicare Part B, which in turn could mean higher Medicare Part B premiums for patients.