1. PIPC and National Alliance for Hispanic Health Statements on HHS Secretary-Designate Xavier Becerra, see details below.
2. You're Invited! PIPC Forum 2020: Putting Patients and People with Disabilities at the Center of the Value Discussion, click here to learn more and RSVP.
3. COVID-19 Response for Vulnerable Patients, see details below.
4. PIPC Statement on Behalf of People with Disabilities and Serious Chronic Conditions on MFN Importing QALYs, see details below.
5. National Health Council Webinar on Multi-Criteria Decision Analysis, click here to read about and watch clips from the webinar.
6. PIPC Primer: PCORI and ICER Background, Funding, and Impact on Patient-Centered Care, click here to view the primer.
7. PCORI Seeks Nominations for Advisory Panels, click here to learn more, submit a nomination, or apply to be on an advisory panel.
8. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
9. ICER's QALY-Based Study Topics: 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.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
PIPC Chairman Tony Coelho released a statement on the news that President-elect Joe Biden had selected California Attorney General Xavier Becerra to lead the Department of Health and Human Services (HHS). "On behalf of the Partnership to Improve Patient Care (PIPC), I want to congratulate my friend Xavier Becerra on his nomination to be the Secretary of the U.S. Department of Health and Human Services," he said. "Over the course of this pandemic, the inherent discrimination in our health care system is more apparent as we have seen people with disabilities and communities of color disproportionately impacted. All the while, Xavier Becerra has been at the helm fighting for the Affordable Care Act and the protection it provides to those with pre-existing conditions from discrimination. We recognize the tremendous challenges facing the agency as it works to rescind failed policies such as the “Most Favored Nation” rule that would import discrimination from foreign countries. We look forward to working with the new administration on solutions that that maintain and expand the ACA’s protections against discrimination from use of quality-adjusted life years and similar metrics that devalue the lives of people with disabilities and fail to consider challenges facing communities of color."
Jane L. Delgado, President and CEO of the National Alliance for Hispanic Health, also released a statement on the announcement. “More than ever, the nation needs experienced, knowledgeable, and skilled leadership at the helm of HHS. Deeply committed to country, service, and all communities, Xavier Becerra will be the steady hand that HHS needs to be the leader in science, health, and human services. Mr. Becerra’s lifelong commitment to addressing the challenges of families struggling to meet their health and human service needs will help ensure that HHS is true to its core mission. Under his leadership, HHS will lead the COVID response in a way that recognizes the sacrifices and losses that so many have endured and create a new path forward. His decades of experience with government at all levels and legislative and regulatory processes have prepared him to be the Secretary of HHS that the country and indeed the global community needs. We look forward to the Senate’s timely confirmation of this critical Cabinet position after the convening of the 117th Congress next year,” she said.
2. You're Invited! PIPC Forum 2020: Putting Patients and People with Disabilities at the Center of the Value Discussion
PIPC will convene patient and disability experts to discuss how we advance comparative clinical effectiveness research as a solution for ensuring patients and people with disabilities are at the center of the value discussion. We will cover the historic opposition to metrics that discriminate in the United States, i.e. the quality-adjusted life year, or QALY, as well as the impetus behind Congressional authorization of the Patient-Centered Outcomes Research Institute (PCORI), its mandate to fund comparative clinical effectiveness research, and its new authorization to collect outcomes data that includes potential burdens and economic impacts for patients. As PCORI moves into its second decade, we look forward to fostering a better understanding of its work.
At the end, we anticipate a lively discussion among patient and disability experts reacting to the presentations, answering your questions and challenging us all to view policies debated in 2021 through the lens of achieving health equity.
The Forum will take place virtually on December 16, 2020 beginning at 3:30 p.m. Eastern. Click here to RSVP.
3. COVID-19 Response for Vulnerable Patients
The Consortium for Citizens with Disabilities (CCD) sent a letter to President-elect Biden's COVID-19 Advisory Board calling for individuals with disabilities to be treated equitably in the response to the virus. Many individuals with disabilities have underlying health conditions that make them more vulnerable to the disease, and CCD is calling for that to be taken into account when the initial doses of COVID-19 vaccine are allocated. In addition, the group warned against rationing care or putting individuals with disabilities at a disadvantage when it comes to receiving COVID-19 treatment. Click here to read the letter.
The Advisory Committee on Immunization Practices (ACIP) announced last week that residents of “long-term care facilities” were included in Phase 1a of allocation in their framework, alongside health care workers. The definition of long-term care facilities is very broad and includes individuals who are, for whatever reason, unable to live independently. However, the real decisionmakers are the states, and ACIP's recommendations provide a guide to governors as they decide how to allocate vaccines.
The Association of University Centers on Disabilities (AUCD) sent a letter to ACIP calling for people with disabilities to be included in phase 1 of ACIP's distribution framework. It also called for caregivers to be included in phase 1. "It is both an ethical imperative to reduce harm and health inequities for this vulnerable population, and a practical measure to mitigate the spread of the novel coronavirus," the letter read. AUCD also issued an FAQ document about vaccine distribution concerns for the disability community. Click here to read the letter. Click here to read the FAQ.
4. PIPC Statement on Behalf of People with Disabilities and Serious Chronic Conditions on MFN Importing QALYs
In November, the Administration released an Interim Final Rule that would allow for the government to reference prescription drug prices established internationally, regardless of the metrics used by those countries or implications for access to care in those countries, for drugs covered under Part B of Medicare. The Partnership to Improve Patient Care and several other organizations expressed strong opposition to this concept when it was originally proposed in 2018.
PIPC Chairman Tony Coelho reiterated his own concerns. He stated, “This is a regrettable legacy for this administration to leave people with disabilities and chronic conditions as well as older adults that are already fighting discrimination in access to health care during the pandemic. Just when they need real relief, they are getting more barriers to care. The White House was well educated about the concerns we share about the discriminatory implications of quality-adjusted life years (QALYs) and similar average metrics. We are all in to fight against policies referencing QALYS - whether U.S. entities that call QALYs the gold standard such as the Institute for Clinical and Economic Review (ICER) - or their explicit importation from foreign countries. I am relieved the President-elect has made it clear he opposes QALYs and look forward to working with him on real solutions as we clean up this mess left behind.”
Maria Town, President and CEO of the American Association of People with Disabilities and a member of PIPC’s Steering Committee, stated, “It is frustrating when policymakers ignore experts and develop policy without consideration of how their actions impact people with disabilities. The United States has consistently taken a stand against the use of metrics such as quality-adjusted life years (QALY) in our public health programs due to their implications for discrimination and restricted access to care for people with disabilities. Even the National Council on Disability (NCD), an independent federal agency, has studied this issue and given counsel to the administration to refrain from pursuing means of reducing Medicare and Medicaid prescription drug costs by modeling U.S. pricing after the pricing in other countries, which is often based on QALYs. Why would we want to value care like other countries if we know it leads to restricted access, especially during a pandemic?”
Patricia Goldsmith, Chief Executive Officer of CancerCare and a PIPC member, stated, “Health outcomes for cancer patients are substantially worse in other countries because their health systems use standards that discriminate to value treatments. The result is restricted and delayed access to cancer treatment. Yet, the White House is proposing to import those standards to the United States in the middle of a pandemic.” Click here to view the statement and click here to read NCD's statement opposing the president's Executive Order on the issue.
5. National Health Council Webinar on Multi-Criteria Decision Analysis
In November, the National Health Council held a webinar on empowering the patient voice in value assessment through multi-criteria decision analysis (MCDA). The webinar featured patient advocates and others working to ensure that patients' voices are heard in the value assessment process. MCDA can help put the things that are important to patients at the forefront of value assessment. Click here to read more and watch clips from the webinar.
6. 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.
7. 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.
8. 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: Canadians with cystic fibrosis are dying as Health Canada drags its feet on providing the drug. Former Minister of Health accuses the pan-Canadian Pharmaceutical Alliance of working slowly in negotiations on a cystic fibrosis drug to save money at the expense of lives. Cancer survivors advocate for Canada to fund lifesaving cancer drug.
- France: Cystic fibrosis patients in France allow their condition to deteriorate to qualify for lifesaving treatment.
- New Zealand: Pharmac withholds submissions it received over plans for limited funding for new, life-changing diabetes drugs.
- United Kingdom: Boy diagnosed with spinal muscular atrophy at seven weeks of age cannot access lifesaving therapy in the UK.
9. ICER's QALY-Based Study Topics: 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.
- Bladder Cancer: 12/15/2020: Final Evidence Report. Meeting 11/20/2020: Midwest CEPAC met to deliberate and vote on evidence presented in ICER's report on digital therapeutics for bladder cancer.
- Opioids: Digital Apps: 12/11/2020: Final Evidence Report. Meeting 11/18/2020: Midwest CEPAC met to deliberate and vote on evidence presented in ICER's report on digital therapeutics for opioid use disorder (OUD).
- Opioids: Supervised Injection Centers: 1/8/2021: Final Evidence Report. Meeting 12/3/2020: The New England CEPAC convened 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: Draft Evidence Report AVAILABLE, comment period OPEN through 1/5/2021.
- Unsupported Price Increase Assessment: 1/8/2021: Final Assessment and Report.
- Lupus Nephritis: Model Analysis Plan available. 1/22/2021: Draft Evidence Report. 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.
- Alzheimer's Disease: Research Protocol available. 1/14/2021: Model Analysis Plan. Meeting 5/7/2020: CTAF will convene virtually to deliberate and vote on evidence presented in ICER's report on Alzheimer's disease.
10. Upcoming Events and Webinars
PCORI Advisory Panel on Healthcare Delivery and Disparities Research Winter 2020 Meeting
December 10, 2020
Click here for details.
The Marathon After the Sprint: Ensuring Value & Equity in the Future of Telehealth
December 11-12, 2020
Click here for details.
PCORI Engagement Awardee Lunch and Learn: Engaging Underrepresented Communities -- Research Partnerships In Action
December 17, 2020
Click here for details.
PCORI Cycle 1 2021 Broad PFA Applicant Town Hall
January 21, 2020
Click here for details.
11. Medical Journal Articles
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.
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.
12. AHRQ Effective Program Updates
OPEN FOR COMMENT THROUGH 1/8/2021: Systematic Review: Physical Activity and the Health of Wheelchair Users. Click here to view.
White Paper: Outcome Measure Harmonization and Data Infrastructure for Patient-Centered Outcomes Research in Depression. Click here to view.
Research Protocol: Maternal and Childhood Outcomes Associated With the Special Supplemental Nutrition Program for Women, Infants and Children (WIC). Click here to view.
Research Protocol: Transitions of Care From Pediatric to Adult Services for Children With Special Healthcare Needs. Click here to view.
Systematic Review: Interventions for Breathlessness in Patients With Advanced Cancer. Click here to view.
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.