New Drug Price Estimation

The 340B price is available for a new covered outpatient drug as of the date the drug is first available for sale. For the purposes of the 340B Program The federal drug discount program authorized under section 340B of the Public Health Service Act and established by Congress under the Veterans Health Care Act of 1992 (Public Law 102-585, codified at 42 USC § 256b). The 340B program requires drug manufacturers to enter into pharmaceutical pricing agreements with the HHS Secretary, under which manufacturers agree not to sell covered outpatient drugs to covered entities above 340B ceiling prices., manufacturers must estimate the ceiling price using the methodology described in the 340B ceiling price and Civil Monetary Penalties (CMP) final rule (82 FR 1210, January 5, 2017), which requires a new drug ceiling price to be estimated using wholesale acquisition cost minus the appropriate rebate percentage (i.e., 23.1% for most single-source and innovator drugs, 17.1% for clotting factors and 13% for generics) until sufficient data is available to calculate the actual 340B ceiling price of the new drug. Once the average manufacturer price (AMP) is known, and no later than the fourth quarter that the drug is available for sale, the manufacturer must calculate the actual 340B ceiling price based on the AMP.

For more information on new drug price estimation, please review the 340B ceiling price and CMP final rule at: https://www.gpo.gov/fdsys/pkg/FR-2017-01-05/pdf/2016-31935.pdf. For purposes of the pricing component, manufacturers should enter the WAC price in the AMP field and notate (in the comment field) the drug as a new drug.