Legislation to expand Alzheimer's treatment introduced

“With over 6 million Americans and 280,000 Pennsylvanians affected by Alzheimer’s disease, we must ensure that as many patients as possible are able to access groundbreaking, innovative treatments to slow or stop the progression of this devastating disorder. The Access to Innovative Treatments Act would ensure that seniors can access potentially lifesaving therapies, and I urge my colleagues to join me in passing this legislation that supports patients and their caregivers,” said Joyce.

Earlier this year, on April 7, CMS announced it would cover the treatments for monoclonal antibodies used to treat Alzheimer’s disease for Medicare beneficiaries. However, this decision to cover monoclonal antibody treatments for Alzheimer’s patients was only applicable to beneficiaries under CMS’s Coverage with Evidence Development (CED) pathway, drastically restricting coverage to the point that less than 1% of Medicare beneficiaries would be eligible to access new, FDA-approved drugs and treatments.

“I know the impact of Alzheimer’s firsthand — I’ve watched my mom struggle with Alzheimer’s over the last several years. While her disease is too far advanced to benefit from scientific breakthrough therapies that could improve her condition, there are hundreds of thousands of people out there who can benefit. CMS’ current policy of applying its coverage decision to an entire class of drugs is detrimental to the families and individuals suffering from this heartbreaking disease” said Barragán. “And the problem exists beyond treatment of Alzheimer’s – a similar determination for any disease would restrict access to breakthrough drugs regardless of their effectiveness. We must work to ensure these breakthrough therapies are accessible. This legislation is a crucial step forward for ensuring that Medicare beneficiaries have access to new drugs when enough data is collected on the product.”

“Scientists, former regulators, and bipartisan members of Congress have been loud and clear: CMS got it wrong, and people are suffering because of it,” said George Vradenburg, chair and co-founder of UsAgainstAlzheimer’s. “We hope that between this bill and the recently introduced Mandating Exclusive Review of Individual Treatments (MERIT) Act patients will get the transparency they deserve and access they need to promising, new treatments just on the horizon.”

“Thank you to Representatives Barragán and Joyce for introducing the bipartisan ‘Access to Innovative Treatments Act of 2022,’ which will help ensure greater Medicare access to FDA-approved treatments for people living with Alzheimer’s disease and other dementia,” said Robert Egge, Alzheimer’s Association chief public policy officer and Alzheimer’s Impact Movement (AIM) executive director. “CMS should not determine coverage based on type of treatment, as no two treatments are the same, even if they are in the same class of drug. The Alzheimer’s community recently experienced the potential harm this practice can bring, and we appreciate congressional champions like Barragán and Joyce for supporting people living with Alzheimer’s and all other dementia.”

“Before its decision on Alzheimer’s disease, CMS had historically covered most FDA-approved drugs for their on-label use, and the agency had never denied coverage of an entire class of drugs based on the safety and efficacy profile of one FDA-approved drug,” said Sue Peschin, president and chief executive officer of the Alliance for Aging Research. “That is for two good reasons. First, the scientific expertise lies within FDA, and respectfully, not within CMS. Second, each FDA-approved drug has a unique molecular structure, different mechanism of action, and different side effect profile, making it wholly inappropriate for CMS to issue class-wide coverage determinations. The Access to Innovative Treatments Act would help fix some of the problems CMS created by departing from its past practice.”