Or. Admin. Code § 925-200-0010

Current through Register Vol. 63, No. 12, December 1, 2024

Section 925-200-0010 - Selecting Prescription Drugs for Affordability Reviews

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.

Or. Admin. Code § 925-200-0010

PDAB 1-2023, adopt filed 07/28/2023, effective 8/1/2023

Statutory/Other Authority: ORS 646A.693 & ORS 646A.694

Statutes/Other Implemented: ORS 646A.694