1. Patient Groups: New Drug Pricing Executive Orders Would Import Discriminatory Metrics, see details below.
2. Patient Advocates Weigh in on Executive Orders in the Press, see details below.
3. Patient Groups Submit Comment Letters to ICER on Draft Evidence Report on UC Treatments, see details below.
4. NCD Chairman: Accessible Care is Equal Care, click here to read the article.
5. Senate COVID-19 Relief Proposal Overlooks Disability Community, Advocates Say, click here to read the article.
6. U.K. Physicians Offer Cautionary Tale for Importing Discriminatory Foreign Policies, see details below.
7. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments, click here to view the webinar.
8. OCR Continues its Work to Resolve COVID-19 Discrimination Cases, see details below.
9. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
10. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney Disease, click here to provide patient input.
11. Upcoming Events and Webinars, see details below.
12. Medical Journal Articles, see details below.
13. AHRQ Effective Program Updates, see details below.
On Friday, the Administration released its anticipated Executive Order related to Medicare. Among its provisions, it 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 Medicare Part B. 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 expressed his own concerns about the Executive Order, especially coming as we celebrate the 30th anniversary of the Americans with Disabilities Act (ADA) that protects people with disabilities from discrimination. He stated, “No one supports lower drug prices more than patients and people with disabilities. But issuing an Executive Order that lowers the cost of drugs for the government by importing discriminatory metrics like quality-adjusted life years, while doing little to help Medicare beneficiaries with their costs, seems not only pointless, but potentially dangerous. We are in the middle of a pandemic and Americans, especially seniors and people with disabilities, are already concerned about accessing the care they need. They do not need more roadblocks thrown in their way.”
Maria Town, President and CEO of the American Association of People with Disabilities and a member of PIPC’s Steering Committee, stated, “As we celebrate the 30th anniversary of the Americans with Disabilities Act, it is important to remember that 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. We should be relying on the thoughtful recommendations from the National Council on Disability, an independent federal agency, calling on the administration to rescind its proposed international price index and to refrain from pursuing means of reducing Medicare and Medicaid prescription drug costs by modeling US pricing after the pricing in other countries, which may heavily rely on QALYs and often deny people with disabilities access to needed care. As people with disabilities fight for their lives in this pandemic, it is a time to expand access to care. Not restrict it.”
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.”
For additional information about the NCD report, please visit www.ncd.gov. PIPC resources are available at www.pipcpatients.org. Additionally, organizations supporting Value Our Health have resources available at www.valueourhealth.org.
2. Patient Advocates Weigh in on Executive Orders in the Press
PIPC Chairman Tony Coelho was quoted in STAT News this week bringing attention to the dangers of the Executive Orders signed last week that could restrict access to critical treatments. He was quoted as saying that the Orders are "not only pointless, but potentially dangerous." Click here to read the article.
American Association of People with Disabilities President and CEO Maria Town was quoted in POLITICO highlighting the problems with sacrificing the health of seniors to cut costs. "Right now the White House and Trump [are] trying to cut costs in Medicare and doing it at the cost of us," she said. Click here to read the article.
3. Patient Groups Submit Comment Letters to ICER on Draft Evidence Report on UC 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 Ulcerative Colitis (UC) treatments. Chairman Coelho criticized ICER for its use of the quality-adjusted-life-years (QALY) metric, noting that ICER fails to capture the true meaning of “value” for patients in its assessment. The letter also knocks ICER for neglecting to account for the heterogeneity of the UC patient population. “UC is a condition that impacts a very heterogeneous patient population, and treatment can vary greatly from patient to patient,” wrote Chairman Coelho. “For this reason, it is imperative that ICER account for this heterogeneity within its model and consider improving its methods.” Click here to read the letter.
Other patient groups, including the Crohn's and Colitis Foundation, submitted comments urging ICER to reconsider its report. Click here to read the comment letter from the Crohn's and Colitis Foundation.
4. NCD Chairman: Accessible Care is Equal Care
Neil Romano, the chairman of the National Council on Disability (NCD), and Stanley M. Bergman the chairman and CEO of Henry Schein, Inc., wrote this week that health care providers must have the resources to care for people with disabilities. "Every life is valuable, they wrote. "The presence of a disability does not diminish that value and people with disabilities should not be abandoned by the medical system they must rely on. COVID-19 has reminded us that the medical establishment has a critical role in fulfilling the mandate of the [Americans with Disabilities Act] – the landmark civil rights law that turns 30 this week. People with mobility disabilities need greater access to preventive care. Although accessible medical equipment is available, it is not commonly found in medical facilities. Most people with disabilities report a good quality of life, while the medical establishment has often devalued, and misunderstood, life lived with a disability. Let us work vigorously to bridge these gaps in understanding. It is time to increase accessible, nondiscriminatory medical care by breaking down the physical and attitudinal barriers that so often leave people with disabilities behind." Click here to read the article.
5. Senate COVID-19 Relief Proposal Overlooks Disability Community, Advocates Say
The COVID-19 relief package recently introduced by Senate Republicans overlooks the concerns of the disability community, including by not adding resources for home- and community-based services, writes Michelle Diament in Disability Scoop. “As the disability community has made clear, this funding can be the difference between a person with a disability staying safely in their own home, versus a person with a disability going into an institutional setting where COVID-19 is spreading like wildfire,” Julia Bascom of the Autistic Self Advocacy Network was quoted as saying. “The Senate has made it clear that this is intended to be their final COVID-19 relief package. It is horrifying that they would consider their job done without addressing this.” Click here to read the article.
6. U.K. Physicians Offer Cautionary Tale for Importing Discriminatory Foreign Policies
A new survey of doctors in the U.K. found that over half have patients who had traveled outside the U.K. to access care. It also found that 82 percent of U.K. physicians agree their patients would benefit from access to more innovative medicines and that 75% of U.K. physicians say their government rations health care to control spending. New proposals to tie drug prices in the United States to such systems would import these discriminatory policies to American seniors and people with disabilities and would reduce access to lifesaving drugs in the U.S. Click here to read a press release on the survey. Click here to read a one-pager.
7. Webinar: Unpacking ICER’s Models Assessing COVID-19 Treatments
On July 9, the Partnership to Improve Patient Care held a webinar to discuss the implications of the Institute for Clinical and Economic Review's assessment on treatments for the novel coronavirus (COVID-19). COVID-19 has presented an unprecedented challenge for our society. It has taken its toll on our health care system and ground much of society to a halt. It has also presented unique challenges for the patient and disability community that are at higher risk for complications should they contract the disease along with the added burden of attempts in many states to implement discriminatory crisis standards thatwould deny them care in a shortage. In the midst of this, ICER has released a model for determining the “value” of treatments for COVID-19. ICER has made clear they intend to continue using this model for future new treatments, making it seminally important that we understand the model and what it could mean for COVID-19 treatment access and future treatment development should it be relied on by policymakers and payers. Participants discussed how this model exacerbates the existing challenges of using QALYs and “average” inputs to determine value, and its relation to the “QALY Logic” that disability lawyers are fighting to ensure civil rights laws are enforced against restricted access to COVID-19 care during the pandemic. Click here to view the webinar.
8. OCR Continues its Work to Resolve COVID-19 Discrimination Cases
On July 20, the Office of Civil Rights (OCR) at the Department of Health and Human Services (HHS) published a guidance emphasizing nondiscrimination policies in the provision of COVID-19 aid and care. The guidance outlines how federal funds for COVID-19 care and aid may not used in a discriminatory manner on the basis of disability, race, color, and national origin, and more. The guidance calls on providers to implement policies preventing discrimination, ensure access to testing sites by racial and ethnic minorities, and generally ensure that resources are not distributed with regard to minority status. Click here to read the bulletin.
PIPC Chairman Tony Coelho is pleased to share that on June 26, 2020, OCR announced a settlement with the State of Tennessee after it updated its crisis standards of care (“CSC”) plan to ensure that the criteria does not discriminate against persons based on disability or age. This is OCR’s fourth resolution with a state regarding disability discrimination concerns during COVID-19. According to the Center for Public Representation, "Medical rationing policies have disproportionately impacted Black people with disabilities, who have higher rates of COVID-19 infection and hospitalization. Today’s resolution sets a national precedent, with OCR building off earlier resolutions of complaints regarding Alabama’s and Pennsylvania’s plans and weighing in for the first time on the discriminatory impact of a number of provisions common in many states’ rationing plans.”
As background, on April 16, 2020, over 400 aging, disability, and patient organizations sent a letter urging HHS to issue further guidance addressing the application of federal non-discrimination laws to plans to ration scarce health care resources during the COVID-19 pandemic. The letter led by the American Association of People with Disabilities, the Bazelon Center for Mental Health Law, the Center for Public Representation, and the Disability Rights, Education and Defense Fund called upon the HHS Office of Civil Rights to provide guidance clarifying, among other things, that federal law prohibits states and health care providers from making treatment allocation decisions based on assumptions that an individual’s disability or age will lessen the possibility of survival beyond the short-term or require the use of greater treatment resources. Click here to read the letter. Click here to read a letter sent by AARP. Click here to read PIPC Chairman Coelho’s opinion in the New York Daily News.
To track nondiscrimination and civil rights activities related to COVID-19, click here to view information on the Center for Public Representation website.
9. 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: Delays in Alberta's approval process keep child with spinal muscular atrophy from accessing a lifesaving treatment. Family of child with spinal muscular atrophy given more time to raise money for lifesaving treatment as province refuses to provide it.
- New Zealand: Mother of teen with cystic fibrosis pleads with Pharmac to provide life-changing medication. Families call on Pharmac to reverse epilepsy drug switch that has caused seven deaths. Tests expose differences in epilepsy drugs, such as the one that led to deaths. Click here to read more. Thousands of patients have been put back on former drug as a result.
10. ICER's QALY-Based Study Topics: Hemophilia A, Sickle Cell Disease, Ulcerative Colitis, Cystic Fibrosis, Bladder Cancer, Opioid Treatments, High Cholesterol, Anemia in Chronic Kidney 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.
- Ulcerative Colitis: Draft Evidence Report and Draft Voting Questions AVAILABLE. 9/2/2020: Revised Voting Questions and Evidence Report. Meeting 9/24/2020: CTAF will convene to deliberate and vote on evidence presented in ICER's report on ulcerative colitis therapies.
- Cystic Fibrosis: Evidence Report and Response to Comments AVAILABLE. Meeting 8/27/2020: CTAF will convene to deliberate and vote on evidence presented in ICER's report on treatments for cystic fibrosis.
- 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: Model Analysis Plan AVAILABLE. 8/26/2020: Draft Evidence Report.
- Bladder Cancer: Research Protocol Available. 8/6/2020: Model Analysis Plan.
- Opioids: Digital Apps: Model Analysis Plan available. 9/17/2020: Draft Evidence Report.
- Opioids: Supervised Injection Centers: Research Protocol Available. 8/11/2020: Model Analysis Plan.
- High Cholesterol: Revised Scoping Document available. 9/8/2020: Research Protocol.
- Anemia in Chronic Kidney Disease: Draft Scoping Document Available. Public Comments Open through 8/7/2020.
- Unsupported Price Increase Assessment: 1/8/2021: Final Assessment and Report.
11. Upcoming Events and Webinars
Webinar: Reducing Low-Value Care Roadmap: How AMGA Is Charting A Course To Change Health Care
August 5, 2020
Click here for details.
IQVIA Webinar: Support Your Clinical and Economic Value Proposition with Real World Data: Data and Technology-Enabled Evidence Generation
August 20, 2020
Click here for details.
PCORI Board of Governors Meeting
August 25, 2020
Click here for details.
PCORI Cycle 3 2020 Improving Methods Applicant Town Hall
September 8, 2020
Click here for details.
2020 PCORI Annual Meeting (A Virtual Event): Accelerating Impact on Care and Patient Outcomes
September 16-17, 2020
Click here for details.
12. Medical Journal Articles
Evaluation of the Use of Cancer Registry Data for Comparative Effectiveness Research, click here to view.
Outcome-Based Payment Schemes: What Outcomes Do Patients with Cancer Value?, click here to view.
Harnessing Real-World Data for Regulatory Use and Applying Innovative Applications, click here to view.
Engaging Patients and Stakeholders in Preresearch: Findings from the Pipeline to Proposal Awards Initiative, click here to view.
Why Clinical Trials May Not Help Patients Make Treatment Decisions: Results from Focus Group Discussions with 22 Patients, click here to view.
Defining Patient Engagement in Research: Results of a Systematic Review and Analysis: Report of the ISPOR Patient-Centered Special Interest Group, click here to view.
The Impact of Drug Quality Ratings from Health Technology Assessments on the Adoption of New Drugs by Physicians in Germany, click here to view.
Developing a Patient- and Family-Centered Research Agenda for Hospital Medicine: The Improving Hospital Outcomes through Patient Engagement (i-HOPE) Study, click here to view.
Annals Clinical Decision Making: Communicating Risk and Engaging Patients in Shared Decision Making, click here to view.
Comparative Effectiveness Research in Critically Ill Patients: Risks Associated with Mischaracterising Usual Care, click here to view.
13. AHRQ Effective Program Updates
Systematic Review: Care Interventions for People Living With Dementia and Their Caregivers. 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.
Rapid Evidence Product: Retention Strategies for Medications for Addiction Treatment in Adults With Opioid Use Disorder. Click here to view.
OPEN FOR COMMENT THROUGH 9/14/2020: Systematic Review: Radiation Therapy for Brain Metastases. Click here to view.
Masks for Prevention of COVID-19 in Community and Healthcare Settings: A Living Rapid Review. Click here to view.
OPEN FOR COMMENT THROUGH 8/13/2020: Key Questions: Management Strategies for Infantile Epilepsy. Click here to view.
Research Protocol: Prehabilitation and Rehabilitation for Major Joint Replacement. Click here to view.
Research Protocol: Disparities and Barriers for Pediatric Cancer Survivorship Care. Click here to view.
Research Protocol: Breast Reconstruction after Mastectomy. Click here to view.
Rapid Evidence Report: Masks for Prevention of COVID-19 in Community and Healthcare Settings: A Living Rapid Review. Click here to view.
Systematic Review: Interventions for Substance Use Disorders in Adolescents. Click here to view.
White Paper: The Evidence Base for Telehealth: Reassurance in the Face of Rapid Expansion During the COVID-19 Pandemic. Click here to view.
White Paper: Standardized Library of Depression Outcome Measures. Click here to view.
Research Protocol: No-Touch Modalities for Disinfection of Hospital/Acute Care Settings: A Rapid Evidence Review. Click here to view.