OAR 836-200-0530: Form and Manner Requirements for Drug Pricing Reporting

(1) General requirements. All reports submitted by drug manufacturers under ORS 646A.689 must: (a) Be provided in an electronic format specified by the department; (b) Be provided via an electronic system specified by the department; (c) Be machine readable; (d) Be capable of being reduced to written form; (e) Clearly indicate the information the manufacturer asserts to be conditionally exempt from disclosure under ORS 192.345 as a trade secret in adherence with OAR 836-200-0540; (f) Include a certification of compliance document certifying that the filing complies with all applicable Oregon statutes, rules, standards and filing requirements; and (g) Adhere to the standards set forth on the department’s website. (2) Prescription Drug Reporting - Price Increase. For drugs meeting the conditions specified in OAR 836-200-0515, a report may be voluntarily furnished to the department and include the following information, along with any documentation to support the information reported under this section: (a) The full trade name of the drug, full chemical name or biologic product name of the drug, and recognized industry standard drug identification information for the drug as specified on the department’s website; (b) The price of the drug at the beginning of the calendar year preceding the report; (c) The price of the drug at the end of the calendar year preceding the report; (d) The highest and lowest prices of the drug at any point during the calendar year preceding the report; (e) The increase in the price of the drug over the preceding calendar year, expressed as a percentage; (f) The price and dosage of the drug the reporting manufacturer used to determine that the drug cost $100 or more for a one-month supply; (g) The length of time the prescription drug has been on the market; (h) The factors that contributed to the price increase, including a narrative description and explanation of all major financial and nonfinancial factors that influenced the decision to increase the wholesale acquisition cost of the drug product and to decide on the amount of the increase; (i) The name of any generic version or biosimilar of the prescription drug available for sale in the United States at the time of the report; (j) The research and development costs associated with the prescription drug that were paid using public funds, including all available information about the sources and uses of these public funds; (k) The direct costs incurred and specific total dollars expended by the manufacturer in the previous calendar year: (A) To manufacture the prescription drug; (B) To market the prescription drug, including spending on direct-to-consumer marketing such as paid advertising, as well as spending to promote the drug to physicians; (C) To distribute the prescription drug; and (D) For ongoing safety and effectiveness research associated with the prescription drug. (l) The total sales revenue for the prescription drug during the previous calendar year; (m) The manufacturer’s net profit attributable to the prescription drug during the previous calendar year; (n) The introductory price of the prescription drug when it was approved for marketing by the United States Food and Drug Administration; (o) The net yearly increase, if any, by calendar year, in the price of the prescription drug during the previous five calendar years; (p) The 10 highest prices paid for the prescription drug during the previous calendar year in any country other than the United States, expressed in dollars according to the prevailing exchange rate at the time of the report; and (q) Any other information that the manufacturer deems relevant to the price increase and that the manufacturer deems will assist the director to complete a review of a drug price under ORS 646A.689.