OAR 836-200-0531: Prescription Drug Reporting – New Prescription Drug

For new prescription drugs meeting the conditions specified in OAR 836-200-0520, the report furnished to the department must include the following information: (1) The full trade name of the drug (proprietary), full chemical name or biologic product name of the drug (nonproprietary), recognized industry standard drug identification information for the drug as specified on the department’s website, drug strength, drug package size, the date the drug was initially approved by the United States Food and Drug Administration, and the date the drug was introduced in the United States market. (2) The price and dosage of the drug the reporting manufacturer used to determine that the price of the drug for a one-month supply exceeds the threshold defined in OAR 836-200-0520. (3) A description of the marketing used in the introduction of the drug, including the types of marketing, target audience, and associated spending for the four quarters prior to launch and planned costs for the four quarters following launch, with any associated explanation: (a) Types of marketing includes digital (e.g., consumer or industry websites, social media), TV or audio, and other types of promotion; (b) Target audience includes consumers, health care professionals, pharmacy benefit managers, insurance carriers, and other entities in the pharmaceutical supply chain. (4) The methodology used to establish the price of the new prescription drug, including all factors, with any associated impact or explanation, that influenced the decision to set the price of the drug at the level it was first set by the reporting manufacturer following its approval for marketing by the United States Food and Drug Administration. Factors may include, but are not limited to: (a) Other prescription drugs including the drug name, labeler name, and price; (b) Estimated manufacturing costs for the prescription drug; (c) Estimated marketing costs for the prescription drug; (d) Estimated distribution costs for the prescription drug; (e) Estimated costs of ongoing safety and effectiveness research associated with the prescription drug; (f) Other costs for the prescription drug; and, (g) Other costs not specifically associated with the prescription drug. (5) Whether the United States Food and Drug Administration granted the new prescription drug a breakthrough therapy designation or a priority review; (6) If the new prescription drug was not developed by the manufacturer, the date of and the price paid for acquisition of the new prescription drug by the manufacturer; (7) The manufacturer’s estimate of the average number of patients in the United States who will be prescribed the new prescription drug each month; and (8) The research and development costs associated with the new prescription drug that were paid using public funds, including all available information about the sources and uses of these public funds.