With the news of a promising experimental treatment that slows the progress of Alzheimer’s disease, a wave of hope rushed through the country. But it also reignited frustrations with Medicare for a restrictive policy that could delay or limit access to the medicine even if it gets FDA approval.
Writing in FoxNews, Joe Grogan, a visiting senior fellow at the USC Schaeffer Center who directed the White House Domestic Policy Council under President Trump, explains how a bureaucratic turf war between government health agencies could prove the biggest treatment hurdle for people living with Alzheimer’s.
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.
FDA is expected to render a decision on accelerated approval for the new treatment by January—just three short months away. There is no indication that Medicare can adapt its coverage policy in this timeframe. Failing to do so would leave millions of seniors in the lurch.
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.
Let’s hope Medicare can reverse course before it’s too late. You read Grogan’s full article here.