In this week's edition...
— Comments Due Soon! Stakeholder Views on Components of "Patient-Centered Value” in Health and Health Care. Click here to view the report.
— Op-Ed: Nothing Life Giving About 'Quality Adjusted.' Click here to read the op-ed.
— Op-Ed: Disabled Lives Aren’t Worth Less. Click here to read the op-ed.
— Helping Patients with Chest Pain in the ER Pinpoint Their Risk of a Cardiac Event. Click here to watch the video.
— PCORI Request for Information to Enhance Workforce Development Now Open. Click here to view the RFI.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
— Comments Due Soon! Stakeholder Views on Components of "Patient-Centered Value” in Health and Health Care. Click here to view the report.
— Op-Ed: Nothing Life Giving About 'Quality Adjusted.' Click here to read the op-ed.
— Op-Ed: Disabled Lives Aren’t Worth Less. Click here to read the op-ed.
— Helping Patients with Chest Pain in the ER Pinpoint Their Risk of a Cardiac Event. Click here to watch the video.
— PCORI Request for Information to Enhance Workforce Development Now Open. Click here to view the RFI.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
— Emerging Threats in States for Use of Discriminatory Metrics. See details below.
— What Happens in Countries Using QALYs and Cost-Based Thresholds? See details below.
— ICER's QALY-Based Study Topics. See details below.
— Upcoming Events and Webinars. See details below.
— AHRQ Effective Program Updates. See details below.
What We're Reading
1. Comments Due Soon! Stakeholder Views on Components of "Patient-Centered Value” in Health and Health Care. PCORI has recently released draft report on potential components of patient-centered value in health and health care. The report, Stakeholder Views on Components of "Patient-Centered Value” in Health and Health Care, summarizes the result of a multi-step process by PCORI to gather views of patients, families, caregivers, and the broader healthcare community on the potential components, attributes, and measurement of patient-centered value and related data collection. Comments on the report can be submitted through Friday, March 3. Click here to view the report.
2. Op-Ed: Disabled Lives Aren’t Worth Less. An op-ed in The Wall Street Journal makes the case for passing the Protecting Health Care for All Patients Act, emphasizing the need to ban the discriminatory QALY metric. "Using Qalys to make coverage or reimbursement decisions violates existing anti-discrimination laws designed to protect people with disabilities. I know the hurtful message it sends to vulnerable people like my daughter. Congress should demonstrate that it will protect patients like her by passing H.R. 485 and officially banning the use of Qalys in federal health programs." Click here to read the op-ed.
3. Op-Ed: Nothing Life Giving About 'Quality Adjusted.' In a recent op-ed, Sally Pipes describes the challenges that the QALY presents to the disability community and makes a case for passing the Protecting Health Care for All Patients Act, Not surprisingly, such QALY-based pricing policies have led to enormous international disparities in access to prescription drugs. Consider that, of the 98 new cancer drugs launched between 2011 and 2019, nearly all of them — 96%, in fact — were available in the United States. In the United Kingdom, just 70% were on offer, while Canadian patients had access to fewer than 60%." Click here to read the op-ed.
4. Helping Patients with Chest Pain in the ER Pinpoint Their Risk of a Cardiac Event. Erik Hess, MD, MSc, professor and vice chair for research in the Department of Emergency Medicine at the University of Alabama at Birmingham, shares the results of his PCORI-funded study, The Chest Pain Choice Trial, which created a decision aid to facilitate conversations between patients experiencing chest pain in emergency rooms and clinicians to better understand the patients’ risk of having a cardiac event. Click here to watch the video.
5. PCORI Request for Information to Enhance Workforce Development Now Open. For this RFI, PCORI is seeking input on the opportunities, gaps, and challenges in the current PCOR workforce landscape, and input on additional programmatic initiatives, investments, and/or partnerships that would accelerate the development of the PCOR workforce and facilitate the conduct of PCOR in alignment with PCORI’s National Priorities for Health, Research Agenda, and Strategic Plan. Comments should be submitted to [email protected]. by March 17, 2023. Click here to view the RFI.
6. PCORI Seeks Nominations for Advisory Panels. PCORI is currently seeking nominations for appointments to its advisory panels. The advisory panels must include patients or patient advocates. PCORI's staff, board, and methodology committee take advisory panels' recommendations into account when making decisions and determinations. PIPC encourages patients and patient advocates to submit nominations to serve on PCORI's advisory panels, including on the Advisory Panel on Clinical Effectiveness and Decision Science, Advisory Panel on Patient Engagement, and Advisory Panel on Rare Disease. Nominations are open through March 31, 2023. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
Minnesota
The Minnesota state legislature has introduced a bill to create a Prescription Drug Affordability Board, HF 17. It was heard by the Commerce Finance and Policy Committee on January 23, 2023. It does not include a bar on using QALYs or other metrics that discriminate. Also, the bill specifically references Canadian prices as a consideration for establishing the upper payment limit for drugs, prices which are explicitly based on QALYs. The bill will receive a hearing in the Senate Commerce Committee tomorrow, Tuesday, February 21 at 1:30 EST.
Massachusetts
An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with disabilities, SD. 2117 and HD. 3356 has been introduced in both the House and Senate. This bill includes important patient protections including a ban on the discriminatory Quality-Adjusted Life Year (QALY).
California
California Attorney General Rob Bonta has solicited information from hospital CEOs across the state about how healthcare facilities and other providers are identifying and addressing racial and ethnic disparities in commercial decision-making tools. In response to this letter, advocates urged Attorney General Bonta to include QALYs and similar metrics in his investigation. Click here to view the Attorney General’s letter. Click here to view a response from advocates.
Oregon
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) Value based Benefits Subcommittee discussed a proposed plan for using QALYs, including proposals to redact the word QALY from the HERC’s deliberations without barring the use of the metric in making decisions. The meeting followed CMS approval of Oregon’s waiver application, which does not bar the use of QALYs in the interim. Click here to read comments submitted by PIPC along with 62 other groups asking CMS to reject the waiver. Click here to view the CMS-approved waiver. At the HERC meeting, the Oregon Health Authority expressed its intent to continue using a prioritized list, shifting it from use under a waiver to use as part of the State Plan Amendment after the waiver expires in 2027. The HERC decided to accept comments on options to either adjust their use of QALYs or to cease mentioning QALYs at meetings and redact their mention from published articles, despite vehement opposition from advocates based on the implications for discrimination and health equity, as well as the potential lack of transparency related to their use to make decisions if simply redacted from studies considered by the HERC. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs, to support Oregon’s health equity goals and to lead in developing alternative coverage strategies that do not discriminate. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act and the implications of QALYs for violating existing federal civil and disability rights laws. Click here to view the options that continue to be under consideration by the HERC to continue using QALYs. Click here to view all of the comments shared with PIPC.
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
ICER's QALY-Based Study Topics
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.
Upcoming Events and Webinars
MedPAC March 2023 Public Meeting
March 2-3, 2023
Click here to view.
MACPAC March 2023 Public Meeting
March 2-3, 2023
Click here to view.
PCORI Board of Governors Meeting
March 7, 2023
Click here to view.
Virtual V-BID Summit 2023: Accelerating Health Equity
March 8, 2023
Click here to view.
How to Supercharge Real World Evidence Generation in Phase IV Trials
March 16, 2023
Click here to view.
PCORnet Studies Applicant Workshop
May 18, 2023
Click here to view.
Medical Journal Articles
A Patient-Centered Comparative Effectiveness Research Study of Culturally Appropriate Options for Diabetes Self-Management. Click here to view.
Payer–patient Engagement Framework to Strengthen Ethical Formulary Decision-making in Rare Disease Arena in the USA. Click here to view.
The Impact on Cost-Effectiveness of Accounting for Generic Drug Pricing: Four Case Studies. Click here to view.
A Perspective on Life-Cycle Health Technology Assessment and Real-World Evidence for Precision Oncology in Canada. Click here to view.
Identifying And Exploring Bias in Public Opinion on Scarce Resource Allocation During The COVID-19 Pandemic. Click here to view.
Machine Learning Applied to Patient-Reported Outcomes to Classify Physician-Derived Measures of Rheumatoid Arthritis Disease Activity. Click here to view.
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Click here to view.
AHRQ Effective Program Updates
Draft Report: Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
Systematic Review: Partian Breast Irradiation for Breast Cancer. Click here to view.
Systematic Review: Use of Telehealth During the COVID-19 Era. Click here to view.
Research Report: Analysis of Requirements for Coverage with Evidence Development (CED) - Topic Refinement. Click here to view.
Technical Brief: Infection Prevention and Control for the Emergency Medical Services and 911 Workforce. Click here to view.
Systematic Review: Management of Infantile Epilepsies. Click here to view.
Systematic Review: Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder. Click here to view.
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
1. Comments Due Soon! Stakeholder Views on Components of "Patient-Centered Value” in Health and Health Care. PCORI has recently released draft report on potential components of patient-centered value in health and health care. The report, Stakeholder Views on Components of "Patient-Centered Value” in Health and Health Care, summarizes the result of a multi-step process by PCORI to gather views of patients, families, caregivers, and the broader healthcare community on the potential components, attributes, and measurement of patient-centered value and related data collection. Comments on the report can be submitted through Friday, March 3. Click here to view the report.
2. Op-Ed: Disabled Lives Aren’t Worth Less. An op-ed in The Wall Street Journal makes the case for passing the Protecting Health Care for All Patients Act, emphasizing the need to ban the discriminatory QALY metric. "Using Qalys to make coverage or reimbursement decisions violates existing anti-discrimination laws designed to protect people with disabilities. I know the hurtful message it sends to vulnerable people like my daughter. Congress should demonstrate that it will protect patients like her by passing H.R. 485 and officially banning the use of Qalys in federal health programs." Click here to read the op-ed.
3. Op-Ed: Nothing Life Giving About 'Quality Adjusted.' In a recent op-ed, Sally Pipes describes the challenges that the QALY presents to the disability community and makes a case for passing the Protecting Health Care for All Patients Act, Not surprisingly, such QALY-based pricing policies have led to enormous international disparities in access to prescription drugs. Consider that, of the 98 new cancer drugs launched between 2011 and 2019, nearly all of them — 96%, in fact — were available in the United States. In the United Kingdom, just 70% were on offer, while Canadian patients had access to fewer than 60%." Click here to read the op-ed.
4. Helping Patients with Chest Pain in the ER Pinpoint Their Risk of a Cardiac Event. Erik Hess, MD, MSc, professor and vice chair for research in the Department of Emergency Medicine at the University of Alabama at Birmingham, shares the results of his PCORI-funded study, The Chest Pain Choice Trial, which created a decision aid to facilitate conversations between patients experiencing chest pain in emergency rooms and clinicians to better understand the patients’ risk of having a cardiac event. Click here to watch the video.
5. PCORI Request for Information to Enhance Workforce Development Now Open. For this RFI, PCORI is seeking input on the opportunities, gaps, and challenges in the current PCOR workforce landscape, and input on additional programmatic initiatives, investments, and/or partnerships that would accelerate the development of the PCOR workforce and facilitate the conduct of PCOR in alignment with PCORI’s National Priorities for Health, Research Agenda, and Strategic Plan. Comments should be submitted to [email protected]. by March 17, 2023. Click here to view the RFI.
6. PCORI Seeks Nominations for Advisory Panels. PCORI is currently seeking nominations for appointments to its advisory panels. The advisory panels must include patients or patient advocates. PCORI's staff, board, and methodology committee take advisory panels' recommendations into account when making decisions and determinations. PIPC encourages patients and patient advocates to submit nominations to serve on PCORI's advisory panels, including on the Advisory Panel on Clinical Effectiveness and Decision Science, Advisory Panel on Patient Engagement, and Advisory Panel on Rare Disease. Nominations are open through March 31, 2023. Click here to learn more, submit a nomination, or apply to be on an advisory panel.
Emerging Threats in States for Use of Discriminatory Metrics
Several states are considering policies that would reference entities such as the Institute for Clinical and Economic Review (ICER), which calls the discriminatory quality-adjusted life year (QALY) the “gold standard” for value assessment, and others are considering policies to import QALY-based coverage and reimbursement decisions from other countries that restrict access to care. We encourage you to keep track of all state-based threats using this new website tracking state activities. Key issues are highlighted below.
- Click here to learn more about the potential for Prescription Drug Affordability Boards to discriminate by incorporating the use of QALYS.
- Click here to view the Value Our Health state template legislation that would protect people with disabilities and chronic conditions from the use of QALYs and similar metrics developed by third parties such as ICER in decisions related to reimbursement and coverage, as well as ensure their engagement in decision-making.
- Click here to view a one pager about the flaws in ICER’s methodology.
- Click here to view information from experts on the downside of referencing foreign countries.
- Click here to learn about statutory protections against use of QALYs.
Minnesota
The Minnesota state legislature has introduced a bill to create a Prescription Drug Affordability Board, HF 17. It was heard by the Commerce Finance and Policy Committee on January 23, 2023. It does not include a bar on using QALYs or other metrics that discriminate. Also, the bill specifically references Canadian prices as a consideration for establishing the upper payment limit for drugs, prices which are explicitly based on QALYs. The bill will receive a hearing in the Senate Commerce Committee tomorrow, Tuesday, February 21 at 1:30 EST.
Massachusetts
An Act Advancing Health Care Research and Decision-Making Centered on Patients and People with disabilities, SD. 2117 and HD. 3356 has been introduced in both the House and Senate. This bill includes important patient protections including a ban on the discriminatory Quality-Adjusted Life Year (QALY).
California
California Attorney General Rob Bonta has solicited information from hospital CEOs across the state about how healthcare facilities and other providers are identifying and addressing racial and ethnic disparities in commercial decision-making tools. In response to this letter, advocates urged Attorney General Bonta to include QALYs and similar metrics in his investigation. Click here to view the Attorney General’s letter. Click here to view a response from advocates.
Oregon
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) Value based Benefits Subcommittee discussed a proposed plan for using QALYs, including proposals to redact the word QALY from the HERC’s deliberations without barring the use of the metric in making decisions. The meeting followed CMS approval of Oregon’s waiver application, which does not bar the use of QALYs in the interim. Click here to read comments submitted by PIPC along with 62 other groups asking CMS to reject the waiver. Click here to view the CMS-approved waiver. At the HERC meeting, the Oregon Health Authority expressed its intent to continue using a prioritized list, shifting it from use under a waiver to use as part of the State Plan Amendment after the waiver expires in 2027. The HERC decided to accept comments on options to either adjust their use of QALYs or to cease mentioning QALYs at meetings and redact their mention from published articles, despite vehement opposition from advocates based on the implications for discrimination and health equity, as well as the potential lack of transparency related to their use to make decisions if simply redacted from studies considered by the HERC. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs, to support Oregon’s health equity goals and to lead in developing alternative coverage strategies that do not discriminate. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act and the implications of QALYs for violating existing federal civil and disability rights laws. Click here to view the options that continue to be under consideration by the HERC to continue using QALYs. Click here to view all of the comments shared with PIPC.
International News: What Happens in Countries Using QALYs and Cost-Based Thresholds?
Other countries are often referenced as examples of how the use of QALYs or similar cost-based thresholds impact access to care.
- Australia: An increasing number of Australians diagnosed with breast cancer are calling on the federal government to fund treatment, as families have been forced to deplete their savings due to the lack of PBS support.
- Canada: Montreal Economic Institute senior policy analyst Krystle Wittevrongel emphasizes that medicines in Canada shouldn't just be cheap, they also must accessible to those who need them most.
- France: Cancer patients are having to resort to crowdfunding to access treatment for a rare and chronic cancer that remains out of reach for many within the patient community.
ICER's QALY-Based Study Topics
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.
- Amyotrophic Lateral Sclerosis (ALS): Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- Sickle Cell Disease: Research Protocol available. 02/27/2023: Model Analysis Plan. Revised Scoping Document available. Draft Scoping Document available. Public Comments closed.
- Non-Alcoholic Steatohepatitis: Draft Evidence Report available. Public comments open until 3/16/2022. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available. Draft Scoping Document available. Public comments closed.
- Menopause: Vasomotor Symptoms: Final Evidence Report and Meeting Summary available. Evidence Report and Presentation available. Draft Evidence Report available. Model Analysis Plan available.
- Alzheimer's Disease: Draft Evidence Report available. Public comments open until 2/2/2023. 3/1/2023: Evidence Report. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- Beta Thalassemia: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available.
- COVID-19: Final Evidence Report and Meeting Summary available. Evidence Presentation and Report available. Draft Evidence Report Available. Public comments closed. Model Analysis Plan available. Draft Scoping Document and Research Protocol available.
- Obesity Management: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Draft Evidence Report available. Model Analysis Plan available. Research Protocol available.
- Multiple Sclerosis: CIS, RRMS, and SPMS: Evidence Presentation available. 2/17/2023: Final Evidence Report and Meeting Summary. Evidence Report available. Draft Evidence Report available. Model Analysis Plan available. Research Protocol available. Revised Scoping Document available. Draft Scoping Document available.
- Gene Therapies for Hemophilia A and B: Final Evidence Report and Meeting Summary available. Evidence Presentation available. Evidence Report available. Draft Evidence Report available. Public comments closed. Model Analysis Plan available. Revised Scoping Document available. Draft Scoping Document available.
Upcoming Events and Webinars
MedPAC March 2023 Public Meeting
March 2-3, 2023
Click here to view.
MACPAC March 2023 Public Meeting
March 2-3, 2023
Click here to view.
PCORI Board of Governors Meeting
March 7, 2023
Click here to view.
Virtual V-BID Summit 2023: Accelerating Health Equity
March 8, 2023
Click here to view.
How to Supercharge Real World Evidence Generation in Phase IV Trials
March 16, 2023
Click here to view.
PCORnet Studies Applicant Workshop
May 18, 2023
Click here to view.
Medical Journal Articles
A Patient-Centered Comparative Effectiveness Research Study of Culturally Appropriate Options for Diabetes Self-Management. Click here to view.
Payer–patient Engagement Framework to Strengthen Ethical Formulary Decision-making in Rare Disease Arena in the USA. Click here to view.
The Impact on Cost-Effectiveness of Accounting for Generic Drug Pricing: Four Case Studies. Click here to view.
A Perspective on Life-Cycle Health Technology Assessment and Real-World Evidence for Precision Oncology in Canada. Click here to view.
Identifying And Exploring Bias in Public Opinion on Scarce Resource Allocation During The COVID-19 Pandemic. Click here to view.
Machine Learning Applied to Patient-Reported Outcomes to Classify Physician-Derived Measures of Rheumatoid Arthritis Disease Activity. Click here to view.
Patient-Centered Pain Care Using Artificial Intelligence and Mobile Health Tools: A Randomized Comparative Effectiveness Trial. Click here to view.
AHRQ Effective Program Updates
Draft Report: Impact of Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
Systematic Review: Partian Breast Irradiation for Breast Cancer. Click here to view.
Systematic Review: Use of Telehealth During the COVID-19 Era. Click here to view.
Research Report: Analysis of Requirements for Coverage with Evidence Development (CED) - Topic Refinement. Click here to view.
Technical Brief: Infection Prevention and Control for the Emergency Medical Services and 911 Workforce. Click here to view.
Systematic Review: Management of Infantile Epilepsies. Click here to view.
Systematic Review: Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder. Click here to view.
Systematic Review: Living Systematic Review on Cannabis and Other Plant-Based Treatments for Chronic Pain. Click here to view.
