Most Medicare beneficiaries could be blocked from accessing the first-of-its-kind therapy for Alzheimer’s disease, if a proposed rule goes into effect.
Only patients who are enrolled in a qualifying clinical trial will have their treatment covered, according to the Centers for Medicaid and Medicare Services’ proposed national coverage determination. As written, it would limit access to all treatments – current and future – in this class. It’s a devastating blow to the Alzheimer’s and dementia community, who is concerned about being denied a newly approved medication, as well as medications that have yet to be approved after years of waiting for disease-modifying medications
Of the 6 million Americans estimated to have Alzheimer’s disease, most are older than 65 and are insured through Medicare. The FDA approved aducanumab in 2021 on an accelerated schedule because of its potential to address the underlying cause of Alzheimer’s disease. It is the only monoclonal antibody treatment currently approved, though others are in late-stage clinical trials.
Snubbing Communities of Color
Anticipation surrounding a targeted Alzheimer’s treatment has been building for years, especially among communities of color. African American and Hispanic people are more likely to develop Alzheimer’s disease. They are also more likely to have a missed diagnosis or be diagnosed in the later stages of the disease, when compared to non-Hispanic white populations.
Despite facing a higher burden of disease and worse health outcomes, people from communities of color are historically underrepresented in clinical trials. The proposed national coverage determination could further the divide by making it even harder for minorities to access treatment.
The location of clinical trials also slights another group of patients – those in rural communities. Clinical trials are most often conducted at academic medical centers in urban cities. This makes it hard for patients who rely on a caregiver or reliable transportation to participate. Beyond these existing challenges, the proposed rule further narrows the pool of potential sites for clinical trials associated with medications in this class.
The proposal’s long-term access implications are a concern, especially for patients from communities of color who are disproportionately impacted by Alzheimer’s disease and underrepresented in clinical trials.
Progress against Alzheimer’s disease and related dementias is slow, but better outcomes are possible with early diagnosis and treatment. The proposed rule undercuts both the Food and Drug Administration and health care providers’ roles in this effort.
The proposed coverage plan diminishes the FDA’s authority to determine the safety and efficacy of drugs. It also limits providers’ ability to prescribe the treatment of their choice. The net effect is a narrowing of already limited treatment options.
Time to Act
In short, CMS’s proposal restricts who could benefit from approved disease-modifying treatments today, and essentially blocks coverage of an entire class of future treatments designed to help older adults facing this devastating disease.
CMS will receive public comments on the proposed determination through February 10. A final decision is expected in April.