OAR Chapter 925 — Department of Consumer and Business Services, Prescription Drug Affordability Board

Division 100 Procedural Rules

Or. Admin. R. 925-100-0001 Model Rules for Rulemaking

The Model Rules for Rulemaking, OAR 137-001-0005 through 137-001-0100, in effect on Jan. 1, 2008, adopted by the Oregon Department of Justice under ORS 183.341, are adopted as the rules of procedure for rulemaking actions of the Prescription Drug Affordability Board. The full text of the Model Rules is available from the Department of Justice, the Prescription Drug Affordability Board, or on the Oregon State Archives website at: https://secure.sos.state.or.us/oard/viewSingleRule.action?ruleVrsnRsn=291164.

History

• Statutory/Other Authority: ORS 646A.693 - 646A.697
• Statutes/Other Implemented: ORS 183.325 - 183.410
• PDAB 2-2022, adopt filed 11/28/2022, effective 12/23/2022
• PDAB 1-2022, temporary adopt filed 06/27/2022, effective 06/27/2022 through 12/23/2022

Or. Admin. R. 925-100-0002 Notice of Rulemaking

(1) Except when adopting a temporary rule, the Prescription Drug Affordability Board will give prior public notice of the proposed adoption, amendment, or repeal of any rule by:

(a) Publishing notice of the proposed rulemaking action in the Secretary of State’s Oregon Bulletin at least 21 days before the effective date of the rule;

(b) Notifying interested people and organizations on the Prescription Drug Affordability Board’s notification lists of proposed rulemaking actions under ORS 183.335; and

(c) Providing notice to legislators as required by ORS 183.335(15).

(2) A person or organization may elect to receive email or hard-copy notification of proposed rulemaking actions of the Prescription Drug Affordability Board.

(a) A person or organization may elect to subscribe to the Prescription Drug Affordability Board’s email notification service at: https://public.govdelivery.com/accounts/ORDCBS/subscriber/new?topic_id=ORDCBS_732.

(b) A person or organization may elect to receive hard-copy notification by sending a request in writing, including the person or organization’s full name and mailing address, to the following address:

History

• Statutory/Other Authority: ORS 646A.693 - 646A.697
• Statutes/Other Implemented: ORS 183.335 & ORS 84.022
• PDAB 2-2022, adopt filed 11/28/2022, effective 12/23/2022
• PDAB 1-2022, temporary adopt filed 06/27/2022, effective 06/27/2022 through 12/23/2022

Or. Admin. R. 925-100-0003 Public Records Requests

(1) Oregon's Public Records Law (ORS 192) provides that every person has a right to inspect any public records of a public body, except records that are exempt from disclosure.

(2) A public record request may be submitted in person, by U.S. Mail, fax or by email to the Prescription Drug Affordability Board (Board). The written request must include:

(a) The name and address of the person requesting the public record;

(b) The telephone number or other contact information of the person requesting the public record;

(c) A sufficiently detailed description of the record(s) requested to allow the Board to search for and identify responsive records; and the

(d) Date and signature of the person requesting the public record.

(3) Public records, except those exempt from disclosure, will be made available upon request for review and copies will be provided at a fee reasonably calculated.

(4) The Oregon Public Records Law allows agencies to recover their actual costs in fulfilling a public records request including actual costs for supplies, research, compilation, postage, shipping and staff time.

(5) Fees will be payable prior to fulfilling a public records request. If the fee is estimated to be greater than $25:

(a) The Board staff will provide the requestor with a written notice of the estimated amount of the fee.

(b) The public records request will not be fulfilled until the requestor confirms in writing that the requestor wants to proceed with the request.

(6) Standard fees for Public Records:

(a) Per page fees reflect current Oregon Department of Administrative Services policy;

(b) $5.00 for each true notarized certification;

(c) Other applicable fees: actual costs or best estimate of costs; and

(d) Miscellaneous fees may include archive retrieval costs, costs of software companies/contracts; other third party costs.

(e) No charge for the first 30 minutes of staff time for processing request. The hourly rate charged for additional staff time is based on the level of skill or expertise required to complete the work performed not the employee-level of the individual actually fulfilling the request.

(f) Clerical labor charges are $25.00 per hour; Managerial labor charges are $40 per hour; Professional (IT, HR, high-level Analyst) $75.00 per hour; and DOJ, special attorney and other applicable legal fees: at the actual hourly rate charged for Public Records Request-related services. Fees are subject to statutory limitation described in ORS 192.324.

(7) The Board may furnish copies of public information without charge or at a reduced fee if it is determined that the waiver or reduction of fees is in the public interest because providing access primarily benefits the general public under ORS 192.324.

(8) A person desiring a waiver or reduction in fees must submit a written request for a waiver.

(9) The Board Executive Director will consider each request on a case-by-case basis based on the information provided by the requestor and the totality of the circumstance at the time of the request.

(10) The Board Executive Director will make fee waiver or reduction decisions based on the guidelines outlined in the Oregon Department of Administrative Services Statewide Standardized Fee Process.

History

• Statutory/Other Authority: ORS 646A.693 - 646A.697
• Statutes/Other Implemented: ORS 192.324
• PDAB 2-2022, adopt filed 11/28/2022, effective 12/23/2022
• PDAB 1-2022, temporary adopt filed 06/27/2022, effective 06/27/2022 through 12/23/2022

Division 200 Prescription Drug Affordability Review

Or. Admin. R. 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.

History

• Statutory/Other Authority: ORS 646A.693 & ORS 646A.694
• Statutes/Other Implemented: ORS 646A.694
• PDAB 1-2023, adopt filed 07/28/2023, effective 08/01/2023

Or. Admin. R. 925-200-0020 Conducting an Affordability Review

The Prescription Drug Affordability Board (PDAB) will conduct an affordability review on the prioritized subset of prescription drugs, selected under OAR 925-200-0010 to identify nine prescription drugs and at least one insulin product that may create affordability challenges for health care systems or high out-of-pocket costs for patients in Oregon.

(1) PDAB will conduct an affordability review by considering, to the extent practicable, the following criteria set forth in ORS 646A.694:

(a) Whether the prescription drug has led to health inequities in communities of color;

(b) The number of residents in this state prescribed the prescription drug;

(c) The price for the prescription drug sold in this state;

(d) The estimated average monetary price concession, discount or rebate the manufacturer provides to health insurance plans in this state or is expected to provide to health insurance plans in this state, expressed as a percentage of the price for the prescription drug under review;

(e) The estimated total amount of the price concession, discount or rebate the manufacturer provides to each pharmacy benefit manager registered in this state for the prescription drug under review, expressed as a percentage of the prices;

(f) The estimated price for therapeutic alternatives to the drug that are sold in this state;

(g) The estimated average price concession, discount or rebate the manufacturer provides or is expected to provide to health insurance plans and pharmacy benefit managers in this state for therapeutic alternatives;

(h) The estimated costs to health insurance plans based on patient use of the drug consistent with the labeling approved by the United States Food and Drug Administration and recognized standard medical practice;

(i) The impact on patient access to the drug considering standard prescription drug benefit designs in health insurance plans offered in this state;

(j) The relative financial impacts to health, medical or social services costs as can be quantified and compared to the costs of existing therapeutic alternatives;

(k) The estimated average patient copayment or other cost-sharing for the prescription drug in this state;

(l) Any information a manufacturer chooses to provide; and

(m) A prescription drug that is designated by the United States Food and Drug Administration (FDA), under 21 U.S.C. 360bb, as a drug for a rare disease or condition is not subject to an affordability review.

(2) PDAB will conduct an affordability review by considering, to the extent practicable, the additional following factors:

(a) In addition to the criteria in subparagraph (1)(a): Whether the pricing of the prescription drug results in or has contributed to health inequities in:

(A) Under-resourced communities; or

(B) Regions with limited pharmacy access.

(b) In addition to the criteria in subparagraph (1)(b): The off label use of prescription drugs used to treat other conditions.

(c) In addition to the criteria in subparagraph (1)(f): The estimated net price. Cost and availability of therapeutic alternatives to the prescription drug in the state, including any relevant data regarding costs, expenditures, availability, and utilization related to the prescription drug and its therapeutic alternatives.

(d) In addition to the criteria in subparagraph (1)(d), (1)(e), and (1)(g): Information submitted by manufacturers related to patient assistant programs and coupons.

(e) Current wholesale acquisition cost of the prescription drug and changes in the prescription drug’s net cost over time.

(f) Analysis to consider acquisition cost for pharmacies.

(g) Effect of price on consumers’ access to the prescription drug by reviewing changes in pricing, expenditure, and utilization over time.

(h) Potential market for prescription drug for labeled and off-label indications and budget impact on various payors in the state.

(i) In addition to the criteria in subparagraph (1)(j):

(A) To the extent such information can be quantified, the relative financial effects of the prescription drug on broader health, medical, or social services costs, compared with therapeutic alternatives or no treatment.

(B) To the extent such information can be quantified, the total cost of the disease and the drug price offset.

(j) In addition to the criteria in subparagraph (1)(k): Patient copayment or other cost sharing data, across different health benefit plan designs, including:

(A) Copayment and coinsurance impacts from:

(i) Patient assistance programs; and

(ii) Copay coupons;

(B) Deductible;

(C) Patient out-of-pocket costs; and

(D) Any other cost sharing data.

(k) Input from Specified Stakeholders:

(A) Patients and Caregivers:

(i) Seek input from patients and caregivers affected by a condition or disease that is treated by the prescription drug under review by gathering information related to:

(I) The impact of the disease;

(II) Patient treatment preferences;

(III) Patient perspective on the benefits and disadvantages of using the prescription drug;

(IV) Caregiver perspective on the benefits and disadvantages of using the prescription drug; and

(V) Available patient assistance in purchasing the prescription drug.

(ii) In seeking additional information, attempt to gather a diversity of experience among patients from different socioeconomic backgrounds.

(B) Individuals with Scientific or Medical Training: Seek input from individuals who possess scientific or medical training with respect to a condition or disease treated by the prescription drug that is under review, including:

(i) The impact of the disease;

(ii) Perspectives on benefits and disadvantages of the prescription drug, including comparisons with therapeutic alternatives if any exist; and

(iii) Input regarding the prescription drug utilization in standard medical practice, as well as input regarding off label usage.

(C) Safety Net Providers: health care providers that care for uninsured patients and patients with low income and receive discounted prices on prescription drugs through section 340B of the federal Public Health Service Act (42 U.S.C. 256b):

(i) The utilization of the prescription drug by the safety net provider patients;

(ii) Whether safety net providers receive a 340B discount for the prescription drug;

(iii) Where safety net providers do not receive a discount, whether access to the prescription drug is impeded; and

(iv) Any other topics identified by safety net provider stakeholders.

(D) Payers:

(i) Total cost of care for disease(s);

(ii) Cost of the prescription drug to the payer;

(iii) The availability of therapeutic alternatives on the formulary;

(iv) Coverage mandates and impacts to per member per month or premiums;

(v) Affordability concerns of the prescription drug, from employer groups and other plan sponsors; and

(vi) Other costs to consider.

(l) Rebates, Discounts, and Price Concessions:

(A) To the extent practicable, estimated manufacturer net-sales or estimated net-cost amounts (including rebates, discounts, and price concessions) for the prescription drug and therapeutic alternatives; and

(B) Financial assistance the manufacturer provides to pharmacies, providers, consumers, and other entities.

(m) Information from the Oregon Health Authority (OHA), Health Evidence Review Commission (HERC), and Pharmacy and Therapeutics Committee (P&T) that is relevant to the prescription drug or therapeutic alternative under review.

(n) In addition to the criteria in subparagraph (1)(m): A prescription drug approved by the FDA for other indications, in addition to a rare disease or condition, is not exempt from an affordability review for those other indications.

History

• Statutory/Other Authority: ORS 646A.693 & ORS 646A.694
• Statutes/Other Implemented: ORS 646A.694
• PDAB 1-2023, adopt filed 07/28/2023, effective 08/01/2023