Create the national formulary & negotiate drug prices

Months 0–18 for the initial formulary; continuous negotiation · National Formulary and Pricing Board; HTA InstituteDiscuss this step

FDA drug and device approval

continues—Drugs & devices

Today

Approval is based on safety and efficacy; price and comparative value are not considered.

Under the plan

Unchanged. Approval stays separate from coverage and price, which the Formulary Board and HTA Institute set afterward.

Trade-off

Keeps approval science-based; a drug can be approved but priced or covered narrowly, delaying patient access.