1. A. The Board shall apply the metrics specified in Health-General Article, §21-2C-08(c), Annotated Code of Maryland, and this regulation to the following data sets to identify drugs eligible for selection for a cost review study:

   1. (1) The claims data in the MCDB;
   2. (2) Available subsets of claims data in the MCDB, such as the commercial market, Medicaid, and Medicare; and
   3. (3) The data obtained from governmental and commercial databases, other databases, and other data sets as available.
2. B. The Board may identify the prescription drug products that meet these statutory metrics and regulatory criteria on at least an annual basis.

3. C. Data Management.

   1. (1) For any metric requiring adjustment for inflation, the adjustment for inflation shall be based on the Consumer Price Index for All Urban Consumers (CPI-U) as reported by the U.S. Bureau of Labor Statistics.
   2. (2) For any data-based metric, the Board may account for data errors and outliers.

4. D. To the extent practicable, and in addition to the statutory metrics set forth in Health-General Article, §21-2C-08(c), Annotated Code of Maryland, the Board may consider the following additional metrics and criteria to identify prescription drug products eligible for selection for a cost review study:

   1. (1) Aggregated Spending and Pricing Data:

      1. (a) The 100 prescription drug products with the highest total gross spending in the most recent available calendar year;
      2. (b) The 100 prescription drug products with the highest total gross spending per patient in the most recent available calendar year;
      3. (c) The 100 prescription drug products with the highest percent change increase in WAC over the most recent available calendar year;
      4. (d) The 100 prescription drug products with the highest percent change increase in WAC over the most recent available 5-year period;
      5. (e) The 100 prescription drug products with the highest dollar increase in WAC per year or course of treatment over the most recent available calendar year;
      6. (f) The 100 prescription drug products with the highest dollar increase in WAC over the most recent available 5-year period; and
      7. (g) The 100 prescription drug products with the highest percent change increase in total gross spending;

   2. (2) Patient Out-of-Pocket Costs:

      1. (a) The 100 prescription drug products with the highest total patient out-of-pocket costs in the most recent available calendar year;
      2. (b) The 100 prescription drug products with the highest average patient total out-of-pocket costs in the most recent available calendar year;
      3. (c) The 100 prescription drug products ranked at the 50th percentile for patient total out-of-pocket costs in the most recent available calendar year; and
      4. (d) The 100 prescription drug products ranked at the 90th percentile for patient total out-of-pocket costs; and
   3. (3) Any prescription drug product added by the Board to the list of prescription drug products eligible for cost review under this regulation.

5. E. At an open meeting, a Board member may propose one or more additional prescription drug products for inclusion on the list of drugs eligible for cost review by:

   1. (1) Moving that the prescription drug product or products be added to the eligible list; and
   2. (2) Identifying how the prescription drug product or products may create affordability challenges for the State health care system or patients.
6. F. After discussion at an open meeting, the Board may vote to add one or more prescription drug products to the list of drugs eligible for selection for a cost review study.

Authority: Health-General Article, §§21-2C-03(f)(1), 21-2C-08(b), and 21-2C-09, Annotated Code of Maryland

Effective date: December 25, 2023 (50:25 Md. R. 1089)

Regulation .05 amended as an emergency provision effective November 14, 2024 (51:25 Md. R. 1140); adopted permanently effective March 3, 2025 (52:4 Md. R. 220)