July 7, 2021 — Rolf Johnson is a glass-half-full kind of guy, but also a realist. As a longtime attorney in Houston, recently retired, he specializes in taking companies public, so he’s also a man who knows how to do his homework.
Johnson also has Alzheimer’s. so, when his neurologist Rolf and Carol, his wife of 60 years, were called in to explain that he would like to write the controversial new edukanumab (Eduhelm). Alzheimer’s The drug just approved by the FDA on June 7, he didn’t hesitate. “I agreed to it immediately,” he says.
But in true lawyer fashion, he also had a laundry list of questions.
“I definitely wanted to know what he knew about the company, the producers, their history,” says 82-year-old Rolf. The company, Biogen, was solid, asking other questions about what it could expect from the drug. The couple both expressed concerns about the cost—a staggering $56,000 per year list price—and were assured that an arrangement was being worked out.
Rolf’s first monthly infusion took place on 30 June.
“There are so many side effects that they warn about, and so far, I haven’t had any of them,” he says.
He is keeping his hopes under control. He knows it won’t reverse the damage he’s already done since his diagnosis 5 years ago. “If it works well, it stops the spread of Alzheimer’s,” he says, “from the time you start taking it.”
His 81-year-old wife and a psychiatrist said: “It’s as good as the treatment for us.”
As advocates and critics debate the FDA’s approval of the new drug, and a group of experts and patient advocates oppose the price, many patients and their families are excited about it, hoping it will cure the debilitating disease. will prevent further damage and help them function. and enjoy time with family and friends.
Eduhelm: Sticking Points
The price of the drug is not the only debatable issue. So there’s the FDA’s quick approval, which was based on clinical trial Data that found a reduction in amyloid plaques compared to those given the drug placebo group. plaques form in the brain and are believed to Memory loss and eventually the inability to perform tasks of daily living. But plaque reduction, critics say, doesn’t prove there’s any clinical benefit, such as remembering a grocery list or way home.
The FDA has also approved it for widespread use. Alzheimer’s patients, although some experts say that it works best in the early stages and should be protected for those patients.
patient’s interest is high
Despite the debate and the unknown, Rolf’s neurologist, Paul Schulz, MD, professor of neurology at McGovern Medical School at the University of Texas Health Science Center in Houston, says he has been asking patients and families about emails and calls. new option.
Since approval, he says, he has received numerous emails and phone calls, some from patients he hasn’t seen in 3 years. “We get a lot of them every day,” says Schulz, who also directs the UT Health Neurocognitive Disorders Center and is a consultant to Biogen.
According to Biogen, more than 900 sites nationwide are ready and ready to deliver monthly infusions.
addressing the cost barrier
For Johnson, one of the controversial points – the price – was resolved. Officials at Memorial Hermann Hospital, UT Health’s teaching hospital, agreed to donate money to Schulz. Madness So that Johnson can get 6 months of infusion at no cost. “The hospital is very helpful,” Schulz says.
By the end of that period, Medicare can make a decision on coverage, experts say. Once a Medicare decision is made, other insurance plans generally follow its lead.
Schultz has found another way to address the issue of prohibitive costs. Several large pharmacies in his area have now agreed to enroll patients and bill Medicare “if they approve it.”
While smaller pharmacies can’t take that potential financial hit, some of the larger ones are capable, he says.
Treat Now, Pay Later?
Mark Archambault, 70, of South Kingstown, RI, was the first person in the world to receive the drug outside of clinical trials. He doesn’t know if he’s on the hook for that fee. So far, he hasn’t paid anything, but says he’s not sure about how the coverage will work.
This did not stop his resolve.
“There was no way I didn’t want to do it,” he says.
He received his first infusion on June 16 at Butler Hospital in Providence, RI. And he half-jokes: “I think the first person in the world to get it [after approval] Shouldn’t pay.”
She is also realistic about what medicine can and cannot do. “It’s a shot for me to be as hopeful as I am now,” he says. “I said yes right away.”
Diagnosed in 2014, Archambault is a longtime real estate agent in South Kingstown, a town of about 30,000 about 30 miles from Providence. He is still active, but he quit managing the office in 2017 and seeks help when needed. “I started having trouble with words very quickly,” he says. “All of a sudden, I can’t get the words out.”
He is open about his diagnosis and seeks help from those close to him. For example, if he’s trying to talk about a car but can’t get the words out, he might say to his daughter or a co-worker that “the thing you sit in and that’s going to take you out of town.” Carries it around.”
He doesn’t have any second thoughts about the decision, he says.
“It’s my turn to do it,” he says.
He has already been a research participant in the Memory and Aging Program at Butler Hospital. At a news conference on the day of the infusion, Stephen Sallove, director of the Neurology and Memory and Aging Program, said that, “Today we usher in a new era in Alzheimer’s treatment,” with a focus on slowing progress. Sailoway was co-chair of the global investigator steering committee for EduHelm’s Phase III study.
“If it works, I guess I may not have to go through those final stages when I don’t know anyone,” Archambault says. “It’s not perfect, but I’m giving it a shot.”
Waiting for reimbursement issue
Others, such as Jay Reinstein, say they will be ready to seek treatment once the reimbursement issue is settled. A former assistant city manager in Fayetteville, NC, he was diagnosed with Alzheimer’s disease in 2018 at the age of 57. Originally planning to work till the age of 65, he had to retire early.
“My neurologist has said I would be a good candidate for EduHelm, and the only delay is waiting for a decision by Medicare on what amount they will cover for the infusion.”
The list price, he says, “is higher than what I can afford at the moment. Once a decision is made, even if it takes months, I plan to move forward with Eduhelm.”
With the new drug, he says, “I understand that there is a potential for swelling in the brain, a potential for bleeding. For me, the benefits are greater.” [potential] Side effects.”
He and his wife Angela celebrated their 30th anniversary in May. He has two daughters, a son and four grandchildren. “I want to be around for my grandchildren and kids,” he says.
To cope, he goes to therapy and a support group and remains hopeful that things will work out. “I’m just waiting for the green light. I’m just crossing my fingers.”
Aduhelm as a step
Patients’ passion and enthusiasm for starting treatment doesn’t surprise Schulz. He says that people have high hopes from the approval of the drug. He agrees that the effects are not perfect and that medicine cannot reverse the damage. “With no disrespect to Biogen, it’s giving us 25 to 40% less degradation on various parameters [measured]. It’s better than no effect.”
“The first important step is to find things that are effective,” he says. After then-President Richard Nixon declared war on cancer in 1971, “we started getting drugs that had a better effect. I think that’s the way it is.”
family, friends on board
Support from family and friends seems to convince people who have started medication or want to receive it that their decision is the right one – and to keep their spirits up. “My daughter is excited about it,” Reinstein says, “as are my parents.”
While his wife, Angela, is more concerned about the potential harm of the treatment, she is also on board.
None of these patients talk about “cures”, but more about holding on to what they have. As they carefully anticipate the future in which they can function, they are also enjoying life in the present.
Archambault laughs at how popular he has become since news of his infusion was publicized. “I’ve heard from a ton of old friends.” They have made very good bookings for lunch and dinner. “None of my friends said, ‘What are you doing?’ ‘Are you mad?'”
Rolf needs to dust off his dancing shoes. Johnson, who was a high school sweetheart, has three adult children and 11 grandchildren. “Our oldest grandson has just got engaged,” says Carroll, who says she is expecting great-grandchildren soon — and isn’t shy about letting family members know. “A big family outing next February. It’s a wedding.”
Rolf says with a smile: “We’re going to dance at that wedding. My high school sweetheart is going with me.”