Share Your Alzheimer's Story with CMS

DJnAZ

I received an email today from the Alzheimer's Association with one block on the page suggesting CMS is considering or has decided to not cover some or all drugs to treat Alzheimer's. Following the suggested link I shared my story, for what it is worth, with CMS.

TO CMS:

My wife, 64, was diagnosed with early onset Dementia in 2021. The exact diagnosis was Mild Cognitive Impairment, MCI. For about two years prior to the official diagnosis it was obvious to our PCP, a neurologist, psychiatrist. other medical personnel as well as our family and friends that she was having cognitive difficulties. After a CT and MRI in early 2021 the presence of amyloid plaque confirmed her dementia.

Her maternal grandmother and mother both died from Alzheimer's complications and while I have been concerned for several years that she might suffer the disease as well, now we know it is a fact. While I can't cite the specific medical and scientific descriptions for her particular condition, I know it is not curable. And at best certain medications can help slow down the disease and perhaps even improve her cognitive abilities. So far, however, the medications she has been prescribed have done virtually nothing and the disease continues to advance at alarming rates.

She has taken Memantine and Donepezil with no apparent improvement in cognition. Other pharmaceutical treatments have been delayed or canceled due to unmanageable costs. While she is not on Medicare until October 2022, from my perspective it is hard to believe Medicare (CMS) is considering or has approved plans to NOT cover dementia/Alzheimer's drugs that may help the patient as well as the family caregiver.

Watching my wife steadily decline is the single most difficult thing I have ever done. Especially knowing that there is little if anything I can do to help her get better. And knowing what awaits her in the not too distant future is even more difficult and depressing. Now, exacerbating the issue is CMS decision to not cover drugs that can potentially help. The drugs may not help everyone with dementia, including my wife. But if they alleviate the patients suffering and improve their lifestyle just a bit then they are worth being covered by CMS.

In addition to this decision to not cover dementia meds, why did I get an increase to my Medicare premium of over 17% that, according to the media and CMS spokespeople, was necessary to pay for Aduhelm, an Alzheimer's drug? There is more than just a little irony when CMS raises my premium to pay for an Alzheimer's drug and at the same time says they are not going to cover Alzheimer's drugs. Then CMS announces Aduhelm will only be used in clinical trials. Why raise my premium if it is only going to trials? In my opinion the drug manufacturer is responsible for the cost while in trials.

I hope you take into consideration what I've written and understand that it comes from the perspective of a family caregiver taking care of a loved one. While trying to live on a fixed income. Thanks for listening.

Crushed

I am sorry but this is a  political pressure campaign as a substitute for medical reality

‘Not a tolerable situation’: Patient groups take aim at CMS over Alzheimer’s coverage decision

Their goal is to strong arm the Centers for Medicare and Medicaid Services into covering Aduhelm, the $28,200-per-year drug, for far more people.

 

https://www.politico.com/news/2022/01/17/alzheimers-coverage-patient-groups-cms-527170

No matter how sad our stories are , and they are sad, there is no clinical evidence whatever that this drug works. 

  







  

https://www.nytimes.com/2021/07/19/health/alzheimers-drug-aduhelm-fda.html

The antibody aducanumab today became the first new Alzheimer's disease drug approved in the United States since 2003. In a controversial decision that shocked some experts, the U.S. Food and Drug Administration (FDA) overruled a group of advisers to conclude that the drug, developed by Biogen, deserved market approval. The decision came despite thin and conflicting evidence from two large clinical trials about the drug's ability to slow patients' cognitive decline.

In announcing the decision, FDA acknowledged those studies of patients with early stage disease "left residual uncertainties regarding clinical benefit." But it opted to approve aducanumab, marketed as Aduhelm, based on strong evidence that it clears a toxic form of the protein beta amyloid, which accumulates in the brains of people with Alzheimer's and is thought to drive neuronal damage. Reduction of these plaques is "reasonably likely to predict important benefits to patients," the agency said.

https://www.science.org/content/article/alzheimer-s-drug-approved-despite-doubts-about-effectiveness

Failure to demonstrate efficacy of aducanumab: An analysis of the EMERGE and ENGAGE trials as reported by Biogen, December 2019

Abstract

Aducanumab recently underwent two large phase III clinical trials that were stopped prematurely by the sponsor Biogen. One trial was trending positive while the other showed no benefits from aducanumab. Post hoc analyses led the sponsor to assert that there was a sufficient efficacy signal to justify a new drug application as a treatment for Alzheimer's disease. The sponsor claimed that subsets of participants receiving sufficiently high doses of aducanumab demonstrated benefits in both trials. In contrast, we identified alternative accounts for the apparent drug benefits in post hoc subgroups that are unrelated to dose effects. Biomarker data were consistent with target engagement, but no evidence was presented to correlate biomarker changes to cognitive benefits. Our analysis supports the conduct of a third, phase III trial with high-dose aducanumab. Aducanumab's efficacy as a treatment for the cognitive dysfunction in Alzheimer's disease cannot be proven by clinical trials with divergent outcomes.

 

https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.12213

  

https://www.science.org/content/blog-post/aduhelm-and-medicare