Or. Admin. Code § 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.
Notes
Statutory/Other Authority: ORS 646A.689
Statutes/Other Implemented: ORS 646A.689
State regulations are updated quarterly; we currently have two versions available. Below is a comparison between our most recent version and the prior quarterly release. More comparison features will be added as we have more versions to compare.
(1) General requirements. All reports submitted by drug manufacturers under this section 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, the report furnished to the department must include the following information, along with any documentation necessary to support the information reported under this subsection:
(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 30-day supply or a course of treatment lasting less than on month;
(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 2018 Or Laws ch 7.
(3) Prescription Drug Reporting - Patient Assistance Programs:
(a) If a reporting manufacturer offers one or more patient assistance programs to consumers residing in Oregon to reduce consumer out-of-pocket costs for a drug meeting the conditions specified in OAR 836-200-0515, the report furnished to the department under subsection (2) of this section must have an appendix that includes at least the following information for each patient assistance program relevant to the drug that is the subject of the report:
(A) The number of consumers residing in Oregon who participated in the patient assistance program over the previous calendar year ;
(B) The total dollar value of the coupons, discounts, copayment assistance or other reduction in costs provided to consumers in this state who participated in the program over the previous calendar year ;
(C) For each drug, the number of refills that qualify for the program, if applicable;
(D) If the program expires after a specified period of time, the period of time that the program is available to each consumer; and
(E) The eligibility criteria for the program and how eligibility is verified for accuracy.
(b) If a reporting manufacturer provides funding for an independent patient assistance program that reduces consumer out-of-pocket costs for a drug meeting the conditions specified in OAR 836-200-0515, the report furnished to the department under subsection (2) of this section must have an appendix that provides the name of the independent program and includes all of the information specified in this subsection that is available to the manufacturer at the time of the report. If the independent program provides services in addition to reducing consumer out-of-pocket costs for the drug that is the subject of the report, the manufacturer may limit the information provided to the information applicable to the drug that is the subject of the report. Reporting manufacturers that provide funding for independent patient assistance programs must make a good faith effort to secure this information.
(c) Reporting manufacturers that provide funding for a bona fide Independent Charity Patient Assistance Program operating in full compliance with the guidance provided in the Department of Health and Human Services Office of the Inspector General's Supplemental Special Advisory Bulletin: Independent Charity Patient Assistance Programs (Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices) are not required to include information about the bona fide Independent Charity Patient Assistance Program in any appendix required by this section.
(4) Prescription Drug Reporting - New Specialty Drug. For drugs meeting the conditions specified in OAR 836-200-0520, the report furnished to the department must include the following information:
(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 and dosage of the drug the reporting manufacturer used to determine that the price of the drug for a 30 day supply or for a course of treatment lasting less than one month exceeds the threshold established by the Centers for Medicare and Medicaid Services for specialty drugs in the Medicare Part D program;
(c) A description of the marketing used in the introduction of the new prescription drug including spending on direct-to-consumer marketing such as paid advertising, as well as spending to promote the drug to physicians, if applicable;
(d) The methodology used to establish the price of the new prescription drug , including a narrative description and explanation of all major financial and nonfinancial factors 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;
(e) Whether the United States Food and Drug Administration granted the new prescription drug a breakthrough therapy designation or a priority review, along with any supporting documentation;
(f) 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;
(g) The manufacturer's estimate of the average number of patients who will be prescribed the new prescription drug each month; and
(h) 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 .
Notes
Statutory/Other Authority: 2018 Or Laws ch 7
Statutes/Other Implemented: 2018 Or Laws ch 7