In This Week’s Issue:
1. PIPC Chairman Tony Coehlo: New York Budget is a Call to Action, click here to read the article.
2. PIPC Comments on IVI's Open-Source Value Platform Model, click here to read the letter.
3. JAMA: Why Physicians Should Trust in Patients, click here to read the article.
4. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy, click here to provide patient input.
6. AUCD: Submit a Proposal for 2019 Conference! Click here for more information.
7. HR Professionals Magazine Highlights PCORI Portfolio, click here to read the article.
8. Request for Comment: Definition of Health Technology Assessment, see below for details.
9. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus, click here to submit your events.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
1. PIPC Chairman Tony Coehlo: New York Budget is a Call to Action, click here to read the article.
2. PIPC Comments on IVI's Open-Source Value Platform Model, click here to read the letter.
3. JAMA: Why Physicians Should Trust in Patients, click here to read the article.
4. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy, click here to provide patient input.
6. AUCD: Submit a Proposal for 2019 Conference! Click here for more information.
7. HR Professionals Magazine Highlights PCORI Portfolio, click here to read the article.
8. Request for Comment: Definition of Health Technology Assessment, see below for details.
9. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus, click here to submit your events.
10. Upcoming Events and Webinars, see details below.
11. Medical Journal Articles, see details below.
12. AHRQ Effective Program Updates, see details below.
1. PIPC Chairman Tony Coehlo: New York Budget is a Call to Action
In spite of advocates' efforts to educate lawmakers on how QALYs discriminate against people with disabilities and apply arbitrary notions of "value" to individuals' lives, the New York State budget included language that would allow for QALY-based value assessments. "Going forward, PIPC will work harder to amplify the voices of advocates calling on policymakers to value our health. It will take your leadership, your guidance and your time to fight back against emerging threats at the state and federal level to restrict access to care based on discriminatory value assessments from groups like ICER. We have to ask, “Value to whom?” Because when value assessments based on averages are applied to coverage decisions, we get caught in the middle without access to care. We know different people respond differently to the same treatments. We know one size does not fit all. And we are going to fight back against anyone that tries to say that value is a one-size-fits-all proposition. I hope you will join PIPC in this fight by sharing your experiences with us and letting us know how we can support your work to convince policymakers to value our health," wrote PIPC Chairman Tony Coehlo. Click here to read the article.
2. PIPC Comments on IVI's Open-Source Value Platform Model
The Partnership to Improve Patient Care (PIPC) submitted a comment letter to the Innovation and Value Initiative (IVI) on their first oncology-specific Open-Source Value Platform (OSVP) model focused on non-small cell lung cancer (NSCLC). PIPC Chairman Tony Coelho complimented the detail and comprehensiveness of the IVI's model, noting the tremendous value that open-source models offer. However, Chairman Coelho strongly encouraged IVI not to utilize the flawed quality-adjusted-life-year metric in its multi-criteria decision analysis (MCDA) component. "As QALYs are assigned by both quality as well as quantity of life, an incremental QALY assessment would prioritize providing treatment to a non-disabled population with a longer theoretical life expectancy, and otherwise perfect health, over a population with a disability or chronic condition," wrote Chairman Coelho. "It is our hope that IVI chooses to be innovative in moving beyond the QALY." Click here to read the letter.
3. JAMA: Why Physicians Should Trust in Patients
A partnership between patients and physicians and shared decision-making can improve health outcomes, wrote Dr. Rachel Grob, Dr. David Meyers, and Gwen Darien in a Viewpoint piece for JAMA. Maintaining health and addressing illness are inherently collaborative processes: these processes cannot effectively proceed unless physicians and patients can count on each other. When physicians stop simply seeking patients’ adherence to their proposed care plans and instead work with patients toward a co-created strategy that reflects each patient’s beliefs, values, preferences, and abilities, the groundwork for mutual trust is effectively laid and healing can begin," they said. Click here to read the article.
4. 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.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy
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. Please note the following upcoming formal ICER deadlines per their website:
6. AUCD: Submit a Proposal for 2019 Conference!
The AUCD Conference welcomes proposals to highlight the work of the disability community. Over 200 different presentations will be accepted to the conference in several different types of sessions, formatted for maximum visibility and interaction with attendees. Proposals are encouraged from students, self-advocates, family leaders, clinicians, and researchers in over 25 topics. Click here for more information.
7. HR Professionals Magazine Highlights PCORI Portfolio
Writing for HR Professionals Magazine, Lisa Marino spotlights PCORI's mental health research studies. "As of August 2018 PCORI had awarded $434 million to fund over 100 comparative clinical effectiveness research studies related to mental and behavioral health. PCORI will assist, through research, patients, clinicians, purchasers and policy-makers, in making informed health decisions by advancing the quality and relevance of evidence-based medicine. PCORI’s Evidence Synthesis Initiative takes that approach. The program includes rigorous reviews of the best evidence available on topics of critical concern to patients and other healthcare stakeholders. The goal is to synthesize all relevant completed studies on a particular clinical question in order to provide evidence that is stronger and more certain than the results of the individual studies," she wrote. Click here to read the article.
8. Request for Comment: Definition of Health Technology Assessment
Dr. Brian O’Rourke of the International Network of Agencies for Health Technology Assessment (INAHTA) and Dr. Wija Oortwijn of Health Technology Assessment International (HTAi) are co-chairing an international joint task group that is proposing an updated definition of Health Technology Assessment (HTA) that consolidates and simplifies the various definitions in existence and which reflects the current and emerging realities of HTA. Along with the co-chairs from INAHTA and HTAi, the joint task group includes representatives from WHO, EUnetHTA, HTAsiaLink, RedETSA, the English Editorial Board of the HTA Glossary, and ISPOR. The group has followed a consensus-building process to develop the proposed updated definition and they are now inviting input from the HTA community to build broad consensus on the updated definition. The deadline to comment is April 30. Click here for more information.
9. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus
In the interest of amplified patient and stakeholder engagement, your organization may be interested that the House Majority Leader’s office is compiling a list of fly-ins, advocacy days, and conferences that will be taking place throughout the year. This information will be shared with all House Democratic offices and used for a variety of purposes including scheduling and messaging. Feel free to share any events you have planned. If we hear of similar efforts by the Minority Leader, we hope to share that as well. Please submit your events here.
10. Upcoming Events and Webinars
Comparative Effectiveness Research: Recent Applications and Future Investments
April 9, 2019
Click here for details.
Big Data, RWD and RWE: What’s the Difference and How is it Changing the Research Landscape?
April 15, 2019
Click here for details.
PCORI Board of Governors Meeting
April 16, 2019
Click here for details.
17th Annual Eyeforpharma Philadelphia
April 16-17, 2019
Click here for details.
Cycle 2 2019 Improving Methods Applicant Town Hall
May 9, 2019
Click here for details.
PCORI Board of Governors Meeting
May 13, 2019
Click here for details.
Advisory Panel on Clinical Trials Spring 2019 Meeting
May 15, 2019
Click here for details.
Advisory Panel on Healthcare Delivery and Disparities Research Spring 2019 Meeting
May 16, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
A New Path Forward for Using Real World Evidence in Randomized Clinical Trials
June 23, 2019
Click here for details.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
11. Medical Journal Articles
Launch of AHRQ's Systematic Review Data Repository (SRDR)+, click here to view.
Knowledge and Use of Evidence-Based Medicine in Daily Practice by Health Professionals: A Cross-Sectional Survey, click here to view.
Quantifying Preferences in Drug Benefit-Risk Decisions, click here to view.
Raising the Impact of Real World Evidence, click here to view.
Why and How to Use Patient-Oriented Research to Promote Translational Research, click here to view.
The Evolution of European HTA and Access to Innovative Medicines, click here to view.
Advocating for New Patient-Centered Tools for Value-Based Treatment Choices in Oncology, click here to view.
Toward a Strategy to Involve Patients in Health Technology Assessment in Spain, click here to view.
Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute, click hereto view.
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies, click here to view.
Letter: Multi-Method Patient-Engagement Approach: A Case Example from a PCORI-Funded Training Project, clickhere to view.
Perspectives of Patients in Identifying Their Values-Based Health Priorities, click here to view.
How Patient's Access to Evidence-Based Medicine Provides Them with a New Hope "The 45 Min—An Insightful Round," click here to view.
Improving Patient-Reported Measures in Oncology, click here to view.
12. AHRQ Effective Program Updates
Systematic Review: Adverse Effects of Pharmacological Treatments of Major Depression in Older Adults, click here to view.
Comment Period: Management of Primary Headaches in Pregnancy, click here to view.
Nonopioid Pharmacologic Treatments for Chronic Pain, click here to view.
Systematic Review Update: Noninvasive Nonpharmacologic Treatments for Chronic Pain, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned, click here to view.
Standardized Library of Depression Outcome Measures, click here to view.
Patient Navigation Models for Lung Cancer, click here to view.
Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update, click here to view.
Long-term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review, click here to view.
In spite of advocates' efforts to educate lawmakers on how QALYs discriminate against people with disabilities and apply arbitrary notions of "value" to individuals' lives, the New York State budget included language that would allow for QALY-based value assessments. "Going forward, PIPC will work harder to amplify the voices of advocates calling on policymakers to value our health. It will take your leadership, your guidance and your time to fight back against emerging threats at the state and federal level to restrict access to care based on discriminatory value assessments from groups like ICER. We have to ask, “Value to whom?” Because when value assessments based on averages are applied to coverage decisions, we get caught in the middle without access to care. We know different people respond differently to the same treatments. We know one size does not fit all. And we are going to fight back against anyone that tries to say that value is a one-size-fits-all proposition. I hope you will join PIPC in this fight by sharing your experiences with us and letting us know how we can support your work to convince policymakers to value our health," wrote PIPC Chairman Tony Coehlo. Click here to read the article.
2. PIPC Comments on IVI's Open-Source Value Platform Model
The Partnership to Improve Patient Care (PIPC) submitted a comment letter to the Innovation and Value Initiative (IVI) on their first oncology-specific Open-Source Value Platform (OSVP) model focused on non-small cell lung cancer (NSCLC). PIPC Chairman Tony Coelho complimented the detail and comprehensiveness of the IVI's model, noting the tremendous value that open-source models offer. However, Chairman Coelho strongly encouraged IVI not to utilize the flawed quality-adjusted-life-year metric in its multi-criteria decision analysis (MCDA) component. "As QALYs are assigned by both quality as well as quantity of life, an incremental QALY assessment would prioritize providing treatment to a non-disabled population with a longer theoretical life expectancy, and otherwise perfect health, over a population with a disability or chronic condition," wrote Chairman Coelho. "It is our hope that IVI chooses to be innovative in moving beyond the QALY." Click here to read the letter.
3. JAMA: Why Physicians Should Trust in Patients
A partnership between patients and physicians and shared decision-making can improve health outcomes, wrote Dr. Rachel Grob, Dr. David Meyers, and Gwen Darien in a Viewpoint piece for JAMA. Maintaining health and addressing illness are inherently collaborative processes: these processes cannot effectively proceed unless physicians and patients can count on each other. When physicians stop simply seeking patients’ adherence to their proposed care plans and instead work with patients toward a co-created strategy that reflects each patient’s beliefs, values, preferences, and abilities, the groundwork for mutual trust is effectively laid and healing can begin," they said. Click here to read the article.
4. 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.
- New Zealand: Breast cancer patients are not receiving access to to life-saving medications. As a result of widespread criticism, PHARMAC is set to review its practices of breast cancer drug funding. Click here to read more. PHARMAC has claimed to cover a breast cancer treatment that it does not cover. Patients in New Zealand also face barriers to access for treatment of spinal muscular atrophy. Click here to read more. New Zealand advocates unfavorably compare its cancer drug coverage to other countries.
- Canada: Discriminatory cost effectiveness measures are blocking access to care for patients with spinal muscular atrophy patients. Click here and here to read more. Click here to view the story of a child with thyroid cancer forced to come to the U.S. for care, and here for an article about high costs of Parkinson's and MS treatments. Click here for a story about a patient with cystic fibrosis whose province does not cover the drug she needs.
- Netherlands: Cost effectiveness measures are blocking access to cystic fibrosis treatments for children. It also remains unavailable for adults because the government has failed to reach an agreement. Click here to read more.
- United Kingdom: English families are moving to Scotland and Ireland in an attempt to access MS drugs not covered by the NHS. Activists are fighting for access to treatments for cystic fibrosis and cancer. Click here and here for articles related to cystic fibrosis. Click here and here to read about the fight for access to cancer drugs in Scotland. Click here for an article related to MS. Click here for more information on the NHS drug approval process. Click here for an article about the fight for access to spinal muscular atrophy drugs.
- France: Patients are alarmed as a multiple sclerosis drug will no longer be covered.
5. ICER Studies: Cardiovascular Disease, SMA, Depression, MS, Duchenne Muscular Dystrophy, Peanut Allergy
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. Please note the following upcoming formal ICER deadlines per their website:
- Arthritis: Open Input Period through 4/8/2019. Meeting 10/31/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
- Cardiovascular Disease : 4/15/2019: Revised scoping document. 9/26/2019 Meeting: Midwest CEPAC to deliberate and vote on ICER's report on evidence presented in ICER's report on additive CVD therapies.
- Spinal Muscular Atrophy: Final Evidence Report and Meeting Summary available.
- Depression: Comment period on Draft Evidence Report OPEN through 4/17/2019. Meeting 5/23/2019: Midwest CEPAC to review evidence on esketamine as a therapy for treatment-resistant depression.
- Multiple Sclerosis: Public Comments OPEN through April 10, 2019 on the Draft Analysis Report. Meeting 5/23/2019: Midwest CEPAC to review ICER's assessment of siponimod (Novartis) for secondary progressive multiple sclerosis.
- Peanut Allergy: Draft Evidence Report: 4/9/2019. Meeting 6/11/2019: CTAF to review ICER's assessment of treatments for peanut allergy.
- Duchenne Muscular Dystrophy: Research protocol available. Meeting 7/25/2019: New England CEPAC to deliberate and vote on evidence presented in ICER's report on treatments for Duchenne muscular dystrophy.
- Unsupported Price Increase Assessment: Open Input Period through 4/19/2019.
6. AUCD: Submit a Proposal for 2019 Conference!
The AUCD Conference welcomes proposals to highlight the work of the disability community. Over 200 different presentations will be accepted to the conference in several different types of sessions, formatted for maximum visibility and interaction with attendees. Proposals are encouraged from students, self-advocates, family leaders, clinicians, and researchers in over 25 topics. Click here for more information.
7. HR Professionals Magazine Highlights PCORI Portfolio
Writing for HR Professionals Magazine, Lisa Marino spotlights PCORI's mental health research studies. "As of August 2018 PCORI had awarded $434 million to fund over 100 comparative clinical effectiveness research studies related to mental and behavioral health. PCORI will assist, through research, patients, clinicians, purchasers and policy-makers, in making informed health decisions by advancing the quality and relevance of evidence-based medicine. PCORI’s Evidence Synthesis Initiative takes that approach. The program includes rigorous reviews of the best evidence available on topics of critical concern to patients and other healthcare stakeholders. The goal is to synthesize all relevant completed studies on a particular clinical question in order to provide evidence that is stronger and more certain than the results of the individual studies," she wrote. Click here to read the article.
8. Request for Comment: Definition of Health Technology Assessment
Dr. Brian O’Rourke of the International Network of Agencies for Health Technology Assessment (INAHTA) and Dr. Wija Oortwijn of Health Technology Assessment International (HTAi) are co-chairing an international joint task group that is proposing an updated definition of Health Technology Assessment (HTA) that consolidates and simplifies the various definitions in existence and which reflects the current and emerging realities of HTA. Along with the co-chairs from INAHTA and HTAi, the joint task group includes representatives from WHO, EUnetHTA, HTAsiaLink, RedETSA, the English Editorial Board of the HTA Glossary, and ISPOR. The group has followed a consensus-building process to develop the proposed updated definition and they are now inviting input from the HTA community to build broad consensus on the updated definition. The deadline to comment is April 30. Click here for more information.
9. Submit 2019 Fly-ins, Advocacy Days, and Conferences to Democratic Caucus
In the interest of amplified patient and stakeholder engagement, your organization may be interested that the House Majority Leader’s office is compiling a list of fly-ins, advocacy days, and conferences that will be taking place throughout the year. This information will be shared with all House Democratic offices and used for a variety of purposes including scheduling and messaging. Feel free to share any events you have planned. If we hear of similar efforts by the Minority Leader, we hope to share that as well. Please submit your events here.
10. Upcoming Events and Webinars
Comparative Effectiveness Research: Recent Applications and Future Investments
April 9, 2019
Click here for details.
Big Data, RWD and RWE: What’s the Difference and How is it Changing the Research Landscape?
April 15, 2019
Click here for details.
PCORI Board of Governors Meeting
April 16, 2019
Click here for details.
17th Annual Eyeforpharma Philadelphia
April 16-17, 2019
Click here for details.
Cycle 2 2019 Improving Methods Applicant Town Hall
May 9, 2019
Click here for details.
PCORI Board of Governors Meeting
May 13, 2019
Click here for details.
Advisory Panel on Clinical Trials Spring 2019 Meeting
May 15, 2019
Click here for details.
Advisory Panel on Healthcare Delivery and Disparities Research Spring 2019 Meeting
May 16, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
A New Path Forward for Using Real World Evidence in Randomized Clinical Trials
June 23, 2019
Click here for details.
2019 PCORI Annual Meeting
September 18-20, 2019
Click here for details.
2019 AUCD Annual Meeting
November 17-20, 2019
Click here for details.
11. Medical Journal Articles
Launch of AHRQ's Systematic Review Data Repository (SRDR)+, click here to view.
Knowledge and Use of Evidence-Based Medicine in Daily Practice by Health Professionals: A Cross-Sectional Survey, click here to view.
Quantifying Preferences in Drug Benefit-Risk Decisions, click here to view.
Raising the Impact of Real World Evidence, click here to view.
Why and How to Use Patient-Oriented Research to Promote Translational Research, click here to view.
The Evolution of European HTA and Access to Innovative Medicines, click here to view.
Advocating for New Patient-Centered Tools for Value-Based Treatment Choices in Oncology, click here to view.
Toward a Strategy to Involve Patients in Health Technology Assessment in Spain, click here to view.
Patient Engagement In Research: Early Findings From The Patient-Centered Outcomes Research Institute, click hereto view.
Quality Decision Making in Health Technology Assessment: Issues Facing Companies and Agencies, click here to view.
Letter: Multi-Method Patient-Engagement Approach: A Case Example from a PCORI-Funded Training Project, clickhere to view.
Perspectives of Patients in Identifying Their Values-Based Health Priorities, click here to view.
How Patient's Access to Evidence-Based Medicine Provides Them with a New Hope "The 45 Min—An Insightful Round," click here to view.
Improving Patient-Reported Measures in Oncology, click here to view.
12. AHRQ Effective Program Updates
Systematic Review: Adverse Effects of Pharmacological Treatments of Major Depression in Older Adults, click here to view.
Comment Period: Management of Primary Headaches in Pregnancy, click here to view.
Nonopioid Pharmacologic Treatments for Chronic Pain, click here to view.
Systematic Review Update: Noninvasive Nonpharmacologic Treatments for Chronic Pain, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Development of Harmonized Outcome Measures for Use in Patient Registries and Clinical Practice: Methods and Lessons Learned, click here to view.
Standardized Library of Depression Outcome Measures, click here to view.
Patient Navigation Models for Lung Cancer, click here to view.
Stroke Prevention in Patients With Atrial Fibrillation: A Systematic Review Update, click here to view.
Long-term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention: A Systematic Review, click here to view.
