1. Arthritis Foundation and Innovation and Value Initiative Release Paper Highlighting Patient Perspectives in Rheumatoid Arthritis. Click here to read the full press release and here to view the white paper.
2. Use of QALY and Similar Metrics has Real and Tragic Implications for People with Disabilities. Click here to read the article.
3. Disability Rights Orgs Urge Supreme Court to Uphold Protections Against Disability Discrimination. Click here to view the press release.
4. The Key to Addressing Rising Health Care Costs is Patient-Centered Evidence. Click here to read the opinion piece.
5. DREDF Releases Report Responding to a Flawed ICER Analyses, Instead Finds that QALY Violates Disability Nondiscrimination Law. Click here to view the report.
6. PCORI Invites Your Input: Science of Engagement Potential Funding Initiative. See below for details.
7. Issue Brief: Implications of Reliance on Health Technology Assessment in the VA and TRICARE Formularies. Click here to read the full report.
8. Washington Must Help Patients Choose, Not Dictate Their Care. Click here to read the article.
9. PIPC Submits Submits Comments on ICER Draft Evidence Report for Severe Asthma. Click here to read the letter.
10. Upcoming opportunity within the Center for Evidence and Practice Improvement at AHRQ, see details below.
11. 2021 PCORI Annual Meeting Scheduled for Nov. 17-19, click here for details.
12. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
13. Emerging Threats in States for Use of Discriminatory Metrics, see details below.
14. ICER's QALY-Based Study Topics: Hypertrophic Cardiomyopathy, Myasthenia Gravis, Atopic Dermatitis, Alzheimer's Disease, Asthma, Type 2 Diabetes, click here to provide patient input.
15. Upcoming Events and Webinars, see details below.
16. Medical Journal Articles, see details below.
17. AHRQ Effective Program Updates, see details below.
The Arthritis Foundation and the Innovation and Value Initiative (IVI) have partnered with people living with rheumatoid arthritis (RA) to publish a new report highlighting the need for healthcare research and value assessment that reflects patient experience and outcomes.
The paper, First-Hand Perspectives in Rheumatoid Arthritis, connects patient experiences with RA to research and value assessment questions that have not been fully considered. Through focus groups and in-depth interviews, themes that emerged include:
- Traditional clinical trials and research do not always capture the full complexity of living with RA, including comorbid conditions, fatigue, mental health, and the impact of hormonal changes.
- Access to effective treatment may be driven by insurance coverage or haphazard testing of treatments rather than by clinical guidelines.
- Costs related to RA include far more than direct medication costs and need to be captured.
- While RA is a progressive disease, people living with it are seeking independence and normalcy versus just symptom management.
Click here to read the full press release. Click here to view the white paper.
2. Use of the QALY and Similar Metrics has Real and Tragic Implications for People with Disabilities.
Matt Valliere of Patient Rights Action Fund wrote an opinion piece published in Newsweek outlining the tragic circumstances of Alta Fixsler's, a child with disabilities in the United Kingdom, death. He writes that, "Fixsler's death was a brutal tragedy caused by ableist, utilitarian assumptions about a young girl's 'quality of life' by non-disabled people... The U.K. attacks the dignity of certain people's lives through the Quality and Disability Adjusted Life Years (QALY/DALY) tool. Using this metric, health officials argue that people like Alta no longer have lives worth living, and death is preferred. The real-world consequences mean that a person with expensive treatment or care needs will not be covered for treatments, based on the idea that a year of his or her life is worth less than a year of an otherwise non-disabled person's life." Click here to read the full article.
3. Disability Rights Orgs Urge Supreme Court to Uphold Protections Against Disability Discrimination
Disability rights organizations filed friend-of-the-court briefs urging the Supreme Court to uphold disability rights by rejecting CVS’s attempt to dismantle non-discrimination protections under Section 504 of the Rehabilitation Act. The press release states, "The Rehabilitation Act was passed in 1973, and alongside the Americans with Disabilities Act, established safeguards against disability discrimination. As a result of these laws, society has become increasingly accessible for people with disabilities. Before the Rehabilitation Act, people with disabilities had no resource to challenge discriminatory practices. A decision in favor of CVS would eviscerate the ability to challenge policies and practices that have a disproportionate impact on people with disabilities.” Click here to view the press release. Click here to view an explainer. Click to view a sample letter here. View more information from Bazelon here and from DREDF here.
4. The Key to Addressing Rising Health Care Costs is Patient-Centered Evidence
In Morning Consult, PCORI Executive Director Nakela L. Cook, MD, MPH, shares the importance of providing more effective and efficient care to people with chronic conditions to address rising healthcare costs. Cook highlights the critical role of comparative clinical effectiveness research, and PCORI, in generating evidence to help improve patient care and health outcomes. Click here to read the opinion piece.
5. DREDF Releases Report Responding to a Flawed ICER Analyses, Instead Finds that QALY Violates Disability Nondiscrimination Law
The Disability Rights Education and Defense Fund ("DREDF") responded directly to a report commissioned for the Institute for Clinical and Economic Review (“ICER”), an organization specializing in clinical cost-effectiveness analyses relying on the QALY, in which its hired legal consultants posit that the use of QALY as a measure of the cost-effectiveness of specific drugs and therapies “poses absolutely no risk of discrimination against any patient group.” DREDF strongly disagrees with this conclusion. In its response, DREDF challenges the factual and legal assumptions of ICER's report and explains how the use of the QALY, even in tandem with alternative measures such as the Equal Value of Life Years Gained (“evLYG”), violates disability nondiscrimination law.
DREDF will join Familia Unida to celebrate National Disabilities Awareness Month and share information about its new report and the ongoing work of the disability community against disability discrimination in healthcare. Click here to view the DREDF report. Click here to view the one-pager. Click here to find summaries in both English and Spanish.
6. PCORI Invites Your Input: Science of Engagement Potential Funding Initiative
PCORI has opened a Request for Information (RFI) to inform the development of a potential funding initiative around the Science of Engagement. Research funding opportunities for the Science of Engagement could expand the evidence base on the approaches for effectively engaging diverse patients and stakeholders throughout the research process. PCORI is seeking input from potential applicants, patients and other stakeholders, and organizations who participate in research or engage communities. Feedback is requested on the research topics that could be most useful to research teams for implementation of more effective engagement. Additionally, they are inviting input on the resources and facilitators necessary to successfully support studies that address these research topics.
The RFI is open from September 27 – November 19, 2021. PCORI will also host two webinars to overview the Science of Engagement and present an opportunity to ask questions about this RFI. You can find more information and download the RFI here. If you have any questions, please email SoE-RFI@pcori.org.
7. Issue Brief: Implications of Reliance on Health Technology Assessment in the VA and TRICARE Formularies
This issue brief from the Partnership to Improve Patient Care (PIPC) provides an overview of the U.S. Department of Veterans Affairs (VA) and the Department of Defense (DoD) TRICARE program policies that rely on health technology assessment to make reimbursement and coverage decisions.
Veterans, members of the military and their families often have unique health care needs and preferences. It is important they are given options for high quality health care that meets their needs. No patient is average, which is why there has been a movement towards personalized medicine in health care with the goal of empowering the patient and clinician so that each person receives the right treatment at the right time. Yet, the U.S. Department of Veterans Affairs (VA) and the Department of Defense (DoD) TRICARE program rely on methods to lower costs by relying on assessments of clinical and cost effectiveness that use flawed and discriminatory methods to determine which treatments it will and will not cover, without considering the holistic value of treatments to the patient and his or her family.
8. Washington Must Help Patients Choose, Not Dictate Their Care
PIPC Chair Tony Coelho wrote an opinion piece published in The Hill. In 2010, he notes that the Affordable Care Act (ACA) “recognizes not only the importance of strong clinical evidence to support decision-making but also the need to use the research to support doctors’ and patients’ decisions, not to dictate what those decisions should be.” Coelho explains that this principle is again under debate "as Congress considers new strategies for informing Medicare reimbursement and coverage" and "the bipartisan history PCORI's creation should provide some lessons." Click here to read the full article.
9. PIPC Submits Submits Comments on ICER Draft Evidence Report for Severe Asthma
In a comment letter to the Institute for Clinical and Economic Review (ICER), the Partnership to Improve Patient Care (PIPC) offered feedback on ICER's draft evidence report for severe asthma treatments.
The letter criticizes ICER's model for being unrepresentative of results real-world settings, as well as its consistent use of the discriminatory quality-adjusted-life-years (QALY) metric. PIPC encourages ICER to review the technical components of its model to ensure accurate results, as well as avoid the use of QALY-based cost effectiveness when evaluating treatments.
"Asthma impacts about 25 million Americans, and it is a condition that disproportionately impacts Black and Hispanic patients," wrote PIPC Chair Tony Coelho. "With this in mind, it is important that ICER handle this assessment in a way that does not exacerbate health inequities that are already very prevalent in the asthma community."
10. Upcoming Opportunity Within the Center for Evidence and Practice Improvement at AHRQ
AHRQ will soon be hiring a Senior Staff Service Fellow in CEPI’s Office of the Director to support activities funded by the Patient-Centered Outcomes Research Trust Fund (PCOR TF) under the National Center for Excellence in Primary Care Research (NCEPCR). The Senior Staff Service Fellow will support AHRQ’s mandated roles under the PCOR TF in evidence dissemination and implementation in primary care as well as of training and capacity building for comparative effectiveness research in primary care settings.
The Senior Staff Service Fellow designs, executes and evaluates projects funded by the PCOR TF to increase the uptake of evidence in primary care including by using new models of primary/ambulatory care delivery, advancing health equity and engaging learning health systems. AHRQ is looking for a team player to lead a multidisciplinary team to design, that leads national initiatives to disseminate and implement PCOR findings related to transforming primary/ambulatory care delivery to make care more equitable and patient-centered including a focus on people living with multiple chronic conditions and other at risk populations.
This Senior Staff Service Fellow will also advise other members of CEPI and AHRQ on dissemination and implementation activities related to the PCOR TF; supports and aligns ongoing primary care projects across all divisions within the Center as well as across AHRQ. Serves as a recognized expert within the areas of primary care, primary care research and implementation science.
11. 2021 PCORI Annual Meeting Scheduled for Nov. 17-19
PCORI announced that its 2021 annual meeting will be held virtually on Wednesday, November 17 through Friday, November 19. The event serves as a report to the nation on PCORI’s progress in funding initiatives to determine which care approaches work best, for whom, and under what circumstances. Click here for details.
12. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Canada: The government finally covered the cost of Trikafta, a life-saving drug, after years of difficult lobbying by CF patients. CF patients can now access Trikafta, however young patients are still suffering due to age restrictions. CF patients are finally able to access Trikafta after long and hard advocating efforts.
13. Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. We encourage sharing resources for advocates in key states mentioned below to ensure protections against discrimination!
- Click here to learn more about the potential for Prescription Drug Affordability Boards to discriminate by incorporating the use of QALYS.
- Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
- Click here to view a one pager about the flaws in ICER’s methodology.
- Click here to view information from experts on the downside of referencing foreign countries.
- Click here to learn about statutory protections against use of QALYs.
Other states to watch: Rhode Island, Minnesota and Washington State are also potential targets for future legislation that could trigger the use of discriminatory QALYs.
Efforts are underway to advance legislation that would create a Prescription Drug Affordability Board in the State of Virginia, triggering concerns about potential discrimination, according to recent news. It is not clear that these efforts will include provisions to bar discrimination and protect patient access to medications, such as achieved by disability advocates in other states such as Oregon where the legislature barred the use of QALYs in similar Board deliberations.
Renewed efforts are anticipated in New Mexico to advance legislation creating a Prescription Drug Affordability Board, triggering concerns about potential discrimination. It is not clear that these efforts will include provisions to bar discrimination and protect patient access to medications, such as achieved by disability advocates in other states. The news about the effort has not mentioned including a ban on the use of discriminatory QALYs nor including patient and disability representation or other patient protections from restricted access to care.
The Maryland legislature passed legislation earlier this year creating a Prescription Drug Affordability Board. The legislation did not include protections for patients and people with disabilities such as barring the use of discriminatory QALYs. The Board has begun meeting to hear from stakeholders, including hearing a presentation from the Institute for Clinical and Economic Review which relies on QALYs to assess treatment value. Legislation was introduced this year to bar the use of QALYs and implement patient protections that has not advanced in the legislature. On August 3, organizations representing patients and people with disabilities sent a letter urging the Board to avoid policies that would potentially discriminate by relying on discriminatory metrics such as QALYs.
The Governor of Colorado has signed into law SB 21-175, which creates a prescription drug affordability review board. SB 21-75 did include an amendment that prohibits the use of QALYs in the section of the bill that determines an upper payment limit. In some states these types of boards and commissions have referenced value assessments based on QALYs from the Institute for Clinical and Economic Review (ICER). In Massachusetts, the Health Policy Commission went so far as to contract with ICER. In order to mitigate this, it is important that the Board has representation from patients and people with disabilities. The Governors office is accepting applications for both the Colorado Prescription Drug Affordability Review Board and the Colorado Prescription Drug Affordability Advisory Council. It is essential that the Board and Advisory Committee include representation from patients and people with disabilities to ensure that that the Board’s deliberations do not include consideration of QALYs and other metrics that may discriminate or lead to restricted access for people with disabilities and chronic conditions or older adults.
The Massachusetts House and Senate have each taken the positive step of introducing An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, H.201 and S.753. This bill would enshrine essential patient protections including a ban on the use of the QALY, a requirement for research to meet patient-centeredness criteria, and robust engagement of the patient and disability communities in health care decision making. H. 201 will not be heard before the Joint Committee on Health Care Financing tomorrow, November 9 at 11am. Details on the hearing and submitting testimony may be found here.
Oregon is applying to the Centers for Medicare & Medicaid Services (CMS) for a new five-year Medicaid waiver known as the 1115 Demonstration. The purpose of the waiver is to reform the state’s Medicaid program. Advocates have expressed concern about the state’s ongoing use of quality-adjusted life years (QALYs) in determining the prioritized list of services under Oregon’s existing waiver. Click here to view the timeline for providing input.
14. ICER's QALY-Based Study Topics: Hypertrophic Myocardiopathy, Myasthenia Gravis, Atopic Dermatitis, Alzheimer's Disease, Asthma, Type 2 Diabetes
The Institute for Clinical Economic Review (ICER) conducts cost effectiveness studies for insurers using the cost-per-QALY methodology. ICER provides guidance on its website for patients and patient advocates to provide direct input related to their experiences with the disease. Click here to provide patient input. Click here to view the topics and deadlines.
- Chemotherapy-Induced Neutropenia: Draft Scoping Document and Research Protocol available. 11/12/2021: Model Analysis Plan. 1/25/2022: Draft Evidence Report.
- COVID-19: Draft Scoping Document and Research Protocol available. 11/22/2021: Model Analysis Plan. 2/3/2022: Draft Evidence Report.
- Type 2 Diabetes: Draft Scoping Document and Research Protocol available. 11/09/2021: Draft Evidence Report. Meeting 1/20/2022: Deliberation and vote on evidence presented in ICER's report on therapies for Type 2 Diabetes.
- Hypertrophic Cardiomyopathy: Evidence Report Available. Evidence Presentation available. 11/16/2021: Final Evidence Report and Meeting Summary.
- Unsupported Price Increase: 11/16/2021: Final Report.
- Asthma: Evidence Report Available. Model Analysis Plan available. Meeting 11/19/2021: New England CEPAC will deliberate and vote on evidence presented in ICER’s report on therapies for severe asthma.
- Fair Access: Coverage Policies in 2020: Protocol Available. 12/01/2021: Final Report.
15. Upcoming Events and Webinars
PCORI Stakeholder Webinar on ADHD in Children and Adolescents
November 10, 2021
Click here for details.
2021 PCORI Virtual Annual Meeting
November 17-19, 2021
Click here for details.
Board of Governors Meeting
December 1-2, 2021
Click here for details.
16. Medical Journal Articles
“It’s Time to Represent”: Shifting the Paradigm to Improve the Quality of Inputs into Value Assessment Frameworks, click here to view.
Evaluation of Financial Outcomes Under a Value-Based Payment Program for Community Pharmacies, click here to view.
Limited Role of Patient Input in Specialty Drug Coverage Policies, click here to view.
The Importance of Collaboration in Pursuit of Patient-Centered Value Assessment, click here to view.
Toward Better Data Dashboards for US Drug Value Assessments, click here to view.
Prevalence of Avoidable and Bias-Inflicting Methodological Pitfalls in Real-World Studies of Medication Safety and Effectiveness, click here to view.
Association of Co-Pay Elimination With Medication Adherence and Total Cost, click here to view.
The Utility of Patient Engagement in Drug Research and Development, click here to view.
Patient-Powered Research Networks of the Autoimmune Research Collaborative: Rationale, Capacity, and Future Directions, click here to view.
Enhancing Patient Research Partner Engagement: Research in Psoriatic Arthritis, click here to view.
Patient Voices in Value-Based Cancer Care: Priorities for the Biden Administration, click here to view.
The Dollar or Disease Burden: Caps on Healthcare Spending May Save Money, but at What “Cost” to Patients?, click here to view.
17. AHRQ Effective Program Updates
Systematic Review: Prehabilitation and Rehabilitation for Major Joint Replacement. Click here to view.
Integrated and Comprehensive Pain Management Programs: Effectiveness and Harms. Click here to view.
Systematic Review: Management of High-Need, High-Cost Patients: A “Best Fit” Framework Synthesis, Realist Review, and Systematic Review. Click here to view.
Research Protocol: Partial Breast Irradiation for Breast Cancer. Click here to view.
Systematic Review: Physical Activity and the Health of Wheelchair Users: A Systematic Review in Multiple Sclerosis, Cerebral Palsy, and Spinal Cord Injury. Click here to view.
Research Report: Developing and Piloting a Tool to Create Dot Plots to Summarize Pooled Data for Multiple Outcomes in Systematic Reviews. Click here to view.
Systematic Review: Malnutrition in Hospitalized Adults. Click here to view.
Research Protocol: Nutrition as Prevention for Improved Cancer Outcomes. Click here to view.
Research Protocol: Telehealth During COVID-19. Click here to view.
Research Protocol: Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: An Update of the PTSD Repository Evidence Base. Click here to view.
Systematic Review: Transitions of Care From Pediatric to Adult Services For Children With Special Healthcare Needs. Click here to view.
Systematic Review: Interventional Treatments for Acute and Chronic Pain. Click here to view.