Washington, D.C. – This week, Congressman Rudy Yakym (IN-02) led other members of the Indiana Congressional Delegation in sending a bipartisan letter to the Biden Administration urging the Centers for Medicare & Medicaid Services to allow access to time-sensitive, FDA approved Alzheimer’s treatments for patients living with the disease.
The letter, which was signed by eight Members of the Indiana House Delegation in the U.S. House of Representatives, was addressed to U.S. Department of Health and Human Services Secretary Xavier Becerra and Centers for Medicare and Medicaid Services Administrator Chiquita Brooks-LaSure.
The full letter can be found HERE and below:
Dear Secretary Becerra and Administrator Brooks-LaSure,
Of the more than 6.7 million patients with Alzheimer’s, more than 110,000 are Hoosiers and that is expected to grow by over 18 percent in the next three years. Unfortunately, Alzheimer’s disease also heavily impacts families of those living with the disease. A recent report by the Alzheimer’s Association shows more than 216,000 Hoosiers were caring for affected loved ones in 2022.
Recently the FDA has approved a monoclonal antibody treatment that demonstrated it slowed down Alzheimer’s for individuals with mild cognitive impairment and we expect another promising treatment to seek approval later this year. While Medicare has traditionally covered all FDA-approved drugs, it has continuously chosen to not allow for unencumbered access to Alzheimer’s treatments.
Our delegation respectfully requests that CMS reconsider its current policy of requiring Coverage with Evidence Development for this class of Alzheimer’s therapeutics. Instead, we urge CMS to allow for the immediate access to FDA-approved treatments for patients that would benefit from these important therapeutics – just as it does with all other classes of FDA approved medicines. With each day of delay, more than 2,000 people transition to more advanced stages of Alzheimer’s and are no longer eligible for these important monoclonal antibody treatments.
One of three seniors die from Alzheimer’s or a related form of dementia. Black and Hispanic Americans are more likely to have Alzheimer’s than White Americans. Women are more likely to be diagnosed with Alzheimer’s disease than men of the same age. Alzheimer’s and other dementias will cost the nation $345 billion in 2023 and by 2050 costs could rise to nearly $1 trillion. In 2022, unpaid Hoosier caregivers worked more than 321,000,000 unpaid hours, which totaled more than $5.1 billion in unpaid care.
The decision by Medicare to restrict access to only patients enrolled in a randomized clinical trial or patient registry severely limits access, especially for rural and minority populations who face more barriers to participating in clinical research, meaning that CED would have an outsized impact on access to care for those patients and their caregivers. The continued CED requirement is an unprecedented barrier to care instituted by CMS, an agency tasked with ensuring that Americans get access to the care they need when they need it.
Please act today to allow patients immediate access so that we can slow the progression of Alzheimer’s in eligible patients, give individuals more time without cognitive impairment and continue to encourage efforts to find a cure to this devastating disease.
In addition to Congressman Yakym, the letter was also signed by U.S. House Representatives from Indiana Jim Baird, Jim Banks, Larry Bucshon, André Carson, Erin Houchin, Frank Mrvan, and Greg Pence.