As you may know, the U.S. Food and Drug Administration (FDA) recently approved a new drug for the treatment of Alzheimer’s disease, Aducanumab, which will be known as Aduhelm. The drug is very controversial, and the evidence about the benefits of the drug are unusually unclear.
What is clear, likely uncontroversial, and has been brought into sharp relief, is the pressing need for a far more organized and supportive system of care for people with dementia and their families whether they choose to take Aduhelm or not. (1)
First, a bit about the debate. Some argue that the biology of Alzheimer’s and of the drug mean that it just has to work — since it removes beta amyloid plaques from the brain, Aduhelm must be effective. Others see the significant side effects, relatively small slowing of actual cognitive decline demonstrated to date, and the drug’s giant financial costs ($56,000 annually) and are outraged.
It is painful to see our friends fighting with one another — the geriatrics community seems unpersuaded by the evidence for the new drug, whereas the Alzheimer’s Association and some neurology researchers are very hopeful for it and the path that it may create for other drugs and further improvement.
The Hidden Costs of Aduhelm Care and Caregiving
If you believe the evidence as it stands, the drug, which needs to be administered as an intravenous infusion every month in perpetuity, can delay the progression of dementia equivalent to a month or two over two years compared to placebo. Getting the drug to those with mild symptoms of Alzheimer’s, however, will require more active screening (i.e., PET scans, MRIs, and spinal taps) and observation than is currently common in primary care. (2) This will require the creation of major new capacity to do regular assessments of millions of people at risk.
Once these people are identified as appropriate candidates for treatment, they and their families will need careful education about the risks and benefits of the drug to make informed decisions about their options. Families will need assistance getting their loved ones to treatment — sometimes over the course of years — while cognitive capacities are still declining, albeit more slowly. Patients and families will need education and support to monitor the potential serious side effects of the drug, which commonly includes swelling of the brain and can include bleeding into the brain.
These will be massive tasks for caregivers, creating an enormous burden of time and effort on those who are already very stressed by the behavioral symptoms of the disease and the demands of caregiving. Moreover, managing the many other medical conditions that are present for almost everyone at the age where Alzheimer’s is common only adds to the burden.
What Coordinated Dementia Care Looks Like
Before the Aduhelm controversy erupted, Archstone Foundation has for several years supported many programs to help those suffering with a cognitive disease and their caregivers. For example, the Alzheimer’s Medical Home program developed by David Reuben, the Archstone Professor of Geriatrics at UCLA, and its caregiver bootcamp, helps coordinate the complex care of older adults with Alzheimer’s and supports their caregivers.
Our recently ended Caregiver program supported Adult Day Health Centers, which provide engaging activities, physical therapy, and medical monitoring for people with dementia and respite for their caregivers. These services may not slow the progression of cognitive decline, but they certainly reduce stress, burden, rates of hospitalization, and raise quality of care. Which is actually more than can be said at this point about Aduhelm.
If Medicare is going to cover this drug and its infusion (under Medicare Part B), it must require that providers selling this service also have the capacity and competence to provide comprehensive geriatric health care and effective care coordination for their patients with dementia, as well as training, respite, and support for their caregivers. The Alzheimer’s Medical Home programs developed by David Reuben at UCLA and Malaz Boustani at Indiana University are good examples of what the wraparound services should include.
It would be unconscionable if patients getting monthly Aduhelm treatment and paying as much as $10,000 a year in out-of-pocket co-payments must also pay for and organize additional trips and see additional providers for the rest of their care. Practices providing Aduhelm treatment must be able to bill for Medicare-approved benefits such as Complex Care Management, Care Transition Management, Advanced Care Planning, and must be integrated with a wide range of other services that will be needed for their patients, such as transportation, caregiver respite, home modification, and many others.
One of the sins of our current health care system is that when dementia is observed, the response in too many places has been, “Goodbye, there is nothing we can do for you.” The problem is so bad that physicians often fail to inform patients or families when dementia is suspected or diagnosed, because they don’t want to “demoralize” the patients about an untreatable disease (or deal with the fuss and questions that will arise from the diagnosis.) Things that actually can be done, such as referral to the Alzheimer’s Association for caregiver training, just don’t happen.
An Opportunity to Transform Dementia Care
Now that there is an ostensible treatment, we cannot allow this pattern of indifference to persist. Yes, now there will be financial incentives for Biogen, manufacturer of the drug, and infusion providers to dispense Aduhelm. But for the drug to actually get to patients and provide full benefits, there will need to be very strong wraparound care just to be sure that people can make the monthly trip to the infusion center.
If providers are going to want to sell this one profitable service, they should be required to sell the lower-margin primary care and care management services their patients will also need. It is only right.
Moreover, on the basis of the current evidence, there will probably come a time when Aduhelm stops being effective and will need to be discontinued. Given the age and health burdens of people with Alzheimer’s, many can be expected to die of other causes while in treatment. It would be just cruel for patients and families to be required to change providers when they are in the midst of these crises and trying to care for an increasingly impaired loved one.
I hope that Aduhelm will have the benefits that its proponents believe. I hope that its approval will lead to a string of ever more effective drugs. But as long as they are treatments that slow the progress of the disease — but not cures that return people to full health — we must not prioritize pharmaceuticals without including a commitment to commonsense geriatric primary care, consistent care management, and caregiver education.
We must not let the way that we pay for drugs create tremendous profits for pharma without being sure that we deliver value to patients.
(1) It reminds me of the proposals of the Trump administration regarding dialysis – one of the few ideas for Medicare reform I agreed with in those four years. Medicare leaders recognized that dialysis companies were making tremendous profits from selling the service, but not incented to promote the health of the whole person, to work harder to get transplants, or even raise the share of people doing peritoneal dialysis at home. The administration’s proposal was essentially to allow current profit margins on dialysis, but to require the companies making the money to support improvements in the broader system of care, even if it means that fewer people will be on dialysis.
(2) In fact, as of July 9, FDA changed its initial expedited approval of the drug for all people with Alzheimer’s at any stage of the disease, to be limited to those in the trial who benefited: those at an early stage of the disease.
Comments
I appreciate the thoughtful essay. Maybe we can take this approval of a dangerous and unproven and expensive drug and use the decision to drive improve dementia care. A worthwhile effort!
But , I do not understand the reasoning behind the idea that approval of aducanumab will accelerate development of other drugs. The approval of this drug will make it much more difficult to study its impact as it will become virtually impossible to find a control group. To accelerate development of understanding of this drug we alternatively would need to accelerate funding of studies on its impact in a study.. Can you explain why you think spending billions of dollars on this medicine to be given outside of a study will accelerate development of other drugs?
In terms of research into effective interventions for such a study, I will add that, based on existing research and my clinical experience of 35 years, I do actually think that effective social engagement, exercise, blood pressure control, hearing aids, and optimal medical care have meaningful impacts on the actual progression of cognitive decline in Alzheimer’s disease. Let’s study this much more directly.
Finally, I think we need to ask why our health care system funds an extraordinarily expensive medication that many expert physicians wouldn’t use even if it was free while not funding the comprehensive care that ensures basic dignity. To me this approval demonstrates that the approval and funding system is broken.
I think we need to ask, how can we get our health care system to appropriate resources based on the impacts of interventions on peoples’ health and lives?
Dr Mittleberger - thank you for your thoughtful comments. To be clear I don’t myself argue that approval of Aducanumab will encourage other (hopefully better) drugs - I am just summarizing the argument of others (e.g., https://www.nature.com/articles/d41586-021-01763-9). However as near as I can understand it, there are two reasons offered why this might be true. The first is a historical analogy - when the first statins (and other drug classes) were developed, they didn’t work very well but they “paved the way” for subsequent drugs that were much more effective. The second reason, is basically the reason underlying the historical pattern: when a drug company sees the big profits being made by another company, they become energized to compete and try to bring their own drug through the regulatory process. (On this hypothesis, drug companies have been becoming ‘disheartened” by the repeated failures and they will now have renewed confidence.) As to the pragmatics of doing a RCT in a crowded market, given the co-pays, I don’t know that I think it will be that hard to get someone to try something new if the company pays full freight. On the other hand, I don’t think placebo is necessarily the right control anyway - as you say life style and general health modifications seem likely to have some effect (and/or the existing pills cognex and namenda also show some small slowing of decline) - shouldn’t the next pill have to beat the old treatments, not just be better than nothing (although I know that’s not what the FDA does).
Thank you for this compelling case for Medicare coverage for comprehensive dementia care. The aducanubad debacle does provide an opportune time to reflect on serious problems with how Medicare structures care for older persons with serious illnesses. For several decades, we have had compelling evidence that comprehensive dementia care improves well being for those with dementia and their caregivers. It is far more effective than any drug used for the condition. Yet Medicare does not pay for comprehensive dementia care as they don’t consider its focus on supporting patients and caregivers outside the domain of medicine.
So, it makes it ironic that we are even talking about paying for aducanubad—a drug that would be a bad choice even if free (and as you point out, its administration will put huge ancillary costs on patients and caregivers)—After a distinguished panel of FDA experts strongly recommended against approval, when we already have the much better option of comprehensive dementia care.
As Medicare considers the process of a National Coverage Determination for aduharm, I agree the time is right to also insist they embark on a similar review process for comprehensive dementia care. It would be absurd to cover aduharm without covering comprehensive dementia care.
Thank you for a thoughtful and thought-provoking article on this subject. Health and healthcare is much more than medicine and medical procedures. This is especially true in addressing long-term and chronic care services. and supports.