by Robin Lasky
, Contributing Reporter | July 02, 2021
Like other drugs that have been developed for this purpose, the Aduhelm trials thus far failed to sufficiently demonstrate such cognitive improvement.
But in an interview with Bio Century, commissioner Woodcock defended the decision
explaining that despite insufficient data on clinical benefits to the patient there is solid evidence that the drug causes significant reductions of amyloid plaque in the brain which, as yet unproven, is sufficiently likely to result in a clinical benefit, making the drug “a very solid accelerated approval”.
Accelerated approval is a status the FDA can assign to drugs that “fill an unmet medical need” even though sufficient evidence of a clinical benefit is lacking based on findings of a surrogate endpoint, i.e., in this instance, amyloid plaque reduction.
Drugs identified for accelerated approval are then required to undergo a stage four trial in order to provide confirmation of a clinical benefit. If the trial fails to sufficiently confirm the necessary clinical findings, the FDA may revoke its approval.
Patrick Hope, Executive Director of the Medical Imaging and Technology Alliance (MITA), also hailed the decision. “The action taken today by the FDA will give patients and caregivers access to the first-ever Alzheimer’s disease-modifying treatment," he said in a statement. "Now, the Centers for Medicare & Medicaid Services (CMS) needs to act to update its outdated coverage and payment policies and provide patients with access to amyloid PET diagnostic drugs.”
According to Biogen, the maintenance dose per patient of Aduhelm is expected to cost $56,000 a year. Further, in order to monitor the effects of treatment and the occurrence of bleeding in the brain and other known dangerous side effects, patients taking Aduhelm require frequent brain monitoring with PET imaging.
CMS has the final say as to what extent Medicare coverage will be afforded for this treatment, but due to the lack of limitations prescribed by the FDA and intense industry lobbying, many fear that if decided incorrectly
, the overall cost of this course of treatment will place an unmanageable financial strain on insurance companies and the Medicare system.
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