Haystack Project's sign-on letter commenting to CMS' proposed NCA for monoclonal antibodies

While the proposed NCA addresses new treatments for an all-too-common condition in Medicare beneficiaries, Haystack Project has serious concerns that it will, if finalized,

• Represent an unprecedented challenge to the validity of the accelerated approval process that is integral to advancing new therapies in rare diseases

• Perpetuate and exacerbate health inequities associated with race, ethnicity, and socioeconomic status - Impermissibly substitute CMS’ analysis of clinical evidence and conclusions for decisions delegated to and made by FDA, and

• Raise significant ethical concerns by conditioning coverage for on-label use of the first FDA-approved treatment with potential to mitigate disease progression on participation in CMS-directed, randomized clinical trials.

The proposed NCA represents an unprecedented challenge to the validity of the accelerated approval process.

See the full comment letter here