In early June, the Food and Drug Administration (FDA) approved the use of Aduhelm (aducanumab) to treat patients with Alzheimer’s disease — the first drug therapy in 18 years to receive approval.
The approval is surrounded in controversy, however. In particular, much reporting on Aduhelm has centered on its cost and concerns about its efficacy and side effects.
Assisted living and memory care operators are optimistic about the potential Aduhelm will have on the quality of life for residents under their care. But providers speaking with Senior Housing News acknowledged the announcement raises more questions than answers:
— Will it be effective for residents living with advanced stages of the disease?
— Will the cost of the treatment make it prohibitive for many assisted living residents?
— Will senior living providers face complicated health monitoring and potential liability concerns related to residents on the drug?
— Could approval of the drug be revoked if it does not prove to be effective on a larger scale?
Assisted living and memory care operators are doing their due diligence to provide as much information as possible for residents and their families to make the decision to administer Aduhelm, once the drug becomes widely available, Seasons Living President and COO Dan Williams told Senior Housing News.
The Lake Oswego, Oregon-based company operates standalone memory care communities in Arizona, California, Kansas, Missouri and Oregon, and has a pipeline of upcoming facilities in California and Texas. Williams acknowledged that his initial reaction to the FDA announcement was positive, but as more became known about the approval process and the limited testing of Aduhelm, that optimism was tempered.
“[Aduhelm] may not be as good as we think,” he said.
A controversial approval process
Much of the controversy surrounding Aduhelm centers around the process by which the FDA approved the treatment.
The agency used its accelerated approval program, through which drug companies can request fast track approval designation at any time during the development of a drug, in order to fulfill an unmet medical need. The FDA authorized 53 new drugs for use under the program in 2020.
Under the program’s guidance, drug companies must still conduct further studies to confirm the anticipated clinical benefit, known as phase 4 confirmatory trials. If these trials confirm a drug has a clinical benefit, the FDA grants traditional approval. If the trials do not prove this, the FDA has regulatory procedures in place that could lead to removing the drug from the market.
Aduhelm is an infusion treatment that attacks beta-amyloid plaque buildup in Alzheimer’s patients, which is believed to damage communication between brain cells and hasten cognitive decline. In its announcement, the FDA noted that it is “reasonably likely” the drug provides a benefit for Alzheimer’s patients, and ordered Biogen to conduct a post-approval study to determine its efficacy.
But the approval runs counter to concerns of an 11-member panel of independent advisors to the FDA over the drug’s effectiveness. Last November, 10 of the 11 panel members voted against approving Aduhelm for use, noting that the evidence provided was insufficient to demonstrate substantial benefits.
In the wake of the FDA’s approval, three members of the advisory panel resigned in protest.
Neurologists with extensive experience treating Alzheimer’s patients contend that Aduhelm’s approval will knock proven drug therapies such as galantamine — an oral medication approved by the FDA in 2003 — out of favor. Additionally, reducing beta-amyloid plaque alone is not enough to treat Alzheimer’s, neurologist Sam Gandy wrote in an op-ed on Stat News. He is the founding and current director of the Mount Sinai Center for Cognitive Health and NFL Neurological Care.
Critics’ concerns are echoed by Dr. Mimoza Metarapi, clinical pharmacist with Medication Management Partners. The Crestwood, Illinois-based company provides medication management and is a dedicated pharmacy partner for assisted living, memory care, and behavioral health communities across the country.
She notes that stakeholders in the care of Alzheimer’s patients need to recognize that, at best, Aduhelm may present marginal benefits for carefully selected patients.
“We will need better amyloid drugs down the line. And we will need [other] drugs that target other elements of the disease, such as tau tangles,” she said.
Still, Metarapi views Aduhelm’s approval as a positive, and she is looking forward to seeing the results of post-approval trials into its effectiveness.
“If that trial fails, approval may be withdrawn,” she said.
Despite these concerns, a sizable cohort of doctors are expressing significant interest in prescribing the treatment to their patients. Global financial services firm Jefferies recently surveyed 50 neurologists and psychiatrists specializing in treating Alzheimer’s patients, and found they are interested in prescribing the drug to 35% of their patients in the early stages of the disease.
With an estimated 6.2 million people in the U.S. living with the disease, the cost of Aduhelm would be a financial boon to Biogen.
Pharmaceutical analysts estimate up to $10 billion in peak sales for the drug, once it becomes widely available. The annual cost for Aduhelm could run to $56,000 per patient, according to Biogen.
But it raises concerns that the treatment would be unaffordable to middle- and lower-income Alzheimer’s patients. On June 12, the Alzheimer’s Association — a leading advocate for Aduhelm’s FDA approval — released a statement calling the drug’s list price “simply unacceptable,” and added that the cost would pose a major hurdle to access and may further impact health equity.
The Alzheimer’s Association publicly called on Biogen to reduce the price tag, Chief Program Officer Kristen Clifford told SHN.
“The Alzheimer’s Association is dedicated to eliminating barriers to access for anyone who could benefit from the treatment,” she said.
It is believed by many observers that, for Alzheimer’s patients on Medicare, the cost will be absorbed under Medicare Part B and Part D coverage, although Metarapi notes this is not a guarantee with treatments that receive accelerated approval.
If Aduhelm is covered, the price tag would place substantial pressure on Medicare Part B and Part D budgets. An April report on Medicare prescription drug spending from the Kaiser Family Foundation revealed that spending for pharmaceuticals under Medicare Part B totaled $37 billion in 2019, while drugs covered under Part D plans totaled $90 billion.
At Biogen’s quoted price, treating 20% of diagnosed Alzheimer’s patients in the U.S. with Aduhelm would generate $69.4 million in pharmaceutical revenues, alone.
The cost of the treatment, if left unchanged, will almost certainly result in an increase in insurance premiums, especially for seniors.
In addition, taking Aduhelm may present side effects including an increase in headaches and risk of falls, and bleeding in or on the brain’s surface. As part of the treatment regimen, patients are advised to be monitored for signs of side effects including having costly MRIs conducted to observe for bleeding. This will increase costs and co-pays for patients, while adding layers of risk and complexity for the senior living providers caring for them.
To that point, the impact Aduhelm therapy will have on general liability insurance premiums for assisted living providers is also unknown, as they will be on the front lines monitoring for signs of side effects.
Williams indicated that Seasons will leave the final decision on Aduhelm treatment to residents and their families. Because it is an intravenous infusion treatment, residents will need to travel off site to have it.
“Our responsibility is to monitor for side effects. Liability [issues] could enter if [residents] have side effects that are not caught,” he said.
The uncertainties and complications related to Aduhelm are giving him pause.
“There were hopes that you could take a pill every night, and that would slow down the progression of disease,” he said. “The excitement [around Aduhelm] has faded a bit.”
In the meantime, providers are gathering as much information as possible so that residents and their families can make an informed decision on Aduhelm, Lewis McCoy, COO at Anthem Memory Care, told SHN. The Lake Oswego, Oregon-based provider operates 11 communities in California, Colorado, Illinois and Kansas.
In spite of the litany of concerns around Aduhelm’s efficacy and FDA approval, he believes that eliminating the barriers for patients to receive the drug outweigh the risks, and may ultimately lead to more interest and investment in other therapies related to treating Alzheimer’s disease.
“That is another side of the equation — the sense of hope and wanting to ensure that hope is not misplaced,” he said. “We have a role to play.”