Mike O’Brien, 73, was fortunate to join a clinical trial for a new Alzheimer’s treatment for those in the early stages of the disease. Still, he and his wife worry about the day the trial ends and they will be on the hook to pay for the exorbitantly priced monthly infusion.
The Food and Drug Administration issued biopharmaceutical company Biogen an “accelerated approval” for aducanumab, also known by its brand name Aduhelm, on June 7. The FDA stipulated as a condition for approval that the company will have to produce further results from a post-market study to prove efficacy.
The announcement “was great news for us,” said Mike’s wife, Sue O’Brien, 71. But the decision to approve it was slammed by expert neurologists on the FDA’s panel of experts tasked with reviewing the clinical trial data, arguing that they did not produce proof of a clear benefit against the progression of the disease. The agency’s approval of Aduhelm prompted resignations from neurologists on the panel. In fact, the recommendation from the panel of experts against FDA approval was nearly unanimous.
Just days later, the company announced that the treatment would come with a prohibitive list price of $ 56,000 for 12 monthly treatments.
The O’Briens were willing to try the treatment nevertheless. They received Mike’s Alzheimer’s diagnosis in November 2015 after noticing some cognitive decline over some previous years. Mike’s symptoms were not immediately noticeable at the time to friends and family. Still, Mike’s brain fog and forgetfulness compelled them to take a neurologist’s advice and join the EMERGE clinical trials for the monthly treatment from Biogen. Mike got his first IV infusion in January 2018.
“I felt good,” Mike said. “I felt my clarity of judgment and memory cleared.”
Mike was enrolled in the trial and received the treatment for about a year until Biogen ended the EMERGE trial in March 2019, having conducted a “futility analysis” that researchers said indicated the company’s trials “were unlikely to meet their primary endpoint upon completion.” This left the O’Briens without the treatment with which Mike was having such success.
“It was a horrible time,” Sue said, adding that Mike had noticeably regressed without the monthly treatment. “He noticed that he was very repetitive, and he even said a couple of times, ‘I feel like my head is really foggy.’”
In the meantime, they joined another Alzheimer’s treatment trial with a product called donanemab from Eli Lilly until June 2020 when Biogen launched another trial of the treatment Aduhelm, called the EMBARK trial, in which Mike would receive progressively higher doses each month. By December 2020, he was back on the full dose and feeling the benefits of the treatment again. But it remains unclear how long the trial will continue, leaving the O’Briens to wonder when they will have to start considering the high cost of the monthly infusion.
“The $ 56,000 price tag is outrageous,” Sue said. “That’s crazy, and I don’t believe that includes the MRIs or the infusion center or the clinicians that serve that patient.”
In fact, the price burden on patients who need to keep up with additional costs of services such as follow-ups with specialists and additional copays for imaging is estimated to reach about $ 11,500, according to the Kaiser Family Foundation.
Biogen will have to continue trials of the treatment to prove efficacy to the FDA, but the timeline for those trials remains unclear. Another halt to the trial could spell disaster for the O’Briens, who consider themselves a success story for the controversial treatment.
“I understand that it’s not going to help everybody, but if I can have this guy sit next to me and look in his eyes … it was our prayers answered,” Sue said.