1. Proposed 'Most Favored Nations' Order Would Import Discriminatory Value Assessments, see details below.
2. Canadian Cystic Fibrosis Advocate Cautions Americans Against Importing Foreign Drug Pricing Policies, click here to read the blog post.
3. National Council on Independent Living Resolution on QALYs, see details below.
4. Opinion: Global Pharmaceutical Models Would Destroy U.S. Innovation, click here to read the op-ed.
5. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
6. Patients Say USPS Slowdown is Delaying Delivery of Life-Saving Medications, click here to read the article.
7. PCORI Annual Meeting September 16-17, click here to learn more and to register.
8. 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, 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.
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.
2. Canadian Cystic Fibrosis Advocate Cautions Americans Against Importing Foreign Drug Pricing Policies
Sandy Stevens shares her personal story of struggling to access needed medication for her fourteen year old daughter, Laura, who lives with Cystic Fibrosis. Sandy strongly cautions Americans against implementing policies that would model Canada’s drug pricing scheme, including the most recent “most favored nations” Executive Order. She describes the persistent challenges Laura faced in Canada in attempting to access drugs prescribed to her by her physicians, including being forced to become so sick she was on a lung transplant list before qualifying for the prescribed treatment. Click here to read the blog post.
3. 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.
4. Opinion: Global Pharmaceutical Models Would Destroy U.S. Innovation
In an op-ed for the Dallas Morning News, Tom Kowalski of the Texas Healthcare and Bioscience Institute in Austin writes about the detrimental impact that international reference pricing would have on U.S. pharmaceutical innovation. "As scientists race for treatments and vaccines to stamp out the spread of COVID-19, American pharmaceutical companies are helping lead the way, with groundbreaking, rapidly developing research that has allowed us to hold out collective hope for an end to this pandemic," he writes. "Yet, while the government has wisely stepped up its partnership with the private sector, investing resources and loosening regulations that would hamper our ability to rush toward a cure, it is on the precipice of making a devastating mistake that could bring innovation to a devastating halt." Click here to read the op-ed.
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.
- Australia: Ending pharmaceutical industry intervention by the Australian government could save patients thousands.
- Canada: Canadian government refuses to fund crucial spinal muscular atrophy therapy for a child as her time runs out. Another child's family has had to raise money for the same therapy without funding from the government. Cystic fibrosis patient fights for others to access life-changing medicines.
- New Zealand: Children with spinal muscular atrophy in New Zealand contemplate moving out of the country to access life-saving medications. New Zealand cancer patients are going without life-saving treatments as COVID-19 keeps them in the country.
- United Kingdom: Family tries to raise funds for mother's cancer treatment that NHS will not fund.
6. Patients Say USPS Slowdown is Delaying Delivery of Life-Saving Medications
Patients are seeing deliveries of life-saving medications slowed amid a slowdown at the United States Postal Service, writes CNBC's Christina Farr. She spoke to several patients, including one with cystic fibrosis who receives her medications by mail as the COVID-19 pandemic prevents her from going to the pharmacy. Click here to read the article.
7. 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.
8. 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
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: Model Analysis Plan available. 9/24/2020: Draft Evidence Report.
- High Cholesterol: Revised Scoping Document available. 9/8/2020: Research Protocol.
- 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: Open Input Period through 8/26/2020. 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.
9. Upcoming Events and Webinars
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.
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.
10. Medical Journal Articles
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.
The Impact of Drug Quality Ratings from Health Technology Assessments on the Adoption of New Drugs by Physicians in Germany, click here to view.
11. AHRQ Effective Program Updates
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.
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.