As someone afflicted with Alzheimer’s, David Welch was happy to see a drug called aducanumab conditionally approved by the U.S. Food and Drug Administration this summer. Now, he and many others are wondering when it will be available locally and how much it will cost patients to obtain, even though some medical experts say there’s no evidence it actually works.
Welch has been part of a clinical trial of the drug for about six years and believes it has kept his memory problems from getting worse. The trial is being conducted by Via Christi Research, part of Ascension Via Christi St. Francis.
“Oh my gosh, I’m still driving, still working,” said Welch, who’s in his 60s. “I’ve still got a normal life. This doesn’t happen with dementia, you know.”
The FDA approved aducanumab for all Alzheimer’s patients in June. A few weeks later, however, the agency said the drug should be used only for patients with mild memory or thinking problems, or about one-fourth of the estimated 6 million Americans affected by the disease. That doesn’t prevent physicians from prescribing it to other Alzheimer’s patients, but it may influence if and how insurance companies and Medicare decide to cover the drug.
The drug, made by Massachusetts-based drug giant Biogen, currently carries a list price of $56,000 per year. It’s sold under the name Aduhelm.
Some experts believe the clinical trials of aducanumab such as the one Welch participated in were inconclusive. The FDA has said its decision was based on the drug’s ability to reduce a protein called amyloid in the brains of Alzheimer’s patients, rather than on proof of its ability to slow cognitive decline in those patients.
The FDA gave what’s known as “accelerated approval” to Aduhelm, meaning that Biogen must conduct a new clinical trial to verify that it’s beneficial to patients. Otherwise, the agency may withdraw approval.
The Alzheimer’s Association and other patient advocates urged FDA approval and continue to champion the drug’s potential.
“We’re still advocating for it to definitely be more widely available and for everybody to be able to afford it,” said Breana Tucker, program director of the association’s central and western Kansas chapters. “That is our stance now.”
Tucker said her office has received “quite a few” calls from people interested in the drug, but she knows of no physicians prescribing it locally at this time.
Biogen’s rollout of Aduhelm was expected to move slowly because its use is relatively complicated. The drug is administered intravenously once every month. MRI brain scans are required before and at six-month intervals while a person is taking Aduhelm. The scans are used to check for brain swelling and bleeding, which can be side effects of the drug. Follow-up cognitive tests are also required.
Janie Krull, director of research at Ascension Via Christi, said Aduhelm seems to have helped most of the people she’s studied. Krull noted that Biogen suspended the clinical studies in 2019 because of doubts about the drug’s effectiveness, then restarted them last year. “I know that some people had a decline over that year they were off the medication,” Krull said. “I think for the majority of the people I have on the study, it’s really held them at where they were” when the study restarted. “A couple of them had a little bit of decline, but it’s hard to say where they’d be without it.”
Dr. Tiffany Schwasinger-Schmidt, director of the KU School of Medicine-Wichita Center for Clinical Research, said she knows of a few local providers who are going through the process of obtaining approval from Biogen to administer Aduhelm.
“My understanding is if it’s not here currently, it should be here soon.”
Typically, insurance companies and Medicare want more information on the long-term effects of a drug such as Aduhelm before covering it, she said. In June, the U.S. Centers for Medicare and Medicaid Services announced it would decide whether to cover Aduhelm within seven months.
The KU research center is taking part in the clinical trial of another Alzheimer’s drug produced by Biogen. Schwasinger-Schmidt called the results “very promising.”
“I think it’s really exciting that we’re making advances on this disease,” she said. “It really does affect so many people and their families.”
Welch got involved in the Aduhelm clinical study because he started having memory problems at age 60, and his family has a history of Alzheimer’s disease. The longtime owner of a heating and air conditioning company, he sold that business to reduce his stress level but continues to work there.
He said he’s been told that he’ll continue to receive Aduhelm for five more months through the Via Christi research center. After that, he’s not sure what will happen, although he wants to keep receiving it. “I’m just trying to wait it out, see how it all works out.”