Equalizing Drug Price Negotiation Period
Official: To amend title XI of the Social Security Act to equalize the negotiation period between small-molecule and biologic candidates under the Drug Price Negotiation Program.
This bill extends the time allowed for negotiating drug prices, giving more time for discussions on costs before prices are finalized.
This bill lengthens the amount of time for which drug products must have market approval in order for the products to qualify for negotiation under the Medicare Drug Price Negotiation Program. The Medicare Drug Price Negotiation Program requires the Centers for Medicare & Medicaid Services to negotiate the prices of certain prescription drugs under Medicare beginning in 2026. Among other requirements, drugs must have had market approval for at least 7 years (for drug products) or 11 years (for biologics) to qualify for negotiation. The bill modifies these provisions so as to require drug products to also have had at least 11 years of market approval in order to qualify for negotiation. The bill's changes apply retroactively.
1. This bill changes the negotiation period for drug prices from 7 years to 11 years. 2. It applies to both small-molecule drugs and biologic drugs under the Drug Price Negotiation Program. 3. The change aims to provide more time for negotiation on drug prices before they are set. 4. The bill's provisions will take effect as if they were part of a previous law enacted in 2022.
Patients who rely on both small-molecule and biologic medications may see changes in drug pricing negotiations.