Prescription Drugs Introduced to Market

In calendar year 2022, approximately 81% of reported new drugs (282 of 347 reports) were introduced to market with a Wholesale Acquisition Cost (WAC) greater than $1,000.

The Department of Health Care Access and Information (HCAI) regularly releases to the public information and data visualizations on new prescription drugs introduced to market in California with a Wholesale Acquisition Cost (WAC) that exceeds the Medicare Part D specialty drug cost threshold. As stipulated by California Health and Safety Code §127681, prescription drug manufacturers must submit a notice to HCAI within three days after the release of the drug in the commercial market in California, and must report additional information to HCAI no later than 30 days after that notice has been submitted.

The data visualizations below provide a graphical display of new prescription drug data submitted to HCAI. The visualizations display the number of prescription drugs introduced to the commercial market in California categorized by WAC at introduction to market.

New Prescription Drugs by Price

  • In calendar year 2022, approximately 81% of reported new drugs (282 of 347 reports) were introduced to market with a WAC greater than $1,000.
  • In calendar year 2022, over a quarter of reported new drugs (90 of 347 reports) were introduced to market with a WAC greater than $10,000.
  • In Quarter 4 2022, approximately 81% of reported new drugs (60 of 74 reports) were introduced to market with a WAC greater than $1,000.
  • In Quarter 4 2022, over half of reported new drugs (38 of 74 reports) were introduced to market with a WAC between $1,001 and $5,000.

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

New Prescription Drugs by Quarter/Year

  • Between Quarter 1 2019 and Quarter 4 2022, approximately 73% of reported new drugs (1,039 of 1,417 reports) were introduced to market with a WAC greater than $1,000.
  • Calendar year 2022 saw the fewest total and first decrease in reported new drugs introduced to market year over year since reporting began: 348 in 2019, 351 in 2020, 371 in 2021, and 347 in 2022.
  • When compared to previous years, calendar year 2022 saw less variation between quarters in the number of new drugs introduced to market.

Note: The tooltip contains a box and whisker plot for the respective quarter, 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:

National Drug Code Template

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.

How HCAI Created this Product:

These visualizations were created using prescription drug data reported to HCAI by prescription drug manufacturers. For a detailed list of the new prescription drug data that HCAI collects, see the data format and file specifications.

Resources

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 program staff are not included in the data and visualizations.

Additional Information

Topic: Cost Transparency
Source Link: Prescription Drugs Introduced to Market
Citation: HCAI – Prescription Drug Cost Transparency, New Drug 2019-2022
Temporal Coverage: Q1 2019 – Q4 2022
Spatial/Geographic Coverage: Statewide
Frequency: Quarterly