aducanumab therapy

What Happens If Aducanumab Wins FDA Approval? It’s Complicated

By | January 22nd, 2021

If aducanumab — an experimental treatment that may slow the progression of Alzheimer’s — gets FDA approval, how will the healthcare system meet the anticipated spike in demand for Alzheimer’s diagnosis and therapy?

Even though the Alzheimer’s drug aducanumab has faced many twists and turns along its path to FDA approval, experts say that approval of Biogen’s drug, which targets amyloid plaques with the intention of slowing the progression of the incurable disease, remains possible. As it awaits its shot at approval by the FDA, experts grapple with the major challenges that may arise if and when the agency does approve the therapy: Some say it may lead to a surge of patients seeking care in an already burdened healthcare system, and trigger significant shifts in clinical and research practice. 

A panel of independent advisers said late last year Biogen failed to prove that aducanumab is an effective treatment for Alzheimer’s, but some people suggest there is reason the believe that the FDA may go against their advice. Meanwhile, other anti-amyloid therapies in the research pipeline have shown promise. As the approval of a new therapy may be on the horizon, practitioners who care for patients with memory problems are now raising the question of whether the nation’s healthcare system is prepared for the significant changes that may come. 

Dr. Erik Musiek, associate professor of neurology at Washington University School of Medicine in St. Louis, co-authored a recent article published in JAMA Neurology about some of the potential obstacles, such as the limited capacities of the nation’s memory clinics and the likely restrictive criteria of a new therapy. 

According to Musiek, approval of aducanumab or similar drugs may prompt people with memory problems, who have never sought treatment from dementia specialists, to seek diagnosis and treatment. The potential surge of patients may tax the capacity of the few academic memory clinics in the nation. 

“It could be a lot of people.” Musiek told Being Patient. “If the drug was approved tomorrow, our clinic and the existing memory clinics in St. Louis, and everywhere else would potentially be overwhelmed. We have to think of how to mobilize for that quickly.” 

“Our clinic has a six month wait as it is,” he added, “and that’s with no aducanumab.” 

Coping With a Shortage of Dementia Specialists

Musiek suggested there could be an added urgency for people to be evaluated by clinicians when aducanumab or a similar drug is available. After all, the symptoms of Alzheimer’s for some people on waiting lists could potentially progress to the point where they may become ineligible for the treatment. 

However, a separate report by the RAND Corporation estimated if a therapy that could slow the progression of Alzheimer’s was available in 2020, patients would have to wait an average of 18.6 months for diagnosis and treatment by dementia specialists. The researchers projected that roughly 2.1 million people may develop Alzheimer’s between 2020 and 2040 while they are on waiting lists. 

“Our analysis suggests that the U.S. health care system lacks the capacity to provide patients with access to treatment within a reasonable time frame, mainly because of constraints in access to specialists to diagnose patients and confirm treatment ineligibility,” the authors of the report wrote. 

“Addressing the capacity constraints may turn out to be as challenging as developing an effective treatment,” they continued, “as it requires solving a complex puzzle consisting of payment policy, regulatory requirements, workforce considerations, and capacity planning at the national and local levels, combined with awareness campaigns.” 

Experts Propose Potential Solutions To Meet the Challenges Ahead

According to Musiek, one potential solution could involve implementing more consistent methods of a dementia diagnosis. Primary care physicians may then be able to determine whether patients are eligible for therapy, alleviating the need for referring them to dementia specialists. However, Musiek noted that people with complex cases of dementia, including mixed pathologies or mimics of Alzheimer’s, would most likely still require a referral to a dementia specialist. 

Musiek also suggested that changes in reimbursement schemes for primary care physicians may grant them more time to assess dementia patients, which is critical as thorough evaluations are time-intensive. 

“We spend pretty long periods of time with [dementia patients],” Musiek said. “We’re afforded that luxury because of academia. Most of us do research and we don’t have to worry about keeping the lights on quite as much as if we were in private practice, or perhaps some other setting. If you’re a primary care doctor, under the current billing and reimbursement system, you just don’t have an hour to spend with every patient that has a memory concern.” 

As the nation faces a shortage of dementia specialists, Musiek hopes the advent of a treatment that may change the course of the disease would attract more aspiring clinicians to enter the field of Alzheimer’s. Currently, he said the limited options for treating Alzheimer’s is often frustrating not only for patients, but also for doctors. The approval of an effective treatment may provide much-needed hope, boosting the future workforce of dementia physicians. 

In the meantime, the demand for brain imaging including PET scans that detect beta-amyloid plaques would likely rise when an anti-amyloid therapy becomes available. While access to PET scans remains limited, especially for people living in rural areas, experts are optimistic that the emergence of new diagnostic tools such as blood tests could help fill the gap. 

Navigating the Likely Complex Guidelines of an Anti-Amyloid Therapy

The Alzheimer’s community have long hoped and waited for an effective treatment. But the authors of the JAMA article wrote that aducanumab and similar drugs would likely be restricted to patients with very mild symptoms of Alzheimer’s. Clinicians may then face the difficult task of explaining to patients with more progressed Alzheimer’s that the opportunity may have passed them by. 

“I’ve had this conversation with my patients who have more advanced disease, asking about [these drugs],” Musiek said, “and I have to explain [that they have] really not been shown to be effective in people that have moderate to severe disease, which is actually a lot of people. Many patients don’t go to the doctors until it’s pretty severe, or the doctors don’t notice until it’s pretty severe.” 

Once officials have released the criteria for a newly approved therapy, the authors said that government agencies, private insurers and advocacy groups should carry out public health initiatives to educate the public and help people manage their expectations.

They wrote that it is critical for practitioners in the field to plan wisely to uphold patients’ trust, ensure effective use of public resources, and continue building momentum in Alzheimer’s research as the approval of the first treatment that may slow the progression of Alzheimer’s could well be on the horizon. 

Contact Nicholas Chan at

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