Jan 22, 2022 6 min read

A recent draft decision by the Centers for Medicare and Medicaid Services (CMS) is not sitting well with the Alzheimer’s Association.

The preliminary decision issued by CMS on Jan. 11 states that the Alzheimer’s drug Aduhelm, which has been approved by the Food and Drug Administration (FDA), will be covered only for patients participating in approved clinical trials.

“The proposed decision is so restrictive it’s hard to consider it coverage,” said Clay Jacobs, executive director of the Greater Pennsylvania Chapter of the Alzheimer’s Association. “It effectively denies access to not only the current, but future FDA-approved treatments that target amyloid and those living with Alzheimer’s disease, regardless of clinical trial results and what the FDA recommends. The potential implications are so significant that we’re asking CMS to reassess it.”

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 insurance portability standards.

Dr. Lee Fleisher, CMS Chief Medical Officer and Director of the Center for Clinical Standards and Quality, said while there is promise with this treatment, the potential for harm exists as well.

“This harm may range from headaches, dizziness, and falls, to other potentially serious complications such as brain bleeds,” he said on the CMS website. “We believe that any appropriate assessment of patient health outcomes must weigh both harm and benefit before arriving at a final decision. Therefore, based on the public comments submitted previously and evidence CMS reviewed, the potential for harm, and important questions that remain, we have determined that coverage with evidence development through clinical trials is the right 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 was 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 some consideration or adjustment to what is the draft right now,” Jacobs said. “There’s a lot of urgency here even as we meet with legislators and the administration of CMS on it.”

Jacobs explained that the Alzheimer’s Association is concerned this draft decision would not impact just one treatment but the entire class of future treatments.

“It’s not just for one treatment,” Jacobs explained. “To have that occur with Alzheimer’s when so many families and individuals are looking for hope, that is what’s truly surprising.”

Something else that Jacobs and others from the Alzheimer’s Association have found surprising is that they have never seen anything like this where any other disease, such as cancer or AIDS, is concerned.

“Treating people with Alzheimer’s different than those with other diseases is something we view as simply unacceptable,” he said.

Jacobs also explained that a decision such as this would limit who could participate to those who live near research institutions or those who can afford to pay for the treatments. Plus, those who participate could receive a placebo or no treatment at all.

“It is essentially a denial of coverage based on all the hurdles that are in the way for somebody to benefit from it,” Jacobs said.

Harry Johns, Alzheimer’s Association CEO, called the draft decision discriminatory toward a certain sector of the population.

“(The Jan. 11) draft decision by the Centers for Medicare and Medicaid Services is shocking discrimination against everyone with Alzheimer’s disease, especially those who are already disproportionately impacted by this fatal disease, including women, Blacks and Hispanics,” Johns said. “With this approach, access to treatment would now only be available to a privileged few, those with access to research institutions, exacerbating and creating further health inequities.

Stacey Pape of Peters Township has witnessed her mother, Audrey Pape, two aunts and her grandmother die from Alzheimer’s disease. She gets emotional when talking about her mom, who died in June 2020 at the age of 91.

Pape, the owner of SP Floors and Design in McMurray, said she’s been involved in recent years with efforts to raise funds for the cause.

“It’s such a devastating disease that when you see a drug – even though they’re looking for more trials to do – that could give them some better quality of life, help decrease 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 fund raise, and you try to find things that can help, and you get it, and they’re saying essentially you have to meet all of these restrictions to get it. The restrictions are so prohibitive, you’re basically not even giving them access to the drug. It’s disappointing and it’s concerning that these are the decisions that are potentially being made.”

Pape added that it’s quite hard to even 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’s no feasible travel distance to get into one, if you can even get into one. Let’s say you get into a clinical trial – there’s a 50-50 chance that you’re even getting the drug. You could be getting a placebo. That’s infuriating to me that you get to this point, and you have to hope for access.”

Since the deadline is tight as to when CMS renders its final decision, the Alzheimer’s Association will use every means necessary to get CMS to reconsider before the decision is final.

“Our role is to be an advocacy organization for the families that are dealing with this disease,” Jacobs said. “We’re using every avenue of communication possible, reaching out to CMS administration not only on a grassroots level, but also with in-depth conversations with the administration themselves. You can’t have treatments or a cure if you don’t have the first one. We’ll work with families and legislators and the administration to do everything we can to get them to reconsider.”