2023 New Jersey Revised Statutes › Title 45 - Professions and Occupations › Section 45:14-82.3 - Manufacturer, notify, increase, wholesale acquisition cost; parameters.

45:14-82.3 Manufacturer, notify, increase, wholesale acquisition cost; parameters.
2. a. A manufacturer shall notify the division if it is increasing the WAC of a brand-name drug by more than 10 percent per pricing unit during any 12-month period, or if it is increasing the WAC of a generic drug priced at greater than $10 but less than $100 per pricing unit by more than 40 percent during any 12-month period, or if it is increasing the WAC of a generic drug priced at $100 or more per pricing unit by more than 10 percent during any 12-month period. The notice shall be provided in writing within 10 days following the effective date of the increase and the division shall notify consumers of the increase on its Internet website.
b. A manufacturer shall notify the division if it introduces: (1) a new drug in the State that has a WAC that exceeds the Medicare Part D specialty threshold; or (2) a biosimilar in the State that has a WAC that is not at least 15 percent less than the WAC of the referenced brand biologic at the time the biosimilar is launched. The notice shall be provided in writing within 10 days following market introduction and the division shall notify consumers of the price on its Internet website.
c. A manufacturer that notifies the division pursuant to subsection a. of this section shall report to the division the following minimum data, and any other data that may be specified by the division, within 20 days following the price increase:
(1) the national drug code, proprietary drug name, non-proprietary drug name, and pricing unit of the brand-name drug or generic drug, as applicable;
(2) sales volume in the State in the previous calendar year and projected sales volume in the State for the current calendar year for the drug or drug group as specified by the division;
(3) the wholesale price and related information for the drug or drug group as specified by the division, which may include but shall not be limited to the year of market introduction, WAC at market introduction, WAC in the previous calendar year, and current WAC;
(4) revenue from the sale of the drug or drug group in the State in the previous calendar year and projected revenue from the sale of the drug or drug group in the current calendar year, expressed in U.S. dollars per pricing unit;
(5) manufacturer cost associated with sales of the drug or drug group in the State as specified by the division in the previous calendar year and projected for the current calendar year;
(6) current calendar-year projections or incurred cost year to date, as the division may indicate, related directly or allocated specifically to sales of this drug or drug group in the State; and
(7) the reason or reasons that the manufacturer increased the WAC of the drug or drug group compared with last year.
d. A manufacturer that notifies the division pursuant to subsection b. of this section shall report to division the following minimum data, and any other data that may be specified by the division, within 20 days following the date of market introduction:
(1) the national drug code, proprietary drug name, non-proprietary drug name, and pricing unit of the new drug;
(2) projected patient volume in the current year for the drug and drug group in the State;
(3) projected revenue for the drug and drug group in the current year in the State; and
(4) WAC at market introduction.
e. If a manufacturer certifies to the division that it does not have access to the State-specific data required to be reported pursuant to this section and has no way of obtaining the data, the division may permit the manufacturer to report the data on a national level upon proof satisfactory to the division that State-specific data is unavailable to the manufacturer. In the event State-specific data is unavailable to the manufacturer, the division shall attempt to obtain the data from other reporting entities subject to the provisions of P.L.2023, c.106 (C.45:14-82.2 et seq.) for any drug or drug group reported on by a manufacturer pursuant to subsections a. and b. of this section.
f. Disclosure of all information reported under this section shall be subject to protections defined in section 9 of P.L.2023, c.106 (C.45:14-82.10).
L.2023, c.106, s.2.