National Coverage Determination May Limit Access to AD Treatment

CMS has released a national coverage determination draft for the Alzheimer’s drug, Aduhelm or aducanumab, but coverage limitations in the draft may create access to care challenges for seniors with Alzheimer’s disease if the draft is finalized, according to an Avalere analysis.

The 2020 Medicare Part B FFS claims informed the researchers about the number of beneficiaries with an Alzheimer’s disease diagnosis or a mild cognitive impairment. The Master Beneficiary Summary File identified relevant beneficiaries who required rural healthcare. 

Additionally, the CMS list of Medicare outpatient hospital providers helped the researchers map out beneficiaries’ access to hospital outpatient departments.

Using these data, the Avalere researchers found that the CMS coverage with development national coverage determination draft—as it stood in March 2022—would restrict access to the Alzheimer’s drug based on its hospital outpatient department setting requirement.

The draft does not address the portion of patients with an Alzheimer’s disease diagnosis who do not have access to a hospital outpatient department. Less than one in ten Medicare fee-for-service beneficiaries who have Alzheimer’s disease or mild cognitive impairment (seven percent) do not have access to a hospital outpatient department in the same county.

The researchers specifically highlighted patients in rural areas who often face access to care problems. Access to hospital outpatient departments is no exception. 

Seven out of ten fee-for-service Medicare beneficiaries with Alzheimer’s disease who require rural healthcare have access to a hospital outpatient department within their own counties, leaving a little less than a third of the populace that may not have access.

However, the presence of hospital outpatient departments is not enough to establish access to care for a population. The researchers noted that not all hospitals will have the capacity to carry out clinical trials, even those with hospital outpatient departments.

One type of facility that Avalere researchers expected to see hosting clinical trials were research centers dedicated to Alzheimer’s disease. 

However, certain areas of the US—particularly the midwest—are devoid of access to Alzheimer’s disease research centers. As of March 2022, there were 33 Alzheimer’s disease research centers and four exploratory Alzheimer’s disease research centers nationwide. They were spread across 26 states.

Eight out of ten fee-for-service Medicare beneficiaries do not have access to an Alzheimer’s disease research center in their home counties. Less than one percent of patients who require rural healthcare have an Alzheimer’s disease research center in their counties.

These National Institutes of Health centers of excellence are already prepared for clinical trials such as those that the national coverage determination would require, including trials for the manufacturers of treatments similar to Aduhelm.

CMS began the Medicare coverage determination process for Aduhelm in July 2021. At the time, one of the primary concerns related to access to care was the high price tag. Medicare Part B premiums saw a record-breaking spike in 2022 due to CMS setting aside contingency reserves for the Alzheimer’s drug. The drug’s cost later dropped from $56,000 to $28,200.

The drug has experienced a controversial reception in the healthcare industry at large. Initially, the Food and Drug Administration (FDA) approved Aduhelm in June 2021, although some experts remained skeptical about the drug’s efficacy. A month later, the administration withdrew its approval for the drug. 

Since then, CMS proposed to cover the drug through a national coverage determination through coverage with evidence development. The agency is expected to finalize its decision on whether or not Medicare will cover the drug by April 11, 2022.