Putting Patients First Blog

JULY 2, 2024

Clarification on QALY Metrics The NHC appreciates CMS’ commitment to excluding Quality-Adjusted Life Years (QALYs) from the negotiation process as outlined in the 2027 draft guidance. Valuing life differently based on disability status, age, or other special populations is inappropriate.

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Drug Pricing Insurance Coverage and Processing HIPAA Labelling 52

Putting Patients First Blog

SEPTEMBER 3, 2024

Manufacturer-Focused Input Question 30: Off-Label Use. CMS has appropriately highlighted the significance of off- label use information, providing a specific avenue for manufacturers to submit data on off-label uses supported by evidence-based guidelines listed in CMS-recognized Part D compendia.

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Drug Pricing Insurance Coverage and Processing Labelling Communication 52

Safe Biologics

MAY 10, 2024

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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Biosimilars Drug Pricing Documentation Labelling 130