Some of the most exciting advances in science and medicine are happening in Alzheimer’s, a disease that is one of the greatest epidemics of this generation. Eli Lilly announced promising results last week for experimental amyloid-targeting drug donanemab. These clinical trial results showed that the drug can slow cognitive and functional decline for people with early-stage Alzheimer’s disease.
While not yet approved by the U.S. Food & Drug Administration (FDA), the clinical evidence suggests that Lilly will join Eiasi and Biogen as important new medicines for Alzheimer’s patients that can significantly slow memory-robbing disease.
Lilly plans to apply this quarter to the FDA for approval, which may lead to a regulatory decision later this year or in 2024. Eisai and Biogen’s Leqembi received accelerated approval from the FDA earlier this year and a decision on full approval is expected by July.
Despite the promising news, there is one challenge for the new Alzheimer’s drugs: limited insurance coverage due to stringencies at Centers for Medicare and Medicaid Services (CMS). The U.S. Medicare program for the elderly has denied routine coverage of anti-amyloid Alzheimer’s drugs. While the Department of Veterans Affairs found Leqembi’s clinical evidence compelling enough to cover the medicine, Medicare will only pay for anti-amyloid drugs granted accelerated approval by the FDA if patients are enrolled in a CMS-approved clinical trial. It is important that Medicare covers these new Alzheimer’s drugs.
While CMS has it wrong on the Alzheimer’s drugs, it is not likely to admit it. I expect the agency to subtly evolve their restrictions in light of new evidence, but not acknowledge any harm caused by questioning the judgment of the FDA, demanding redundant clinical trials that offered inequitable access to an FDA-approved treatment, and establishing a new precedent that creates a costly and unnecessary administrative burden.
CMS’s refusal to acknowledge FDA’s recommendations on Alzheimer’s drugs is not new, and it appears that CMS is exploring pilot programs and new policies that would apply the restrictive Alzheimer’s coverage model to other classes of drugs that earn Accelerated Approval or demand lowball prices to grant patients access to the most cutting-edge medicine.
CMS is treating Accelerated Approval as an incomplete or less scientific form of FDA approval, which appears to be part of a Biden Administration effort to establish price controls on new medicines that are outside the scope of those covered by the Inflation Reduction Act. This is counter to the interests of patients--in this case, the seniors that this agency was explicitly created to serve.
Understanding the long term value of a new treatment is incredibly important, so that drug manufacturers should be collecting data and gathering evidence over the life cycle of a medicine and payers should regularly review that information to understand if a therapy is delivering on its promise. There is no need to second guess the FDA or call into question the legitimacy of an approval pathway to gain leverage: Evidence, value, and price can be established through negotiated contracts between payers and manufacturers that include carrots and sticks based on real world outcomes.
The latest clinical trial from Lilly adds to the growing body of evidence that show that this new generation of anti-amyloid treatments is creating real value for Alzheimer’s patients by slowing cognitive and functional decline--welcome news for the millions who suffer from Alzheimer’s or serve as their caregivers.
We should celebrate the advances in science that are leading to revolutionary medicine. More than a decade worth of clinical failures in Alzheimer’s has shown that at every step we can learn more about the disease and potential treatments. This new generation of Alzheimer’s treatments represent a major step forward in helping patients with this terrible disease.
Rather than bickering over evidentiary standards for Medicare coverage, we need to give patients access so we can learn more about the disease and these treatments. We will ultimately benefit as we learn how to manage the disease and encourage continuous improvement in our ability to treat patients over time.
