backOn December 19, the Centers for Medicare & Medicaid Services released two most favored nation (“MFN”) drug pricing proposed rules: the “Global Benchmark for Efficient Drug Pricing” (“GLOBE”) and “Guarding U.S. Medicare Against Rising Drug Costs” (“GUARD”) models. If adopted, these rules would implement new mandatory drug rebate schemes for select drugs in Medicare Parts B and D, respectively. These proposals augment a third recently announced voluntary model called “GENErating cost Reductions fOr U.S. Medicaid” (“GENEROUS”), under which participating manufacturers would pay MFN-based supplemental rebates to state Medicaid programs in exchange for standardized (and potentially advantageous) coverage criteria. The public comment periods for both proposed rules close on February 23, 2026, and manufacturers must decide whether to participate in the GENEROUS model by March 23, 2026.
We will discuss the details of the proposed and announced models, including the specific drugs, manufacturers and beneficiaries subject to each model, as well as the baskets of countries used for international price comparisons. Our discussion will cover how international analogs are identified, how net prices are determined across the relevant ex-U.S. markets and how MFN-based rebates would be calculated under each demonstration. We will also address key implementation challenges associated with these complex and far-reaching frameworks, along with the significant timing considerations, given the rapidly approaching public comment and application deadlines. Finally, we will outline the key issues we recommend manufacturers address in their comments.
For questions, or for registration information, contact Ella Peek.