Prescription Drugs Introduced to Market

New Prescription Drugs by Price#

• The majority of prescription drugs introduced in 2023 had a WAC from $1,000.01 to $5,000 (225 reports).
• Prescription drugs with a WAC greater than $10,000 experienced the largest number of reports for a price category in Q2 (131 reports).
• In 2023, 83.9 percent of reported new drugs (490 of 584 reports) were introduced with a WAC greater than $1,000.

Note: The tooltip contains a box and whisker plot of the respective WAC Price Category, where each dot represents a submitted report.

CTRx Term Definitions#

Wholesale Acquisition Cost#

Wholesale Acquisition Cost (WAC) is defined in the U.S. Code as “…the manufacturer’s list price for [a] drug or biological to wholesalers or direct purchasers in the United States, not including prompt pay or other discounts, rebates or reductions in price…”

National Drug Code (NDC)#

The pharmaceuticals industry assigns a unique three-segment number, called the NDC, to each drug product manufactured and sold. NDCs must be provided to the federal Food and Drug Administration (FDA), and are used for ordering, billing, inventory management, and recalls.

HCAI requires that relevant reporting uses the 11-digit format of the NDC. The three-segments of the format can be broken into the following:

The labeler code, also known as the manufacturer code, identifies who manufactures, repacks, or distributes a given drug product.

The product code identifies the drug, its strength, dosage form, and formulation specific to the firm that manufactures the given drug product.

The packaging code typically identifies the number of product units in the given product (package size), but also may indicate the type of packaging used.

Resources#

• Data Dictionary – Prescription Drugs Introduced to Market
• CTRx Program Webpage
• CTRx Regulations

Note:

• Not all new prescription drugs are required to be reported to HCAI – there are new prescription drugs that do not meet the statutory requirements for reporting, and new prescription drugs that do not meet the definition for reporting pursuant to HCAI Regulations and Section 321(g) of Title 21 of the United States Code.
• Some prescription drug manufacturers choose to report new prescription drugs that are introduced to market with a WAC that does not explicitly exceed the specified threshold, but that may exceed the pricing threshold when accounting for the combined price of a standard course of therapy.
• New drug reports that have been submitted to HCAI but that are still under review by HCAI staff are not included in the data and visualizations.