CMS coverage policy is detrimental to Alzheimer’s patients

The biopharmaceutical industry isn’t the only voice raising concerns. Patient advocacy organizations and policymakers have all asked CMS to reconsider the policy.

Gabby MigliaraApril 4, 2023

CMS coverage policy is detrimental to Alzheimer’s patients.

This week marks a somber anniversary for patients with Alzheimer’s. Last year, the Centers for Medicare & Medicaid Services (CMS) finalized a national coverage determination (NCD) that, for the first time ever, uses a coverage with evidence development (CED) policy that forces Medicare patients into highly restrictive research studies to simply gain access to new Alzheimer’s medicines that have been approved by the U.S. Food and Drug Administration (FDA). PhRMA has consistently raised the alarm about the discriminatory nature of this policy, urging CMS to withdraw its proposal in February of last year. Unfortunately, CMS instead finalized its policy with only minor changes and has since left Medicare patients with effectively no access to these medicines.

Alzheimer’s patients, like other patients with neurodegenerative diseases, already face many barriers to treatment. CMS’ decision makes accessing these safe and effective medicines even harder. Their coverage determination severely restricts patient access to these medicines even if the patient matches the criteria for the intended patient population. For example, some patients are compelled to participate in a clinical trial (if one is even available) to obtain access, traveling far distances to the nearest site. CMS should be helping patients access care, not creating more issues for patients battling this devastating disease.

In the one year since this policy was approved, the science has continued to advance, and more research has come out demonstrating the value of this new class of treatments. Already, two additional products are under review with the FDA for traditional approval. And yet, CMS recently stated it still does not have enough data on this class of treatments and refuses to reconsider the NCD despite calls from the patient community to do so.

This decision raises doubt that CMS will reconsider the policy in any timely manner, given the length of time CMS tends to leave these coverage policies in place. It can be as long as 16 years, with some policies having no end in sight. As Ian Kremer, Executive Director of Leaders Engaged on Alzheimer’s Disease, noted in a recent Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting, “In fact, CED creates a circular process. We don’t have coverage because we don’t have data, and we don’t have data because we don’t have coverage.” As a result, Alzheimer’s patients may be without full access to important new treatment options for unknown lengths of time.

The biopharmaceutical industry isn’t the only voice raising concerns. Patient advocacy organizations and policymakers have all asked CMS to reconsider the policy.

  • “Each day matters to someone living with early stage Alzheimer's disease when it comes to slowing the progression of this disease. CMS’s policy to block access to these treatments eliminates people’s options, resulting in continued irreversible disease progression and contributes to greater health inequities.” Joanne Pike, DrPH, President and CEO of the Alzheimer’s Association

  • “This decision creates a barrier to care for older Americans, especially individuals living in rural and underserved areas. Alzheimer’s does not discriminate and patients across the country are losing access to this treatment based on CED requirements. Patients, families, and caregivers living in rural and underserved areas should have the same opportunity for access to treatment.” 74 Bipartisan Members of the House of Representatives

  • “Medicare’s refusal to provide comprehensive coverage of Alzheimer’s medicines will be felt far beyond the Alzheimer’s community. Federal officials will be able to use it as a precedent to further undermine the FDA’s authority and restrict access to future therapies for other serious conditions, such as cancer, ALS, and rare diseases.” Sue Peschin, President and CEO of the Alliance for Aging Research

CMS must reconsider this discriminatory policy and stop preventing patients from accessing the medicines they need. For more information on how this policy burdens patients, read our fact sheet.

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