ICER Final Report on Aduhelm’s Value and Cost-Effectiveness

On August 5, 2021, the Institute of Clinical and Economic review (ICER) released its final report on the cost and effectiveness of Aduhelm (aducanumab).(1) The first FDA-approved Alzheimer’s drug in approximately 20 years. The accelerated approval of Aduhelm has raised a lot of controversy around the drug’s clinical benefits, mostly due to discordant results of two almost identical, simultaneous phase 3 clinical trials— EMERGE and ENGAGE.

The ICER final evidence report pointed out that both randomized clinical trials have demonstrated reduction in beta amyloid plaques, one of the hallmarks of Alzheimer’s disease. However, EMERGE met its primary endpoint for the change in mean score on the Clinical Dementia Rating scale (CDR), while ENGAGE did not. Consistent secondary result trends were also observed, where EMERGE showed nominally statistical significance while ENGAGE did not. The report also raised concerns about ARIA (Amyloid-related imaging abnormalities) that can cause serious adverse events such as serious such as brain hemorrhages.

As a result, ICER ruled that the current evidence is “insufficient” to conclude that Aduhelm’s clinical benefits outweigh the risks.

Furthermore, ICER calculated that in order to be cost-effective, Aduhelm should cost about $2,950- $8,360 a year, which is almost a 90% discount from the drug’s current annual price of $56,000.

Although a promising new treatment for Alzheimer’s patients, there are a few clinical and logistical considerations for plan sponsors when it comes to coverage:

• Diagnostic tests for Alzheimer’s disease include PET scan, lumbar puncture and MRI, which are expensive imaging tests.

• When a patient develops an ARIA, the patient require additional MRI monitoring, which also incurs extra costs.

• Certain large health systems such as Cleveland Clinic, Mount Sinai and the VA have decided to not prescribe Aduhelm(2) at this time, which creates access limitation for patients at these systems.

Although Aduhelm’s FDA approval has been controversial, it is undeniable that there is a tremendous unmet need for a new disease-modifying drug such as those that target beta amyloid plaques. As patients with Alzheimer’s and their caretakers are more aware of the benefits and risks of Aduhelm, the demand for the drug might become higher. Health plans and health systems should therefore be prepared for thorough discussion regarding drug’s medical coverage and the logistics around it.