People living with Alzheimer’s disease got good news this week: an experimental treatment has been shown to slow the disease by 27% compared with a placebo. This is the strongest evidence yet that a new class of treatments which remove amyloid plaques in the brain is key to progress in fighting the disease.
According to Eisai and Biogen, the companies that make the new treatment, the Food and Drug Administration (FDA) has committed to decide whether to grant broader access to the drug by January 6 of next year. But Medicare preemptively restricted access to these treatments. They must urgently revise this policy.
Around 6 million Americans have Alzheimer’s, and this number is expected to double over the coming decades. The disease devastates them and their loved ones’ lives. Several promising treatments target amyloid plaque in the brain, one of the early indicators of this devastating disease. Removing this plaque may transform the experience of people living with the early stage of the disease, as the promising new test results seem to confirm.
But Medicare created a policy earlier this year that will severely restrict access to this whole category of treatments. The new data highlights that Medicare’s restrictive approach comes at exactly the wrong time, just as hope swells around the most exciting medical advancements in Alzheimer’s in two decades.
Medicare’s clampdown stems from a deeper power struggle between Medicare and the FDA. The FDA has considerable flexibility in its governing statute and regulations, as Congress and advocates rightly demand faster and more drug approvals to meet the needs of an aging population. By contrast, Medicare is sclerotic and hidebound.
Historically, Medicare covers the cost of FDA-approved medicines for Medicare beneficiaries, including medicines granted accelerated approval under an FDA program providing faster review for medicines targeting untreated, serious conditions. But when FDA granted accelerated approval in summer 2021 to an Alzheimer’s medicine that was part of this new class of plaque-targeting treatments, the system broke down.
Critics raised alarm over the potential cost to Medicare if most beneficiaries qualified for treatment. Medicare imposed a lengthy review process and ultimately discarded its own norms by restricting access not only to that particular treatment, but to all future medicines in the same class. This policy now forms a barrier to patient entry, set intentionally high to drive down access.
Now, Medicare beneficiaries can only get these medicines by enrolling in clinical trials conducted in select universities and hospitals. Most of these centers are in urban areas, requiring rural Americans to drive long distances just to gain access to the trials. This restriction on access widens the disparity in Alzheimer’s treatment between rural and urban areas.
A study published in JAMA, found rural Medicare beneficiaries with Alzheimer’s spend more time in nursing homes, less time in the community, and die earlier than urban beneficiaries. Indeed, Medicare’s access restrictions hurt the very groups that the Biden administration claims to champion. Women, African Americans and Hispanics are more prone to Alzheimer’s, and would benefit the most from quick and reliable access to new treatments.
The news of promising results from one plaque-targeting treatment shows that Medicare must immediately revisit its restrictive policies. Consistent with prior practice, Medicare did not even establish how long data must be collected for or when it will reassess the data to determine if the drug modifies disease progression and can be covered outright without the need for a clinical trial. Of the 27 other therapies that have been covered with similar restrictions, only four have graduated since 2005.
The operation of clinical trials to collect data is resource intensive and burdensome for innovators, providers and patients alike, and given this week’s promising results for a similar drug, Medicare should reconsider these requirements. The agency needs to clearly define when it covers these medicines once approved — and how it will do so quickly and fairly. Without such reform, future FDA approvals will only lead to more bureaucratic turf wars, robbing patients and their families of precious time.
Government agencies should stick to their core responsibilities. The FDA should focus on the science to justify approval, and Medicare on ensuring appropriate insurance coverage. Medicare straying into FDA’s lane will bring nothing but despair to those suffering the ravages of this awful disease.