1. Effective Treatments for People with Chronic Diseases and Disabilities are Being Denied Based on the Discriminatory Quality-Adjusted Life Year. Click here to read the full article.
2. NCD Calls for Build Back Better to Bar QALYs Throughout Medicare and Medicaid. Click here to view the letter.
3. In Response to Disability Rights Orgs, CVS Backs Down From Pursuing Supreme Court. Click here to view the announcement.
4. Assessing the Value of Medicine for Diverse Patients: Implications of a QALY Approach for Health Disparities. Click here to read the full findings and report.
5. Perspectives of Patients and Providers on ICER’s Assessment of Treatment for HCM. Click here to read the full release.
6. 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.
7. Use of QALY and Similar Metrics has Real and Tragic Implications for People with Disabilities. Click here to read the article.
8. DREDF Releases Report Responding to a Flawed ICER Analyses, Instead Finds that QALY Violates Disability Nondiscrimination Law. Click here to view the report.
9. Issue Brief: Implications of Reliance on Health Technology Assessment in the VA and TRICARE Formularies. Click here to read the full report.
10. Washington Must Help Patients Choose, Not Dictate Their Care. Click here to read the article.
11. Upcoming opportunity within the Center for Evidence and Practice Improvement at AHRQ, see details below.
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: ICER's QALY-Based Study Topics: Chemotherapy-Induced Neutropenia, COVID-19, Type 2 Diabetes, Hypertrophic Cardiomyopathy, Asthma, Unsupported Price Increase, Fair Access: Coverage Policies, 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.
Jenn McNary, patient advocate and mother of two children with Duchenne Muscular Dystrophy published an opinion piece in the Boston Globe supporting the passage of a bill before the Massachusetts Legislature, An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with Disabilities, which would codify patient protections, including a ban on the use of the Quality-Adjusted Life Year. Ms. McNary shares her real-life experience of having ICER’s QALY-based assessment cited as a reason her son could not access a treatment that had previously been effective for him and cautions about Massachusetts’ continued partnership with ICER. Click here to read the full article.
2. NCD Calls for Build Back Better to Bar QALYs Throughout Medicare and Medicaid
The Chair of the National Council on Disability sent a letter to Congress "to strongly encourage the inclusion of an unambiguous ban on the quality adjusted life year (QALY) within the text of the Build Back Better Act (H.R. 5367) and located within the bill text in such a way as to convey unequivocal application to the entire Sec. 1194.” He stated, "Consistent with our advice regarding the discriminatory nature of the QALY for people with disabilities and chronic illnesses, as documented in our 2019 report, Quality-Adjusted Life Years and the Devaluation of Life with a Disability, I further encourage you to utilize the reconciliation package as an opportunity to expressly prohibit the use of the QALY by Medicaid and Medicare.” Click here to view the letter.
3. In Response to Disability Rights Orgs, CVS Backs Down From Pursuing Supreme Court
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. In response, CVS decided to not pursue the matter further before the Supreme Court. On November 10, CVS Health, the American Association of People with Disabilities, the Bazelon Center for Mental Health Law, the Disability Rights Education and Defense Fund, and the National Council on Independent Living announced that they are working together to seek policy solutions to protect equitable access to health care for all Americans and continue to protect the fundamental rights of people with disabilities. Maria Town, President and CEO of the American Association of People with Disabilities, stated, "Hard-fought progress has been preserved today through dialogue and partnership between advocates and CVS Health. We look forward to working collaboratively with CVS Health to find solutions that will ensure that health benefits are equally available and affordable to people with disabilities.” Click here to view the announcement.
4. Assessing the Value of Medicine for Diverse Patients: Implications of a QALY Approach for Health Disparities
Cost-effectiveness analyses have been under consideration as a way to help set prices for prescription drugs in the U.S. However, cost-effectiveness typically involves the use of the quality-adjusted life year (QALY) or similar metrics that have been shown to have a discriminatory impact on older adults and people with a disability. Further, addressing systemic health inequities continues as a key priority for many policymakers. Given concerns about use of the QALY for other patient populations, the Alliance for Aging Research asked Charles River Associates to examine the implications for health disparities of adopting cost-effectiveness analysis, including Quality-Adjusted Life Years. The report examines the impact on Black and Latinx populations for two conditions, Alzheimer’s disease and colorectal cancer. Click here to read the full findings and report. Click here to read the full release.
5. Perspectives of Patients and Providers on ICER’s Assessment of Treatment for HCM.
On November 16, 2021, the Institute for Clinical and Economic Review (ICER) published its final evidence report for mavacamten, a new treatment for Hypertrophic Cardiomyopathy (HCM), a disease of the heart muscle affecting over 1 in 500 people. ICER conducted its assessment prior to having data from long-term studies into the effectiveness of the treatment, which was released last week. The FDA is also not scheduled to make a decision regarding approval of the first in class treatment until 2022. Lisa Salberg, Founder and CEO of the Hypertrophic Cardiomyopathy Association (HCMA), engaged with ICER as a patient advocacy representative and patient throughout this process. Ms. Salberg began on the journey to educate, advocate, and support other patients based on her personal experience with HCM. This included medical errors that nearly cost her life, the death of her sister - also due to medical errors - and the diagnosis of several family members. The HCMA currently has 43 Recognized Center of Excellence programs for the treatment of HCM and represents over 15,000 families living with the condition. Click here to read the full release.
6. Arthritis Foundation and Innovation and Value Initiative Release Paper Highlighting Patient Perspectives in Rheumatoid Arthritis
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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
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.
- Australia: Qinlock, a rare cancer drug, will finally be subsidized by the government, but only for certain suffering cancer patients. Melanoma cancer patient's daughter is fighting to raise money to fund her mother's life-saving medication.
- Canada: Ulcerative colitis patient and advocates are urging the government continue to cover his life saving drug. After forcing CF patients to endure an agonizing wait, the government will allow limited access to Trikafta, a life-saving drug.
- New Zealand: Mother of CF patient is urging the government to quickly come up with additional funding to cover Trikafta for suffering patients. Rare disease advocates are fighting to draw more attention to those with rare diseases and their needs for care.
- United Kingdom: Cancer patient is struggling to raise funds to buy a life saving drug after being refused the drug because of a technicality. MS patient is raising funds for treatment because of the increased difficulty to access it. Mother of cancer patient is frantically fundraising to improve her child's chances of survival after doctor's dismissed her symptoms as growing pains.
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 was heard before the Joint Committee on Health Care Financing on November 9. Written testimony is being accepted until tomorrow, November 16. It is important the Committee hear about the discriminatory implications of QALYs from the patient and disability communities. Details on 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: Chemotherapy-Induced Neutropenia, COVID-19, Type 2 Diabetes, Hypertrophic Cardiomyopathy, Asthma, Unsupported Price Increase, Fair Access: Coverage Policies
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: Model Analysis Plan available. Draft Scoping Document and Research Protocol available. 1/25/2022: Draft Evidence Report.
- COVID-19: Model Analysis Plan available. Draft Scoping Document and Research Protocol available. 2/3/2022: Draft Evidence Report.
- Type 2 Diabetes: Draft Evidence Report available. Public Comments open until 12/08/21. Draft Scoping Document and Research Protocol available. Meeting 1/20/2022: Deliberation and vote on evidence presented in ICER's report on therapies for Type 2 Diabetes.
- Hypertrophic Cardiomyopathy: Final Evidence Report and Meeting Summary available. Evidence Report Available. Evidence Presentation available.
- Unsupported Price Increase: Final Report available
- Asthma: Evidence Presentation available. Evidence Report Available. Model Analysis Plan available. 12/16/2021: Final Evidence Report and Meeting Summary.
- Fair Access: Coverage Policies in 2020: Protocol Available. 12/01/2021: Final Report.
15. Upcoming Events and Webinars
Board of Governors Meeting
December 1-2, 2021
Click here for details.
Advisory Panel on Healthcare Delivery and Disparities Research Winter 2021 Meeting
December 9, 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.