This article was originally published in RealClearHealth on August 23, 2022.
By Joe Grogan
Approximately six million Americans are living with some form of Alzheimer’s, a number poised to double over the coming decades. Citizens are living 30 years longer than a century ago, primarily due to incredible advances in the field of medicine. Future opportunities are limitless if we foster an environment that rewards rather than discourages innovation. Unfortunately, that’s not what our leaders in Washington are doing.
People living with early-stage Alzheimer’s disease have more reason for hope than ever. FDA is currently reviewing several promising new treatments that target amyloid plaque in the brain, one of the early indicators of this devastating disease. Yet patients may not be able to access these medicines even if FDA approves them. The Centers for Medicare & Medicaid Services (CMS) created a policy earlier this year, based on evidence from one treatment, which will severely restrict access to the treatments. With new data imminent, the agency should update its guidance to avoid delaying access to life-changing therapies.
Alzheimer’s disease has tremendous effects on both the person living it with it as well as their loved ones. It is hard to understand CMS’s rationale in restricting access just as hope swells around the most exciting medical advancements in Alzheimer’s in two decades. The move reflects a deeper power struggle between the FDA, which has swelled with flexibilities in regulation and statute as Congress and advocates demand faster and more drug approvals, and a sclerotic, hidebound CMS, charged with determining patient eligibility for reimbursement for two of the largest healthcare programs in the country: Medicare and Medicaid.
Historically, CMS covers the cost of FDA-approved medicines for Medicare beneficiaries. This includes medicines granted accelerated approval, an FDA program initiated in 1992 to ensure faster review for medicines that address serious conditions which fill an unmet medical need.
But when last summer FDA granted accelerated approval to an Alzheimer’s medicine that was part of a new class of treatments targeting amyloid plaques, critics raised alarm over the potential cost to Medicare if most beneficiaries were to qualify for treatment. CMS initiated a lengthy review process and ultimately broke with norms by restricting access not only to the new medicine, but to all future medicines in the same class.
Now, Medicare beneficiaries can only secure access to these medicines by enrolling in certain clinical trials conducted in academic centers and hospitals around the country. Most of these centers are in urban areas, requiring long drives by rural Americans to gain access to the trials. Limiting access in this way exacerbates disparities in Alzheimer’s treatment in rural vs urban areas; a study published in JAMA found that rural Medicare beneficiaries with Alzheimer’s spend more time in nursing homes, less time in the community, and have shorter survival than their urban counterparts. CMS’s policy is a barrier for entry set intentionally high to drive down access.
With two new medicines under FDA review, CMS must clearly define how it will provide coverage for these medicines should FDA approve them—and articulate how it will provide that coverage quickly. Without this guidance, FDA approval is sure to trigger more bureaucratic in-fighting that will rob patients and their families of the most precious commodity they have: time. CMS’s policy restricts access to care for a groundbreaking class of therapies without considering their individual merits. Ironically, considering all of the Biden Administration’s emphasis on health disparities, women, African Americans, and Hispanics are more likely to develop Alzheimer’s and are therefore harmed most by such restrictive coverage policies.
Capitol Hill is only adding to the challenge with the so-called Inflation Reduction Act of 2022. The bill’s artificial government-set mandates and penalties will divert financial resources from research and development, with even the most conservative estimates from the Congressional Budget Office suggesting losses of innovative therapies as a result. And when it comes to Alzheimer’s disease, CMS’s actions create more uncertainty and risk by narrowing the path to market.
Government agencies should stick to their core responsibilities: FDA should focus on the science to justify approval and CMS on coverage. CMS’s straying into FDA’s lane hurts the patients they should be helping. Every day CMS fails to revise its Medicare reimbursement policy is another day of despair for those suffering the ravages of deadly diseases.
Joe Grogan is a visiting senior fellow at the USC Schaeffer Center and served as director of the White House Domestic Policy Council under President Donald J. Trump. He consults with pharmaceutical companies including those working on Alzheimer’s treatments.