The Centers for Medicare & Medicaid Services are considering establishing a national Medicare coverage policy for monoclonal antibody drugs that treat Alzheimer’s disease, including the newly approved drug aducanumab (Aduhelm).
CMS announced on Tuesday that it has initiated a National Coverage Determination Analysis, or NCD, a formal process that will allow it to review and determine the potential coverage policy for monoclonal antibodies, which target beta-amyloid – a feature cerebral disease.
The coverage decisions have the potential to place some restrictions on access to drugs, but a strong advocate for Alzheimer’s patients welcomes the decision. “An NCD would help prevent regional and community disparities due to difficult barriers to overcome, especially for those who have greater difficulty accessing health services,” the Alzheimer Association wrote in a statement, also released. Tuesday.
A well-designed analysis would create “rapid and open access to crucial information regarding efficiency, safety and fairness to help ensure that all who could benefit from it have access,” the organization said. In the meantime, he calls on CMS to provide immediate advice to help healthcare providers and patients access coverage.
“Patients and their families are understandably eager to start treatment now; providers need to understand what will be covered while we wait for a possible NTM, ”he said.
Coverage determinations for aducanumab are currently made locally by Medicare administrative contractors, according to CMS. The agency’s NTM analysis will include a 30-day public comment period.
“Alzheimer’s disease is a devastating disease that has touched the lives of millions of American families,” said CMS administrator Chiquita Brooks-LaSure. “We want to take a very careful look at Medicare coverage for new treatments in light of the available evidence. “