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General Comments The NHC appreciates CMS’ commitment to actively engaging with stakeholders, including patients, consumer advocates, and health experts, in implementing the Medicare DrugPrice Negotiation Program (DPNP).
Ohio, Judge Newman) issued the first substantive order addressing legal challenges to the DrugPrice Negotiation Program of the Inflation Reduction Act. Novo’s Complaint is the ninth pending legal challenge to the DrugPrice Negotiation Program, and the fourth filed in the District of New Jersey. Becerra et al.
Overall, while the NHC appreciates CMS’ intent to streamline the data submission process and make it more accessible, we encourage ongoing dialogue and adjustments to ensure that the process remains patient-centered, efficient, and capable of capturing the full spectrum of information necessary to inform meaningful drugprice negotiations.
The NHC also requests that CMS highlight when and how the agency removed QALY-based metrics from consideration in MFP justification documentation. Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy.
From the post: The HHS Budget in Brief document describes the policy objective simply enough: “ Permit Biosimilar Substitution without Prior FDA Determination of Interchangeability” and clarifies that this means “deem all approved biosimilars to be interchangeable with their respective reference products”. 1 and go into effect in 2026.
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