1. NMQF, Axis Advocacy, Sick Cells, and PIPC Release a White Paper on Value Assessments' Impact on Health Disparities, click here to read the paper.
2. Advocates Call for Focus on People with Disabilities in Vaccine Allocation Framework, see details below.
3. AAPD, NCD, and NCIL Caution About the Discriminatory Implications of the QALY and Foreign Reference Pricing, click here to view the webinar.
4. Proposed 'Most Favored Nations' Order Would Import Discriminatory Value Assessments, see details below.
5. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
6. PCORI Annual Meeting September 16-17, click here to learn more and to register.
7. 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, Lupus Nephritis, Multiple Myeloma, click here to provide patient input.
8. Upcoming Events and Webinars, see details below.
9. Medical Journal Articles, see details below.
10. AHRQ Effective Program Updates, see details below.
National Minority Quality Forum, Axis Advocacy, Sick Cells, and Partnership to Improve Patient Care released a white paper investigating the limitations of applying traditional value assessments to communities of color. The paper finds that the pervasive issues that concern the patient and disability communities about value assessments, like over reliance on averages and the use of the Quality-Adjusted Life Year, become even more concerning when assessing treatments for conditions that disproportionately impact communities of color. If relied on in coverage decisions, these assessments could have the effect of exacerbating health disparities. Click here to read the paper.
2. Advocates Call for Focus on People with Disabilities in Vaccine Allocation Framework
Last week, the National Academies of Sciences, Engineering, and Medicine published a discussion draft of its Preliminary Framework for an Equitable Allocation of COVID-19 Vaccine. Stakeholders had just four days to comment on the discussion draft, with comments closing on Friday, September 4. Several disability groups commented, calling for a greater focus on people living with disabilities to ensure that they are not discriminated against when a COVID-19 vaccine is available. The Association of University Centers on Disabilities (AUCD) strongly recommended to include individuals with disabilities and the array of direct care professionals – paid and unpaid – who serve them in the first phase allocation of COVID-19 vaccine. The Consortium for Citizens with Disabilities (CCD) also provided comments stating that people who live or work in congregate settings should receive priority in allocation of a vaccine and expressed concerns about the need for more input related to health disparities. Not Dead Yet further stated that people with disabilities who faced potential COVID-19 triage should be prioritized. Click here to read the AUCD letter. Click here to view the CCD letter which will be posted later today. Click here to view the Not Dead Yet letter.
3. AAPD, NCD, and NCIL Caution About the Discriminatory Implications of the QALY and Foreign Reference Pricing
The American Association of People with Disabilities (AAPD) released a webinar featuring an interview between Maria Town, the President/CEO of AAPD, and Ana Torres Davis, Senior Attorney for the National Council on Disability (NCD), as well as a presentation by Kelly Buckland, Executive Director of the National Council on Independent Living (NCIL), about dangers of quality-adjusted life years (QALYs) for discrimination against people with disabilities and their importation from foreign countries into Medicare. The webinar focused on the National Council on Disability’s 2019 report that recommended that the administration rescind a proposal to use an international pricing index in Medicare and strongly advocated against President Trump’s proposed Executive Order due to its implications for importing discrimination and restricted access to care for people with disabilities. Click here to view the webinar.
4. Proposed 'Most Favored Nations' Order Would Import Discriminatory Value Assessments
The administration is preparing to release an Executive Order importing QALY-based prices to Medicare, hurting patients, and reducing access. PIPC Chairman Tony Coelho has long been fighting against these changes, writing in February that a similar proposal would "would do little to reduce out-of-pocket costs and would harm people with disabilities and serious chronic conditions." Click here to read the blog post.
The National Council on Disability (NCD) released a statement after the signing of the recent Executive Order 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.
Chairman Coelho also reiterated his concern in an op-ed in The Hill, writing that with the signing of an Executive order importing QALY-based prices to Medicare, 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.
5. 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: Cystic fibrosis drug could reduce severe disease incidence and death if made available to Canadians. Health Canada is urged to fast-track a life-changing cystic fibrosis drug. ALS drug finally approved in B.C., 22 months after Health Canada approved its use.
- New Zealand: New Zealanders with inflammatory bowel disease call for better access to medication. Cystic fibrosis parents campaign for access to life-saving drugs. Advocate and breast cancer sufferer dies.
- United Kingdom: Family forced to raise money to afford bile duct cancer treatment unavailable on the NHS.
6. 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.
7. 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, Lupus Nephritis, Multiple Myeloma
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. 9/8/2020: 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: Meeting 8/27/2020: CTAF convened to deliberate and vote on evidence presented in ICER's report on treatments for cystic fibrosis. 9/23/2020: Final Evidence Report.
- 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: Draft Evidence Report AVAILABLE. Comment period OPEN through 9/23/2020.
- 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: Model Analysis Plan available. 9/24/2020: Draft Evidence Report.
- High Cholesterol: Research Protocol available. 9/24/2020: Model Analysis Plan.
- Anemia in Chronic Kidney Disease: Research Protocol available. 10/14/2020: Model Analysis Plan.
- Unsupported Price Increase Assessment: 1/8/2021: Final Assessment and Report.
- Lupus Nephritis: Draft Scoping Document AVAILABLE, Comment Period OPEN through 9/21/2020, 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: Open Input Period through 9/17/2020.
- Service Dogs for PTSD: Open Input Period through 10/2/2020.
8. Upcoming Events and Webinars
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.
STAT News: Getting Real World Data about Covid-19
September 17, 2020
Click here for details.
PCORI: New Evidence to Inform Decisions
October 16, 2020
Click here for details.
9. Medical Journal Articles
Potential Impact of Missing Outcome Data on Treatment Effects in Systematic Reviews: Imputation Study, click here to view.
Advancing Community-Engaged Research: Increasing Trustworthiness Within Community-Academic Partnerships, click here to view.
Patient and Other Stakeholder Engagement in Patient-Centered Outcomes Research Institute Funded Studies of Patients with Kidney Diseases, click here to view.
Patient-Reported Outcomes: Central to the Management of COVID-19, click here to view.
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.
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.
10. AHRQ Effective Program Updates
OPEN FOR COMMENT THROUGH 9/28/2020: Systematic Review: Acute Treatments for Episodic Migraine. Click here to view.
OPEN FOR COMMENT THROUGH 9/28/2020: Systematic Review: Treatments for Acute Pain. Click here to view.
OPEN FOR COMMENT THROUGH 9/16/2020: Key Questions: Transitions of Care from Pediatric to Adult Services for Children with Special Healthcare Needs. Click here to view.
Technical Brief: Strategies for Patient, Family, and Caregiver Engagement. Click here to view.
Research Protocol: Interventions To Decrease Hospital Length of Stay. 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 9/8/2020: Key Questions: Models of Care that Include Primary Care for Adult Survivors of Childhood Cancer. Click here to view.
OPEN FOR COMMENT THROUGH 9/28/2020: Systematic Review: Cervical Ripening in the Outpatient Setting. Click here to view.
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.