Landmark Alzheimer’s drug to become available in Dayton region despite controversy

This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. On Monday, June 7, 2021, the Food and Drug Administration approved Aduhelm, the first new medication for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP)
This image provided by Biogen on Monday, June 7, 2021 shows a vial and packaging for the drug Aduhelm. On Monday, June 7, 2021, the Food and Drug Administration approved Aduhelm, the first new medication for Alzheimer’s disease in nearly 20 years, disregarding warnings from independent advisers that the much-debated treatment hasn’t been shown to help slow the brain-destroying disease. (Biogen via AP)

Credit: Uncredited

Credit: Uncredited

About 220,000 Ohioans live with Alzheimer’s.

The FDA for the first time approved a medication to treat Alzheimer’s and not just the symptoms, but the controversial decision comes after an external advisory group concluded there’s not enough evidence that the drug works to slow the disease.

There’s a large and emotional demand for treatment for Alzheimer’s.

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About 220,000 Ohioans — disproportionately women, Black and Latino residents — now live with this ultimately-fatal type of dementia, which increasingly attacks the brain and impairs memory and behavior.

The newly approved medication is called aducanumab, or brand name Aduhelm, and will be available in the Dayton region as a monthly infusion as soon this summer. The price before insurance is about $56,000 a year.

There hasn’t been an Alzheimer’s drug approved in 18 years, and aducanumab is approved as the first medication that could actually slow the disease.

“That’s why the excitement is there,” said Dr. Kenneth Pugar, with the Dayton Center for Neurological Disorder and Kettering Health. “However, it has to be tempered, because it is certainly not a cure, and this drug, it’s efficacy was not robust in studies. In fact, the decision was very controversial.”

Patients taking aducanumab saw their thinking skills decline 22% more slowly than patients taking a placebo, the Associated Press reported. But that meant a difference of just 0.39 on an 18-point score of cognitive and functional ability.

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And it’s not clear how such metrics translate into practical benefits, like greater independence or ability to recall important details.

There are also possible side effects, such as temporary brain swelling.

In November, the FDA’s outside expert panel voted “no” to questions on whether drugmaker Biogen showed the drug was effective. Industry publication STAT reported Tuesday that a neurologist on the advisory committee resigned in protest of the drug’s approval.

The FDA is not required to follow the advisory group’s conclusion. Biogen is required to continue studying the effects and confirm benefits as part of the particular type of approval process for aducanumab.

Pugar said he would recommend the medication in select patients.

“In my opinion, those with mild disease, if they were otherwise fairly healthy, and had no other contraindications, I think that this is a reasonable option,” Pugar said.

The drug was only studied on people in early or mild cases, but the FDA label approved the drug for anyone with Alzheimer’s.

“I suspect we won’t get a good response in those cases with more advanced dementia,” said Dr. Pugar, with Kettering Health. “And of course those are families who are very much wanting something, but that is not the target for this drug.”

The Dayton community walks to end Alzheimer’s in a 2019 fundraiser. FILE
The Dayton community walks to end Alzheimer’s in a 2019 fundraiser. FILE

Patient groups advocate for hope, progress

Alzheimer’s Association and Us Against Alzheimer’s, which advocate for patients and caregivers, have been strong supporters of this medication’s approval.

Eric VanVlymen, Ohio regional leader of the Alzheimer’s Association, said a big thing about the medication is that patient’s will first have a diagnosis by looking for a biomarker associated with the disease, in this case the brain plaque.

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“Ultimately what this does is it moves the entire push for how we treat Alzheimer’s earlier and using biomarkers,” VanVlymen said. “It sets up the opportunity for us to begin treating people far before dementia symptoms start.”

Dr. Christopher Janson, director of Clinical Neuroscience Institute’s Memory Center at Premier Health, said he has been closely following the drug trials and FDA process and said while there was some controversy, he thinks the drug has a strong enough scientific rational to move forward.

Premier Health will have aducanumab for patients as soon as it is available this year.

“There’s a strong case to be made for moving ahead with this medication, especially since it’s the only modifying drug we’ve got in our arsenal,” Janson said.

UC Health also announced it will be among initial sites in Ohio to give aducanumab.

$56,000 price

Biogen said the drug price will be about $56,000 for a typical year of treatment. Most patients would pay far less out of pocket because of insurance coverage or discounts.

The price multiplied across hundreds of thousands of patients is expected to have a big impact on the budgets of Medicare and private insurers.

VanVlymen said the next step for the Alzheimer’s Association is making sure people have access and that the drug isn’t just for the richest.

It’s not clear how different insurance plans will cover the medication.

Some insurers might not authorize the meds for everyone who wants it. Others might require screening to demonstrate the patient has abnormal deposits of the protein that the prescription is designed to attack.

“Right now, the only two ways we can prove that is with a very expensive test called an amyloid PET scan, and Kettering has one but they’re very expensive, or spinal tap, which are moderately expensive but also invasive,” said Pugar, who said an unanswered question is what insurance companies will require to authorize coverage.

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Ge Bai, associate professor with Johns Hopkins, who has studied health care pricing and drug supply chains, said that because Aduhelm has no competitors currently, public and private insurers won’t be able to get meaningful price concessions for this drug.

She said that will mean higher financial burden on taxpayers, higher premium for privately insured individuals, and higher drug spending for employers.

“Private payers may choose not to cover this drug, but the resistance from patient advocacy group will be relentless,” Bai said.

Associated Press contributed to this report.

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