SCRIPT Act

Price Increases: Manufacturers are required to submit information about specified price increases from the previous calendar year by January 31 of the following year. Specified price increases include: A price increase of at least 15% for a prescription drug product with a wholesale acquisition cost of $100 or more for a 30-day supply. 

New Products: Manufacturers are required to submit information about any new prescription drug product within 30 days of it being available for purchase in the state. For new products, the price threshold for reporting is $100 or more for a 30-day supply – consistent with the statute’s threshold for existing products.

Price Increases: the law specifies a deadline of January 31 for submission of data pertaining to price increases made in the previous calendar year. 

New Products: reporting is a two step process, triggered once per product (per NDC) when it first becomes available for purchase in North Carolina:

• Initial notice (within 3 days): Notify interested parties of the price of the new prescription drug.
• Follow up (within 30 days): If the drug was acquired (i.e., not developed by the manufacturer), disclose the NDC, drug name,  date and price of acquisition using the NCDHHS SCRIPT Act Submission Portal.  
• New product submissions will be accepted on a rolling basis in order to allow for disclosure within 30 days of the product being made available for purchase in the state. 
  
   

Under the law, the NCDHHS Secretary is required to assess civil penalties not to exceed $1,000 per day for each day the manufacturer delays submission of information.

All manufacturer submissions will be made available on the NCDHHS website. Since submission of a Form 10-K or any other public disclosure fulfills manufacturer obligations under the law, if submitted, those documents which will be posted are already in the public domain.

NCDHHS is working on the submission and publication process and will provide updates on this webpage.

Information provided to the Secretary or an interested party under Article 4D shall be considered trade secret under Article 24 of Chapter 66 of the General Statutes, confidential, exempt from public inspection and copying under Chapter 132 of the General Statutes, and shall not be disclosed directly or indirectly unless the information is already in the public domain. Additionally, manufacturer obligations under Article 4D are satisfied by submission of a SEC Form 10-K, which is already publicly available under the SEC’s EDGAR Database.

NCDHHS is working on a template for manufacturers to use and will provide updates on this webpage. For now, manufacturers should use a format of their choice and upload the files to the NCDHHS SCRIPT Act Submission Portal. If additional information is needed, someone will follow-up with the point of contact indicated in the submission. 

• For disclosure of price increases, manufacturers at a minimum should include the following data elements:
  • National Drug Code (NDC)
  • Drug Name
  • The date and price of acquisition of the drug, if it was not developed by the manufacturer 
  • A schedule of price increases for the drug for the five years prior to the calendar year
• For disclosure of prices for new products, manufacturers at a minimum should include the following data elements:
  • National Drug Code (NDC)
  • Drug Name
  • The date and price of acquisition of the drug, if it was not developed by the manufacturer

No. Supplemental filings are only subject to reporting if the supplement results in a new NDC and WAC.

Inner pack NDCs are not required to be reported under the SCRIPT Act. Reporting focuses on the drug (NDC) tied to price, availability, and acquisition.

No. A labeler code change alone does not require a new product notice. If the change is accompanied by a price increase that meets the 15% threshold (and WAC ≥ $100/30day), the priceincrease reporting requirement may be triggered.

While the law does not specify a lookback period, for acquisition-related information, the Department applies a five year lookback aligned to the five year schedule of price increases required for annual reporting.

Use the WAC at the highest recommended dosage for a full 30 day treatment duration when determining if the $100 threshold applies and when assessing whether a 15% price increase occurred. Document dosing assumptions used.

No. Annual reporting is required only when trigger events occur (i.e., each price increase ≥ 15% for drugs with WAC ≥ $100/30 day). If no such increases occurred—and no new products meeting the threshold were introduced—no filing is necessary.

SCRIPT Act, Part VIII defines interested parties as all of the following:

• State agencies that purchase prescription drugs or employ prescribers
• Health insurance companies
• Health care service plan providers
• Pharmacy benefits managers