A recent draft decision from the Centers for Medicare and Medicaid Services (CMS) does not sit well with the Alzheimer’s Association.
The preliminary ruling issued by CMS on January 11 states that the Alzheimer’s drug Aduhelm, which has been approved by the Food and Drug Administration (FDA), will only be covered for patients participating in approved clinical trials.
“The proposed decision is so restrictive that it’s hard to think of as a hedge,” said Clay Jacobs, executive director of the Alzheimer’s Association’s Greater Pennsylvania chapter. “It effectively denies access not only to current treatments, but also to future FDA-approved treatments that target amyloid and people living with Alzheimer’s disease, regardless of clinical trial results and recommendations from the FDA. The potential implications are so significant that we are asking CMS to reassess them.
CMS is a federal agency within the U.S. Department of Health and Human Services that administers the Medicare program and works in partnership with state governments to administer Medicaid, the Children’s Health Insurance Program (CHIP), and health standards. health insurance portability.
Dr. Lee Fleisher, CMS chief medical officer and director of the Center for Clinical Standards and Quality, said while this treatment shows promise, the potential for harm also exists.
“This harm can range from headaches, dizziness and falls to other potentially serious complications such as brain hemorrhages,” he said on the CMS website. “We believe that any proper assessment of patient health outcomes must weigh both harms and benefits before arriving at a final decision. Therefore, based on the public comments previously submitted and the evidence reviewed by CMS, the potential for harm and the significant questions that remain, we have determined that coverage by developing evidence through clinical trials is the correct decision for Medicare patients, clinicians and caregivers, and we look forward to receiving feedback on the proposal.
Aduhelm is the only FDA-approved drug for Alzheimer’s disease with mild cognitive impairment.
Once the draft decision is announced, there is a 30-day period for public comment. According to the CMS website, a final decision will be announced by April 11.
“There really is a short window here for a review or adjustment to what is currently on the draft,” Jacobs said. “There is a lot of urgency here even as we meet with lawmakers and CMS administration on this.”
Jacobs explained that the Alzheimer’s Association is concerned that this proposed decision will impact not just one treatment, but the entire class of future treatments.
“It’s not just for treatment,” Jacobs explained. “That this is happening with Alzheimer’s disease when so many families and individuals are looking for hope is what is really surprising.”
Something else that Jacobs and others at the Alzheimer’s Association have found surprising is that they’ve never seen anything like it with respect to any other disease, such as cancer or AIDS.
“Treating people with Alzheimer’s disease differently than people with other diseases is something that we consider simply unacceptable,” he said.
Jacobs also explained that a decision like this would limit who could participate to those who live near research institutions or those who can afford to pay for the treatments. Additionally, those who participate could receive a placebo or no treatment at all.
“It’s basically denial of coverage based on all the barriers that prevent someone from getting it,” Jacobs said.
Harry Johns, CEO of the Alzheimer’s Association, called the proposed decision discriminatory against a certain sector of the population.
“The Centers for Medicare and Medicaid Services’ (January 11) proposed ruling is a shocking discrimination against all people with Alzheimer’s disease, especially those already disproportionately affected by this deadly disease, including women, blacks and Hispanics,” Johns said. “With this approach, access to treatment would now only be available to a privileged few, those who have access to research institutions, which exacerbates and creates new health inequalities.
Stacey Pape of Peters Township saw her mother, Audrey Pape, two aunts and her grandmother die of Alzheimer’s disease. She gets emotional when talking about her mother, who died in June 2020 at the age of 91.
Pape, the owner of SP Floors and Design in McMurray, said she has been involved in recent years in efforts to raise money for the cause.
“It’s such a devastating disease that when you see a drug – even if they’re looking for more trials – it could give them a better quality of life, help lessen some of the effects of Alzheimer’s and maybe give them more time. I would have given anything for that for my mom,” Pape said. “You do things, you fundraise and you try to find things that can help, and you get it, and they’re basically saying you have to meet all of these restrictions to get it. The restrictions are so prohibitive that you’re not even giving them access to the drug. It’s disappointing and worrying that these are the decisions that are potentially made.”
Pape added that it is even quite difficult to find a clinical trial.
“If you go online and try to access a clinical trial, there isn’t even one in Pennsylvania,” she said. “There is no possible travel distance to enter it, if you can even enter it. Let’s say you’re in a clinical trial – there’s a 50% chance you’ll even get the drug. You may be given a placebo. It’s infuriating to me that you’ve come to this point, and you have to hope for access.
Since the deadline is tight as to when CMS will make its final decision, the Alzheimer’s Association will use any means necessary to get CMS to reconsider before the decision is final.
“Our role is to be an advocacy organization for families struggling with this disease,” Jacobs said. “We use all possible channels of communication, reaching out to the CMS administration not only locally, but also through in-depth conversations with the administration themselves. You can’t have a treatment or a cure if you don’t have the first one. We will work with families, lawmakers and the administration to do everything in our power to get them to reconsider. »