Senator Collins Blasts CMS’ Refusal to Cover FDA-Approved Alzheimer’s Treatment, Calls on HHS Secretary Becerra to Change Course

03.22.23

Click HEREto watch Senator Collins' Q&A with Secretary Becerra. Click HERE to download.

Washington, D.C.-In a continuation of her efforts to expand Alzheimer's patients' access to treatments, U.S. Senator Susan Collins, the Vice Chairman of the Appropriations Committee, urged U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra to direct the Centers for Medicare and Medicaid Services to reconsider its unfair coverage decision that is blocking a FDA-approved drug for Alzheimer's patients. Secretary Becerra was testifying today at a Labor, Health and Human Services, Education, and Related Agencies Appropriations Subcommittee hearing to justify HHS' fiscal year 2024 budget request.

In January, the FDA granted accelerated approval of a second drug that shows promise for treating patients in the early stages of Alzheimer's. CMS still refuses to provide coverage for this drug, however, and instead is sharply limiting access for this entire class of drugs to individuals enrolled in CMS-approved clinical trials.

As a founder and co-chair of the Congressional Task Force on Alzheimer's disease, Senator Collins has led the charge against this unprecedented action taken by CMS. Last month, she authored a bipartisan letterthat was signed by 20 senators urging CMS to stop putting these promising new treatments out of reach for most patients.

Senator Collins:

Secretary Becerra, welcome. You may have noticed this week that there is a sea of purple in Washington, D.C., and that purple is worn by advocates for those who are suffering from Alzheimer's disease, are afflicted with it themselves, or are caring for someone-or who have lost someone-to this devastating disease. I know that's true of both your family and my family as well. So, it is with great disappointment that CMS is blocking and acting as a roadblock for patient access to drugs that could be very helpful to these patients, particularly, in the early stages of this devastating disease. I just do not understand CMS's misguided and outright unprecedented decision to not cover a whole class of Alzheimer's drugs. It is not CMS's job to second-guess the drug approvals of the FDA. That's not what CMS is supposed to do.

So last month, I led a bipartisan letter signed by 20 senators, bipartisan, asking HHS and CMS to reconsider the restrictive coverage requirements, in light of the FDA's accelerated approval. And I'm disappointed that I haven't received an answer to that letter, which was sent more than a month ago. I'm also perplexed why CMS does not respond to a letter from the American Academy of Neurology that was sent on February 2 that says that the questions CMS has raised have been answered in a massive, successful clinical trial and a peer-reviewed publication reviewing the results of that trial. And that was phase three data. CMS promised to expeditiously look at the data, and yet, we just get silence.

Furthermore, 200 Alzheimer's researchers have also written to CMS and said there's no question that this drug should be allowed for patients who are receiving Medicare. It's not enough, as I believe Senator Capito pointed out earlier, to say you can get it if you're in a clinical trial. That is of so little help to states like ours, where there may not even be a clinical trial going on. Or there may be one that's far away from most of the people in the state.

So, I'm just asking you to tell CMS to let this drug be used, and let people get access to it when the patient, and his or her clinician, agrees it is the appropriate treatment. That's all we're asking.

Secretary Becerra:

Senator, I don't know if there was a particular question, other than to ask CMS. And certainly, CMS has had to review this. Many of the people who are at CMS, who went through this process, have also had loved ones who've gone through illnesses like Alzheimer's. I myself, I've mentioned this, and my wife, have gone through this. There is no doubt that we want to get to the types of life-saving treatments that Americans can benefit from. The difficulty here is that we have to remember that the process that the Food and Drug Administration uses is different from the process that, legally, the Centers for Medicare and Medicaid Services must use to make their determinations. And while it may not make a lot of sense to folks-you have to go into the weeds to understand the distinction-there is a legal distinction, and CMS has to remain consistent in the way it treats any drugs. And so, I will absolutely make sure I take back the information. CMS has said that as soon as they collect the evidence that lets them believe that they now can move to a different level, a different stage, they would. If FDA were to give approval-standardized approval-to the drug, they could then make further progress in broadening the scope of access. But CMS is trying to use the standard it has in place to legally follow its obligations in when it makes a determination for Medicare.

Senator Collins:

Well, I would just suggest to you that CMS now has all the evidence that it can possibly need to grant that approval, given this clinical trial, which was considerable and produced good results, and the 200 researchers. CMS needs to stay in its lane. FDA is in charge of drug approval, not CMS.

Secretary Becerra:

Senator, if you'll allow me? Even FDA is asking the drug manufacturer to continue to provide evidence of the efficacy of the drug. They have not said, with finality, that this drug is safe and effective. They're still waiting for more evidence to come in.

Senator Collins:

Well, I don't know what more evidence you can need than a stage three clinical trial. And it is it's just extremely frustrating. As is the fact that the President's budget does not provide additional funding specifically targeting Alzheimer's research. And that's something I hope we can correct. Thank you.

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As the Chair and Vice Chair of the Senate Appropriations Committee, Senators Patty Murray (D-WA) and Susan Collins are pressing forward with the work of writing our nation's spending bills as quickly as possible. Under their leadership, the Senate Appropriations Committee is moving full steam ahead with subcommittee hearings on the President's budget-providing an important opportunity to assess our country's needs for the coming year and for every appropriator to weigh in on the President's budget.

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