1. NCD and PIPC Chairman Issue Statements Opposing Executive Order to Reference Foreign QALY-Based Prices, see details below.
2. National Council on Independent Living Resolution on QALYs, see details below.
3. PCORI Annual Meeting September 16-17, click here to learn more and to register.
4. Patient Advocates Weigh in on Executive Orders in the Press, see details below.
5. Patient Groups Submit Comment Letters to ICER on Draft Evidence Report on UC Treatments, see details below.
6. NCD Chairman: Accessible Care is Equal Care, click here to read the article.
7. Senate COVID-19 Relief Proposal Overlooks Disability Community, Advocates Say, click here to read the article.
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: 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.
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 published an op-ed in The Hill today, writing that 30 years after the passage of the Americans with Disabilities Act the administration is not looking out for people who that law is designed to protect. With the signing of four drug pricing-related executive orders, the administration is subordinating the health of individuals with disabilities, older adults, and patients with chronic diseases to election-year politics and cost concerns. "In the last week, we watched President Trump panic at his sinking poll numbers and decide to issue a slew of executive orders — more to create talking points for his campaign about how he was “lowering drug prices” and with little consideration for the practical reality that the policies do nothing to provide relief to Medicare beneficiaries with their out-of-pocket costs," Chairman Coelho writes. "The most troubling is the one not yet released, which the president has described as imposing deep price cuts on physician-administered treatments in Medicare by importing prices set by foreign governments based on the 'patient unfriendly' quality-adjusted life year (QALY) metric." Click here to read the article.
The National Council on Disability (NCD) also released a statement calling out the harms of using an international pricing index -- which relies on the use of discriminatory measures like QALYs. Click here to read the statement.
2. National Council on Independent Living Resolution on QALYs
The membership of the National Council on Independent Living (NCIL) unanimously adopted a Resolution Opposing the Use of Quality Adjusted Life Years (QALY) in all decisions concerning health care coverage. The Resolution was jointly developed by Not Dead Yet and the Autistic Self Advocacy Network for consideration in conjunction with NCIL’s Annual Conference held virtually beginning in July. In addition to declaring opposition to the use of QALYs, the NCIL pledged to provide technical assistance to stakeholders to ensure that discriminatory measures are not used in medical decision-making. Click here to read a blog post from Not Dead Yet on the resolution, and click here to read the resolution.
3. PCORI Annual Meeting September 16-17
Make plans now to attend PCORI's sixth Annual Meeting, Accelerating Impact on Care and Patient-Centered Outcomes, being held virtually September 16-17. The meeting will highlight results from several PCORI-funded studies and explore how we can shorten the time from research to improved health for patients. During the meeting, attendees will:
- Learn about our efforts to disseminate research findings
- Network with others
- Examine PCORI’s emphasis on engagement
- Explore participation in developing our research agenda
- Listen to powerful, inspiring keynote speakers
Click here to learn more and to register.
4. Patient Advocates Weigh in on Executive Orders in the Press
PIPC Chairman Tony Coelho was quoted in STAT News last 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.
5. 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.
6. 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.
7. 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.
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: 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.
9. 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: Model Analysis Plan available. 9/17/2020: Draft Evidence Report.
- 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. 8/17/2020: Revised Scoping Document.
- Unsupported Price Increase Assessment: 1/8/2021: Final Assessment and Report.
10. Upcoming Events and Webinars
Webinar: Increasing Access to Necessary Care During the COVID-19 Pandemic & Beyond
August 13, 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.
11. Medical Journal Articles
How to Include Patient-Reported Outcome Measures in Clinical Trials, click here to view.
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.
12. AHRQ Effective Program Updates
OPEN FOR COMMENT THROUGH 9/14/2020: Systematic Review: Radiation Therapy for Brain Metastases. Click here to view.
OPEN FOR COMMENT THROUGH 9/18/2020: Systematic Review: Integrating Palliative Care in Ambulatory Care of Non-Cancer Serious Chronic Illness. Click here to view.
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.
Masks for Prevention of COVID-19 in Community and Healthcare Settings: A Living Rapid Review. 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.