1. NCD Chair: To Improve Care for People with Disabilities, Confront the QALY, click here to read the blog post.
2. Sickle Cell Mom: 'Cost Effectiveness' Does Not Consider Personal, Economic Burdens, click here to read the article.
3. TRANSCRIPT AVAILABLE: PCORI Board Approves Principles for Considering the Full Range of Outcomes Data, see details below.
4. Senate HELP Committee Discusses International Pricing, Germany and Health Technology Assessment, see details below.
5. Inside Health Policy: PIPC Reminds Democrats They Promised Not to Use QALYs, click here to read the article (subscription required).
6. IVI Webinar Series: Toward Equity in Value Assessment, see details below.
7. Emerging Threats in States like CO, ND, and ME for Use of Discriminatory Metrics, see details below.
8. 2021 AUCD Virtual Gala, click here to learn more and register.
9. Vaccination Equity and Communication, see details below.
10. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
11. ICER's QALY-Based Study Topics: Myasthenia Gravis, Atopic Dermatitis, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease, click here to provide patient input.
12. Upcoming Events and Webinars, see details below.
13. Medical Journal Articles, see details below.
14. AHRQ Effective Program Updates, see details below.
Andres Gallegos, the Chair of the National Council on Disability (NCD), wrote in a blog for Health Affairs that "explicit and implicit discriminatory bias within the health care professions represent an insidious virus against which people with disabilities have been fighting for decades" and that confronting QALYs is a critical step in addressing those biases. "Although the US government does not have a single policy on QALYs, some Medicaid programs, and increasingly, private health insurers, government agencies, and health economists are showing interest in leveraging QALYs to secure cost savings," he writes. "QALYs can be used to place a lower value on treatments that extend the lives of people with chronic illnesses and disabilities compared to those treatments that benefit people without disabilities. Indeed, programs based on the QALY have been found by the Department of Justice (DOJ) to violate the Americans with Disabilities Act (ADA). Decision-making tools designed around measures that devalue the lives of people with disabilities are discriminatory and have no place in modern policy." Click here to read the blog post.
2. Sickle Cell Mom: 'Cost Effectiveness' Does Not Consider Personal, Economic Burdens
Adrienne Shapiro, the Executive Director of Axis Advocacy and the mother of a daughter living with sickle cell disease, writes in Real Clear Health that the health care debate focuses short-sightedly on the price of drugs and not on the holistic costs of living with disease. "Looking to outside entities like the Institute for Clinical and Economic Review (ICER) or importing foreign pricing models, as seen in H.R. 3, a bill passed by the House of Representatives in 2019, is not the answer," she writes. "Though this might sound like an easy solution, but ICER and the referenced countries rely on the discriminatory Quality-Adjusted Life Year (QALY), as confirmed by a recently released CBO report acknowledging that the bill scored savings because government would reference QALYs. To determine what they will cover and whether they will pay for a treatment, many foreign countries rely on cost-effectiveness analyses based on QALYs and studies that fail to represent people like [my daughter] Marissa. We’ve known for over 30 years that the QALY fails patients and people with disabilities, as it is well known to place a lower value on the lives of people with disabilities and chronic illnesses and on the improvement in quality of life needed to make treatment 'worth it.'" Click here to read the article.
3. TRANSCRIPT AVAILABLE: PCORI Board Approves Principles for Considering the Full Range of Outcomes Data
Patients and people with disabilities applauded that the Patient-Centered Outcomes Research Institute (PCORI) Board of Governors approved principles guiding its work to consider the full range of outcomes data in its research during its March 16 meeting.
With this move, PCORI will start the important process of identifying potential burdens and economic impacts important to healthcare stakeholders and undertake efforts to develop “methodological standards” that will more fully inform how PCORI-funded studies should consider and capture relevant economic and cost data in the conduct of their research. Their collaborative and transparent process will benefit the entire field of comparative effectiveness research and inform efforts to address high costs and achieve value in a manner that is centered on patients and people with disabilities.
PIPC Chairman Tony Coelho stated, “Finally, an independent and credible entity will be working with patients and people with disabilities to capture data on the economic and cost outcomes that matter to them. By undertaking this much-needed and long overdue work, PCORI will empower health stakeholders to translate evidence into better decisions that drive better health, without discriminating against our most vulnerable citizens. I have always said that PCORI is a key player in advancing patient-centered solutions to achieving affordability and value. I am excited to see PCORI stepping up to take a leadership role in this discussion.”
Click here to read the full statement. Click here to view a transcript of the meeting.
4. Senate HELP Committee Discusses International Pricing, Germany and Health Technology Assessment
Recently, the Senate Health, Education, Labor, and Pensions Subcommittee on Primary Health and Retirement Security held a hearing comparing drug pricing practices here in the U.S. and in other countries, including those that use health technology assessments based on discriminatory QALYs that can result in lower access for older people and people with disabilities. In addition, there was discussion of Germany's model for pricing new life-changing drugs, which one Senator pointed out to use a restrictive view of clinical benefit. Evidence has shown that 22 new medicines were withdrawn from the German market between 2011 and 2016 due to receiving unfavorable terms in the system. Furthermore, only 53 percent of new drugs launched globally between 2008 and 2012 were available in Germany in 2013. Click here to read PIPC's fact sheet on access concerns in the German system. Click here to view PIPC’s statement about PCORI’s work to collect and analyze a broad range of outcomes data that matter most to patients.
5. Inside Health Policy: PIPC Reminds Democrats They Promised Not to Use QALYs
In an article posted in advance of a Senate Health, Education, Labor, and Pensions hearing comparing the U.S. prescription drug prices to those abroad, Inside Health Policy highlights that Democrats promised not to use discriminatory QALYs in their party platform. The article highlights PIPC Chairman Tony Coelho saying that the use of QALYs "devalues treatments for people with disabilities and the elderly who have fewer years to live." In addition, the article points out that the Congressional Budget Office relied heavily on ICER and its QALY-based analyses when evaluating House Democrats' signature drug pricing legislation from last year. Click here to read the article (subscription required).
6. IVI Webinar Series: Toward Equity in Value Assessment
The Innovation and Value Initiative will host a series of three webinars, Toward Equity in Value Assessment. The series will kick off on April 22 with a session called "Meaningful Action Toward Health Equity," and will feature guests including the LUNGevity Foundation's VP of Reserach, Dr. Upal Basu Roy, and the National Minority Quality Forum's VP of Clinical & Social Research and Development, Dr. LaTasha Lee.
The second session, "IVI Model Scope on Major Depressive Disorder," will take place May 3, 2021 at 1:00 pm Eastern and will cover the major points of the new model scope for the MDD initiative and address the importance of a patient-centric model for MDD.
The last session, "Policy and Partnership Solutions to Create Enduring Progress," will have its date announced soon.
Click here to register for the first and/or second session and to learn more.
7. Emerging Threats in States like CO, ND, and ME 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 or are considering policies to import QALY-based decisions from other countries. Yet, federal policymakers have emphasized that the use of discriminatory metrics is subject to civil rights laws such as the Americans with Disabilities Act. 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.
North Dakota is currently considering a piece of legislation, SB 2170, which would import QALYs from Canada. The bill directly references the prices paid for drugs in five Canadian provinces. Before applying for coverage by the provinces, all drugs must complete a Common Drug Review by CADTH, which uses QALYs. The result of this is that in Canada is that many individuals living with disabilities are unable to receive the treatments and care they need. The National Council on Disability (NCD) warned in its 2019 report that similar coverage denials and loss of access to care could also be the outcome if the United States if we reference other countries. The NCD also highlighted in its report that Section 504 of the Rehab Act and Section 1557 of the ACA also apply to Medicaid programs because they receive federal financial assistance. Click here to view S.B. 2170. Click here to view the NCD report. Click here to view the NCD's recent letter to CMS against importing QALYs. S.B. 2170 narrowly passed by vote in the Senate on February, 19, 2021. S.B. 2170 has not yet received a vote in the House.
The Colorado state legislature has introduced SB 21-175 creating a prescription drug affordability review board. In some states these types of boards and commissions have led to referencing 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. An amendment to SB 21-75 was adopted that prohibits the use of QALYs in the section of the bill that determines an upper payment limit. A similar amendment in the sections establishing the commission’s authority to perform value assessments for treatments would prevent QALYs from being used to target treatments for people with disabilities and older adults. The Value Our Health legislative template provides a path for states to protect patients and people with disabilities by also creating standards for the evidence that drives decision-making and assuring engagement of patient and disability stakeholders, in addition to barring QALYs.
Maine has introduced a bill, S.P. 262, which would rely solely on the Institute for Clinical and Economic Review, ICER, to determine whether a price increases on certain therapies were supported by additional evidence. We remain concerned about states referencing ICER, particularly as a sole source of information, and will be watching developments in Maine closely.
In good news, Connecticut has introduced the Value Our Health template legislative language! CT HB06242 "An Act Prohibiting Health Insurers From Using A Dollars-per-quality Adjusted Life Year Or Any Similar Measure As A Threshold” was introduced by Representative Michelle Cook. Please share the great news with advocates in Connecticut that may have interest in being supportive! Click here to view the bill.
8. 2021 AUCD Virtual Gala
Join AUCD on April 14, 2021 for its AUCD for All Virtual Gala. This year’s Gala is free for everyone to attend and in a virtual, accessible format. This year’s theme is Celebrating 50 Years of Leadership: Looking Back, Moving Forward in recognition of AUCD’s 50th Anniversary. During the Gala, AUCD will reflect on its past accomplishments while amplifying the voices of current and future leaders in the disability community. Click here to learn more and register.
9. Vaccination Equity and Communication
There is critical ongoing work to assure equity in the prioritization of vaccinations, as well as communication to address reluctance and ensure access to information and systems. PIPC Steering member the Association of University Centers on Disabilities (AUCD) aggregated the following resources that we wanted to share:
- Elevated COVID-19 Mortality Risk Among Recipients of Home and Community-Based Services: A Case for Prioritizing Vaccination for This Population
- National Council on Disability letter to Governors Association
- COVID-19 Vaccine Prioritization Dashboard
- Measuring the impact of COVID-19 vaccine misinformation on vaccination intent in the UK and USA
- COVID-19 Vaccination Intent, Perceptions, and Reasons for Not Vaccinating Among Groups Prioritized for Early Vaccination — United States, September and December 2020
- KFF COVID-19 Vaccine Monitor: What Do We Know About Those Who Want to “Wait and See” Before Getting a COVID-19 Vaccine?
10. 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: Disabled Canadians face uphill struggle for regular care as COVID-19 drains resources. Advocates call on Ontario to provide life-saving cystic fibrosis drugs to patients. B.C. woman petitions province to cover cost of 'life-changing' migraine medication.
- United Kingdom: Advocates and patients feel betrayed after life-changing drug made available only to children.
11. ICER's QALY-Based Study Topics: Atopic Dermatitis, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease
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.
- Myasthenia Gravis: Draft Scoping Document available. 4/12/2021: Revised Scoping Document.
- Atopic Dermatitis: Model Analysis Plan available. 5/14/2021: Draft Evidence Report. Meeting 7/23/2021: An assessment of treatments for atopic dermatitis by the New England CEPAC.
- Lupus Nephritis: Meeting 3/26/2021: New England CEPAC convened to deliberate and vote on evidence presented in ICER's report on treatments for lupus nephritis. 4/16/2021: Final Evidence Report.
- Multiple Myeloma: Evidence Report and Responses to Public Comments AVAILABLE. Meeting 4/16/2021: An assessment of idecabtagene vicleucel, ciltacabtagene autoleucel, and belantamab mafodotin for the treatment of multiple myeloma.
- Alzheimer's Disease: Model Analysis Plan available. 5/5/2021: Draft Evidence Report.
12. Upcoming Events and Webinars
PCORI Increasing Vaccine Confidence among Long-Term Care Workers: Expedited COVID-19 PFA -- Applicant Town Hall
April 19, 2021
Click here to view.
PCORI Board of Governors Meeting
April 13, 2021
Click here to view.
AI, Big Data and Deep Real-World Evidence – The Challenges and Opportunities
April 22, 2021
Click here to view.
Building Data Capacity for Patient Centered Outcomes Research: A Comprehensive Ecosystem for PCOR - Workshop 3
June 14, 2021
Click here to view.
PCORI Advisory Panel on Patient Engagement Summer 2021 Meeting
July 15-16, 2021
Click here to view.
13. Medical Journal Articles
The Dollar or Disease Burden: Caps on Healthcare Spending May Save Money, but at What “Cost” to Patients?, click here to view.
Embedding Clinical Trials Within Routine Health-Care Delivery: Challenges and Opportunities, click here to view.
Approval and Coverage of Cancer Drugs in England, Canada, and the US, click here to view.
Experiences of an HCV Patient Engagement Group: A Seven-Year Journey, click here to view.
Choosing Important Health Outcomes for Comparative Effectiveness Research: 6th Annual Update to a Systematic Review of Core Outcome Sets for Research, click here to view.
Health Technology Assessment With Diminishing Returns to Health: The Generalized Risk-Adjusted Cost-Effectiveness (GRACE) Approach, click here to view.
Comparative Effectiveness Research Needs to Consider Optimal Dosing and Scheduling, click here to view.
Are Patients More Adherent to Newer Drugs?, click here to view.
Improving the Quality of Person-Centred Healthcare from the Patient Perspective: Development of Person-Centred Quality Indicators, click here to view.
Six Ways to Foster Community-Engaged Research During Times of Societal Crises, click here to view.
14. AHRQ Effective Program Updates
Rapid Evidence Product: Improving Pain Management in the Context of America's Opioid and Substance Use Disorders Crisis. Click here to view.
OPEN FOR COMMENT THROUGH APRIL 21, 2021: Breast Reconstruction After Mastectomy: A Systematic Review and Meta-Analysis. Click here to view.
Systematic Review: Cervical Ripening in the Outpatient Setting. Click here to view.
Surveillance Report: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
Rapid Evidence Review: Antibody Response Following SARS-CoV-2 Infection and Implications for Immunity. Click here to view.
White Paper: Standardized Library of Lumbar Spondylolisthesis Outcome Measures. Click here to view.
Research Report: A Prospective Comparison of Evidence Synthesis Search Strategies Developed With and Without Text-Mining Tools. Click here to view.
Technical Brief: Disparities and Barriers to Pediatric Cancer Survivorship Care. Click here to view.
Technical Brief: Automated-Entry Patient-Generated Health Data for Chronic Conditions: The Evidence on Health Outcomes. Click here to view.
REQUEST FOR INFORMATION OPEN UNTIL APRIL 16, 2021: Use of Clinical Algorithms That Have the Potential To Introduce Racial/Ethnic Bias Into Healthcare Delivery. Click here to view.