1. Over 40 Leading Patient and Disability Groups Join PIPC Letter Opposing Most Favored Nations Rule, click here to read the letter.
2. AJMC: Practical Patient-Centered Value Assessment is Needed, click here to read the article.
3. PIPC Submits Comment Letter to ICER on Draft Evidence Report for High Cholesterol Treatments, click here to read the letter.
4. PIPC and National Alliance for Hispanic Health Statements on HHS Secretary-Designate Xavier Becerra, see details below.
5. COVID-19 Response for Vulnerable Patients, see details below.
6. PCORI Seeks Nominations for Advisory Panels, click here to learn more, submit a nomination, or apply to be on an advisory panel.
7. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
8. ICER's QALY-Based Study Topics: Atopic Dermatitis, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, Lupus Nephritis, Multiple Myeloma, Alzheimer's Disease, click here to provide patient input.
9. Upcoming Events and Webinars, see details below.
10. Medical Journal Articles, see details below.
11. AHRQ Effective Program Updates, see details below.
More than 40 leading groups and individuals representing the patient and disability communities signed onto the Partnership to Improve Patient Care's (PIPC) comment letter to the Department of Health and Human Services (HHS) opposing the Trump administration's Most Favored Nations (MFN) rulemaking.
The letter outlines several concerns with the regulation, chiefly that it would: (1) rely on the discriminatory quality-adjusted-life-year (QALY) metric and other means of cost-effectiveness assessment that would harm patients; (2) lead to discrimination that is in direct conflict with American civil rights and disability policy; and (3) cause undue disruption in the health care system that will result in immediate access issues for patients.
"The MFN model is not in the best interest of America and would disproportionately harm seniors, patients, people with disabilities, people of color and other vulnerable communities," the letter states. "We encourage the administration to work directly with patients and people with disabilities to determine an appropriate way to lower health care costs that does not undermine their access to care." Click here to read the letter.
2. AJMC: Practical Patient-Centered Value Assessment is Needed
In the American Journal of Managed Care, Sachin Kamal-Bahl, Ph.D., and Bryan Luce, Ph.D., say that a better understanding of the factors that matter to patients is needed to ensure that value assessment accounts for patient needs. "Traditional value assessment methods, which rely on the conventional Quality Adjusted Life Year (QALY), have their limitations," they write. "In particular, basing a therapy’s value solely on the QALY may overlook some elements of value that matter most to patients, such as the treatment’s impact on their ability to work or stay active, the potential for reduced side effects, or the impact on family and caregivers." Click here to read the article.
3. PIPC Submits Comment Letter to ICER on Draft Evidence Report for High Cholesterol Treatments
In a letter to the Institute for Clinical and Economic Review (ICER), Partnership to Improve Patient Care (PIPC) Chairman Tony Coelho provided feedback on ICER’s draft evidence report for high cholesterol treatments. The letter criticizes ICER for making incorrect assumptions about atherosclerotic cardiovascular disease (ASCVD), and that the model is not reflective of the indicated population. Chairman Coelho also took issue with ICER for using Disability-Adjusted Life Year (DALY) weights that have not been generated by patients at all. "ICER continues the concerning trend of looking to an 'average' patient, instead of determining value to the relevant patient populations in question," stated Chairman Coelho. "We encourage ICER to revise its model to be reflective of the actual patient population and to segment voting questions to determine value to subgroups." Click here to read the letter.
4. PIPC and National Alliance for Hispanic Health Statements on HHS Secretary-Designate Xavier Becerra
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.
5. COVID-19 Response for Vulnerable Patients
In March, the National Council on Disability requested the quick issuance of guidance to make clear that, under federal law, people with disabilities had the right to receive nondiscriminatory care. HHS' Office of Civil Rights (OCR) issued a bulletin on March 28 on the civil rights responsibilities of healthcare providers during the COVID-19 pandemic that detailed responsibilities for non-discrimination under the Americans with Disabilities Act (the ADA) and other federal laws. OCR made clear that treatment decisions must be made consistent with federal law - based on an individualized assessment of the patient based on objective medical evidence – not influenced by stereotypes, assessments of quality of life, or judgments about a person’s relative “worth” based on the presence or absence of disabilities. This guidance served an important purpose, but even its issuance has not completely stopped the development of discriminatory COVID-19 policies across the nation, and OCR continues to receive complaints alleging that states and hospitals across the nation are discriminating in access to COVID-19 care under the ADA, Section 504 of the Rehabilitation Act (Section 504), and the Affordable Care Act (the ACA). Several federal lawsuits have also been filed alleging discrimination in access to COVID-19 care for people with disabilities. In a comment letter, NCD expresses its concerns on a vaccine allocation framework developed by the National Academies, particularly that it should include a clear statement that people with disabilities have a federally protected right to equally access healthcare. Click here to read the comments.
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 in late November 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.
6. 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.
7. 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: Cancer patient recovers after receiving drug that the government refuses to fund.
- New Zealand: The Diabetes Foundation accuses Pharmac of "penny pinching" and encourages it to cover life-changing drugs for all patients with Type 2 diabetes.
- United Kingdom: Dad runs every street in his city to raise awareness of NHS not covering a life-changing PKU drug. Parents call for NHS to cover a PKU drug so that their children can eat normally.
8. ICER's QALY-Based Study Topics: Atopic Dermatitis, 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.
- Atopic Dermatitis: Draft Scoping Document Available. 1/15/2021: Revised Scoping Document.
- Bladder Cancer: Final Evidence Report AVAILABLE.
- Opioids: Supervised Injection Centers: Final Evidence Report AVAILABLE.
- High Cholesterol: Draft Evidence Report AVAILABLE. 1/22/2021: Evidence Report and Response to Public Comments. Meeting 2/5/2021: The Midwest CEPAC will convene to review treatments for high cholesterol.
- Anemia in Chronic Kidney Disease: Draft Evidence Report Available. 1/28/2020: Evidence Report and Response to Public Comments.
- Unsupported Price Increase Assessment: 1/12/2021: 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: Model Analysis Plan available. 2/11/2021: Draft Evidence Report. Meeting 4/16/2021.
- 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.
9. Upcoming Events and Webinars
PCORI Board of Governors Meeting
January 12, 2020
Click here for details.
PCORI Cycle 1 2021 Broad PFA Applicant Town Hall
January 21, 2020
Click here for details.
10. Medical Journal Articles
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.
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.
11. AHRQ Effective Program Updates
Systematic Review: Treatments for Acute Pain. Click here to view.
Systematic Review: Acute Treatments for Episodic Migraine. Click here to view.
Research Protocol: Interventional Treatments for Acute and Chronic Pain: Systematic Review. Click here to view.
Research Protocol: Diagnostic Errors in the Emergency Department. Click here to view.
OPEN FOR COMMENT THROUGH 12/30/2020: Key Questions: Antenatal Care. 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.
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.