Aduhelm - The Path Forward

The CMS decision regarding Aduhelm’s coverage policy is expected to become available in the next few weeks. This is one of the most anticipated CMS decisions in recent years. I’m not going to rehash what has led to this being so highly debated as that has been thoroughly covered and addressed; instead, I’m going to focus on the future.

There is a lot at stake with this decision. Alzheimer’s Disease (AD) is a devastating disease that not only affects the patient, but it also has the potential to impact the entire family. Witnessing some of my family members go through AD/Dementia, and seeing others serve as caregiver, was heartbreaking. It is very clear after reviewing hundreds out of the thousands of comments left during the comment period that this issue is very personal for many people, especially for those who have been affected by this horrendous disease. Aduhelm, though far from a perfect drug, offers hope in a disease state where hope is in very short supply. In addition, companies that have a beta amyloid product in development have collectively spent thousands of hours to get to this stage, and there are billions of dollars at stake for pharma manufacturers. The CMS decision can undermine all of these efforts as well as take away hope from a community that desperately needs it.

While I think it is imperative to objectively analyze what happens with Aduhelm, it is far more valuable and important to develop a path forward. Given the rapid scientific advances that have been made in the last few years, CMS and FDA are very likely to find themselves in a similar situation unless proactive measures are taken to help ensure a different outcome. I fully realize it is nearly impossible for CMS and FDA to predict the future, but collaboration and a proactive mindset are integral to developing a solution. Wasting valuable resources on lobbying or advertising will not help next time a similar situation arises. How do the FDA and CMS account for instances where the science may be ahead of guidelines and regulations? How will payers develop coverage policy for therapies with similar dynamics? I do not have the answer. However, I hope that CMS and the FDA closely scrutinize this situation, extract key learnings, and move forward in a collaborative manner that will ensure that the next time, patients are not left in limbo or given false hope. For some conditions, all patients have is the hope of a promising therapy that may change the course of their disease, which is why it is imperative to set aside differences and strive towards a common goal of finding a viable solution. Health equity and being patient centric are universal goals across healthcare. If those goals are real, then we owe it to patients to come up with a solution.