Cost Transparency: Prescription Drugs (CTRx)

Manufacturers must report to OSHPD information on new prescription drugs with a Wholesale Acquisition Cost (WAC) of more than $670 for a course of therapy. Reported information on specified prescription drugs introduced to market from January 1st through June 30th of 2019 is now available.

View Specified Prescription Drugs Introduced to Market

Purchasers

Register to receive 60-day advance notice of a specified increase in the wholesale acquisition cost of a prescription drug from…

Manufacturers

Register to submit prescription drug information and download the list of registered prescription drug purchasers for the purpose of the…

About CTRx and SB 17

Overview and information on the CTRx Program and Senate Bill 17

Purchasers#

Register for Rx Purchaser Notifications#

Register to receive 60-day advance notice of a specified increase in the wholesale acquisition cost of a prescription drug from prescription drug manufacturers.

Manufacturers#

Register to Submit Prescription Drug Pricing Information#

Registration is open for manufacturers to access the online system to submit prescription drug information to OSHPD, as required by SB 17. The SIERA-CTRx online system will be available on January 1, 2019 for the submission of information for specified new prescription drugs introduced to market and specified increases in the wholesale acquisition cost of existing prescription drugs.

Submit Prescription Drug Pricing Reports#

Once registered to access the SIERA-CTRx online system, manufacturers may login and submit prescription drug pricing reports to OSHPD.

Current List of Registered Rx Purchasers#

Download the list of registered prescription drug purchasers for the purpose of 60-day advance notice of a specified increase in the wholesale acquisition cost of a prescription drug, as required by Senate Bill 17. This list will be updated weekly or as needed to include all current registrants.

Cost Transparency Rx (CTRx) Program#

Contact the CTRx Program at ctrx@oshpd.ca.gov. To receive regular informational updates about the program, subscribe to the CTRx mailing list.

SB 17 Overview#

Senate Bill (SB) 17 (Chapter 603, Statutes of 2017)

The implementation plan outlined below describes the provisions of SB 17 involving OSHPD. There are also provisions that will be implemented by the Department of Managed Health Care and the California Department of Insurance.

Read Senate Bill 17

Beginning January 1, 2018, SB 17 requires OSHPD to make available a registry of public and private purchasers for purposes of the 60-day advance notice requirement for specified increases in the wholesale acquisition cost of a prescription drug. Public and private purchasers may register with OSHPD beginning December 1, 2017 on this website.

Beginning January 1, 2019, drug manufacturers must notify OSHPD within three days of introducing a new drug at a wholesale acquisition cost that exceeds the specified threshold. Within 30 days of this notification, manufacturers must submit additional information to OSHPD. OSHPD will publish this information on its website quarterly.

Beginning after January 1, 2019, drug manufacturers are required to submit to OSHPD information on the rationale for cost increases for existing drugs that fall under the reporting requirement. OSHPD will collect this information beginning April 2019 and publish on its website within 60 days of receipt from each manufacturer on a quarterly basis.

Read Data Submitter Workshop Presentation

Regulations#

The regulations for CTRx (SB 17) were adopted January 1, 2019, and can be found on the OSHPD Laws and Regulations webpage.  Public workshops (detailed below) and written comments were solicited and the feedback provided was used to inform these regulations.

Wholesale Acquisition Cost (WAC)#

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…”

FAQs#

What is Senate Bill 17?#

SB 17 (Hernandez, Statutes of 2017) seeks to increase prescription drug cost transparency by:

  1. Requiring advance notification to public and private purchasers before a significant prescription drug wholesale acquisition cost increase occurs, and making public certain information associated with the increase.
  2. Requiring the provision of information about the impact to health care plans and insurers of cost increases.

What is happening now?#

Drug manufacturers must now provide notice to specified purchasers 60 days in advance of the planned effective date of an increase in the wholesale acquisition cost of certain prescription drugs when that increase is greater than 16%, including the proposed increases and the cumulative increases that occurred within the previous two calendar years prior to the current year. In 2019, manufacturers must provide additional information to the Office of Statewide Health Planning and Development (OSHPD) after raising the WAC of a prescription drug above a certain level, and must provide information regarding new prescription drugs introduced to market above a specified wholesale acquisition cost threshold. OSHPD will publish this information quarterly on its website.

What is OSHPD’s publishing schedule?#

OSHPD will publish quarterly on its website information from drug manufacturers related to new prescription drugs beginning in spring of 2019. Beginning in June of 2019, OSHPD will publish quarterly on its website prescription drug WAC increase information for existing prescription drugs.

Are prescription drug purchasers required to register with OSHPD?#

No. Registration is purely voluntary. However, specified prescription drug purchasers must register with OSHPD in order to receive advance notice of specified prescription drug wholesale acquisition cost increases.

I reimburse prescription drug manufacturers, but I am not a direct purchaser. Am I eligible to register for advance notice?#

Yes. State purchasers, licensed health care service plans, health insurers holding a valid outstanding certificate of authority from the Insurance Commissioner, and pharmacy benefit managers as defined in subdivision (j) of Section 4430 of the Business and Professions Code that purchase or reimburse for prescription drugs are eligible to register for advance notice from manufacturers.

Will OSHPD issue regulations regarding the purchaser registration and manufacturer advance notice?#

Yes. Over the next year, OSHPD will promulgate regulations. For up-to-date information regarding the upcoming SB 17 rulemaking process, please visit the OSHPD website and/or sign up for CTRx Informational Announcements.

Does a prescription drug manufacturer need to report to OSHPD all cost increases for a given quarter in a one-time report? Is there an indefinite quarterly reporting requirement for each drug cost increase above the specified threshold?#

Specific prescription drug cost increase reporting requirements will be addressed during the outreach and rulemaking process. OSHPD welcomes and encourages stakeholder participation throughout the process of developing regulations for SB 17.

When must manufacturers begin notifying OSHPD of introduction of a new prescription drug to market at a wholesale acquisition cost exceeding the threshold set for a specialty drug under Medicare Part D program?#

The new drug reporting requirements of SB 17 take effect January 1, 2019.

When does OSHPD plan to make available a form for manufacturers to report required cost increase and new drug information to OSHPD?#

The format for reporting prescription drug cost increase and new drug information to OSHPD will be addressed during the outreach and rulemaking process. OSHPD anticipates that it will make available to manufacturers the prescribed format on or before January 1, 2019. OSHPD welcomes and encourages stakeholder participation throughout the process of developing regulations for SB 17.

I am aware that there is an active lawsuit challenging the constitutionality of SB 17. Do I need to comply with SB 17 while the lawsuit is active?#

Yes. Unless a court issues an order preventing OSHPD from implementing SB 17, you must comply with law. No order is in place at the present time.