CMS National Coverage Determination May Worsen Health Inequities

April 11, 2022 - The CMS national coverage determination for the Alzheimer’s drug Aduhelm, or aducanumab, may fail to support health equity, as underrepresented populations may have limited access to clinical trial opportunities, according to an Avalere analysis. 

CMS recently finalized the national coverage determination, which states that Medicare will cover FDA-approved monoclonal antibodies that target amyloid plaque for Alzheimer’s treatment through a coverage with evidence development (CED) approach.

This means that Medicare can cover the drugs only in the context of CMS-approved or National Institutes of Health (NIH)-supported randomized controlled trials in hospital outpatient department settings. The draft memo also required trial participation to be representative of the national population with Alzheimer’s.

After CMS published the draft national coverage determination memo, the agency received praise from stakeholders for its decision to prioritize closing disparity gaps among people with Alzheimer’s.

However, stakeholders also noted that prior Medicare national coverage determinations that used CED were not successful in accurately including underrepresented populations.

To understand the potential impact of the national coverage determination on Medicare fee-for-service beneficiaries, Avalere projected the access that racial minorities will have to Alzheimer’s monoclonal antibodies clinical trial sites.

Alzheimer’s Disease Research Centers (ADRCs) will likely conduct clinical trials for the drug. Other hospital outpatient settings may also conduct trials, but the Avalere brief questioned how many hospitals serving underrepresented populations will be able and willing to participate.

ADRCs are typically highly concentrated in certain regions, such as coastal and densely populated areas, which may limit access to underrepresented communities. There are 33 ADRCs and four exploratory ADRCs across the country.

Among non-White beneficiaries with an early onset Alzheimer’s diagnosis, nearly eight percent do not have access to a hospital outpatient department in their county. Additionally, 88 percent of North American Native, 75 percent of Black, 61 percent of Hispanic, and 51 percent of Asian beneficiaries with early onset Alzheimer’s do not have an ADRC in their county.

A past Avalere analysis highlighted how the coverage determination requirements could also limit treatment access for rural beneficiaries.

The national coverage determination also stated that Medicare would cover monoclonal antibodies for beneficiaries who have a clinical diagnosis of mild cognitive impairment from Alzheimer’s or mild Alzheimer’s dementia.

This requirement may also worsen access for racial minorities, as individuals in minority populations are often underdiagnosed with early onset Alzheimer’s.

Avalere found that Black and Hispanic beneficiaries account for 9.2 percent of beneficiaries with early onset Alzheimer’s and mild dementia. However, these individuals make up 14 percent of beneficiaries with a more advanced Alzheimer’s diagnosis, suggesting that a portion of Black and Hispanic beneficiaries may not receive diagnoses for early onset Alzheimer’s.

This disparity in early Alzheimer’s diagnoses may create additional barriers for racial minorities when accessing and receiving Medicare coverage for the Alzheimer’s drug.

“The results showing proximity to potential trial sites and disparities in diagnosis rates raise questions about the expected ability to recruit trial populations that are that representative of the national population with AD (Alzheimer’s Disease),” the analysis stated.

Additionally, the findings raise questions as to whether CMS will be able to tackle enough trials in a timely manner to ensure all eligible beneficiaries gain access to the treatment.

Avalere noted that although the analysis highlights the potential effect on Medicare FFS beneficiaries, stakeholders should also consider how the CED approach could impact racial minorities in Medicare Advantage plans.

The FDA approved the use of Aduhelm for Alzheimer’s patients in June 2021, a decision that prompted varied reactions from the healthcare industry.

Likewise, the CMS national coverage determination received mixed reviews from stakeholders. AHIP applauded the agency’s decision to prioritize patients but emphasized the need for more clinical data on treatment efficacy.

Meanwhile, the Alzheimer’s Association criticized the draft, calling it discriminatory against patients with Alzheimer’s and stating that the coverage determination focused on an individual treatment rather than a class of anti-amyloid therapies.