Medicare must clear patient access to Alzheimer’s treatments

The recent FDA approval of aducanumab fills a nearly two-decade gap since the last Alzheimer’s treatment was approved — and it moves talk of a therapy that actually slows disease progression from theoretical to reality.

But now the attention must turn to ensure that this drug — and the diagnostic tests — are accessible and affordable to those who need it.

Unfortunately, our nation’s healthcare system is not fully prepared, and barriers to access and early detection and care persist. Until patients no longer encounter systemic barriers to a timely diagnosis and access for disease-modifying treatments, the work is not over. The fight must continue and grow in urgency.

Most frustrating is the fact that current barriers to access aren’t due to obscure insurance company policies or complex, anti-patient utilization management rules — they’re due to Medicare. 

Consider assessments: A recent analysis of Medicare data suggests that Asian, Black, and Latino patients are more likely to receive a later dementia diagnosis than their white counterparts. Across all racial and ethnic groups, only a minority of all beneficiaries received a timely dementia diagnosis and comprehensive evaluation. The latest therapies — aducanumab included — are designed to work best when administered to patients at the earliest stages of memory issues. When it comes to administering cognitive assessments, Medicare’s guidance for health providers is opaque and needs improvement.

I am very concerned about access for patients such as those on Medicare fee-for-service without supplemental insurance — both for the treatment and for the diagnostic tests that clinicians will want to confirm presence of amyloid in the brain. These tests could include positron emission tomography (PET) scans, lumbar punctures, or, most recently, blood-based biomarker diagnostics. The most expensive of these tests, the PET scan, can cost more than $4,000, while far more affordable blood-based tests are not yet widely available.

The Centers for Medicare and Medicaid Services (CMS) do not cover these tests — but without them, Medicare patients can’t be prescribed aducanumab. Patients therefore would be forced to pay up to thousands of dollars out-of-pocket — on top of already expensive Alzheimer’s care — just to find out if they have a shot at the first treatment shown to slow the progression of the disease.

After 20 years of waiting for an Alzheimer’s treatment, CMS cannot be what obstructs access to this drug for patients, for whom every day matters.

Alzheimer’s is one of the most urgent health inequities of our time. Black Americans are two to three times more likely, and Latinos are 1.5 times more likely, to have Alzheimer’s disease than non-Hispanic whites, and by 2030, nearly 40 percent of Americans diagnosed with Alzheimer’s are projected to be Black or Latino.

Despite the staggering impact of the disease on people of color, it will be wealthier, mostly white patients who are able to pay out-of-pocket for tests to determine their eligibility for aducanumab — again leaving minority patients behind. In order to bring a true end to this disease and alleviate the challenges it poses for millions of families across the country, the lived experience of individuals in all communities and from all backgrounds must be considered. 

By 2050, the number of people age 65 and older with Alzheimer’s dementia is projected to reach 12.7 million. It is clear that the societal and economic impacts of Alzheimer’s are immense — the cost on the healthcare system in 2021 is estimated at over $350 billion — and will continue to grow exponentially without intervention. If drugs such as aducanumab are to have any benefit for patients, the healthcare system, and society, those drugs need to get into the hands of the people who need them most.

By not improving its focus on early detection and covering the diagnostic tests that allow a patient to be prescribed this new drug, CMS is letting economics define who can and cannot access the treatment.

Fully covering PET scans and other amyloid diagnostic tests for all Medicare beneficiaries would be a massive step forward in tackling this disease, and it would have a disproportionately positive impact on low-income patients and patients of color.

CMS must ensure that everyone, from every community and socioeconomic background, has access to needed therapies and services.

Additionally, because of the complexity of the disease, some physicians have already declared they will not prescribe aducanumab for their patients, believing the benefit does not outweigh the potential risk. Scientific bias is dangerous, potentially discriminatory and disrespectful to patients who have a right to participate in such decisions. No one can possibly care more about a patient’s life than the patient and his or her family. Joint consultation and patient decision-making must be at the forefront of the treatment decision.

This is only the beginning for innovation in future Alzheimer’s treatments and therapies. While our nation needs to address access issues for this latest therapy as soon as possible, let’s also think about future healthcare system readiness for the treatments and therapies of tomorrow.

When this first-in-class drug ultimately makes way for a best-in-class drug, our system must be ready. Patients and their families are counting on it.

George Vradenburg is the co-founder and chairman of UsAgainstAlzheimer’s.