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In comments submitted this week, PhRMA urged the Centers for Medicare & Medicaid Services (CMS) to withdraw its proposed national coverage determination (NCD) for monoclonal antibodies (mAbs) for the treatment of Alzheimer’s disease. The proposed policy would set a dangerous precedent of CMS severely restricting patient access to FDA-approved medicines, putting in place barriers to treatment options for a devastating illness, especially for patients in underserved communities. We urge CMS to instead provide Medicare patients with appropriate and timely access to Alzheimer’s disease treatments.

Here are key concerns we raised in our comment letter:

• In proposing significant access barriers to current and future medicines for patients with Alzheimer’s disease, CMS is failing to help address an area of unmet medical need. An estimated 6.2 million Americans aged 65 and older are living with Alzheimer’s disease, and it is the sixth leading cause of death in the United States. It is an area of significant unmet medical need, with very few treatment options available to patients. Prior to last year, the only FDA-approved treatment options were medicines to partially manage symptoms by helping to maintain mental function and control behavioral changes. Recent scientific advances are providing hope to patients through a new class of therapies directed at the underlying cause of the disease – with one such therapy already FDA-approved. However, CMS is proposing a coverage framework that would significantly restrict coverage of this entire class of treatments, creating significant hurdles for patient access through Medicare. This would be devastating for patients as new treatments are desperately needed to curb this burdensome disease.
  
  
• CMS is proposing a highly restrictive coverage policy that would limit coverage exclusively to patients who are able and willing to participate in clinical trials. CMS is proposing to use a Coverage with Evidence Development (CED) paradigm that ties coverage to participation in CMS-approved or NIH-supported clinical trials. Requiring patients to enter randomized clinical trials in order to gain access to these important treatment options would significantly constrain access for patients. For one, not all patients will be able or willing to participate in a clinical trial. Further, the proposal specifies trials must take place in the hospital outpatient setting, which means patients who would normally receive treatment from an independent physician office or at an infusion center would not qualify unless they changed where they received their treatment. On top of that, CMS has proposed excluding patients with other health conditions that may significantly contribute to cognitive decline. This restriction alone is likely to eliminate a significant number of patients with Alzheimer’s disease from eligibility, as patients with dementia are more likely to have multiple health conditions. We believe the proposed CED will unnecessarily impede Medicare patients’ access to this class of treatments.
  
  
• The CMS proposal undercuts FDA’s authority to determine whether treatments are safe and effective and should be made available as an option for patients and caregivers. The FDA’s drug review program is the global gold standard for regulatory review and approval, involving a rigorous, science-based evaluation of safety and effectiveness before any new medicine is approved for use by patients. Despite this, the CMS proposal questions the FDA’s judgment and undermines the substantial, longstanding trust that patients and other stakeholders have in the FDA. Historically, CMS has generally recognized that FDA approval of a medicine provides a robust basis for deeming the medicine to be “reasonable and necessary” for at least some patients and ensuring it is covered and available to Medicare beneficiaries. This approach recognizes that, when treatments are evaluated and approved by the FDA, patients and their physicians can and will evaluate their available options and make individualized decisions about the treatment approach that is best for them. But the CMS coverage proposal threatens to make a stark departure from this approach, one that would have the effect of substituting the agency’s own judgment not only for FDA’s, but for that of a patient and physician about what is best for the individual.
  
  
• The proposed coverage policy would worsen existing disparities in access to care by significantly restricting where and to whom the treatments are available. The framework CMS proposes, including rigid study design criteria, systematically undervalues the preferences, priorities and health care needs of diverse populations that make up the United States. The CED-only coverage policy is especially devastating as applied to treatments for Alzheimer’s disease because this disease disproportionately impacts a number of diverse patient populations. For example, patients with other conditions, like down syndrome, would be prevented from accessing the medicine because of the requirements under the CED-only coverage policy that clinical trial participants not have other health conditions.
  
  Another example, as CMS itself acknowledges in the proposed decision memo, is that some racial and ethnic community groups are disproportionately impacted. One in three Native Americans is impacted by Alzheimer’s disease, and Black Americans and Hispanic Americans are at least two times more likely to develop Alzheimer’s disease than non-Hispanic white Americans. The LGBTQ community is similarly impacted.
  
  While these underrepresented populations may be equally willing as the general population to participate in a clinical trial, there are still challenges in recruitment. Those challenges are made more difficult in this proposal because of the restriction on coverage to clinical trial sites, which will acutely impact disadvantaged and socioeconomically deprived communities, as identification, enrollment and participation in a clinical trial will likely require significant resources.

While biopharmaceutical companies have made tremendous progress in scientific and medical innovations for neurodegenerative diseases like Alzheimer’s over the past decade, efforts are in vain if patients are prevented from accessing these life altering treatments.

Read the full comments here.

Lauren Neves

Lauren Neves is Vice President of Policy at PhRMA focusing on the value of cancer medicines, medication adherence, and payment and delivery reform. Prior to joining PhRMA, Lauren earned her law degree and worked as a market access and health policy consultant to health care and pharmaceutical clients.

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