“Something is very, very wrong within HHS when two of its agencies are at war.”

Washington, D.C. (January 26, 2022) – Patient advocacy group UsAgainstAlzheimer’s today urged Health and Human Services Secretary Xavier Becerra to direct the Centers for Medicare and Medicaid Services (CMS) to reconsider its intention to effectively block Medicare coverage for up to a decade for an entire class of drug treatments for Alzheimer’s disease.

The January 11 announcement by CMS would deny Medicare coverage for Aduhelm and the entire class of anti-amyloid monoclonal antibodies, expect for patients who are able to participate in restrictive clinical trials.

“This decision would gut the first—and currently the only—class of drugs aimed at slowing progression. CMS’s proposal would leave us with no options for years—perhaps an entire decade,” UsAgainstAlzheimer’s said in a letter to Becerra. “Tragically, 1,000 Americans a day progress to mid-stage Alzheimer’s disease, meaning that, 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 treatments.”

A potential 10-year delay in access to this class of treatments is “especially intolerable” since the Food and Drug Administration has approved Aduhelm, the first drug in this class, only to have CMS propose to effectively reverse not only the FDA 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 organization wrote to Becerra, warning that the proposed coverage decision would set up CMS as the final arbiters of whether Americans can access a therapeutic drug, a role that CMS has no history of playing.

The full text of the letter is below.

The Honorable Xavier Becerra
Secretary of the Department of Health and Human Services 
200 Independence Ave, SW
Washington, DC 20201
 

Dear Mr. Secretary,

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 and 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, 1000 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 two 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.

Thank you,

George Vradenburg
Chairman and Co-Founder

Russ Paulsen
Chief Operating Officer

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AboutUsAgainstAlzheimer’s

UsAgainstAlzheimer’s exists to conquer Alzheimer’s disease. We take on the toughest problems; bring all of “Us” together to break down barriers; advocate for research that will speed treatments to market; and drive changes that matter most to people living with the disease.We will not rest until brain-span equals lifespan - for everyone.