#1DCBS Consumer and Business Services Oregon Prescription Drug Price Transparency Program#2Agenda 1. Overview of Oregon's Prescription Drug Price program 2. New drug reporting 3. Annual price increase reporting 4. Information claimed to be trade secret 5. Report timelines 6. Assessments and civil penalties 2#3Oregon's Drug Price Transparency Program The Prescription Drug Transparency Act (HB 4005), enacted during the 2018 Legislative Session, established Oregon's Drug Price Transparency program Increase transparency on prescription drug costs and prices from pharmaceutical manufacturers Collect prescription drug information from health insurance companies Provide consumers a way to report personal prescription drug price increases 3#4Overview: Manufacturer reporting Prescription drug manufacturers are required to report: - - New prescription drugs – cost more than $670 a month or course of treatment Reporting began on March 15, 2019 - Annual price increase – drugs priced more than $100/month with a 10% net yearly price increase • • Reports due July 1, 2019 4#5Overview: Account creation A reporting manufacturer is defined in the administrative rule (OAR 836-200-0505) as an entity: Required to be registered with the Oregon Board of Pharmacy as a drug manufacturer; That engages in the manufacture of prescription drugs as defined in 2018 OR Laws ch.7; and • That sets or changes the wholesale acquisition cost (WAC) of the drug(s) it manufactures. LO 5#6New drug reporting Required: New drug comes to market at a price exceeding $670 for a thirty-day supply or a course of treatment lasting less than one month Deadline to Report: Within 30 days of the drug's market entry date Where to Report: dfr.Oregon.gov/drugtransparency, iReg 6#7Your session will expire in 60 minutes f you remain on this page. OREGON.gov Department of Consumer and Business Services Insurance iReg-Drug Prices Home Drug Prices New Drugs Correspondence Filings Details New drug reporting Start New Drug Filing NDC: Trade Name: Chemical Name: Next Cancel FILLAR ALHEUR COU COUNTY MALL A HAIVORSON, OREGON STATE A GABY ARCHIVES DCBS 9.0.0 Instructions Log out 7#8Your session will expire in 30 minutes if you remain on this page. OREGON.gov Department of Consumer and Business Services Insurance IReg-Drug Prices - Details Home Drug Prices New Drugs Correspondence Filings Details Filing Details New drug reporting: Data elements Filing Status: * NDC: Trade Name: Chemical Name: * Marketing Description: * Wholesale Acquisition Cost (WAC): Dosage: In Progress PILLAR OF ROME, MALHEUR COUNTY GARY HALVORSON. OREGON STATE ARCHIVES DCBS 9.0.2 Trade Secret? Instructions Log out 8#9New drug reporting: Data elements ● Full trade name of the drug ● ● Full chemical or biologic product name of the drug • 11-digit NDC for the drug product Price and dosage of the drug the manufacturer used to determine the price exceeded the threshold 6#10• ● New drug reporting: Data elements Description of the marketing used introducing new prescription drug, including: - Spending on direct-to-consumer marketing and paid advertising – Spending on promotion of drug to physicians or other health professionals Methodology used to establish the price of the new prescription drug, including: - narrative description and explanation of all major financial and nonfinancial factors that influenced the set the price of the drug 10#11. . . • New drug reporting: Data elements Whether there was a breakthrough designation or priority review granted and any support documentation Date and price paid for acquisition of the new prescription drug Estimate of the average number of patients who will be prescribed the new prescription drug each month Research and development costs associated with the new prescription drug that were paid using public funds 11#12* Pricing Methodology: * FDA Priority or Breakthrough: Yes Ⓒ No Acquisition Cost: 0.00 New drug reporting: Data elements Trade Secret? Required if the drug was acquired Trade Secret? Acquisition Date: Required if the drug was acquired Trade Secret? Estimated Avg. Number of 0 Patients per Month: Patients per Month Description: 12#13R&D Costs Using: * International Public Funds: 0.00 * USA Federal Public Funds: 0.00 * All States Public Funds: 0.00 * All Local Public Funds: 0.00 * Public Funds Sources and Uses: Documents 10 records per page Doc Type Showing 0 to 0 of 0 entries New drug reporting: Data elements Reason for Inclusion TS? Justification Document No data available in table Attach New Document Continue To Certification Save Progress Cancel Start/Open Correspondence Trade Secret? Trade Secret? Trade Secret? Trade Secret? Trade Secret? Search: ← Previous Next → 13#14Annual price increase reporting Required: WAC was $100 or more and there was a net yearly increase of 10 percent or more in the WAC of the prescription drug Deadline to Report: July 1, 2019 for the first year - March 15 for all subsequent years Where to Report: dfr. Oregon.gov/drugtransparency, iReg 14#15. • Annual price increase reporting: Data elements Full trade name of the drug Full chemical or biologic product name of the drug . 11-digit NDC for the drug product . Price and dosage of the drug the manufacturer used to determine the cost $100 or more 15#16· . Annual price increase reporting: Data elements The price of the drug at the beginning of the calendar year preceding the report The price of the drug at the end of the calendar year preceding the report The highest and lowest prices of the drug at any point during the calendar year preceding the report The increase in the price of the drug over the preceding calendar year, expressed as a percentage 16#17Annual price increase reporting: Data elements • The length of time the prescription drug has been on the market • 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 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 17#18• Annual price increase reporting: Data elements The direct costs incurred and total dollars expended by the manufacturer in the previous calendar year: - To manufacture the prescription drug - 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 - - To distribute the prescription drug For ongoing safety and effectiveness research associated with the prescription drug 18#19Annual price increase reporting: Data elements • 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 . • . The total sales revenue for the prescription drug during the previous calendar year The manufacturer's net profit attributable to the prescription drug during the previous calendar year The introductory price of the prescription drug when it was approved for marketing by the United States Food and Drug Administration 19#20• • • Annual price increase reporting: Data elements The net yearly increase by calendar year, in the price of the prescription drug during the previous five calendar years 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 Any other information that the manufacturer deems relevant to the price increase 20#21• Annual price increase reporting: Data elements- Patient assistance programs The number of consumers residing in Oregon who participated in the patient assistance program over the previous calendar year 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 For each drug, the number of refills that qualify for the program If the program expires after a specified period of time, the time that the program is available to each consumer The eligibility criteria for the program and how eligibility is verified for accuracy 21#22Information claimed to be trade secret For information claimed to be trade secret within the report, the manufacturer will be prompted to provide a written explanation of why it is exempt by demonstrating all of the following: 1. The information is not patented 2. The information is known only to certain individuals within the manufacturers organization and used in a business the organization conducts 3. The information has actual or potential commercial value 4. The information gives the manufacturer an opportunity to obtain a business advantage over competitors who do not know or use it 5. The public interest does not require disclosure of the information 22#23Information claimed to be trade secret If the manufacturer asserts that disclosure of any information provided in a report is prohibited by state or federal law, the manufacturer must clearly indicate: - · Relevant information - Explain the basis of the assertion, including any citations of the applicable state and federal law The burden of proof to establish information as conditionally exempt from disclosure as a trade secret is on the manufacturer submitting the filing. 23#24Information claimed to be trade secret * Marketing Description: Trade Secret Justification* Please provide a succinct explanation demonstrating all of the following for the data element: 1. The information is not patented; 2. The information is known only to certain individuals within the manufacturer's organization and used in a business the organization conducts; 3. The information has actual or potential commercial value; 4. The information gives the manufacturer an opportunity to obtain a business advantage over competitors who do not know or use it; and 5. The public interest does not require disclosure of the information. Trade Secret? 24#25Information claimed to be trade secret: Review process The department shall review the manufacturer's explanations and make a determination on a case-by- case basis. - The department will notify the manufacturer and provide a written explanation, if it is determined that any information claimed to be trade secret must be disclosed - Within 15 days of receiving the notification for disclosure, the manufacturer may submit an appeal letter to the director of DCBS and request reconsideration. 25#26Information claimed to be trade secret: Review process The director or director's designee will review the appeal and issue an appeal determination within 15 days, or within a time period necessary to obtain legal review, of receiving an appeal letter. If the director's determination would result in the disclosure of information claimed to be trade secret, the department will notify the manufacturer of the director's decision at least 21 days in advance of disclosing the information. 26#27Information claimed to be trade secret: Review process If the department exempts information from disclosure provided by a manufacturer, the department will post an explanation for exempting the information and a general description of the information. A person may petition the Attorney General, as provided in ORS 192.411, to review a decision made by the department to exempt information from disclosure. 27#28Report timelines: Additional information requests Within 60 calendar days of receiving a report from a prescription drug manufacturer, the department may submit a written request for supporting documentation or additional information to: • ● Clarify or substantiate the previously reported material Enable an analysis of factors affecting drug prices for the purpose of providing recommendations to the Oregon State Legislature. Manufacturers will receive an alert on their iReg account. 28#29Report timelines: Additional information requests Within 60 calendar days of receiving a request for information, a prescription drug manufacturer must provide a full and complete written response to the department's request All information claimed to be a trade secret must be clearly identified and accompanied with an explanation as specified under OAR 836-200-540. Any requested information that is unavailable to the manufacturer must include a written explanation as specified by 836-200-0525. 29#30. Report timelines: Additional information requests Within 15 calendar days of receiving a request for more information, a manufacturer may request up to an additional 30 days to respond to the information request - The request for additional time must explain the grounds for the request and the need for additional time, submitted in writing on the iReg system The department shall respond in writing, within 15 days. of receiving the manufacturer's request explaining the decision to grant the request, deny the request, or grant with an amount less than requested. 30#31Report timelines: Public disclosure Timeframes for disclosure As soon as practicable after receiving a filing No later than 90 days after receiving a filing from a manufacturer No later than 60 days after receiving a response to a request for additional information from a manufacturer Action The department shall post to its website the name of the manufacturer and the prescription drug that is the subject of the filing The department shall post to its website the information provided by the prescription drug manufacturer in the filing The department shall post the response to its website 31#32Report timelines: Public disclosure Information claimed to be trade secret in a report filing, additional information response, or correspondence will not be posted until a final determination has been made by the department or the director. Any information claimed to be trade secret determined by the department to be exempt from disclosure will not be posted to the department's website. 32#33Assessments There are two primary assessments for the Drug Price Transparency program: 1. Annual assessment paid by all prescription drug manufacturers and 2. Reporting assessment paid by prescription drug manufacturers who file a report(s) during the current reporting year Billing for all assessments will occur by October 1st each year. 33#34Annual Assessment ● Assessments Prescription drug manufacturers who meet the requirements of a reporting manufacturer, as defined in OAR 836-200-0505, will be required to pay an annual assessment of $400. Reporting Assessment ● Reporting manufacturers that file reports are required to pay an additional report assessment for each report filed. The amount of the report assessment will vary depending on the number of reports the department receives each year. 34#35Civil penalties Missing, inaccurate, or Untimely incomplete data Failure to submit responses for required report additional information First $500 per day maximum $1,500 per day $2,500 per day violation for first 30 days maximum for first 30 days maximum for first 30 days $1,000 per day maximum after 30 days $3,000 per day $5,000 per day maximum after 30 maximum after 30 days days Subseque $1,000 per day nt maximum $3,000 per day maximum $5,000 per day maximum violations 35#36Program Contacts Info on Oregon's Drug Price Transparency Program: . Visit dfr.oregon.gov/drugtransparency Email [email protected] Call 503-947-7200 Cassie Soucy, Program Coordinator Email: [email protected] Phone: 503-983-3895 36