In This Week’s Issue:
1. The Perils of QALYs Event at the Coelho Center, click here to read more.
2. Coelho Center Celebrates its First Year, click here to read more about the Center.
3. You're Invited! Value Our Health Briefings on Capitol Hill, see below for details.
4. ICER Seeks Public Input for 2020 Value Assessment Framework, click here for more information and to comment.
5. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
6. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, Duchenne Muscular Dystrophy click here to provide patient input.
7. ISPOR Conference Discussion of the Shortfalls of QALYs, click here to read more.
8. NVHR Hepatitis C Patient Summit, click here to apply to the patient summit.
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. The Perils of QALYs Event at the Coelho Center, click here to read more.
2. Coelho Center Celebrates its First Year, click here to read more about the Center.
3. You're Invited! Value Our Health Briefings on Capitol Hill, see below for details.
4. ICER Seeks Public Input for 2020 Value Assessment Framework, click here for more information and to comment.
5. International News: What Happens in Countries Using QALYs and Cost-Based Thresholds to Determine Coverage? See below for more.
6. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, Duchenne Muscular Dystrophy click here to provide patient input.
7. ISPOR Conference Discussion of the Shortfalls of QALYs, click here to read more.
8. NVHR Hepatitis C Patient Summit, click here to apply to the patient summit.
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. The Perils of QALYs Event at the Coelho Center
The Coelho Center on Disability Law, Policy, and Innovation held an event this week to discuss the shortcomings of QALYs and how they discriminate against people with disabilities. A panel including PIPC Chairman Tony Coelho and Executive Director Sara van Geertruyden spoke about how cost-effectiveness analyses all too often treat patients as averages, not as individuals. "I started PIPC in an effort to make research more patient-centered, with patient and people with disabilities at the table throughout the process so that it answered questions that matter to us. Over the years, PIPC has grown to bring that same passion to engaging patients and people with disabilities in Medicare and Medicaid decisions about access to care," said Chairman Coelho. Click here to read more.
2. Coelho Center Celebrates its First Year
The Coelho Center on Disability Law, Policy, and Innovation at Loyola Law School in Los Angeles celebrated the end of its inaugural academic year. The Center, founded by and named for PIPC Chairman Tony Coelho, serves to collaborate with the disability community to cultivate leadership and advocate innovative approaches to advance the lives of people with disabilities. Over its first year, the Center held a number of events to engage people with disabilities and the broader community in breaking down barriers for the disabled community. Click here to read more about the Center.
3. You're Invited! Value Our Health Briefings on Capitol Hill
Value Our Health, a coalition including PIPC and a wide variety of groups advocating for patients and people with disabilities, is holding two briefings on value assessments on Capitol Hill on June 20. Please join our esteemed panel to learn about value assessments, their potential for discrimination, and related public policy threats at the federal and state level. Click here to RSVP for a breakfast briefing on the House side and click here to RSVP for a lunch briefing on the Senate side.
4. ICER Seeks Public Input for 2020 Value Assessment Framework
As part of its biannual process of revising its value assessment framework, ICER is seeking public comment on potential changes to improve its process. This is an important opportunity for patients and people with disabilities to tell ICER that one-size-fits-all conceptions of "value" ignore what is important to them. Specifically, the use of QALYs discriminates against older people and people with disabilities, and it has no place in determining the value of treatments. ICER is specifically seeking comment on the QALY and its cousin, the equal-value life year gained (evLYG) metric. PIPC looks forward to working with its partners to develop comments that will highlight for ICER how the use of QALYs and evLYGs devalues their lives, with suggestions on addressing the methodological flaws in its current model. ICER is accepting comments through June 10, 2019, and plans to publish draft changes to its framework based on comments received on August 16th. Click here for more information and to comment.
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.
6. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, 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:
7. ISPOR Conference Discussion of the Shortfalls of QALYs
The National Health Council's Dr. Eleanor Perfetto discussed criticisms of the QALY at ISPOR's annual conference. "Some of the limitations that the QALYs have are things like potentially being discriminatory against people who are older or people who have severe illnesses or disabilities, so those are things that need to be taken into consideration. Very often the QALY does not take into account patient views. So it’s really important that if a value assessment or a health technology assessment is going to be conducted that’s going to be using a QALY, the entire assessment should have patient input into it," she said. Click here to read more.
8. NVHR Hepatitis C Patient Summit
The National Viral Hepatitis Roundtable (NVHR) will be hosting a hepatitis C patient summit July 29-30th 2019 in Atlanta, timed with World Hepatitis Day on July 28th. The summit - NVHR’s first national patient gathering - will bring together 100 patients recently cured of or currently living with Hepatitis C who have had limited experience engaging in other advocacy programs. Click here to apply to the patient summit.
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
PCORI at AcademyHealth 2019 Research Meeting
June 2-4, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
Getting Real: The Changing Tide on Real-World Evidence in Drug Development
June 5, 2019
Click here for details.
Advisory Panel on Clinical Effectiveness, and Decision Science Spring 2019 Meeting
June 14, 2019
Click here for details.
PCORI Board of Governors Meeting
June 18, 2019
Click here for details.
Understanding FDA’s Real-World Evidence Program: A Presentation of the AMIA Public Policy Committee
June 21, 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.
PCORI Advisory Panel on Patient Engagement Summer 2019 Meeting
June 27-28, 2019
Click here for details.
Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes
July 11-12, 2019
Click here for details.
NVHR Hepatitis C Patient Summit
July 29-30, 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
As Health Technology Assessment Evolves So Must its Approach to Patient Involvement, click here to view.
Evaluation of Value-Based Insurance Design for Primary Care, click here to view.
Leveraging Patient/Community Partnerships to Disseminate Patient Centered Outcomes Research in Geriatrics, click here to view.
Enabling Individualised Health in Learning Healthcare Systems, click here to view.
Analysis of Sponsor Hearings on Health Technology Assessment Decision Making, click here to view.
Study Verifies Value of Real-World Evidence, click here to view.
A Framework for Aiding the Translation of Scientific Evidence into Policy: The Experience of a Hospital-Based Technology Assessment Unit, click here to view.
Multi-Criteria Decision Analysis for Health Technology Assessment: Addressing Methodological Challenges to Improve the State of the Art, click here to view.
Novel Therapies for an Aging Population: Grappling With Price, Value, and Affordability, click here to view.
How Well Does the Patient-Centered Outcomes Research Institute Fund Primary Care and Comparative Effectiveness Research?, click here to view.
Addressing Health System Values in Health Technology Assessment: The Use of Evidence-Informed Deliberative Processes, click here to view.
12. AHRQ Effective Program Updates
Technical Brief: Pharmacological and Nonpharmacological Treatments for Post-Traumatic Stress Disorder, click here to view.
Systematic Review: Management of Infertility, click here to view.
Key Questions: Cervical Ripening in the Outpatient Setting, click here to view.
Key Questions: Radiation Therapy for Brain Metastases, click here to view.
Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder, click here to view.
Systematic Review: Diagnosis and Treatment of Clinical Alzheimer's-type Dementia (CATD), click here to view.
Systematic Review: Comparative Effectiveness of Analgesics to Reduce Acute Pain in the Prehospital Setting, click here to view.
Systematic Review: Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention, click here to view.
Systematic Review: Telehealth for Acute and Chronic Care Consultations, click here to view.
White Paper: Standardized Library of Asthma Outcome Measures, click here to view.
Research Protocol: Characteristics of Existing Asthma Self-Management Education Packages, click here to view.
Systematic Review: Can Physical Activity Improve the Health of Wheelchair Users?, click here to view.
Comment Period: Registries for Evaluating Patient Outcomes: A User's Guide: Fourth Edition, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Systematic Review: Pharmacologic and Non-pharmacologic Therapies in Adult Patients with Acute Exacerbation of COPD, click here to view.
Integrating Palliative Care With Chronic Disease Management in Ambulatory Care, click here to view.
The Coelho Center on Disability Law, Policy, and Innovation held an event this week to discuss the shortcomings of QALYs and how they discriminate against people with disabilities. A panel including PIPC Chairman Tony Coelho and Executive Director Sara van Geertruyden spoke about how cost-effectiveness analyses all too often treat patients as averages, not as individuals. "I started PIPC in an effort to make research more patient-centered, with patient and people with disabilities at the table throughout the process so that it answered questions that matter to us. Over the years, PIPC has grown to bring that same passion to engaging patients and people with disabilities in Medicare and Medicaid decisions about access to care," said Chairman Coelho. Click here to read more.
2. Coelho Center Celebrates its First Year
The Coelho Center on Disability Law, Policy, and Innovation at Loyola Law School in Los Angeles celebrated the end of its inaugural academic year. The Center, founded by and named for PIPC Chairman Tony Coelho, serves to collaborate with the disability community to cultivate leadership and advocate innovative approaches to advance the lives of people with disabilities. Over its first year, the Center held a number of events to engage people with disabilities and the broader community in breaking down barriers for the disabled community. Click here to read more about the Center.
3. You're Invited! Value Our Health Briefings on Capitol Hill
Value Our Health, a coalition including PIPC and a wide variety of groups advocating for patients and people with disabilities, is holding two briefings on value assessments on Capitol Hill on June 20. Please join our esteemed panel to learn about value assessments, their potential for discrimination, and related public policy threats at the federal and state level. Click here to RSVP for a breakfast briefing on the House side and click here to RSVP for a lunch briefing on the Senate side.
4. ICER Seeks Public Input for 2020 Value Assessment Framework
As part of its biannual process of revising its value assessment framework, ICER is seeking public comment on potential changes to improve its process. This is an important opportunity for patients and people with disabilities to tell ICER that one-size-fits-all conceptions of "value" ignore what is important to them. Specifically, the use of QALYs discriminates against older people and people with disabilities, and it has no place in determining the value of treatments. ICER is specifically seeking comment on the QALY and its cousin, the equal-value life year gained (evLYG) metric. PIPC looks forward to working with its partners to develop comments that will highlight for ICER how the use of QALYs and evLYGs devalues their lives, with suggestions on addressing the methodological flaws in its current model. ICER is accepting comments through June 10, 2019, and plans to publish draft changes to its framework based on comments received on August 16th. Click here for more information and to comment.
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: An immigrant child with cystic fibrosis and his family may face deportation due to the cost of treating the disease.
- New Zealand: Patients say more protests against PHARMAC's lack of funding for cancer drugs are likely. Patients are fighting to have PHARMAC cover spinal muscular atrophy drug Spinraza. Click here and here for more.
- Canada: An Ontario woman living with CF advocates for greater access to lifesaving drugs.
- United Kingdom: A "breakthrough" multiple sclerosis drug will be covered by the NHS only after 21,000 patients petitioned the group. Parents launch legal action against the NHS over non-coverage of lifesaving drugs for their children.
- France: Patients are alarmed as a multiple sclerosis drug will no longer be covered.
6. ICER Studies: Type 2 Diabetes, Arthritis, Cardiovascular Disease, 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: Revised Scoping Document available. 6/14/2019: Research Protocol. Meeting 10/31/2019: CTAF to an update to its 2017 rheumatoid arthritis assessment.
- Type 2 Diabetes: Draft Scoping Document now available, public comment open through 5/22/2019. Meeting 11/14/2019: The New England CEPAC will convene to deliberate on ICER's review of oral semaglutide for the treatment of type 2 diabetes.
- Cardiovascular Disease : Research Protocol now available. 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.
- Depression: Evidence Presentation available. 6/20/2019: Final Evidence Report and Meeting Summary.
- Multiple Sclerosis: Evidence Presentation available. 6/20/2019: Final Evidence Report and Meeting Summary.
- Peanut Allergy: Draft Evidence Report available. 5/28/2019: Responses to public comments. Meeting 6/11/2019: CTAF to review ICER's assessment of treatments for peanut allergy.
- Duchenne Muscular Dystrophy: Public comment period OPEN on Draft Evidence Report and Draft Voting Questions through 6/18/2019. 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: 10/8/2019: Final Report.
7. ISPOR Conference Discussion of the Shortfalls of QALYs
The National Health Council's Dr. Eleanor Perfetto discussed criticisms of the QALY at ISPOR's annual conference. "Some of the limitations that the QALYs have are things like potentially being discriminatory against people who are older or people who have severe illnesses or disabilities, so those are things that need to be taken into consideration. Very often the QALY does not take into account patient views. So it’s really important that if a value assessment or a health technology assessment is going to be conducted that’s going to be using a QALY, the entire assessment should have patient input into it," she said. Click here to read more.
8. NVHR Hepatitis C Patient Summit
The National Viral Hepatitis Roundtable (NVHR) will be hosting a hepatitis C patient summit July 29-30th 2019 in Atlanta, timed with World Hepatitis Day on July 28th. The summit - NVHR’s first national patient gathering - will bring together 100 patients recently cured of or currently living with Hepatitis C who have had limited experience engaging in other advocacy programs. Click here to apply to the patient summit.
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
PCORI at AcademyHealth 2019 Research Meeting
June 2-4, 2019
Click here for details.
2019 NEC Symposium
June 2 - 5, 2019
Click here for details.
Getting Real: The Changing Tide on Real-World Evidence in Drug Development
June 5, 2019
Click here for details.
Advisory Panel on Clinical Effectiveness, and Decision Science Spring 2019 Meeting
June 14, 2019
Click here for details.
PCORI Board of Governors Meeting
June 18, 2019
Click here for details.
Understanding FDA’s Real-World Evidence Program: A Presentation of the AMIA Public Policy Committee
June 21, 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.
PCORI Advisory Panel on Patient Engagement Summer 2019 Meeting
June 27-28, 2019
Click here for details.
Leveraging Randomized Clinical Trials to Generate Real-World Evidence for Regulatory Purposes
July 11-12, 2019
Click here for details.
NVHR Hepatitis C Patient Summit
July 29-30, 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
As Health Technology Assessment Evolves So Must its Approach to Patient Involvement, click here to view.
Evaluation of Value-Based Insurance Design for Primary Care, click here to view.
Leveraging Patient/Community Partnerships to Disseminate Patient Centered Outcomes Research in Geriatrics, click here to view.
Enabling Individualised Health in Learning Healthcare Systems, click here to view.
Analysis of Sponsor Hearings on Health Technology Assessment Decision Making, click here to view.
Study Verifies Value of Real-World Evidence, click here to view.
A Framework for Aiding the Translation of Scientific Evidence into Policy: The Experience of a Hospital-Based Technology Assessment Unit, click here to view.
Multi-Criteria Decision Analysis for Health Technology Assessment: Addressing Methodological Challenges to Improve the State of the Art, click here to view.
Novel Therapies for an Aging Population: Grappling With Price, Value, and Affordability, click here to view.
How Well Does the Patient-Centered Outcomes Research Institute Fund Primary Care and Comparative Effectiveness Research?, click here to view.
Addressing Health System Values in Health Technology Assessment: The Use of Evidence-Informed Deliberative Processes, click here to view.
12. AHRQ Effective Program Updates
Technical Brief: Pharmacological and Nonpharmacological Treatments for Post-Traumatic Stress Disorder, click here to view.
Systematic Review: Management of Infertility, click here to view.
Key Questions: Cervical Ripening in the Outpatient Setting, click here to view.
Key Questions: Radiation Therapy for Brain Metastases, click here to view.
Protocol: A Rapid Evidence Review of Retention Strategies for Medications for Addiction Treatment (MAT) in Adults with Opioid Use Disorder, click here to view.
Systematic Review: Diagnosis and Treatment of Clinical Alzheimer's-type Dementia (CATD), click here to view.
Systematic Review: Comparative Effectiveness of Analgesics to Reduce Acute Pain in the Prehospital Setting, click here to view.
Systematic Review: Long-Term Drug Therapy and Drug Holidays for Osteoporosis Fracture Prevention, click here to view.
Systematic Review: Telehealth for Acute and Chronic Care Consultations, click here to view.
White Paper: Standardized Library of Asthma Outcome Measures, click here to view.
Research Protocol: Characteristics of Existing Asthma Self-Management Education Packages, click here to view.
Systematic Review: Can Physical Activity Improve the Health of Wheelchair Users?, click here to view.
Comment Period: Registries for Evaluating Patient Outcomes: A User's Guide: Fourth Edition, click here to view.
Treatment of Acute Pain: An Evidence Map, click here to view.
Systematic Review: Pharmacologic and Non-pharmacologic Therapies in Adult Patients with Acute Exacerbation of COPD, click here to view.
Integrating Palliative Care With Chronic Disease Management in Ambulatory Care, click here to view.
