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Jeff Borghoff knew there was something wrong with his face creating a rumor and then falling apart. When he was just 51 years old when he received a devastating initial diagnosis of Alzheimer’s disease, his biggest fear was a rapid deterioration in his mental powers.
Desiring to get away with the situation, the former computer executive enrolled in the clinical trial of the experimental drug Alzheimer’s drug biogen. Six years later, Borghoff admits that he has dealt valuable time with his wife and three children.
“Our fear was that there would be a big decline in every faculty in my head, but so far it hasn’t been that way,” he says. “I had some symptomatic problems. . . but medications are more time, my loved ones are more time, things are critical. “
Now, after the drugs were approved by U.S. drug regulators this week, about 35 million people living with Alzheimer’s around the world will be waiting for hope.
However, there is the tail of what can certainly be good news for the patient. A variety of issues, ranging from the cost of the drug to questions about evidence of efficacy, will accumulate pressure on health systems that have already suffered from pandemics and may be poorly equipped to meet the expectations raised.
Drug approval jeopardizes the creation of a political and commercial divide between the U.S. – which is priced at $ 56,000 a year – and in Europe, many governments may be much more skeptical of its value.
As the debate complicates, the chorus of anger is growing in the eyes of the FDA the decision to take the green light drug first, given the scant evidence of its effectiveness. Three top scientists have resigned from their advisory board this week, citing a supposedly objective and data-driven acceptance process.
Biogen originally quit the drug after unnecessary analysis suggested it was ineffective. When he looked at a larger data set, he found that patients taking a higher dose “had significant advantages in measures of cognition and function, such as memory, orientation, and language.”
Craig Garthwaite, a professor of hospital and health services at Northwestern University, said it was “horrible” for the FDA to bow to patient pressure groups and not listen to its scientific advisors. “He says he’s ‘surprised’ by this idea, even if we don’t know or it doesn’t work, we should try to give people hope.”
However, experts believe it is likely that health insurers will feel compelled to cover the drug as approved by the FDA. In an unexpected twist, the regulator approved it for all patients with the disease, only those with the first stage of the disease, who were examined in a clinical trial.
Most U.S. patients will be on Medicare, public health insurance over the age of 65. Biogen told investors it expects to cover a “vast majority” of patients. Some experts predict that the drug will become the largest Medicare-administered drug.
Potential costs go beyond medication. The demands of its administration call into question the established models of care for those with dementia, creating the need for different types of staff and expensive equipment unrelated to the treatment of the disease.
The cost of intravenous medical, radiological, and imaging intravenous infusion could range from $ 2,000 to $ 15,000 or more above the drug’s price tag, according to a group representing more than 4,000 U.S. hospitals in the Premier.
According to David Thomas, head of policy at Alzheimer’s Research UK, “they pay close attention to people with dementia [in the UK] it is done from memory clinics, largely because older psychiatrists work there ”. Unlike a neurologist, these doctors “often lack the experience in diagnoses and controls needed to provide treatments to change the disease.”
Another major challenge, he stressed, is securing the necessary equipment. Diagnoses of those suspected of having the disease usually include low-key cognitive tests that do not require special hardware.
To be eligible for aducanumab, the patient must have a certain level of protein that can be produced in the brain, tissues, or organs of the amyloid, which is established by positron emission tomography (PET) or more invasive. it is usually a cheaper tap at the waist, which involves the removal of fluid from the spine.
Patients who are eligible should have an intravenous infusion with adducanumab every four weeks and should undergo regular MRI scans to detect dangerous side effects such as brain inflammation and bleeding.
When Alzheimer’s Research UK recently interviewed psychiatrists in the country, “the majority said it would take five years to be ready to provide treatment – only a third could think in a year,” says Thomas.
Sanjiv Sharma, Borghoff’s doctor and founder of the Advanced Memory Institute in New Jersey, accepts the obstacles if they are to reach everyone who could benefit. But there is no doubt that the US must tread the path. “If we can’t do it [here], being the most developed country in the world, where can we do it? “, he says.
‘Economic incentive for drug use’
Soeren Mattke, director of the Center for Chronic Disease Care at the University of Southern California, has argued that few developed countries are well-prepared for drug preparation, let alone middle-income and emerging countries like China and Brazil, which are less sophisticated. health infrastructure.
However, treatment funding in the US will create its own business models, he suggests. Medicare doctors are paid a 6% share of the price of the drug, plus infusion and visitation fees.
“It simply came to our notice then. . . neurologists or psychiatrists or geriatricians realize, ‘well, I can really make a living from this by only distributing the living medicine through my practice’, which is a very powerful draw to establish diagnostic facilities for finding patients, ”he says.
This could lead to conflicts of interest, Northwestern’s Garthwait suggests. “There’s an economic incentive to use the drug, even if it doesn’t think it will work.”
Mattk also acknowledges that there are no equal incentives in subsidized health systems, such as Canada and the UK, where long admissions and limited budgets can limit the ability to purchase equipment or hire new staff.
“I’m a little nervous about the change the government has put in place because we all know that governments don’t act very quickly,” he added.
In the U.S., Biogen has helped prepare more than 900 U.S. infusion sites to deliver the drug. It predicts “modest” revenue in 2021, but then a million-dollar option in the coming years, as it could be given to between 1 million and 2 million patients in the US.
Roni Christopher, vice president of design and intervention for the Premiere analysis team, spent the past year developing standard assessments of the patient’s cognitive status, radiologists detecting side effects, and examining whether infusion sites have enough seats. .
Even with these logistical approaches, the most experienced health systems may not be ready to care for patients until the fall. The FDA’s decision to open the drug to all Alzheimer’s patients will lead to “bigger floods,” Christopher says.
“Consumer or patient pressure will command a lot here because it’s a destructive disease,” he added.
Quality money?
It is greater than how the medicine is to be delivered, in fact, that the amount of health systems — and the taxpayers who finance them — will be willing to pay for a drug with such a proven low impact.
In some parts of Europe, where so-called “health technology assessments” are used to assess the value of money for a new drug, there is still no need to agree on whether the drug should be offered to patients. In the UK, as the National Institute for Health and Care Excellence has a strong international impact, officials are privately concerned that expectations are being created that will not be easily met.
Umer Raffat, an analyst at Evercore ISI, hopes that despite the European authorities getting the green light from adducanumab, they will “not accept the price of more than $ 10,000 a year,” which will make it difficult for Biogen to decide. To sell to the US five times the European price.
They believe this inequality of vision will spark Republican politicians who believe that other countries that are negotiating cheaper drug prices are freeing themselves from American innovation.
On the other side of the political corridor, some Democrats are using the price set by Biogen to prove that Medicare should allow prices to be negotiated, which is the potential power of the government to negotiate with the non-drug industry.
Murray Aitken, executive director of the IQVIA Institute of Human Data Sciences in New Jersey, believes that health systems are asking how much they should pay for a drug that offers a rare expectation to raise long-standing questions about whether European governments should spend more of their gross domestic product on health.
He adds: “As a civil society, we will create a greater dialogue for ourselves, given how we distribute our wealth…. It may lead to this broader social debate and debate, which I would probably say has been delayed.”
At home in New Jersey, Jeff Borghoff has no doubt about the value of medicine, which is supposed to have extended his profitable life. “I know it’s not a cure and it probably won’t fix everything damaged in the brain as a result of Alzheimer’s,” says Borghoff. He added: “I’m 57 years old. I’ll be fine if I’m 70, I’ll be fine and I hope the medication will help me do that.”
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