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Jeff Borghoff knew something was wrong when his face began to shake, and then he collapsed. At just 51 years old he realized that Alzheimer’s disease had started, his biggest fear was a severe damage to his mental health.
To address this issue, a former IT official signed a biogen test for Alzheimer’s Biogen, aducanumab. Six years later, Borghoff says the treatment has been due to spending more time with his wife and three children.
“Our fear was always that there would be a great decrease in all my thoughts, but so far it has not happened,” he says. “I’ve had some problems. . . but the treatment is almost always, most of the time with my loved ones, these are the most important things. ”
Now, following the approval of the drug this week by U.S. drug regulators, many of the nearly 35m people living with Alzheimer’s around the world are waiting for the inclusion of hope.
However there is a sting in the tail on what may seem like good news for patients. A number of problems, from the cost of the drug to questions about its effectiveness, will add to the stress on the lives of those who already have the epidemic and who are unable to meet the expectations discussed.
The legalization of the drug poses a political and business risk between the US – where a $ 56,000-a-year price tag is set – and Europe, where many governments may be skeptical of its benefits.
What makes this controversy even more difficult is the FDA’s growing anger the idea of lighting a green product at first, given little evidence of its usefulness. Three leading scientists have abandoned their advisory work this week, surprisingly rejecting what is considered to be legitimacy.
Biogen initially discontinued the drug after a vain evaluation of its effectiveness. But after analyzing the larger set, it found that patients who drank high doses “found significant benefits in cognitive functioning and functioning such as memory, mind, and language”.
Craig Garthwaite, a professor of medicine and health services at Northwestern University, says it is “dangerous” for the FDA to bow to pressure groups of patients who disobey its scientific advisers. He says he is “confused” by “this idea even though we do not know or it does not work we should try to give people hope”.
However experts believe that health insurance may be responsible for covering the drug now that it has been approved by the FDA. Unexpectedly, the supervisor approved for all patients with the condition – not just those with a pre-existing stage of the disease, who were trained in clinical trials.
Most U.S. patients will stay on Medicare, a health insurance for over 65 years, which Biogen told fundraisers expected to cover “the majority” of patients. Some experts predict that this will be Medicare’s largest investment in over-the-counter medications.
The possibilities extend beyond medicine. The difficulty of delivering this seems to be in conflict with the management strategies of those with dementia, leading to the need for a wide variety of staff and valuable resources that have little to do with the disease.
The cost of injecting medicine, radiology and imaging can increase between $ 2,000 and $ 15,000 or more in the cost of medicine, according to estimates from the Premier, a group representing more than 4,000 U.S. hospitals.
David Thomas, chief of research at Alzheimer’s Research UK, says that “a great deal of care for people with dementia. [in the UK] occurs from memory clinics, which are primarily staffed by elderly psychiatrists. “Unlike a medical professional, these doctors” are often unaware of the diagnostic and therapeutic interventions required to address the underlying disease “.
Another major challenge, he says, is finding the right tools. The diagnosis of suspected cases of the disease often involves a series of tests, which do not require special equipment.
To receive aducanumab, the patient must have a certain level of bloody, a protein that can reside in the pockets or organs, which is established through positron emission tomography (PET) tests or severe damage, but is cheaper, injectable, which involves spinal fluid removal.
Qualified patients should be given intravenous fluids every four weeks with aducanumab and receive regular MRI scans that can detect side effects such as inflammation of the brain and blood vessels.
When Alzheimer’s Research UK recently surveyed psychiatrists in the country recently, “many said it could take up to five years to be ready for treatment – assuming they can do it in a year,” said Thomas.
Sanjiv Sharma, a physician and founder of Borghoff’s Advanced Memory Institute of New Jersey, acknowledges the impending hurdles if it could reach all potential beneficiaries. But there is no doubt that the US should light the way. “If we can’t do that [here], as the most developed country in the world, what can we do? ”, He says.
‘Promoting the use of drugs’
Soeren Mattke, director of the Center for Improving Chronic Illness Care at the University of Southern California, says few developed countries are now ready to offer the drug – not only in middle-income and developing countries such as China and Brazil, which have less technical expertise.
However, in the US the cost of treatment will help its businesses, he says. Medicare pays doctors 6% of the cost of the drug, plus admission and fees.
“The US only does business once. . . “Physicians or psychiatrists or therapists realize, ‘well, I can live a normal life and just distribute the medicine through what I do’, then the strongest pull is to set up a training center to find patients,” he says.
This could lead to their own disagreements, points the Northwestern Garthwaite. “There is real encouragement to use this drug even though you think it might help.”
Mattke also acknowledges that similar incentives do not exist in most financial institutions, which are funded by the general public such as Canada and the UK, while long-term approval and low incomes can make buying equipment possible, or being able to find workers.
“I am appalled by the changes that the government has made because we all know that governments do not act quickly,” he added.
In the U.S., Biogen has helped set up more than 900 facilities in the U.S. to deliver the drug. It expects “low” funding by 2021, but the potential to raise billions of dollars in the future, as it can be given between 1m and 2m patients in the US alone.
Roni Christopher, Vice President of design and intervention at the analytics team at Premier, spent last year testing everything from conducting a proper patient knowledge test to training radiologists to see its risks, as well as checking if the intervention sites had adequate seats.
Even with this in mind, more experienced health systems will not be ready to treat patients until the autumn. The FDA’s idea of launching the drug for all Alzheimer’s patients, is proving to be an “overwhelming flood” of interest, says Christopher.
“Patient users or stressors tell us more here, because it is a serious illness,” he adds.
The value of money?
More importantly, though, than the question of how these drugs are delivered and the amount of health systems – as well as the taxpayers who support them – should be willing to pay for non-essential drugs.
In some parts of Europe, where so-called “health testing” is used to measure the financial value of a new drug, the war must be even more closely linked if the drug is to be given to patients. In the UK, the National Institute for Health and Care Excellence has a lot of power around the world, officials have personal worries that they expect the impossible to happen easily.
Umer Raffat, a researcher at Evercore ISI, hopes that even if aducanumab receives green light from the European regime, it “does not allow more than $ 10,000” a year, which puts Biogen at risk of choosing whether to sell to the US five times the European price.
The diversity of this approach is provoking Republican politicians who believe that other countries that fall in the price of drugs are liberating American technology.
On the other side of the political spectrum, some Democrats are using the price set by Biogen as evidence that Medicare should be allowed to negotiate prices – which would apply to the pharmaceutical companies that the government has chosen not to exercise.
Murray Aitken, director of the IQVIA Institute for Human Data Science in New Jersey, believes that the question of how much money to pay for drugs that, while inaccurate, offer high hopes, could lead to delays in whether European governments should spend more on food.
He adds: “It can lead to more discussions in our group, in which we share our resources… It can lead to more discussions and discussions, which I would say are probably too late.”
At home in New Jersey, Jeff Borghoff has no doubt about the value of a drug he believes will increase his chances of a meaningful life. “I know it’s not a drug and it probably won’t cure anything that has damaged my brain from Alzheimer’s,” says Borghoff. He added: “I am 57 years old. I will be fine when I am in my 70’s, it can go well and I hope the treatment will help me to do this.”
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