Legislation expands access to breakthrough Alzheimer’s treatments

There’s new hope in the fight against Alzheimer’s. Federal legislation called the Access to Innovative Treatments Act can turn this hope into reality for seniors afflicted by this disease.  

In July, the Food and Drug Administration (FDA) gave traditional approval to Leqembi (lecanemab), a new medicine that may reduce cognitive decline among Alzheimer’s patients by 27 percent. This treatment is part of a new drug class of monoclonal antibodies that reduces amyloid plaque buildups in the brain, the protein that accumulates in the brains of people with Alzheimer’s disease. These therapies offer patients and caregivers more quality time with loved ones.

In response to traditional FDA approval, the Centers for Medicare and Medicaid Services (CMS) announced it would only cover Leqembi for patients who participate in a “registry,” a CMS-backed evidence-gathering process to determine how the drug works in the real world. This decision marks the first time the CMS has refused to broadly cover a therapy that has traditional FDA approval. The CMS also did not take this opportunity to initiate a formal process to reconsider their National Coverage Determination policy. As a result, Alzheimer’s patients desperate for treatment may still face unnecessary coverage barriers. 

We know the Alzheimer’s burden firsthand. We’ve watched our mothers battle this disease over the last several years. Like tens of millions of Americans, we’ve seen Alzheimer’s consume our loved ones and rob them of their personality and identity. We’ve struggled to find competent caregivers and balance our careers and other family responsibilities with our own part-time caregiving. We’re not surprised polls show most family caregivers rate their emotional stress as high or very high. 

Our mothers’ conditions are too advanced to qualify for these early-intervention medicines even if they were accessible through Medicare. Yet broad CMS coverage may still help patients who aren’t eligible by ushering in the investment needed to develop additional treatments and (one day) a cure. There are around 140 other potential Alzheimer’s medications in the clinical pipeline. Without reliable CMS coverage, we could see a decreasing in funding and biomedical innovation needed to bring the most promising ones to market. 

Alzheimer’s can follow in the footsteps of other diseases like Duchenne muscular dystrophy, rheumatoid arthritis, and multiple sclerosis, for which many new treatments have been recently approved following an initial breakthrough. Every new medication gives families and caregivers the hope we so desperately need. 

Federal legislation introduced by Rep. Nanette Díaz Barragán (D-Calif.) would help far more Alzheimer’s patients access Leqembi and subsequent innovative treatments. The Access to Innovative Treatments Act would prevent the CMS from issuing coverage restrictions for entire classes of drugs and require the agency to judge each one on its individual merits. The agency’s blanket class-wide approach threatens access to effective therapies for other serious medical conditions, including cancer, meaning this bill would also help other patients access breakthrough medications more easily.

The bill would also require the CMS to adhere to a consistent and transparent timeline to change Medicare coverage decisions once CMS trials and/or registries prove a medication’s effectiveness. This provision ensures that bureaucratic delays don’t prevent Medicare beneficiaries from accessing clearly proven treatments for Alzheimer’s or any other chronic disease. It would end the ongoing uncertainty about when all eligible Alzheimer’s patients can eventually access Leqembi and clarify an endpoint for requiring participation in a CMS-approved registry to receive Medicare coverage. This is bipartisan legislation that can succeed in today’s bipartisan Congress. 

Alzheimer’s afflicts approximately 7 million Americans, and rates are set to explode as baby boomers age. The annual economic cost of the disease, which disproportionately impacts women and people of color, will grow from $345 billion today to approximately $1 trillion by 2050. There is time to turn things around. But to do so, the CMS must broadly cover new treatments that slow progression of Alzheimer’s disease and other dementias. Doing so can mark the turning point in America’s fight against this terrible disease.

Nanette Diaz Barragán represents California’s 44th District and is the chair of the Congressional Hispanic Caucus. Terry Wilcox is the executive director of Patients Rising.