List of Comments
Comments and questions, or alerts to broken links, should be sent to firstname.lastname@example.org.
PLEASE NOTE: The Public Comments included here are not an endorsement of the views or information by National Alzheimer's Project Act, its Advisory Council members, the Administration or the federal agencies involved in this project.
Eli Lilly and Company (Lilly) is excited that meaningful change for people living with Alzheimer’s disease is now upon us. However, the potential benefits of amyloid plaque-reducing therapies, including those approved in the future, can become reality only if patients have timely and equitable access to both therapies and diagnostics.
We are concerned that the Centers for Medicare & Medicaid Services’ (CMS’) Proposed National Coverage Determination (NCD) for amyloid plaque-reducing therapies threatens to undermine the National Alzheimer’s Project Act (NAPA) and the National Plan to Address Alzheimer’s Disease (National Plan).
First, CMS’s proposal to apply the same coverage standard across the entire class of amyloid plaque-reducing therapies and the omission of how a drug that has demonstrated clinically meaningful change in cognition and function will move through and beyond Coverage with Evidence Development (CED) undermines the NAPA’s goal of accelerating the development of treatments that would prevent, halt, or reverse the course of Alzheimer’s disease.1
Second, the Proposed NCD as written may undermine Goal 1 of the National Plan, which is to “prevent and effectively treat Alzheimer’s Disease and Related Dementias by 2025.” Lilly appreciates that effective treatments, not all treatments, should be the touchstone for satisfying that goal. However, limiting access to the entire class of amyloid plaque clearing drugs -- even those not yet evaluated by FDA -- presents a significant roadblock to the goal of deploying treatments by 2025.
Finally, the Proposed NCD as written and recent Part B premium increases attributed, in part, to Alzheimer’s therapeutics, highlights a serious lack of coordination within HHS. This is directly contrary to NAPA’s requirement that HHS deploy an integrated and coordinated response to Alzheimer’s across the federal government. These disconnects highlight HHS’s siloed approach. We urge better alignment, particularly between CMS’s Coverage Analysis Group, CMS’s actuaries, and the Food and Drug Administration (FDA).
As stewards of the National Plan, it is imperative that the Advisory Council encourages HHS to resolve these conflicts, insist on better coordination within HHS, and demand timely access for patients to emerging Alzheimer’s therapies. We encourage the Advisory Council to provide this important feedback through formal comments on the Proposed NCD.
1. Pub. L. No. 111-375, § 2(c) (Jan. 4, 2011)
It is well documented that Alzheimer’s Disease and Related Dementias (ADRD) disproportionately affect the Hispanic/Latino community.1 As this population ages, the number of Latinos with Alzheimer’s disease is expected to grow to 3.5 million individuals by 2060.2 CHWs are trusted members of the community who empower their peers through education and connections to health and social resources.3 CHWs are known to improve healthy behaviors and chronic disease management,4,5 which is linked to risk reduction for cognitive decline and dementia.6 CHWs are uniquely qualified to reach vulnerable individuals at high risk for developing dementia and provide culturally and linguistically appropriate services.
Funding CHW programs to promote brain health awareness and provide health education around dementia risk reduction practices can have a substantial impact on vulnerable and underserved communities, especially those disproportionately affected by ADRD such as the Hispanic/Latino and African American communities. CHW programing has been shown to provide a positive Return on Investment,7 and culturally specific CHW-led interventions have the potential to significantly decrease the financial burden of ADRD a on healthcare systems as well as individuals and families affected by dementia. CHW programs addressing dementia risk reduction help address the National Plan to Address Alzheimer’s Disease’s new goal to Accelerate Action to Promote Health Aging and Reduce Risk Factors for ADRD, specifically, Strategy 6.D: Expand Interventions to Reduce Risk Factors, Manage Chronic Conditions and Improve Well-Being through the Aging Network.
In summary, the CHW profession is exceptionally qualified to promote brain health initiatives and implement risk reduction interventions in high-risk, vulnerable communities. Providing opportunities for funding such CHW programs can have a significant impact on communities disproportionately affected by dementia as well as reduce the financial burden of ADRD.
I would like to thank the Advisory Council for allowing the Global Alzheimer’s Platform Foundation, a patient-centered organization dedicated to accelerating clinical trials to discover cures or treatments for Alzheimer’s, to provide comments on the critically important questions before the whole Alzheimer's community regarding the CMS draft national coverage determination that was issued on January 11, 2022.
Ten years ago, the National Alzheimer's Plan Act was enacted. Among its requirements, was the congressional directive that the Secretary of Health and Human Services, this Advisory Council, and all the relevant agencies of the federal government would work together to collaborate on research and clinical practice to eventually find either a cure or an effective treatment for Alzheimer's disease by 2025.
It is my sad duty to report that in our opinion, you, the Advisory Council need to tell Secretary Becerra that we are in fact in great danger of not meeting that 2025 goal. We are running out of time to avert this failure.
On June 7, the FDA gave accelerated approval to Aduhelm, a Biogen drug for reducing beta-amyloid plaque in the brain to slow the progression of Alzheimer's disease. This disease modifying drug is the first FDA approved drug for Alzheimer’s patients in over 20 years--giving newfound hope to Alzheimer’s patients. They did this pursuant to their authority under the accelerated approval portion of the New Drug Act, a statute that expressly gives the authority to the FDA to approve a drug that effects changes in a surrogate endpoint adequate to convince the FDA that it is “reasonably likely…to predict clinical benefit.”
On January 11, any hope created by the FDA's decision for hundreds of thousands of Alzheimer's patients was reversed when CMS issued a draft national coverage determination that limited the coverage to patients in CMS approved randomized clinical trials that would be required for the whole class of Alzheimer's drugs such as Aduhelm. This elimination of hope, this restriction on the first class of AD therapies in 20 years is in fact, the most restrictive CED ever issued by CMS for any drug.
By the NCD’s terms, beginning now and for many years to come, less than 1% of the people who could benefit from this class of drugs will have access to these treatments.
Here is exactly what happened. CMS conducted a literature review and overweighted old trial results to support its position and underweighted unhelpful studies, such as an NIH meta study that reviewed 17 clinical trials focused on the benefits of clearing beta-amyloid and found a statistically significant cognitive benefit. CMS took 7 months to unwind decades of research and concluded that beta amyloid plaque may in fact not be the cause of Alzheimer's disease, a position that casts uncertainty and doubt on all the NIH and pharmaceutical trials that are currently being conducted in Alzheimer’s disease.
Then, it not only severely restricted access to Aduhelm specifically but overreached and extended their determination to the entire class of drugs that are up for approval in the FDA for the next two years, without affording any of these drugs the opportunity to present their data on safety and effectiveness. CMS is eviscerating FDA’s effective use of accelerated approvals for Alzheimer’s drugs and putting other disease indications at risk as well. Previously, all FDA drugs advanced with accelerated approval that have come before CMS have been covered by CMS for reimbursement to label. Moreover, CMS is requiring trials that will take up to 10 years to undertake in a hospital-based network ill-suited to conducting these trials quickly or recruiting diverse populations. This is a perfect storm. Not only will the RCTs be limited to a handful of patients covered by Medicare, but broad coverage and access will not be available for a decade or longer. This is unconscionable.
Let's step back a second. The classic definition of discrimination is similarly situated people receiving substantially different government treatment. Cancer, HIV, Multiple Sclerosis, have all received accelerated approvals from the FDA and then coverage to label by CMS.
On the other hand, if this NCD is finalized, Alzheimer's patients will receive the most restrictive NCD for a drug in the history of the agency--not coverage to label. One of many discriminatory and unwelcome firsts:
- This is the first time CMS has tried to overrule FDA on accelerated approval.
- This is the first time that CMS has opined on the cause of Alzheimer's disease, in conflict with the FDA, NIH and the private sector.
- This is the first time CMS has issued an NCD-CED for an entire class of drugs.
- And, this is the first time that CMS has prescribed an NCD requiring randomized clinical trials for drugs that will take a decade to conduct as written.
There is now a scientific and clinical schism between FDA and CMS, and NIH is alarmingly silent on this question; a question that puts its research portfolio in doubt. FDA and NIH are the centers of excellence for the study and regulation of neurology. CMS does not even have a neurologist on its staff. This disequilibrium violates the intent of The National Alzheimer's Plan Act and puts the 2025 goal out of reach.
More importantly, the Secretary needs to understand that every day a minimum of 1,000 Alzheimer’s patients will progress in their disease to a point where this new class of drugs cannot help them. If CMS finalized this discriminatory NCD as written, over 3 million patients could be denied access to these Alzheimer’s modifying therapies. Alzheimer’s patients cannot stand for this callous disregard for their future.
Why are Alzheimer’s patients being subjected to an unprecedented, onerous process? The NCD puts CMS in direct conflict with the FDA and NIH research. It will not yield quick or meaningful results, and it will not result in more diverse populations in the studies. It puts millions of Alzheimer’s patients at risk of never being able to benefit from this class of drugs. The FDA has spoken, let patients and their doctors decide whether to use these drugs to combat their progressive, fatal disease.
We call on the Advisory Council to engage with the Secretary and put him on notice. CMS must change its NCD back to its long-standing practice of “coverage to label.” The Secretary should also encourage CMS, FDA, and NIH to collaborate on methods for collecting additional evidence of safety and benefit for this class of drugs while patients and their doctors utilize these treatments. This process must begin now to avert the unwarranted denial of disease modifying therapies to Alzheimer’s patients and thwarting the goals articulated by Congress in the National Alzheimer’s Plan Act.
Thank you for allowing me to share our views on behalf of the Global Alzheimer's Platform Foundation and the millions of Alzheimer's patients that will benefit from this class of therapies.
I serve as the Senior Director of Public Policy at the National Down Syndrome Society, the leading human rights organization for all individuals with Down syndrome.
On behalf of NDSS and the Down syndrome community, I wish to thank the Council for the opportunity to speak today. During the October 2021 meeting, a few of my colleagues addressed the Council to share why it’s critical for this body to address the needs of our community, and they recommended actions that could help you do so. I’d like to follow up on those recommendations today.
The critical link between Down syndrome and Alzheimer’s disease is genetic. Because the amyloid precursor protein that is the basis for Alzheimer’s disease to occur is present on chromosome 21, people with Down syndrome, who have three copies of chromosome 21 instead of two, are at a higher risk for developing Alzheimer’s disease. In the real world, people with Down syndrome have a 90% chance of developing Alzheimer’s disease. They will see the onset of these symptoms earlier in life than members of the general public, and, once they do, they will experience a faster progression of the disease. Alzheimer’s disease is currently the number one cause of death for individuals with Down syndrome. It could not be any clearer that the Down syndrome community has an urgent need for support from the Alzheimer’s community.
In October we recommended that this council establish a special subcommittee to focus on how HHS can improve the diagnostic and clinical supports available to individuals with Intellectual and Developmental Disabilities, including Down syndrome. Today I wish to reiterate that request because the need for the subcommittee has only become more pressing in the past few weeks.
On January 11th, CMS proposed to cover aducanumab under a Coverage with Evidence Development (or CED) framework. Part of that CED protocol excludes people with Down syndrome and other intellectual and developmental disabilities entirely. This exclusion from coverage now will have both short- and long-term negative effects on our community because aducanumab is a breakthrough treatment, and the CED is meant specifically to help develop evidence of the drug’s effectiveness. If CMS moves forward with this exclusion, whatever evidence might be developed, none of it will apply to our community, and people with Down syndrome will be no closer to gaining covered access to a safe Alzheimer’s treatment. Instead, our community will be farther away than everyone else. As new developments are made based on the health outcomes of aducanumab, that gap will only widen.
We will be addressing remarks directly to CMS as part of the public comment process, but we also believe that this sequence of events demonstrates that, where Alzheimer’s disease is concerned, the Down syndrome community needs champions within the federal government. We believe that members of this council, as part of a special subcommittee on intellectual and developmental disabilities, can be those champions.
Thank you again for the opportunity to speak today. All of us at NDSS are eager to work with you to promote positive outcomes for our community and stand ready to assist however we can.
Hello…thank you for allowing me to present my story today. Joe and Loretta were my parents…both died from Alzheimer's disease. I was their caretaker.
I am now diagnosed with MCI due to Alzheimer's disease. My brain scan shows that I have pathologically significant levels of beta Amyloid in multiple areas of my brain. Aduhelm has been shown to remove this sticky amyloid from my brain,…this fact is scientifically proven and undisputed.
I have been receiving FDA approved Aduhelm infusions for 5 months without any complications. This decision was arrived at with my Geriatrician. This is MY informed decision. I want to repeat that…MY Decision for MY Brain.
The draft decision by CMS leaves me in fear and dread again. Others and I thought we were going to be in the first wave of patients stopping Alzheimer’s in its tracks,…instead it appears that due to this discriminatory CMS draft I and others may instead be drowned by that wave.
There is a tipping point in Alzheimer’s disease, which is early cognitive decline. Progression of decline past that that tipping point means there is no hope.
Aduhelm is aimed at arresting early cognitive decline.
So to those who seek to create barriers to the one and only treatment option myself and millions of others have available, please stop.
If you have a better alternative, please share it with me, but do so quickly. I have a progressive, fatal disease. My tipping point is getting closer. I have no time to debate.
I am literally begging CMS to provide coverage and access to treatment, as it does for other FDA approved drugs. We need hope, not false hope, but real hope.
For too many of us in the early stages of this dreadful disease this is a life or death decision. The Draft position by CMS MUST NOT BECOME POLICY!!!
I was diagnosed with Alzheimer's about 6½ years ago. I have been taking medication for the past 6 years which seems to be slowing the progression of the disease. I have been also in non-stop clinical trials for the last 5 years. Being in a clinical trial allows me to participate in my disease It is important to me to prolong my life as long as possible.
Denying coverage of a medication that could help people live and function longer, is heartless. You cover all other diseases but you choose not to cover an uncurable disease that right now affects 6.2 million people. And that number is expected to increase by 16% by 2025.
By putting a stipulation for people to have to be enrolled in a clinical trial to get coverage of the drug is absurd. The majority of people are not even aware of such trials. And if they are, they probably are not in proximity to the trials, have the means to get there, can make the required commitment and are also perhaps wary of them.
I want to prolong my life in hope that the longer I live the greater the odds that I will die of something else and not put my family through the anguish of seeing me disappear or the financial strain to my wife.
My request of you is to work with insurance companies and the pharmaceutical industry to decrease the price of this medication and any future medications that become available so that it is more accessible to those suffering from this disease. The fact that a price tag of $58,000 is placed upon a medication for a horrid disease is aggrecious. Could you afford it?
I and all those that have Alzheimer's deserve the right to try and live our lives, and quite honestly save our lives as long as we can. To have hope that this disease won't take us away from ourselves and our loved ones. Who are you to deny that right? If you had this disease, wouldn’t you want a chance to live longer?
Thank you for your strong support of people living with Alzheimer’s disease and their families. The way you speak about your father and your own role as a caregiver is moving. We appreciate your powerful representation for the 6 million Americans who have this devastating disease and the tens of millions more who love them.
Thank you also for being the first Secretary to add a sixth goal to the National Alzheimer’s Plan.
And, finally, thank you for directing the Centers for Medicare & Medicaid Services (CMS) to reconsider the Medicare premium increase. Alzheimer’s patients have been paying their Medicare premiums for their entire working lives and it was shameful for CMS to publicly blame them for this premium hike.
Alzheimer’s patients and their families need your leadership again. CMS has released a draft decision which effectively would deny coverage for an entire class of Alzheimer’s medicines, regardless of the benefits shown for those medicines in regulatory trials. This decision would gut the first--and currently the only--class of drugs aimed at slowing progression.
CMS’s proposal to cover only patients in CMS clinical trials and not all who would benefit would leave us with effectively no access to new Alzheimer’s treatments for years--perhaps an entire decade.
Tragically, 1,000 Americans a day progress to mid-stage Alzheimer’s disease, so, over 10 years, more than 3.5 million Alzheimer’s victims would be on an irreversible, painful path to their death while their government effectively blocked access to FDA-approved treatments.
A potential 10-year delay in access is especially intolerable since one of your agencies (FDA) has approved the first drug in this class, but another of your agencies (CMS) has proposed to effectively reverse not only the FDA’s approval for the current drug but for future drugs as well.
Something is very, very wrong within HHS when two of its agencies are at war.
The proposed decision would set up CMS as the final arbiters of whether Americans can access an Alzheimer’s therapeutic drug, a role they have no history of playing. Your FDA is staffed with thousands of scientists who are experts in drug review. Some of them have literally written the book on how clinical trials should be conducted and how to evaluate efficacy and safety. Scores are neurologists. Please do not let CMS--with zero neurologists, zero experts in clinical trial design, and zero history of reviewing the safety and efficacy of therapeutic drugs--deny access to new treatments because they want to try out a new idea on Alzheimer’s patients.
CMS publicly characterized its proposal as “Coverage with Evidence Development,” but the fine print in its proposed Decision is explicit that the entire class of drugs is “non-covered” except for the few thousand who might participate in CMS-approved clinical trials, not the estimated 2 million Americans who might benefit from drugs in the class.
Some may argue the proposed decision is supported by science, but that cannot be true since it applies to drugs where final clinical trials are not completed and whose data are not yet reported. The draft NCD preemptively and effectively dismisses scientific evidence that has not yet even been produced.
CMS, appropriately, says that it seeks to improve the racial and ethnic diversity in Alzheimer’s clinical trials. We support that goal 100%, as evidenced by our years of advocacy, by the creation of the UsAgainstAlzheimer’s Center for Brain Health Equity, and by our work with many stakeholders in the Alzheimer’s field to improve the infrastructure needed to achieve that goal. However, CMS inexplicably undercuts its own position by exempting trials supported by NIH from this proposed rule which, as NIH itself acknowledges, have been unable to achieve adequate levels of diversity. And “CMS trials” would need to be done exclusively in tertiary-care hospital centers, which have historically underperformed community sites in recruiting diverse trial participants. A laudable goal without an effective plan for how it might be achieved, and with material adverse effects on patients, is not good policy.
As you know, Alzheimer’s is a progressive, fatal disease. If this decision is allowed to become final, the 1,000 Americans every day who progress beyond the reach of any of these drugs and their families would be out of hope, consigned by their government to decline and, ultimately, death. Every day matters.
We very much want your intervention, again, with CMS to cause it to reconsider its proposed non-coverage of the first class of Alzheimer’s drugs. FDA-approved drugs for Alzheimer’s patients ought to be covered by Medicare, consistent with the FDA label, while additional, real-world evidence of the performance of the drugs is developed. Patients, informed by their doctors should have the choice of whether to use these drugs; CMS should not take that away.
We stand ready to convene Alzheimer’s stakeholders, including the world’s experts in the disease, to provide any help you might need.
Hello. I am the Advocacy Manager for the Association for Frontotemporal Degeneration. Thank you for the updates this afternoon and for this opportunity to address the council.
As I was reading the New York Times this weekend I found the weekly health quiz. I was surprised to see that one the questions in the quiz was “What is the most common form of dementia in people under 65”. The quiz listed 4 possible answers to this question, since it is a multiple-choice quiz, and the answers were the four diseases covered by the National Plan. While I can’t draw any direct lines between NAPA and the New York Times health quiz, I doubt that this was just a coincidence and like to think that it reflects the progress made since NAPA began almost a decade ago. At the very least it made me pause for a moment of reflection.
Ten years ago, mention of FTD in the New York Times would have been a big deal to the 4 or 5 of us who worked at AFTD. Now, none of the 30 people I work with has mentioned it. While this is far from a rigorous way to measure progress it is hard not to see how far understanding and awareness of dementia has come in the relatively short amount of time since NAPA started.
On the other hand, while preparing for the next ADRD research summit this March and reviewing progress and milestones from previous summits as well as the updated actions in the National Plan I was once again struck by how cumbersome the AD/ADRD shorthand is and how confusing the term Alzheimer’s disease and Alzheimer’s disease related dementias is. This is especially true when trying to introduce or explain the research summits and the National Plan to people who are not already familiar with it. There is a growing gap between what professionals and experts know about dementia and what the public needs to understand about dementia in order for NAPA to accomplish its goals. At this point the shorthand term AD/ADRD is helping keep that gap open by generating more confusion than clarity about the aims of NAPA.
In order to close the gap there needs to be a better way for everyone to talk about dementia. And that is exactly what the Dementia Nomenclature Initiative has been working on and is ready to share as widely as possible. AFTD urges the council to continue to support the work started by the dementia nomenclature initiative and adopt the nomenclature and communication framework the initiative has developed as much as is possible.
This decision amounts to shocking discrimination to everyone with Mild Cognitive Decline and Alzheimer’s disease.
With this approach access to treatment would now only be available to a privileged few, those with access to research creating further health inequities.
Millions of Americans have a type of condition the FDA has approved a drug to treat, which is Mild Alzheimer’s related cognitive decline. This move by CMS vastly limits the number of individuals who could use the drug.
This decision is highly unusual and is the first time the CMS limited Medicare beneficiaries access to an FDA approved drug in this way.
This denies the daily burden of people living with Alzheimer’s disease, and the clinical trial requirement will exclude all individuals who may benefit.
Private insurance companies will now follow the FDA’s lead. Knowing how many FDA approved treatments for cancer and other diseases that have significant side effects and often outweigh the clinical benefits, the CMS has never denied access to those drug treatments.
This decision is driven by the cost of this drug.
This preliminary decision is extremely disappointing and borders on discrimination.
For me, who was diagnosed over 3 years ago with a frequent accumulation of amyloid plaque as a result of an Amyloid PET Scan, this decision denies me an opportunity for a longer and productive life.
At the age 52, I was diagnosed with Younger Onset Alzheimer’s.
As you know Alzheimer’s has no cure, no prevention, or even a way to slow the progression down.
I have tried all of the outdated medications available. Neither of which are disease modifying. And I can only take one of them.
My only hope is these new medications; however due to the restrictions being imposed, by CMS they have now signed my death warrant.
Because of my age, I do not qualify for many of the clinical trials. Last year, I was finally considered for a trial in Charleston, SC.
This is over 220 miles one way from my home. They wanted us there 3 days a week every other week.
How can I do that? Financially it would ruin us paying for the hotel stays, gas, food, and the upkeep on our vehicle alone.
Being diagnosed with Alzheimer’s at such a young age has a negative stigma as it is. People look at you like you are already gone and have nothing left to contribute to the world.
Well, I am not gone. I am still here. I am fighting to be here every day.
Now there may be a chance for another treatment for me but it is being taken away because I am not a part of the privileged few. This is not fair.
Because of this decision I will not be allowed to see my children and grandchild grow up.
They say when you are diagnosed with Younger Onset Alzheimer’s you usually have 8-10 years before you slip away, well that basically means I have five more years and I will be gone at 61.
Can you look into my family's eyes and explain to them why they will lose their Grandmother, Mother, and Wife at such a young age? Please urge CMS to think of everyone.
I think I have been speaking here for 10 years now. I feel like my friends and I with dementia are not being heard. We lose our civil rights when diagnose with dementia on your medical record. Why?
Ten years ago, I meet Dr. Terman here at NAPA, as we had similar interest. While then we did not totally agree we did make progress to see what needs to be done. I want to live life to the fullest with dementia, but I also want to die on my time with dignity so I do not suffer from the worst parts of this disease. That is not possible in the USA because of the laws. In the last 10 years many countries made big strides on the right to die, but nothing changed here.
Why can’t my present self be able to put my wishes in writing now, so it can be honored in the future, when I am no longer capable because mind because has deteriorated from cognitive issues. I know what I want, and it should be my choice.
When my sister decided to give up from cancer, she said her good byes and within 8-12 hours she had died from morphine overdose. She died peacefully. Why can I not die the same way, in peace. Am I not being tortured enough daily by this disease already?
I have seen to many people take their lives to early just because they had no choice. These folks died way to early because the laws were against them. Let’s not wait another 10 years as to may have already died years before they should have.
I am from Eagan, Minnesota, and I’m joining today to talk about the recent decision by the Centers for Medicare & Medicaid Services (CMS) to effectively not cover current and future Alzheimer’s disease treatments targeting amyloid.
As only one of the more than 6 million Americans living with this life-sentencing disease, I want to voice my humanistic argument against CMS’s decision to require that me and my peers living with Alzheimer’s find, locate and enroll in a treatment-qualifying clinical trial for an already approved FDA treatment.
I was diagnosed with mild cognitive impairment in 2015. Problems with my cognition first started when regular activities became increasingly more difficult. I faced challenges with fixing things around the house--a life-long passion of mine--and I forgot how to cut my wife’s hair--something I did throughout our marriage. These changes were frightening.
For people living with Alzheimer’s disease, time is extremely precious. Time is all we have--and the loss of time is what we fear the most. On average--from diagnosis to death--we have four to eight years of life with Alzheimer’s. With our diagnosis, we don’t have a cure, or a disease-modifying treatment, until now.
In June 2021, the FDA approved a disease-modifying treatment (the first ever!) that finally gives us living with Alzheimer’s a sliver of hope. Hope that we might be able to spend more time with our spouse, children and loved ones. So, I ask you why is my government taking away our hope by requiring additional obstacles for an already FDA-approved treatment?
What makes Alzheimer’s any different from other life-defying diseases like cancer, heart disease and HIV/AIDS? It’s simply unacceptable. It’s beyond baffling to me to limit access to a current FDA-approved treatment for Alzheimer’s available to the public--a treatment that may treat the underlying cause of the disease--but it is being barricaded by a government institution.
For me and my family, I simply want the same opportunity as people facing other diseases--that have since discovered disease-modifying treatments--access to treatments that may give us more time. Until there is a cure, we want more time.
I am asking CMS to please change its decision. Don’t limit the time--the precious time--people living with Alzheimer’s have--by making us jump through added hoops to access a treatment the FDA has already approved for public use. Give us the more time we deserve.
Thanks for letting me share my story.
Included below are comments regarding the Dementia Nomenclature Initiative (DeNomI) AFTD submitted in response to the NINDS RFI (NOT-NS-22-032) on priorities and progress in Alzheimer’s disease-related dementia research for the 2022 ADRD research summit. AFTD’s input was respectfully received and acknowledged, but we are disappointed to learn that this year’s summit will not include a session on dementia nomenclature, as it has in previous years. Consequently, there is no session chair or NIH lead to whom we can direct our input on DeNomI. AFTD has supported DeNomI since its inception and strongly believes that the communication framework the Initiative has developed can help broaden the national conversation on improving care and advancing research on dementia and the variety of diseases that cause it. We respectfully share our comments below and urge the Advisory Council to continue to support the important work of the Dementia Nomenclature Initiative.
AFTD input on 2019 ADRD Research Summit Session 4: Dementia Nomenclature.
AFTD unequivocally encourages that the second phase of the Dementia Nomenclature Initiative (DeNomI) be supported by either the NAPA Advisory Council or, preferably, by a federal agency involved with dementia research, dementia care and services, or dementia education and awareness. The nomenclature and communication framework proposed by the DeNomI does not require changes to diagnostic criteria or other facets of clinical care or research; however, it will substantially enhance communication between and across researchers and clinicians and between clinicians and their patients. It will also improve the public’s understanding of what dementia is and the fact that there are multiple underlying diseases that can cause it. The DeNomI nomenclature and communication framework will facilitate more meaningful discussions between clinicians and their patients and families about all aspects of a dementia diagnosis including prognosis, symptomology, and care planning as well as improving differential diagnosis for non-AD dementias. This framework clearly describes the observed clinical features and their severity and explains the relationship between clinical symptoms and multiple possible disease processes, as well as how that distinction may determine an individual’s eligibility for certain research studies.
Communicating this same distinction between clinical manifestation and underlying pathophysiology is critical to research as well. For example, researchers may approach a brain bank requesting dementia tissue without clarity on whether the biosample they are seeking is related to a specific phenotype or specific underlying disease mechanism. This lack of precision can easily undermine the validity of studies, and slow down progress as a whole.
Clear and accurate communication about neurodegenerative disease, and particularly about risk and the importance of cognitive screening, is essential if we are to avoid the stigma and misdiagnosis often surrounding the dementia journey and ensure there is an available, identified, and informed population of research-ready participants.
The Dementia Nomenclature Initiative grew out of ideas and recommendations discussed by the NAPA advisory council and we urge the council to continue to champion this effort and do what it can to ensure that the Initiative is able to move on to the second phase of its work.
I have mild cognitive impairment diagnosed in 2017. I am disappointed with the CMS decision involving Medicare covering Aduhelm and related treatments only if you are involved in a clinical trial.
I have attempted to participate in a trial but since I live in a rural area over 400 miles from a trial location, I haven’t been able to be included.
Also the cost of the medication is only $28,000 a year which is just a fraction of of the cost of cancer or treatments for other diseases. Aduhelm would provide me hope that the disease will not progress or even possibly reverse.
Thank you to the Advisory Council for this opportunity to speak to the inclusion of rural caregivers in clinical care.
I am a clinician researcher at the Oregon Alzheimer’s Disease Research Center. I have been studying the use of telehealth in both clinical assessments and caregiver support since 2016.
In Oregon almost 50% of adults over the age of 65 live in rural areas,1 yet the majority of dementia specialists live and work in metropolitan areas. This mismatch in availability of clinicians for rural families has spurred our team, over decades, to bridge the care gap using technology, for example:
- We found that standard cognitive and caregiver assessments, when used with videoconferencing, have high reliability, indicating clinicians can use the assessments with confidence.2
- Our annual Dementia 360 series provides videoconference-based education and support to clinicians across the 98,000 square miles of Oregon using the ECHO model.3
- My own research, funded by the NIA, is currently testing Tele-STELLA,4 a videoconference-based caregiver support intervention.5
- Due to removal of Medicare’s Originating Site rule our clinical team can now provide care for those living with dementia, and their caregivers, using videoconferencing.
My overarching point is that our NIA-funded Oregon ADRC has clearly demonstrated the importance of, and ability to, include rural caregivers in clinical studies and trials using technology-based strategies. Our efforts have been readily translated into our clinical services that include caregivers across the dementia spectrum.
However, unfortunately, access to high-speed internet is still limited for rural families. In 2021, the National Telecommunications and Information Administration noted that, in many parts of the country, communities still lack broadband access at the FCC’s current benchmark speeds (https://www.ntia.doc.gov/press-release/2021/ntia-creates-first-interactive-map-helppublic-see-digital-divide-across-country).
In addition, increasing access must be paired with adequate technology support as a workforce of experts to deliver optimal remote dementia care.
Our technology-based work and funding at the Oregon ADRC has been informed by the National Plan for Alzheimer’s Disease’s comments on the need for telehealth availability for rural families.6 I urge the committee to continue to prioritize this need, so that any family living with Alzheimer’s in the US can access the care and support they need.
- Oregon Office of Rural Health. Aging in rural and frontier Oregon: Challenges facing rural and frontier home health agencies. In: Health OOoR, ed. Portland, OR2016.
- Lindauer A, Seelye, A., Lyons, B., Dodge, H.H., Mattek, N., Mincks,K., Kaye, J., Erten-Lyons, D. Dementia care comes home: Patient and caregiver assessment via telemedicine. Gerontologist. 2017;Oct(57(5):e85-e93).
- Lindauer A, Wild K, Natonson A, et al. Dementia 360 ECHO: Using technology to facilitate diagnosis and treatment. Gerontology & Geriatrics Education. 2020:1-7.
- Lindauer A, Messecar D, McKenzie G, et al. The Tele-STELLA protocol: Telehealth-based support for families living with later-stage Alzheimer's disease. J Adv Nurs. 2021;77(10):4254-4267.
- Teri L, McCurry SM, Logsdon R, Gibbons LE. Training community consultants to help family members improve dementia care: A randomized controlled trial. Gerontologist. 2005;45(6):802-811.
- Alzheimer's A. Alzheimer's from the frontlines: Challenges a national Alzheimer's plan must address. In. Vol 2016.
I am a psychiatrist and bioethicist. Two years after I wrote the 2007 book, The Best Way to Say Goodbye, I created the patient decision aid, My Way Cards, which now has 50 illustrated conditions. It describes each condition at the fourth-grade level of reading comprehension and asks patients: “Would this condition cause you severe enough suffering to want to be allowed to die of your underlying disease?” If “Yes,” patients will thereby inform future treating physicians when to write this order: “Cease assisted feeding and hydrating.” While needed to prevent prolonged dying, some physicians refuse to write this controversial order.
Patients can complete their living wills by collaborating with advance care planning counselors and diligently review their advance decisions three times before memorializing them on video. Yet by themselves, clear and convincing living wills may not be effective. Strategies such as these must be added: (1) A bilateral contract assigns the role of “advocate” to proxies/agents and empowers them to bridge the relationship between the capacitated patient of the past and the treating physician of the future so the evolving contract can be binding and irrevocable. (2) Patients complete “Future POLSTs” during advance care planning that must be consistent with their living will requests. Why are POLSTs effective? They are sets of immediately actionable orders that healthcare providers must generally honor across treatment settings. (3) Patients swear or affirm their POLST is true in front of a Remote Online Notary so their POLST can be entered into evidence in a court of law. (4) Advanced online security features can reduce virtually all doubt about the patient’s identity and the POLST was not modified since signing. If successful, patients will not suffer from the Dementia Fear or hasten their dying prematurely. Instead, they will enjoy living until they experience a peaceful and timely dying based on their personal values.