July 7, 2021 – Rolfe Johnson is the half-full glass type, but also realistic. Long-time Houston lawyer, recently retired, he specializes in IPOs, so he’s also a man who knows how to do his homework.
Johnson also has Alzheimer’s disease. So when his neurologist called to tell Rolfe and Carol, his wife of 60 years, that he would like to prescribe aducanumab (Aduhelm), the controversial new Alzheimer’s drug that was just approved by the FDA on June 7, he didn’t hesitate. “I accepted right away,” he says.
But like a real lawyer, he also had a long list of questions.
“I certainly wanted to know what he knew about the company, the manufacturer, what their history was”, explains Rolfe, 82 years old. Assured that the company, Biogen, was strong, he asked further questions about what he could expect from the drug. The couple both expressed concern about the cost – an incredible list price of $ 56,000 per year – and were assured that an arrangement was being worked out.
Rolfe had his first monthly infusion on June 30.
“There are a number of side effects they warn about, and so far I haven’t had any,” he says.
He keeps his expectations under control. He knows it won’t repair the damage already done since his diagnosis 5 years ago. “If it works well, it prevents the spread of Alzheimer’s disease,” he says, starting “from the moment you start taking it.”
His wife, 81, a psychotherapist, intervenes: “It’s as good as a medicine for us.”
As advocates and critics debate FDA approval of the new drug and a chorus of experts and patient advocates protest the price, many patients and their families are thrilled, hoping it will prevent it. the wasting disease to get worse and will help them to function. and spend time with your family and friends.
Aduhelm: Friction points
The price of the drug is not the only point of debate. The same goes for the FDA’s fast-track approval, which was based on clinical trial data that found a reduction in amyloid plaques in people given the drug, compared to those in the placebo group. Plaques build up in the brain and are thought to lead to memory loss and eventually the inability to perform tasks of daily living. But reducing the plaque, critics say, doesn’t prove there is a clinical benefit, like remembering a grocery list or the way home.
The FDA has also widely approved it for use in patients with Alzheimer’s disease, although some experts say it works best in the early stages and should be preserved for these patients.
Patient interest is high
Despite debate and unknowns, Rolfe’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 inundated with emails and calls from patients. and families, inquiring about new option.
Since the approval, he says, he has received numerous emails and phone calls, some from patients he has not seen for 3 years. “We get a lot of it every day,” says Schulz, who also heads the Center for Neurocognitive Disorders at UT Health and is a consultant for Biogen.
According to Biogen, more than 900 sites across the country are ready and prepared to give monthly infusions.
Addressing the cost barrier
For the Johnsons, one of the controversial points – the price – has been resolved. Officials at Memorial Hermann Hospital, UT Health’s teaching hospital, agreed to donate the money to Schulz’s dementia program so that Johnson could receive 6 months of infusions at no cost to him. “The hospital is very supportive,” says Schulz.
At the end of this period, Medicare can make a decision on coverage, experts say. Once Medicare decides, other insurance plans usually follow suit.
Schulz found another way to solve the problem of prohibitive costs. Several large pharmacies in her area have agreed to infuse patients now and bill Medicare “if and when they approve”.
While small pharmacies cannot take this potential financial blow, some of the larger ones can, he says.
Process now, pay later?
Marc Archambault, 70, of South Kingstown, RI, was the first person in the world to receive the drug outside of clinical trials. He does not know whether he should pay these fees or not. So far he hasn’t paid anything but says he’s not sure how the cover will work.
It didn’t stop his determination.
“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 have it [after approval] shouldn’t have to pay. “
He, too, is realistic about what the drug can and cannot do. “It’s a chance for me to stay hopeful as I am now,” he said. “I said yes right away.”
Diagnosed in 2014, Archambault is a longtime real estate agent in South Kingstown, a town of about 30,000 people, about 30 miles from Providence. He’s still active, but he gave up running the office in 2017 and asks for help when he needs it. “I started having trouble with words quite early on,” he says. “All of a sudden I can’t get the word out.”
He is open about his diagnosis and asks for help from those close to him. For example, if he tries to talk about a car but cannot pronounce the words, he will tell his daughter or a coworker to tell him the word for “the thing you are sitting in and it shows you around.” the city “.
He had no doubts about the decision, he said.
“It’s my turn to do it,” he said.
He had previously participated in research in the Memory and Aging program at Butler Hospital. At a press conference on the day of the infusion, Stephen Salloway, MD, director of neurology and the Memory and Aging program, said, “Today we usher in a new era in the treatment of disease. Alzheimer’s ”, with an emphasis on slowing the progression. Salloway was co-chair of the Global Investigator Steering Committee for Aduhelm’s Phase III studies.
“If it works, I feel like I might not have to go through those final stages when I don’t know anyone,” says Archambault. “It’s not perfect, but I’m taking a chance.”
Waiting for refund problem
Others, like Jay Reinstein, say they will be ready for treatment once the reimbursement issue is decided. A former assistant general manager of Fayetteville, North Carolina, he was diagnosed in 2018 at the age of 57 with younger-onset Alzheimer’s disease. Originally planning to work until the age of 65, he had to take early retirement.
“My neurologist said I would be a good candidate for Aduhelm, and the only delay is to wait for a decision from Medicare to determine how much they will cover for the infusion.”
List price, he says, is “more than I can afford at the moment. Once the decision is made, even if it takes months, I plan to move forward with Aduhelm.”
Meanwhile, he says, “I try to focus on the things that I do well. He says he’s taking Alzheimer’s drugs, donepezil (Aricept) and memantine (Namenda), and “I feel like it’s helping me.”
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 outweigh the [potential] Side effects.”
He and his wife, Angela, celebrated their 30th birthday in May. They have two daughters, a son and four grandchildren. “I want to be there for my grandchildren and my children,” he says.
To cope, he goes to therapy and a support group and is hopeful that things will work out. “I’m just waiting for the green light. I’m just fingers crossed.”
Aduhelm as a first step
The passion and enthusiasm of the patients to start treatment did not surprise Schulz. The drug’s approval “gives people a lot of hope,” he says. He agreed that the effects were far from perfect and that the drug could not repair the damage. “Without disrespecting Biogen, this gives us 25 to 40% less reduction on various parameters [measured]. It’s much better than no effect. “
Approval, he says, “is the first important step in finding things that are effective.” After then-president Richard Nixon declared war on cancer in 1971, “we started getting drugs that worked better. I think it’s the same.”
Family, friends on board
The support of family and friends seems to convince those who have started the drug or want to get it that their decision is sound and to keep their spirits up. “My daughter is excited about this,” Reinstein says, “as are my parents.”
While his wife, Angela, worries more than he about the potential inconvenience of the treatment, she is also on board.
None of these patients are talking about “healing”, but rather holding on to what they have. As they cautiously anticipate a future in which they can function, they also benefit from the present life.
Archambault has been laughing at his popularity since news of his brew was made public. “I’ve heard from a ton of old friends.” He booked pretty solid for lunch and dinner. “None of my friends said, ‘What are you doing?’ ‘Are you crazy?'”
Rolfe needs to dust off his dancing shoes. The Johnsons, who were high school sweethearts, have three grown children and 11 grandchildren. “Our oldest grandson just got engaged,” says Carol, who says she hopes to have great-grandchildren soon – and isn’t shy about letting family members know. “There is a big family wedding next February.”
Rolfe smiles as he walks in, “We’re going to dance at this wedding. My sweetheart from high school is coming with me.”
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