The recent Aduhelm FDA approval debacle, unfortunately, has the potential to be a gut-punch to ophthalmologists in a couple of ways.
First, there’s the approval itself. While ophthalmologists have had to wait a decade for FDA approval of various treatments that were already being used in other countries, Aduhelm, an Alzheimer’s drug, won a relatively quick approval despite multiple questions about its efficacy. In fact, the FDA’s Peripheral and Central Nervous System (PCNS) Drugs advisory committee voted nearly unanimously against approval of Aduhelm. The panel said it saw a lack of efficacy in preventing cognitive decline. In a stunning turn, though, the agency went ahead and approved it anyway, based on the biomarker of amyloid-beta plaques.
Three of the panelists resigned after their input was apparently ignored. One of the panelists, Harvard University professor Aaron Kesselheim, MD, called it, “probably the worst drug approval decision in recent U.S. history.”1
Aduhelm’s second blow to ophthalmologists may prove to be more palpable: Despite having questionable efficacy, Medicare is expected to pay $56,000 for a year’s worth of Aduhelm. Of course, other treatments of rare diseases are expensive, but Alzheimer’s isn’t rare. By one estimate, if only a quarter of the U.S. Alzheimer’s patients used Aduhelm, it would cost the system $29 billion. For perspective, this amount represents 78 percent of Medicare’s total spending on Part B drugs in 2019, and is five times the FDA’s entire budget .2 Of course, if the drug were highly effective in patients, this probably would be worth it. However, as the panel noted, the efficacy is debatable.
What effect could this amount of spending have on reimbursements for other interventions, such as cataract surgery? CMS persists in lecturing surgeons about the need to be efficient and economize; it enacted a 15-percent reimbursement cut for cataract surgery in 2020, and that was without a $29-billion drug looming.
In the fact sheet CMS circulated to announce the 15-percent cut to cataract surgeons’ reimbursement, it stated, “The 2020 PFS final rule is one of several rules that reflect a broader Administration-wide strategy to create a healthcare system that results in better accessibility, quality, affordability, empowerment, and innovation.” If this is true, then it’s time for CMS to put its money where its mouth is and take a hard look at whether it’s worth bankrupting the system for a drug with so many questions about its true efficacy. CMS should begin the process of a National Coverage Determination on Aduhelm, to determine who benefits from it and who doesn’t, to make sure its precious funds are going to the right places. That’s how you create a health-care system that results in better quality and affordability.
— Walter Bethke
Editor in Chief
1. Biospace.com. https://www.biospace.com/article/3rd-fda-alzheimer-s-advisory-panel-member-resigns-over-biogen-approval/.