Current through Register Vol. 51, No. 19, September 20, 2024
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) The claims data in the MCDB;
(2) Available subsets of claims data in the
MCDB, such as the commercial market, Medicaid, and Medicare; and
(3) The data obtained from governmental and
commercial databases, other databases, and other data sets as
available.
B. The Board
may identify the prescription drug products that meet these statutory metrics
and regulatory criteria on at least an annual basis.
C. Data Management.
(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) For any data-based
metric, the Board may account for data errors and outliers.
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) Aggregated Spending and Pricing Data:
(a) The 100 prescription drug products with
the highest total gross spending in the most recent available calendar
year;
(b) The 100 prescription drug
products with the highest total gross spending per patient in the most recent
available calendar year;
(c) The
100 prescription drug products with the highest percent change increase in WAC
over the most recent available calendar year;
(d) The 100 prescription drug products with
the highest percent change increase in WAC over the most recent available
5-year period;
(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;
(f) The 100 prescription drug products with
the highest dollar increase in WAC over the most recent available 5-year
period; and
(g) The 100
prescription drug products with the highest percent change increase in total
gross spending;
(2)
Patient Out-of-Pocket Costs:
(a) The 100
prescription drug products with the highest total patient out-of-pocket costs
in the most recent available calendar year;
(b) The 100 prescription drug products with
the highest average patient total out-of-pocket costs in the most recent
available calendar year;
(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
(d) The 100 prescription drug products ranked
at the 90th percentile for patient total out-of-pocket costs; and
(3) Any prescription drug product
added by the Board to the list of prescription drug products eligible for cost
review under this regulation.
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)
Moving that the prescription drug product or products be added to the eligible
list; and
(2) Identifying how the
prescription drug product or products may create affordability challenges for
the State health care system or patients.
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.
