3 questions providers must ask themselves about Aduhelm’s approval

By Nick Hula, senior analyst

This moment is undeniably historic, but not without controversy. In light of this controversy, I think it's helpful to define what this drug is, and what it is not.

Aduhelm is the first FDA-approved disease-modifying therapy for Alzheimer's disease–the sixth-leading cause of death in the United States. It will benefit certain patient early in their disease progression.

This drug is not a silver bullet. The FDA approval is conditional upon Biogen conducting a large post-approval, Phase 4 confirmatory study to prove Aduhelm's ability to slow cognitive decline in patients. The health care industry still has a long way to go to improve the lives of the millions of Americans living with this disease today and in the future. This is a starting point, not a finish line.

What does this mean for the future of Alzheimer's treatment?

This decision certainly provides a boost to the amyloid approach to Alzheimer's treatment, an approach that has met with repeated failures for more than a decade. Other drugs in the pipeline targeting this biomarker, such as Eli Lilly's Donanemab, can certainly expect a boost in their prospects after FDA approved Aduhelm for clearing a relatively low bar for clinical efficacy.

This approval also signals hope that the 2020s could be a historic decade for advancements in Alzheimer's treatment. Given the FDA's clear appetite for treatments, combined with the Biden administration's proposed funding for an Advanced Research Project Authority for Health and the industry's improving understanding of the disease's pathology, it's not unrealistic that we could have multiple disease-modifying therapies on the market by 2030.

What does this mean for providers?

This news should serve as a wake-up call for health care leaders across the country: We need greater investment in memory care.

In the days leading up to the FDA decision, much of the industry chatter revolved around the access barriers patients would face in event of approval. Put plainly, most provider organizations lack the infrastructure needed to capitalize on Aduhelm.

Providers should be asking themselves the following questions:

1. Do we have the necessary infusion, imaging, and specialist capacity to meet increased demand?

   Some markets won't have infusion capacity to satisfy the demand for Aduhelm right away. A RAND analysis estimated that average waiting times could even be as high as 18 months, during which some patients could deteriorate to the point that they are no longer eligible for the drug. Some organizations, such as Dent Neurological Institute, are already considering extending hours, adding infusion capacity, or building new infusion facilities over coming months to meet demand.

   In addition, before a patient begin receiving Aduhelm, they must receive a PET scan to identify the presence of amyloid plaque, followed by regular MRI scans to monitor for side effects. This could strain imaging capacity and drive up total costs of care.

   Finally, in many markets, demand for memory care already far surpasses supply. With the introduction of the Aduhelm, demand for diagnosis, treatment, and care management is set to skyrocket.

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3. Can we reach patients in an equitable manner?

   Aduhelm's imaging and infusion capacity requirements create significant access barriers. Patients living in rural areas may be unable (or unwilling, given the drug's unclear clinical benefit) to drive or fly hours every month to clinics that can administer Aduhelm. Even individuals who live closer to care sites may not be able to find a loved one or caregiver who can take time off work to transport them on a regular basis.

   Financial access will also be a concern. It is still unclear whether payers will be willing to cover the drug given the uncertainties around clinical benefit.

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5. Do we have a sustainable model for memory care?

   From a financial perspective, the most successful organizations barely break even on memory care. The costs associated with managing Alzheimer's disease far outweigh potential revenue, even with the reimbursement associated with this new treatment. Organizations must improve their population health efforts and engage patients and their loved ones in reducing costly episodes of care such as falls and unnecessary ED visits.