The June 2021 announcement that Aducanamab –known by its shelf name Aduhelm™ -was granted FDA-accelerated approval as a treatment for Alzheimer’s disease created a flurry of excitement in families whose loved ones have been diagnosed with the terminal disease.
Aduhelm is considered the first therapy to demonstrably remove amyloid plaques, one of the notorious primary troublemakers responsible for initial cognitive decline in Alzheimer’s disease.
Optimism has since waned as the realities of the drug are further scrutinized and publicized. Troubling to many was learning that the FDA overruled recommendations made by its own advisory panel members, who were almost unanimously against approving the controversial drug.
“Although the controversies over the aducanumab have several components,” reported Mike Terry of life science publication Biospace, “this issue of beta-amyloid clearance is a central one.” Terry continued, “The FDA’s accelerated approval—which requires a post-market study to prove efficacy—was based on a ‘surrogate endpoint’ that the drug cleared beta-amyloid, not on slowing cognitive decline.”
Label Change
The initial Aduhelm label stated that the drug was, “indicated for the treatment of Alzheimer’s disease,” which experts criticized as too broad a use. July 8, the FDA updated the drug’s label to use for “mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.”
Aduhelm In Action
Because Aduhelm is only suitable for patients with early-stage Alzheimer’s, the signs of which can often be overlooked by loved ones, early intervention and drug therapy may be more challenging. And of the two diagnostic tests that can confirm the disease (spinal tap and PET scan), only the former has been reported as approved for insurance coverage and is the more invasive of the two.
Aduhelm also requires intravenous administration every four weeks at an infusion center, which may be an additional barrier and is dependent upon transportation, caregiver support, and scheduling. But most troubling, care advocates express, is its cost –$56,000 per month.
Public Opportunity for Comment
On July 12, federal officials announced they are seeking a national coverage policy for Aduhelm, which is expected to take approximately a year. The Centers for Medicare and Medicaid Services (CMS) will accept public comments through August 11 on how this coverage should be detailed. A draft decision is expected by January 12, 2022, and a finalized policy is expected by April 12, 2022.
“Alzheimer’s is a devastating illness that has touched the lives of millions of American families, and as CMS opens our National Coverage Determination analysis, we invite interested stakeholders to participate,” said CMS Administrator Chiquita Brooks-LaSure.
“We want to consider Medicare coverage of new treatments very carefully in light of the evidence available. That’s why our process will include opportunities to hear from many stakeholders, including patient advocacy groups, medical experts, states, issuers, industry professionals, and family members and caregivers of those living with this disease.”
For Families
Many questions remain about Aducanumab/Aduhelm’s practical integration into the daily lives of the more than 500,000 people newly diagnosed with Alzheimer’s disease each year. We’ve compiled a number of resources below to help families become educated about the drug, its application, and its future.
Alzheimer’s Association Webinar on Aducanumab
5 Things to Know About Aducanumab (Aduhelm)
U.S. Food & Drug Administration BLA Accelerated Approval Document
Centers for Medicare and Medicaid Services National Coverage Press Release
Aducanumab Saga Continues as FDA Committee Members Resign Over Approval
Angel Companions dementia care training –ALZ’smart is recognized by the Alzheimer’s Association for incorporating evidenced-based Dementia Care Practice Recommendations in the following topic areas: Alzheimer’s and dementia, person-centered care, assessment, and care planning, activities of daily living, and behaviors and communication.