1. Chairman Coelho Congratulates President-elect Joe Biden, see details below.
2. PIPC Primer: PCORI and ICER Background, Funding, and Impact on Patient-Centered Care, click here to view the primer.
3. PIPC Releases Targeted Literature Review on Patient-Centered Cost Outcomes, read the whole paper here.
4. Chairman Coelho to Receive Lifetime Achievement Award from the Bazelon Center, click here to learn more about the awards and to get a ticket for the live stream.
5. New IVI Issue Brief on Pandemic-Era Value Assessment, click here to read the issue brief.
6. Patient Advocate: Socialized Medicine and Rationing COVID Care Defy American Principles, click here to read the op-ed.
7. Men's Health Network Summit, 13th Annual Meeting, click here to view the Summit.
8. PhRMA Foundation Challenge Award Program Funding Opportunity, see details below.
9. PCORI Seeks Nominations for Advisory Panels, click here to learn more, submit a nomination, or apply to be on an advisory panel.
10. RESCHEDULED -- National Health Council Webinar on Multi-Criteria Decision Analysis, click here to learn more and register.
11. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
12. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease, click here to provide patient input.
13. Upcoming Events and Webinars, see details below.
14. Medical Journal Articles, see details below.
15. AHRQ Effective Program Updates, see details below.
PIPC Chairman Tony Coelho offered his congratulations to President-elect Joe Biden, highlighting the President-elect's commitment to ensure that people with disabilities are not denied health care using discriminatory QALYs. Chairman Coelho's statement read: "As Chairman of the Partnership to Improve Patient Care (PIPC), I want to express my sincere congratulations to President-elect Joe Biden. Patients and people with disabilities are eager and excited to work with the President-elect and his team on policies that will improve their health and quality of life. We are relieved that the President-elect is committed to ensuring people with disabilities are not denied the health care they need based on the use of the discriminatory quality-adjusted life year (QALY) in Medicare and Medicaid, a position that has strong bipartisan support. We are equally committed to working with the new administration and the new Congress on health reforms that improve the affordability of treatments without the discriminatory implications imposed by health care evaluations relying on QALYs and similar metrics based on averages. No patient is average. As the new Congress and administration advance much-needed policies to address patient affordability, entities such as the Patient-Centered Outcomes Research Institute (PCORI) have the potential to play an invaluable role in demonstrating the differential impact of treatments on subpopulations, allowing the United States to advance patient-centered policies uniquely suited to its diverse health system."
2. PIPC Primer: PCORI and ICER Background, Funding, and Impact on Patient-Centered Care
Amidst the debate around value driven health care, it is important to understand what organizations can support such a system. Two prominent organizations, the Patient-Funded Outcomes Research Institute (PCORI) and the Institute for Clinical and Economic Review (ICER), are positioned to help decision makers compare available treatment options. However, their approaches differ significantly. PIPC put together a primer on the differences between the two organizations. Click here to view the primer.
3. PIPC Releases Targeted Literature Review on Patient-Centered Cost Outcomes
In September 2020, the Board of Governors for the Patient-Centered Outcomes Research Institute (PCORI) approved the proposed Principles for the Consideration of the Full Range of Outcomes Data for public comment. The goal of these principles is to outline PCORI’s compliance with its reauthorization legislation, which states that, in addition to clinical outcomes, research should also endeavor to capture patient-important outcomes that assess the economic burden of treatments and services. While PCORI remains prohibited from conducting cost-effectiveness analyses or other analyses that rely on the Quality-Adjusted Life Year or similar metrics, the additional focus on cost outcomes that matter to patients moves towards addressing a gap in value assessment. Recently PIPC partnered with Xcenda to conduct a targeted literature review to better understand how patient-important cost outcomes were considered in studies and where further research by PCORI may help fill in some critical evidence gaps. Read the whole paper here.
4. Chairman Coelho to Receive Lifetime Achievement Award from the Bazelon Center
On Tuesday, November 17, PIPC Chairman Tony Coelho will receive a Lifetime Achievement Award from the Bazelon Center for Mental Health Law at its annual awards, held virtually this year. This year's awards are celebrating the 30th anniversary of the passage of the Americans with Disabilities Act. The Bazelon Center advocates for individuals with mental disabilities through a unique combination of litigation, public policy advocacy, coalition building and leadership, public education, media outreach and technical assistance. Click here to learn more about the awards and to get a ticket for the live stream.
5. New IVI Issue Brief on Pandemic-Era Value Assessment
The Innovation and Value Initiative (IVI) released a new issue brief dedicated to the question of how value assessment should evolve to account for diagnostics, therapies and vaccines to combat the COVID pandemic. The research brief in IVI's Value Blueprints series offers recommendations to improve health economic modeling and address the diverse needs of patients and those who pay for care. Click here to read the issue brief.
6. Patient Advocate: Socialized Medicine and Rationing COVID Care Defy American Principles
Khrystal Davis, the mother of a child with spinal muscular atrophy, wrote in Inside Sources last week that a movement towards socialized medicine, exemplified by President Trump's executive order calling for "most-favored nation" drug pricing, will hurt children like hers. "COVID-19 has resurrected this un-American idea [the QALY] of rationing healthcare. States have sought to advance Crisis Standards of Care that allow them to deny care for people with disabilities and serious medical conditions. This logic is not dissimilar from the devaluation of life that underpins the QALY," she wrote. "Meanwhile, as states actively ration care, the Trump administration issued an executive order that ties the prices we pay for prescription drugs to prices in foreign, socialist countries where QALYs provide the rationale for restricting coverage and access. This is the same concept as a recent bill pushed by House Speaker Nancy Pelosi and progressive democrats.... I worry that due to the president’s executive order, I may not be able to protect my son, even by returning to my conservative roots in St. Louis." Click here to read the op-ed.
7. Men's Health Network Summit, 13th Annual Meeting
Men’s Health Network conducted its 13th Annual Meeting in Memphis, Tennessee discussing challenges faced by men with prostate cancer, colorectal cancer, lung conditions and HPV. The meeting was sponsored by Men’s Health Network Tennessee, Tennessee Cancer Coalition, Church Health Center, Awaken Wellness, Black Nurses Association, American Cancer Society, Common Table, Families Matter, Carpenter's Primary Health, and Partners and Prayers. Click here to view the Summit.
8. PhRMA Foundation Challenge Award Program Funding Opportunity
The PhRMA Foundation announced a new Challenge Award program soliciting research proposals to evaluate how value assessment can better serve diverse populations and address the drivers of health disparities. The foundation will award a total of $85,000 to researchers whose papers advance solutions to that question. Interested candidates should submit letters of intent to the Foundation by no later than December 1, 2020, to initiate the application process. Qualified applicants will be contacted no later than December 21, 2020, with a request to submit the full paper describing their response to the challenge question. To learn more about the application process, click here. For more details about the award, click here to view a brochure.
9. PCORI Seeks Nominations for Advisory Panels
PCORI is currently seeking nominations for appointments to its advisory panels. The advisory panels must include patients or patient advocates. PCORI's staff, board, and methodology committee take advisory panels' recommendations into account when making decisions and determinations. PIPC encourages patients and patient advocates to submit nominations to serve on PCORI's advisory panels, including on the Advisory Panel on Clinical Effectiveness and Decision Science, Advisory Panel on Patient Engagement, and Advisory Panel on Rare Disease. Nominations are open through March 31, 2020. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
10. RESCHEDULED: National Health Council Webinar on Multi-Criteria Decision Analysis
On November 19, 2020, the National Health Council will hold a webinar in tandem with release of a white paper summarizing findings from a Roundtable on Patient-Centered Multi-Criteria Decision Analysis (MCDA). Speakers will introduce MCDA and describe comments, suggestions, and takeaways that emerged during the discussion. Researchers, value assessors, and the patient community agree that conventional approaches to value assessment often inadequately account for the many dimensions of value important to patients. Researchers have identified multi-criteria decision analysis (MCDA) as one promising approach to provide a more comprehensive measure of value. The Webinar will take place at 11:00 a.m. on November 19. Click here to learn more and register.
11. 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: Family self-funds revolutionary spinal muscular atrophy treatment as Health Canada continues to refuse to approve it. Drugs patients need may stop being provided through hospitals in order to cut costs.
- New Zealand: Man with melanoma self-funds treatment as Pharmac will not pay for it. Breast cancer advocate demands end to "unfair and outdated evaluation process" for new drugs. Type 2 diabetes patients await Pharmac decision on funding of critical new drugs. Indigenous Maori are not able to access critical diabetes treatments. Breakthrough drug that could give a child with cystic fibrosis a future is not funded by Pharmac. Pharmac CEO says that budget is why they let down New Zealanders.
- United Kingdom: After his twin died of the disease, a man with cystic fibrosis finally gains access to lifesaving drug.
12. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, 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.
- Sickle Cell Disease: Evidence Report and Responses to Comments AVAILABLE. Meeting POSTPONED: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for sickle cell disease.
- Hemophilia A: 11/20/2020: Final Evidence Report. Meeting 10/30/2020: New England CEPAC convened to deliberate and vote on evidence presented in ICER's report on treatments for hemophilia.
- Bladder Cancer: Evidence Report AVAILABLE. Meeting 11/20/2020: Midwest CEPAC will convene virtually to deliberate and vote on evidence presented in ICER's report on digital therapeutics for bladder cancer.
- Opioids: Digital Apps: Evidence Report AVAILABLE. Meeting 11/18/2020: Midwest CEPAC will convene virtually to deliberate and vote on evidence presented in ICER's report on digital therapeutics for opioid use disorder (OUD).
- Opioids: Supervised Injection Centers: Evidence Report and Responses to Public Comments AVAILABLE. Meeting 12/3/2020: The New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on supervised injection facilities.
- High Cholesterol: Draft Evidence Report AVAILABLE, Comment Period OPEN through 12/11/2020. Meeting 2/5/2021: The Midwest CEPAC will convene to review treatments for high cholesterol.
- Anemia in Chronic Kidney Disease: Model Analysis Plan available. 11/30/2020: Draft Evidence Report.
- Unsupported Price Increase Assessment: 1/8/2021: Final Assessment and Report.
- Lupus Nephritis: Research Protocol available. 11/20/2020: Model Analysis Plan. Meeting 3/26/2021: New England CEPAC will convene to deliberate and vote on evidence presented in ICER's report on treatments for lupus nephritis.
- Multiple Myeloma: Research Protocol available. 12/17/2020: Model Analysis Plan.
- Service Dogs for PTSD: 11/30/2020: Final Assessment and Report.
- Alzheimer's Disease: Draft Scoping Document available. 11/18/2020: Revised Scoping Document. Meeting 5/7/2020: CTAF will convene virtually to deliberate and vote on evidence presented in ICER's report on Alzheimer's disease.
13. Upcoming Events and Webinars
PCORI Advisory Panel on Healthcare Delivery and Disparities Research Winter 2020 Meeting
December 10, 2020
Click here for details.
14. Medical Journal Articles
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.
Improving Comparative Effectiveness Research of Complex Health Interventions: Standards from the Patient-Centered Outcomes Research Institute (PCORI), click here to view.
Improving Access and Quality of Health Care in the United States: Shared Goals Among Patient Advocates, click here to view.
Using Electronic Health Record Data to Identify Comparator Populations for Comparative Effectiveness Research, click here to view.
Pharmaceutical Pricing Benchmarks: Governmental Versus Private Sector, click here to view.
Researchers, Patients, and Other Stakeholders' Perspectives on Challenges to and Strategies for Engagement, click here to view.
Accounting for US Public Funding in Drug Development: How Can We Better Balance Access, Affordability, and Innovation?, click here to view.
Competencies for Professionals in Health Economics and Outcomes Research: The ISPOR Health Economics and Outcomes Research Competencies Framework, click here to view.
Translating Stakeholder-Driven Comparative Effectiveness Research into Practice: The PCORnet Bariatric Study, click here to view.
15. AHRQ Effective Program Updates
Research Protocol: Integrated Pain Management Programs. Click here to view.
Systematic Review: Management of Primary Headaches in Pregnancy. Click here to view.
Research Protocol: Models of Care That Include Primary Care for Adult Survivors of Childhood Cancer. Click here to view.
White Paper: Roadmap for Narratively Describing Effects of Interventions in Systematic Reviews. Click here to view.
Systematic Review: Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder. Click here to view.
Technical Brief: Prevention, Diagnosis, and Management of Opioids, Opioid Misuse, and Opioid Use Disorder in Older Adults. Click here to view.
Research Protocol: Living Systematic Review on Plant-Based Treatment for Chronic Pain. Click here to view.
Research Report: Testing a Machine Learning Tool for Facilitating Living Systematic Reviews of Chronic Pain Treatments. Click here to view.
OPEN FOR COMMENT THROUGH 11/23/2020: Safety of Vaccines Used for Routine Immunization in the United States: An Update. Click here to view.
Research Protocol: Malnutrition in Hospitalized Adults. Click here to view.