PNW Advocates Confab
4th Tuesday of the Month at Noon PST
Working together to strengthen community and connections around health: advocacy, health policy, innovations, and tools.
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Madonna McGuire Smith
Sara Traigle van Geetruyden
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Zoom Meeting ID: 823 1895 2369 Passcode: 614588
About PNW Advocates Confab
A community made up of advocacy organization, policy drivers, health innovators, and patients invested in collaborative outcomes that make our society healthier.
Upcoming Meetings of Interest
Prescription Drug Affordability Board (PDAB)
June 26, 2024
9:30 AM
Community Letter to PDAB
December 4, 2023
Oregon Prescription Drug Affordability Board
350 Winter Street NE
Salem, OR 97309-0405
pdap@dcbs.oregon.gov
Subject: Consumer Engagement
Dear Members of the Oregon Prescription Drug Affordability Board:
On behalf of 25 community-based organizations and people living with challenging health conditions, we are writing to express our concern about the Prescription Drug Affordability Board’s (PDAB) process for engaging people with disabilities and chronic conditions, depriving it from incorporating their experiences and voices in its decisions. Therefore, we would like to provide the following comments and recommendations:
- Board representation: There is no representation of patients or people with disabilities on the Board. While the statute creating the PDAB did not require inclusion of patients and people with disabilities on the board, it also did not exclude from the board people with the required expertise who also identify as people living with a chronic condition or disability. Therefore, we urge efforts to identify people to serve as board members that are qualified people with disabilities or chronic conditions. Also, we urge the current board to recommend to the legislature that seats be explicitly added to the board for patients and people with disabilities.
- Engagement Opportunities: We are concerned that the PDAB meeting agendas have not formally involved expert advisors living with a condition treated by the selected drugs for review, nor have the meetings to date given priority to hearing their testimony. For example, Colorado held separate meetings for each of the 5 drugs selected for review, with one meeting specifically for patients and one meeting for clinicians treating the specific population of patients and researchers. Colorado also has an advisory council that reports to the board, which includes patients and people with disabilities. We request that the board work with patients and people with disabilities to schedule engagement opportunities, one for patients and one for clinicians and researchers, as part of its deliberations related to affordability. These engagement sessions should provide an opportunity for communication between the board and stakeholders, consistent with state law.
- Transparency of Deliberations: During Oregon’s legislative debate creating the PDAB, it was a priority for many in the patient and disability communities to ensure that its process did not rely on evidence that is discriminatory or biased, which would exacerbate existing health inequities. Therefore, many of our organizations supported provisions barring the use of quality-adjusted life years (QALYs) or similar formulas. Yet, the board is engaged with the Program on Regulation, Therapeutics, and Law (PORTAL), which has presented to the board options for considering comparative cost and benefit that explicitly includes 1) using existing health technology assessments which historically rely on QALYs or similar measures such as the equal value of life year gained (evLYG), 2) referencing the evidence rating from the Institute for Clinical and Economic Review (ICER), an entity which calls QALYs the “gold standard,” and 3) directly using QALYs and evLYG as part of reviews. Therefore, we urge the Board to publicly disclose for comment the evidence under consideration from third parties related to clinical effectiveness, cost effectiveness, and any comparators used in judgements of therapeutic benefit. This step is essential to protect the process from being undermined by considerations of evidence that is biased, discriminatory, or unlawful. Similarly, the board should avoid using a flawed comparator to judge whether a treatment is affordable or effective.
- Emphasis on Patients in Affordability Review: The statute creating the PDAB allows for the selection of treatments that the board determines “may create affordability challenges for health care systems or high out-of-pocket costs for patients.” We are concerned that the Board has brought in third parties to advise their process such as PORTAL, a third party whose work is focused on achieving savings for payers as opposed to achieving lower out-of-pocket costs for patients. As the process moves forward, we urge the board to work closely with organizations representing patients and people with disabilities to ensure that their real world affordability concerns are driving the board’s determinations.
It will be important for the board to balance input from patients, people with disabilities, providers, and researchers. For example, at the most recent PDAB meeting on November 15, we appreciated a guest physician’s excellent presentation on the various ways she prescribes insulin to her patients. However, the board did not ask questions to the provider that would have been useful such as whether the drug worked in some populations and not others or whether one easier to adhere to than another? Also, the patient’s experience was missing from the presentation. For real communication, we would have preferred the board elicit the patient experience by asking targeted questions such as whether one drug caused the patient to access the emergency room more frequently than the other, or which was cheaper for overall out-of-pocket costs or had fewer side effects resulting in more productivity. This kind of nuanced information could be elicited as part of engagement opportunities for impacted stakeholders.
We respect you have been given an enormous task and would like to work with the committee to develop a more robust process for community engagement. The statute does not prohibit the board from directly engaging patients and people with disabilities. In fact, the law states, “The board shall accept testimony from patients and caregivers affected by a condition or disease that is treated by a prescription drug under review by the board and from individuals with scientific or medical training with respect to the disease or condition.” Additionally, the statute conveys an expectation that the evidence under consideration will be disclosed to the public as long as it is not a trade secret or otherwise prohibited from being shared.
Oregon’s goal of increased health equity demands the inclusion of patients and people with disabilities in this process. Thank you for your vital work in reducing the cost of prescription drugs for all Oregonians. We look forward to hearing from you.
Sincerely,
ALS Northwest, Portland, OR
Answer2Cancer Inc., Portland, OR
Caring Ambassadors Program, Oregon City, OR
Cystic Fibrosis Research Institute, Palo Alto, CA
Disability Rights Oregon, Portland, OR
Eastern Oregon Center for Independent Living, Pendleton, OR
HIV Alliance, Roseburg, OR
ICAN, International Cancer Advocacy Network, Phoenix, AZ
National Bleeding Disorders Foundation, New York, NY
National Psoriasis Foundation, Portland, OR
Pacific Northwest Bleeding Disorders , Corvallis, OR
Partnership to Improve Patient Care, Washington, DC
Project Access Northwest, Seattle, WA
The Community for Positive Aging, Portland, OR
Individuals
Bailey Burkhalter, Medford, OR
Mary Canton, Tigard, OR
Joanna M Cooper, Riddle OR
Jacqueline Gethner, Portland, OR
Jeffrey Graves Pendleton, OR
Joy Krumdiack, Bellingham, WA
Christopher J McFarland MPH CADC I, Corvallis, OR
Robbie Noche, Portland, OR
Hannah Roy, Ontario, OR
Paul Terdal, Portland, OR
Micheal Thurman, Portland, OR
Respectfully submitted by Lorren Sandt, Caring Ambassadors Program
Follow-up Community Letter to Oregon Legislators
Feb 29, 2024
Chair Deb Patterson
Senate Committee on Health Care
900 Court St. NE, S-411,
Salem, Oregon 97301
Chair Rob Nosse
House Committee on Behavioral Health and Health Care
900 Court St. NE, H-472
Salem, Oregon 97301
Dear Chair Patterson and Chair Nosse:
As organizations representing patients, people with disabilities and older adults, we are writing with regard to our concerns about the implementation of the State Prescription Drug Affordability Board and the need for oversight from legislators. When the bill creating the board passed, we were assured that its processes would be transparent, provide for robust engagement of patient and disability stakeholders and avoid reference to discriminatory evidence related to the effectiveness and value of treatments being evaluated. We have been very disappointed. At this stage, it is now clear that our efforts to engage the board members and staff in addressing our concerns are not working. As you know, the board itself is not operating at full capacity and is trying to recruit new members.[1] Therefore, we urge the legislature to pause the board’s activities and initiate legislative oversight of the board’s implementation.
On December 4, 2023, several organizations reached out to the board to ask it to address our concerns about board representation, the lack of engagement opportunities for expert advisors living with a condition treated by the selected drugs for review, the transparency of its deliberations, including its use of measures such as the quality-adjusted life year (QALY) and equal value of life year gained (evLYG) to measure the effectiveness and value of treatments, and finally the need to emphasize patients in affordability reviews. To date, we have not received a response or been given an opportunity to meet. In fact, their processes have only gotten worse. Our prior letter to the board is provided to you as an addendum to this letter.
We continue to be concerned that the board’s meetings do not welcome patient input. The board’s agenda does not provide any guidance on the information being sought from patients to help in their deliberations. The time allotted for patient input is very limited and does not provide for a robust back and forth discussion between the board members and concerned patients and people with disabilities. It is not clear to us what information is being considered by the board and on which patients and people with disabilities could be providing input. The affordability review timeframes for each treatment under consideration are very short during the meetings with little engagement opportunity. There is not a separate dedicated engagement opportunity for patients and people with disabilities related to each drug being reviewed, which is highly inconsistent with the process in other states. In summary, the board process is confusing and instills little confidence that its conclusions will accurately represent the effectiveness and value of treatments under consideration.
The lack of public testimony to-date is a strong indicator that the current process is not working. In the December meeting, public comment was limited to 1 minute per person.
The legislation creating the board, SB 844, stated, “The board shall accept testimony from patients and caregivers affected by a condition or disease that is treated by a prescription drug under review by the board and from individuals with scientific or medical training with respect to the disease or condition.” The legislation also listed several criteria focused on the patient experience of accessing drugs being evaluated, including “health inequities for communities of color,” “impact on patient access” and “estimated average patient copayment or other cost-sharing,” yet the affordability review seems less focused on patient affordability than costs borne by the state. We share concerns about health system costs, but do not want the board’s work to be at the expense of patients for whom existing therapeutic alternatives may not be the most clinically effective. We want to understand how the board is defining existing therapeutic alternatives and whether they are as effective as the treatments being reviewed. It is insufficient for the state to conclude less expensive alternatives are just as effective without hearing from patients. The goal of this process should be to ensure patients have access to the treatment that is most effective to treat their disease or condition. This requires a robust feedback loop and dedicated time to engaging patients and people with disabilities, including time for the board to respond, ask questions and solicit additional information.
Additionally, when the legislature passed SB 844, patients and people with disabilities were assured that QALYs and similar measures were barred from the board’s consideration. Yet, the Institute for Clinical and Economic Review (ICER), an entity that calls QALYs the gold standard and that has developed the similar evLYG measure, as well as associated pro-QALY entities such as the Program on Regulation, Therapeutics, and Law (PORTAL), are deeply engaged in the board’s work. Therefore, it is of the utmost importance for the evidence under consideration by the board to be transparent to the public to allow for patients and people with disabilities to weigh in with the board if consideration of certain evidence may be in conflict with its statute. We have shared these concerns with the board, yet we continue to be kept in the dark about the underlying evidence that may support its decisions.
In closing, we hope that the legislature will consider our concerns, pause the board’s implementation, and conduct much-needed oversight of its activities. Thank you for your consideration and efforts to advance a health system that is equitable and allows for patients to affordably access the most clinically effective treatment.
Sincerely,
Organizations:
AiArthritis
ALS Northwest
Biomarker Collaborative
Caring Ambassadors Program
Cystic Fibrosis Research Institute
Exon 20 Group
ICAN, International Cancer Advocacy Network
MET Crusaders
National Bleeding Disorders Foundation
Pacific Northwest Bleeding Disorders
Partnership to Improve Patient Care
PD-L1 Amplifieds
The Bonnell Foundation: Living with cystic fibrosis
The ALS Association
The Coelho Center for Disability Law, Policy and Innovation
The Headache and Migraine Policy Forum
Individuals:
Laura Bonnell
Mary Canton
Lance Christian
Joy Krumdiack
Robbie Thurman-Noche
Cc: Governor Kotek
Members of the Oregon Legislature
TK Keen, DCBS
Ralph Magrish, DCBS
PDAB committee
[1] https://dfr.oregon.gov/pdab/Documents/20240131-PDAB-applicant-summary.pdf
About the PDAB
Senate Bill 844 created the Prescription Drug Affordability Board (PDAB) to evaluate the cost of prescription drugs and determine whether they present an affordability challenge for consumers and health systems in Oregon. PDAB’s review will inform rulemaking criteria for evaluating drugs, including health inequities in diverse communities, the number of Oregon residents prescribed the drug, the price of the drug in Oregon, and other criteria. The board has studied the prescription drug distribution and payment system in Oregon and the generic drug market and provided recommendations to the Legislature. The Oregon Legislature acted on the board recommendations by passing Senate Bill 192 in June 2023. The board statutory authority is ORS 646A.693-697.