The Prescription Drug Affordability Board (PDAB) will select
from the list of eligible prescription drugs, provided by the Department of
Consumer and Business Services pursuant to ORS 646A.694, a subset of drugs to
prioritize for an affordability review under OAR 925-200-0020 by considering
the following for the selection of prescription drugs:
(1) Whether any prescription drugs are on
each of the insurer reported top 25 lists under ORS 743.025.
(2) Whether the prescription drug is included
in the manufacturer new drug report or price increase report under ORS 646A.689 for the previous calendar year.
(3)
Historical and current manufacturer drug price increases, based on wholesale
acquisition cost (WAC) information. For drugs with multiple nation drug codes
(NDC), a measure of central tendency will be used for a price
comparison.
(4) The date of U.S.
Food and Drug Administration (FDA) approval of the prescription drug and
whether the prescription drug was approved through an expedited pathway.
Expedited approval includes fast track, priority review, accelerated approval,
and breakthrough therapy designation. For brand-name drugs and biological
products, whether there are any approved and marketed generic drugs or
biosimilar drugs for the specific brand-name drug or biological
product.
(5) Where there are
therapeutic alternatives, the cost and availability of potential
alternatives.
(6) Whether the
prescription drugs have a patent expiration or data exclusivity expiration
within 18 months.
(7) For insulin
drugs marketed in the U.S. and available in Oregon, criteria for selection may
include, but not limited to, those products with the highest insurer reported:
(a) Overall spend;
(b) Per-patient spend; and
(c) Patient out-of-pocket cost.