Prescription Drugs Introduced to Market

Overview#

The Office of Statewide Health Planning and Development (OSHPD) presents information 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. Prescription drug manufacturers submit information to OSHPD within a specified time period after a drug is introduced to market. The current public release includes all the data in completed reports submitted as of May 3, 2021 by prescription drug manufacturers for specified New Prescription Drugs with introduction to market dates in January through March 2021. For a full list of the information of New Prescription Drugs collected by OSHPD, see the data format and file specifications.

Note: Not all required New Prescription Drugs are reported, additionally, some of the reported New Prescription Drugs are not required. There are New Prescription Drugs that do not meet the statutory requirements for reporting and prescription drugs that do not meet the definition for reporting under the Regulations and Section 321(g) of Title 21 of the United States Code. Due to reporting requirements, the graphs may not include all reported prescription drugs.

Table of Contents#

New Drug Data Analytics#

The graph below includes submitted New Prescription Drug data for Quarter 1 of 2021. The graph displays data that shows the number of Prescription Drugs Introduced to the Market by WAC at introduction to market. The data included in the graphs can be downloaded on the California Health and Human Services Open Data Portal (ODP). 

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

Download Dataset#

The current year New Prescription Drug data available for download is updated monthly. Click the ‘Download Dataset’ button below to view/download the latest New Prescription Drug Dataset.

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.

OSHPD 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.

Annual Dataset Updates#

Annual datasets of reports from the preceding year are reviewed in the second half of the current year to identify if any revisions or additions have been made since the original release of the datasets. If revisions or additions have been found, an update of the datasets will be released. Datasets will be clearly marked with ‘Updated’ in their titles for convenient identification. Not all datasets may require an updated release. The review of previously released datasets will only be conducted once to determine if an updated release is necessary. Datasets with revisions or additions that may been made after the one-time review can be requested. These requests should be made via email at ctrx@oshpd.ca.gov.

Data and Resources#


Additional Information#

Topic: Healthcare
Temporal Coverage: January to May 2021
Spatial/Geographic Coverage: Statewide
Frequency: Monthly
Citation: Office of Statewide Health Planning and Development (OSHPD), Prescription Drug Cost Transparency