The Council for Informed Drug Spending Analysis (CIDSA), a nine-member panel of experts that provides independent analysis of policies to lower drug costs and spending, issued a public comment letter in support of the Centers for Medicare & Medicaid Services (CMS) draft National Coverage Determination (NCD) for Aduhelm, Biogen's new and controversial Alzheimer’s treatment. The proposed NCD limits the coverage of Adulhelm to only those patients enrolled in clinical trials. CIDSA recognizes the proposed NCD will ensure appropriate access to treatment while limiting Medicare spending.
"The rigorous standards proposed are an essential component in not only developing the future evidence necessary to determine whether [monoclonal antibodies for Alzheimer’s treatment] are indeed clinically-efficacious but also to manage drug spending and address ever-rising launch prices of clinician-administered therapies," wrote the experts in a letter to Administrator Brooks-LaSure.
The panel supported four key components of the NCD that would balance access with cost. These included the use of Coverage with Evidence Development, a randomized controlled trial (RCT) design, patient eligibility criteria, and the use of clinically-meaningful trial outcomes. CIDSA argued that the use of RCTs will ensure development of future Alzheimer’s treatments is not hampered by the presence of Aduhelm in the market. CIDSA further explained that this approach could promote future competition that will result in lower Medicare spending.
In June of 2021, the Food and Drug Administration’s (FDA’s) approval of Aduhelm was swiftly criticized because of a high price tag coupled with limited safety and efficacy data. Prior to FDA approval, CIDSA members Sean Dickson and Richard Frank joined other experts in the field calling on CMS to implement an NCD for Aduhelm to balance access and cost. CMS announced its proposed NCD in January and will now have the opportunity to incorporate more than 1,000 public comments with their final NCD. The final determination is expected this April.
A full copy of letter can be found here.
CIDSA, the Council for Informed Drug Spending Analysis, is a nonpartisan expert group funded by West Health and focused on bringing a non-pharma perspective to drug spending policy dialogue. Learn more at www.cidsa.org and on Twitter at @CIDSAexperts.