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This year’s Alzheimer’s and Brain Awareness Month offers an important opportunity to remember the severe toll that Alzheimer’s takes on patients and family caregivers. Unfortunately, this year also provides a painful reminder that Medicare patients are facing severe access restrictions to the first class of treatments that could change the underlying progression of the disease. In April, the Centers for Medicare & Medicaid Services’ (CMS) finalized a national coverage determination (NCD) that will, for the first time ever, force Medicare patients into highly restrictive research studies (in some cases involving prospective clinical trials) to gain access to new Alzheimer’s medicines that have been approved by the U.S. Food and Drug Administration (FDA) as safe and effective.
More than 6 million Americans — most of them age 65 or older — live with Alzheimer’s disease, a devastating degenerative brain disease and the most common form of dementia. Alzheimer’s is the seventh leading cause of death in the United States. Not only do patients need effective treatments and a cure, but the health care system does, too. The burden of Alzheimer’s is expected to cost the nation more than $1.1 trillion by 2050. Unfortunately, CMS’ decision makes accessing the newest available treatments extremely difficult for patients with Alzheimer’s.
How does CMS’s national coverage policy inhibit access for Medicare patients to new Alzheimer’s medicines? It applies a policy known as Coverage with Evidence Development (CED), which in this case means Medicare will only cover the one approved medicine today for Alzheimer’s patients who are willing and able to participate in a specified clinical trial or registry. While CMS has often applied CEDs to medical devices, diagnostics and surgical procedures, it’s a policy that is rarely applied to medicines. In fact, this is only the second time that CMS has applied CED to a prescription medicine, making it more difficult for Alzheimer’s patients to gain Medicare coverage of this new medicine compared to other types of medicines. With such limited treatment options and with the added burden of needing to participate in a clinical trial or registry to access this class of treatments, this decision is flawed and concerning.
Also of concern is the length of time that CMS tends to leave CEDs in place. For instance, some CED programs have lasted up to 16 years according to the American Journal of Managed Care. The same study noted that it was very rare for a CED to be retired, meaning there is often no end in sight for the barriers to access that come with these policies. As a result, Alzheimer’s patients may be without full access to important new treatment options for unknown lengths of time given CMS’s recent decision to apply a CED to the entire new class of monoclonal antibodies directed against amyloid for the treatment of Alzheimer’s disease.
Despite challenges and setbacks, biopharmaceutical researchers have pushed forward in the search for lifesaving treatments and cures for many neurodegenerative diseases, including Alzheimer’s. But progress means nothing if patients cannot access or face significant challenges to accessing these treatments. With this coverage decision, CMS is standing in between doctors, Alzheimer’s patients and their caregivers, preventing them from deciding whether a particular FDA-approved medicine is the right option for them. Medicare was created to provide access to treatments and care for our nation’s aging population, yet CMS made a policy decision that threatens that access. Ultimately, it is patients who lose out.
Learn more about the increasing need to address and conquer Alzheimer’s disease, including the necessity to enact policies that do not limit access to life-changing treatments.
Nicole Longo
Nicole Longo is Deputy Vice President of public affairs at PhRMA focusing on Medicare, 340B, importation and more. She previously worked for a D.C.-based public affairs firm where she assisted a wide range of clients with communications efforts on everything from trade policy to agriculture policy to health care policy. Outside the office, Nicole can be found trying new restaurants (usually Italian), taking an occasional barre class and cheering on the Cincinnati Bengals.
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