In This Week’s Issue:
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. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
4. STAT News: Disability Advocacy Gains Traction in Presidential Politics, click here to read the article.
5. AARDA’s Randy Rutta Talks Step Therapy, click here to read the full interview.
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, 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.
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. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
4. STAT News: Disability Advocacy Gains Traction in Presidential Politics, click here to read the article.
5. AARDA’s Randy Rutta Talks Step Therapy, click here to read the full interview.
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, 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.
1. NCD and PIPC Chairman Issue Statements Opposing Executive Order to Reference Foreign QALY-Based Prices
PIPC Chairman Tony Coelho published an op-ed in The Hill last week, 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 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.
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. 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.
4. STAT News: Disability Advocacy Gains Traction in Presidential Politics
After years of not receiving the sort of attention they deserve, disability rights have gained a prominent place in the presidential race, writes Juliet Isselbacher for STAT News. Social media opened the door for community activism and coordination, she wrote. "In particular, the nonpartisan #CripTheVote hashtag has given people with disabilities, who account for 20% of the U.S. population, a way to unite and amplify the power of their voting bloc. Disability advocate Tiara Mercius described #CripTheVote — launched by disability activists Alice Wong, Gregg Beratan, and Andrew Pulrang in 2016 — as a 'virtual coffee shop' for people with disabilities to discuss what they want out of elected officials. [One advocate] said that nearly all the candidates with whom she consulted told her they had staff assigned to monitor the hashtag #CripTheVote. Taking advantage of this attention from campaigns — as well as their wide reach on Twitter — the movement’s co-founders put out an open invitation for presidential candidates or President Trump to join them in a live Twitter chat." Click here to read the article.
5. AARDA’s Randy Rutta Talks Step Therapy
The American Autoimmune Related Disorder Association's (AARDA) President and CEO Randy Rutta sat for an interview this week in which he spoke about the dangers of mandated "fail first" utilization management strategies. "Step therapy is not appropriate in situations where the physician, though backed by available clinical evidence, is prohibited from prescribing the best option for treatment," said Mr. Rutta. "And is certainly not appropriate in cases where a patient is stable and successful on a certain regimen and, due to a change in their insurance status – they change jobs, their employer changes insurance companies, or a formulary shifts – they are forced by step therapy to switch treatments, often with dire negative effects. Ironically, it is not unusual for step therapy to push patients back onto medicines that have failed them in the past." Click here to read the full interview.
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:
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
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.
8. Upcoming Events and Webinars
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.
9. Medical Journal Articles
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.
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.
10. AHRQ Effective Program Updates
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.
Research Protocol: Breast Reconstruction after Mastectomy. Click here to view.
PIPC Chairman Tony Coelho published an op-ed in The Hill last week, 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 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.
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. 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.
4. STAT News: Disability Advocacy Gains Traction in Presidential Politics
After years of not receiving the sort of attention they deserve, disability rights have gained a prominent place in the presidential race, writes Juliet Isselbacher for STAT News. Social media opened the door for community activism and coordination, she wrote. "In particular, the nonpartisan #CripTheVote hashtag has given people with disabilities, who account for 20% of the U.S. population, a way to unite and amplify the power of their voting bloc. Disability advocate Tiara Mercius described #CripTheVote — launched by disability activists Alice Wong, Gregg Beratan, and Andrew Pulrang in 2016 — as a 'virtual coffee shop' for people with disabilities to discuss what they want out of elected officials. [One advocate] said that nearly all the candidates with whom she consulted told her they had staff assigned to monitor the hashtag #CripTheVote. Taking advantage of this attention from campaigns — as well as their wide reach on Twitter — the movement’s co-founders put out an open invitation for presidential candidates or President Trump to join them in a live Twitter chat." Click here to read the article.
5. AARDA’s Randy Rutta Talks Step Therapy
The American Autoimmune Related Disorder Association's (AARDA) President and CEO Randy Rutta sat for an interview this week in which he spoke about the dangers of mandated "fail first" utilization management strategies. "Step therapy is not appropriate in situations where the physician, though backed by available clinical evidence, is prohibited from prescribing the best option for treatment," said Mr. Rutta. "And is certainly not appropriate in cases where a patient is stable and successful on a certain regimen and, due to a change in their insurance status – they change jobs, their employer changes insurance companies, or a formulary shifts – they are forced by step therapy to switch treatments, often with dire negative effects. Ironically, it is not unusual for step therapy to push patients back onto medicines that have failed them in the past." Click here to read the full interview.
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
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: Revised Scoping Document available. 8/24/2020: Research Protocol.
- 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.
8. Upcoming Events and Webinars
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.
9. Medical Journal Articles
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.
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.
10. AHRQ Effective Program Updates
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.
Research Protocol: Breast Reconstruction after Mastectomy. Click here to view.
