Jeff Borgov noticed something was wrong after his face cramped and then hung down. When he was only 51 years old and had a catastrophic diagnosis of early-onset Alzheimer’s disease, his greatest fear was the rapid deterioration of his mental strength.
Desperate to keep the condition away, a former IT executive applied for a clinical trial of Biogen’s experimental Alzheimer’s disease drug, aducanumab. Six years later, Borgoff admits controversial treatment for his precious extra time with his wife and three children.
“What we’ve always been afraid of was a sharp decline in all my mental abilities, but to this day it hasn’t,” he says. “There were some symptomatological problems … But the drug is really more time, more time with my loved ones, they are important.”
Now, with this week’s drug approval by US drug regulators, many of the estimated 35 meters living with Alzheimer’s disease around the world are waiting for their own desired infusion.
Still, there is a puncture wound on the tail about what may clearly look like good news to the patient. A series of issues, from the cost of a drug to a question about evidence of its effectiveness, has already been hit by a pandemic and into a healthcare system that may not be equipped to meet the expectations raised. Will put pressure on you.
Drug approval risks widening political and business disparities between the United States, which has a $ 56,000 annual price tag, and Europe, where many governments may be far more skeptical of its value. there is.
Complicating the debate is the growing anger at the FDA. Decision to turn the drug into a green light Considering that there is little evidence of its effectiveness in the first place. Three key scientists have resigned from the advisory board this week. This is probably due to an unusual denial of an objective, data-driven approval process.
Biogen originally abandoned the drug after futile analysis suggested that it was ineffective. However, when we examined a larger data set, we found that patients taking high doses “provided significant benefits in measuring cognition and function such as memory, orientation, and language.”
Craig Garthwaite, a professor of hospital and medical services at Northwestern University, said it was “terrible” that the FDA succumbed to patient pressure groups and did not listen to scientific advisors. He says he is “confused” by “this idea that we should try it to give hope to people, whether we don’t know it or it doesn’t work.”
Still, experts believe that health insurance companies are likely to feel obliged to cover the drug now that it has been approved by the FDA. With an unexpected twist, regulators have approved it for all patients in that condition, not just those in the early stages of the disease studied in clinical trials.
Most U.S. patients will join Medicare, a public health insurance company over the age of 65, and Biogen said it expects investors to cover the “majority” of patients. .. Some experts predict that it will soon be the largest spending on Medicare for the medications that doctors administer.
Drugs are not the only potential cost. The urgency of administering it appears to challenge established patterns of care for people with dementia, creating the need for different types of staff and expensive equipment that are not usually associated with the treatment of the disease.
The cost of intravenous drug, radiology, and imaging can be $ 2,000 to $ 15,000 or more in addition to the drug price tag, according to Premier’s estimate, a group representing more than 4,000 US hospitals. there is.
David Thomas, Head of Policy at Alzheimer’s Research UK, said: [in the UK] It is mainly conducted from a memory clinic where a geriatric psychiatrist is resident. Unlike neurologists, these physicians “often do not have the diagnostic and monitoring experience needed to administer disease-modifying treatments.”
Another big challenge is getting the equipment you need. Diagnosis of a suspected illness usually involves a discreet cognitive test that does not require special hardware.
To qualify for aducanumab, patients must have specific levels of amyloid, a protein that can accumulate in tissues and organs, in the brain. This is established by either a positron emission tomography (PET) scan or a more invasive one, but is usually a cheaper lumbar puncture that involves removing fluid from the spine.
Eligible patients should then be given an intravenous injection of aducanumab once every four weeks and undergo regular MRI scans that can detect dangerous side effects such as cerebral edema and bleeding.
When Alzheimer’s Research UK recently surveyed domestic psychiatrists, “the majority said it could take up to five years to be ready for treatment. Only three minutes thought they could do it in a year. It was one, “says Thomas.
Borgoff’s doctor and founder of the Advanced Memory Institute in New Jersey, Sanjiv Sharma, acknowledges the obstacles ahead when it comes to reaching all those who have the potential to benefit. But he definitely needs the United States to pave the way. “If we can’t do that [here]“As the most developed country in the world, where can we do that?” He says.
“Financial incentives for using drugs”
Soeren Mattke, director of the Center for Chronic Disease Care Improvement at the University of Southern California, claims that few developed countries are currently ready to administer the drug. Health infrastructure.
But in the United States, he suggests that ready-to-treat funding will create a unique business model. Medicare pays doctors for injections and visits in addition to the 6% price of the drug.
“Because the United States is so entrepreneurial, once … neurologists, psychiatrists, and geriatricians said,” Well, just distribute the drug in my practice and it’s actually this. You can live a good life. ” This is a very powerful attraction for setting up a diagnostic facility to find patients, “he says.
This may result in its own conflict of interest, Northwestern University’s Garthwaite suggests. “There is a real financial incentive to use the drug, even if it seems ineffective.”
Mattke also acknowledges that more controlled, publicly funded healthcare systems, such as Canada and the United Kingdom, do not have the same incentives. Long approvals and limited budgets in Canada and the United Kingdom can limit the purchase of equipment and the hiring of new staff.
“I’m a little nervous about the changes caused by the government because everyone knows that the government doesn’t act very fast,” he adds.
In the United States, Biogen has helped prepare more than 900 infusion sites across the United States to deliver drugs. While “moderate” revenue is expected in 2021, billions of dollars are expected in the future as it could reach 1 to 2 million patients in the United States alone.
Roni Christopher, Vice President of Design and Intervention for Premier’s Analytical Group, has spent the past year developing a standard assessment of a patient’s cognitive status, training radiologists to detect side effects, and even enough for the injection site We’ve researched everything from assessing the availability of good seats. ..
Even with these logistics insights, the most experienced healthcare systems may not be ready to treat patients until fall. According to Christopher, the FDA’s decision to release the drug to all patients with Alzheimer’s disease will lead to a “greater flood” of interest.
“Because it’s such a catastrophic illness, consumer or patient pressure will determine a lot here,” she adds.
Even bigger than the question of how medicines are delivered is the health system, and the taxpayers who fund them, willing to pay for medicines with such little-proven effects.
In parts of Europe where so-called “health technology assessments” are used to assess the monetary value of a new drug, the dispute over whether to provide the drug to patients has not yet taken seriously. In the UK, where the National Institute for Health and Care Technology Evaluation has international influence, authorities are personally concerned about rising expectations that cannot be easily met.
Evercore ISI analyst Umer Raffat predicts that even if aducanumab is approved by European authorities, it “will not allow more than $ 10,000” annually, and Biogen will be five times more expensive than Europe in the United States. To sell to.
This difference in approach seems to offend Republican politicians who believe that other countries negotiating cheaper drug prices are effectively liberating American innovation.
On the other side of the political aisle, some Democrats use biogen-set prices as evidence that Medicare should be allowed to negotiate prices. This is a potential bargaining power with the pharmaceutical industry that the government has chosen to exercise less.
Murray Eightken, executive director of the IQVIA Institute for Human Data Science in New Jersey, said the question of how much the healthcare system should pay for drugs that provide a rare axis of hope, albeit flawed, has long been a question. We believe that it may encourage the postponed public evaluation. Whether the European government should spend a higher proportion of GDP on health.
He adds: “It can cause a bigger conversation for us as a civil society in terms of how we distribute wealth … I would say it is probably postponed. , May cause broader social debate and debate. “
At his home in New Jersey, Jeff Borgoff has no doubt about the value of the drug he believes has extended a meaningful life lease. “I know it’s not a cure, and it probably won’t fix everything that’s been damaged in my brain from Alzheimer’s disease,” says Borghoff. He adds: “I’m 57. It’s okay if I live in my 70s. I hope it’s a good run and the medicine helps me do it.”
The Alzheimer’s economy: is the new $56,000-a-year drug worth it? Source link The Alzheimer’s economy: is the new $56,000-a-year drug worth it?