Biogen’s Aduhelm: An Update on the Commercial Rollout

The Food and Drug Administration’s (FDA’s) approval of Biogen’s Aduhelm (aducanumab) on June 7, 2021, stirred controversy. Hailed as a breakthrough in treating Alzheimer’s disease, the drug targets the buildup of amyloid beta plaques in the brain, which are thought to be a driver of the disease. Yet there remains a question of whether reducing plaque buildup improves patient memory or cognitive functioning, or addresses other behavioral disruptions associated with the disease, such as agitation, aggression, psychosis, depression, and apathy. Data from late-stage studies with aducanumab, lecanemab, and donanemab do appear to show a correlation between the degree of amyloid reduction and clinical outcomes.

While media attention has faded, the core question remains: Is the drug clinically effective? Answering that question is Biogen’s obligation, since the company was required by the FDA to do a confirmatory study.

In the meantime, most of my peers in academic settings are in the same boat. In my experience, most of them are in a holding pattern. We haven’t started using the drug on any commercial patients, although we do have a pool of people who have expressed interest in infusions once their insurance coverage is cleared. There is an increased urgency to move a few patients forward to test the waters. From what I hear from around the country, there have been at most between 10 and 20 commercial usages of the drug so far at any one center.

At my center, one person has said he has the means to pay for his wife’s treatment, but that he wanted to know whether the insurance approval would be retroactive when it comes. The truth is, we don’t know.

Will Insurance Cover Biogen’s Aduhelm?

Clarity on insurance coverage is the key. The Centers for Medicare & Medicaid Services (CMS) has yet to make a national coverage decision (NCD), which will be crucial. In New York, the state Medicare operation has said they won’t cover it until there is an NCD. The same holds true for Blue Cross-Blue Shield and other large commercial insurers, which still consider the treatment experimental.

One possibility that has been raised is that the CMS could issue a Coverage with Evidence Development (CED), which essentially would permit reimbursement if the drug were used in some sort of well-defined clinical trial or data collection situation. That would provide an opportunity for a large study of the real-life use off aducanumab. If the data collection route was chosen, results would have to be based on biomarkers much more than on clinical outcomes because the raters of those clinical outcomes probably would not have a very sophisticated level of training in that area.

In a way, it would have been wonderful to start with a broad clinical trial or data collection program instead of waiting for broad commercial availability through coverage. Starting that way also would avoid our current holding pattern when other drugs like aducanumab — gantenerumab, lecanemab, and donanemab — become available. Currently, many suspect that those drugs will head down an accelerated approval pathway like aducanumab’s based on their ability to lower amyloid.

A recent letter from several leaders at the FDA to the New England Journal of Medicine laid a better path for possible future approvals based on biomarker engagement while we await clinical outcomes.

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About Anton Porsteinsson

Dr. Anton Porsteinsson is the Director of the Alzheimer’s Disease Care, Research and Education Program at the University of Rochester, New York. He also serves as the William B. and Sheila Konar Professor of Psychiatry, Neurology, Neuroscience, and Medicine. Dr. Porsteinsson is board certified in psychiatry with added qualifications in geriatric psychiatry. He has clinical and research interests in both the cognitive deficits and behavioral changes associated with dementia. Dr. Porsteinsson is active in clinical research with an interest in novel pharmacologic agents in the treatment of Alzheimer’s disease and other dementias.

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This healthcare industry article is adapted from a GLG teleconference. If you would like access to events like this or would like to speak with healthcare industry experts like Anton Porsteinsson, or any of our approximately 1 million Network Members, contact us.

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Complete Questions Asked during the Teleconference

• Can you define your current practice, research, and patient population, including the percentage of patients eligible for Aduhelm vs. who that are likely to start on the drug in the next year?
• Have patients expressed interest in paying out of pocket for Aduhelm to initiate therapy before there’s a way to obtain payor coverage?
• Do you anticipate dosing any patients on commercial Aduhelm before the end of 2021, or is your institution more likely to wait until CMS has worked out the NCD process currently underway?
• If CMS’s NCD results in a Coverage with Evidence Development (CED) output, how could a CED impact patient access, prescriber sentiment, or other practical issues relating to getting Aduhelm to eligible patients?
• What are the most practical, real-world impacts of a potential CED stemming from the NCD process?
• Several companies presented new data at the AAIC conference last month. Can you touch on the updates for Biogen and Ionis’s BIIB080, Athira’s ATH-1017, Cassava’s simufilam, and Cortexyme’s atuzaginstat?
• Given the controversies around the development of Cassava’s simufilam, what is your objective assessment of the drug, the underlying science, and the company’s approach towards simufilam’s development pathway?
• What are your thoughts on the Cortexyme data for COR388, or atuzaginstat, that were reported at AAIC 2021?