Jeffrey L. Cummings
As a neurologist with more than 30 years in the field of Alzheimer’s disease, I have had many heartbreaking conversations with patients and their loved ones. More than six million people in America are living with Alzheimer’s disease, and that staggering number is expected to double within the next 30 years unless there is a change.
However, I am more optimistic about that change and physicians’ ability to slow the course of this devastating illness than I have ever been in the past.
Until 2021, no new treatments were approved for Alzheimer’s since 2004, and none of the drugs approved before 2021 slowed the disease.
Since 2021, the FDA has approved two disease-altering treatments (aducanumab/Aduhelm and lecanemab/Leqembi), and more are nearing clinical trial completion and FDA review.
The pace of advancement is accelerating. However, benefiting people living with Alzheimer’s disease depends on their having coverage for these treatments and access to diagnosis and treatment. Unfortunately, that process has been much slower.
Recently, after 10 years of requiring clinical trial participation for greater coverage, the Centers for Medicare and Medicaid Service has proposed lifting the one-scan-per-lifetime limit on amyloid PET imaging critical for diagnosing and tracking the progress of Alzheimer’s disease. This change is vital to the identification and diagnosis of individuals who may benefit from treatment with the newly approved treatments.
For the first approved agent, Aduhelm, participation in a clinical trial was required for Medicare coverage. Since no clinical trials exist in the United States, only those who can afford the out-of-pocket costs of the drug have access.
For the newest FDA-approved therapy, Leqembi, access barriers remain. Medicare requires participation in a clinical registry before allowing coverage. Doctors must submit patient data into a clinical registry approved by Medicare.
While there’s nothing wrong with collecting more information, Medicare has never required registries before as a condition of coverage for the intended use of medicines that have FDA approval.
And there are more questions about this registry than answers, such as whether there will be costs involved, possible limits on eligible Medicare beneficiaries, and exactly how this data will be collected and protected.
Medicare has turned down requests to reconsider its coverage decision for Leqembi, despite the completion of large clinical trials and receiving traditional approval from the FDA, and that the request came from the nation’s neurologists through the American Academy of Neurology.
Because the treatments are approved for use on people in the early stages of illness, delayed access means more people progress and lose the opportunity to qualify for treatment. As more than 2,000 Americans transition from mild to moderate Alzheimer’s-related dementia each day, this tragedy multiples rapidly.
The distressing fact is that there is still a harmful dichotomy between the treatment of Alzheimer’s patients and the treatment of Americans afflicted with other diseases. Medicare covers all other FDA-approved drugs prescribed for their approved uses without the kind of access barriers we’re seeing applied to Alzheimer’s treatments.
This makes little health or economic sense given that there are already more than six million Americans with this disease, projected to more than double by 2050. It is costing our nation $350 billion, not to mention 18 billion hours of caregiving each year.
The lack of alignment between science and access is doing serious harm in multiple respects.
Younger Alzheimer patients (those under age 65) depend on private insurance to reimburse drug costs. Some private insurers are refusing to cover Leqembi at all.
We know Alzheimer’s disease can take years to manifest, so diagnosing and treating people younger than 65 may yield significant benefits.
Our leaders must address this dilemma with the urgency that people living with Alzheimer’s and their families require.
We are continually compiling data demonstrating the effectiveness of these treatments and how best to give them safely in clinical practice. We are learning about their significant value in slowing disease progression and allowing patients more time to live independent, fulfilling lives.
Broadening access to current treatments would enhance our knowledge base and lead to improved therapies.
If the scientific experts at the FDA determine that a newly developed treatment can help us progress in the battle against this devastating disease, then Medicare shouldn’t stand in the way of patients benefiting from it.
Jeffrey L. Cummings is a professor of neurology at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University.
