In this week's edition...
— PIPC Chair Tony Coelho Testifies to Massachusetts Legislature Supporting Statewide QALY Ban, Michigan Bill Threatens Expanded Use of QALYs and Similar Measures. See details below.
— ICER Finalizes 2023 Updates to Value Assessment Framework. See details below.
— Comments on Proposed Rule on Accessibility of Web Information and Services of State and Local Government Entities Due October 3. See details below.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
— CMS Process Should Provide Robust and Ongoing Engagement of Patients and People with Disabilities in Negotiation Process. See details below.
— Letter from Over 1900 Researchers, Organizations and Individuals Opposing NIMHD Exclusion of People with Disabilities. See details below.
— 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.
— Job Openings. See details below.
— PIPC Chair Tony Coelho Testifies to Massachusetts Legislature Supporting Statewide QALY Ban, Michigan Bill Threatens Expanded Use of QALYs and Similar Measures. See details below.
— ICER Finalizes 2023 Updates to Value Assessment Framework. See details below.
— Comments on Proposed Rule on Accessibility of Web Information and Services of State and Local Government Entities Due October 3. See details below.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
— CMS Process Should Provide Robust and Ongoing Engagement of Patients and People with Disabilities in Negotiation Process. See details below.
— Letter from Over 1900 Researchers, Organizations and Individuals Opposing NIMHD Exclusion of People with Disabilities. See details below.
— 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.
— Job Openings. See details below.
What We're Reading
1. PIPC Chair Tony Coelho Testifies to Massachusetts Legislature Supporting Statewide QALY Ban, Michigan Bill Threatens Expanded Use of QALYs and Similar Measures. On September 20, 2023, the Massachusetts Joint Committee on Health Care Financing considered legislation, H. 1183 and S. 730, that would prohibit reliance on discriminatory measures, including quality-adjusted life years (QALYs) to determine whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs. PIPC Chair Tony Coelho testified in support of this legislation.
"We have a 30-year track record of public opposition to QALYs and similar measures. Research from the National Council on Disability, an independent federal agency advising on disability policy, found that the use of the QALY is discriminatory and recommended that policy makers and insurers reject its use. I authored the ADA to counter disability bias and stigma for future generations. Combined with existing laws including the Affordable Care Act, the Inflation Reduction Act and Section 504 of the Rehab Act, there is no question that metrics like QALYs are not fit for use in our health system.”
In Michigan, legislators introduced a suite of bills, S. 483, S.484, and S.485, that would create a Prescription Drug Affordability Board (PDAB) and institute upper payment limits for certain prescription drugs. The bill received a hearing on September 20, 2023 in the Senate Committee on Finance, Insurance, and Consumer Protection, but patient advocates that attended to testify were unable to do so due to "time constraints” as noted here. Click here to view testimony from Laura Bonnell, Bonnell Foundation.
2. ICER Finalizes 2023 Updates to Value Assessment Framework. Today, the Institute for Clinical and Economic Review published its 2023 update. ICER continues to favor a health system perspective in its cost effectiveness analyses, and continues to use the quality-adjusted life year (QALY) and a similar measure called the equal value of life year gained (evLYG), despite advocacy from patients and people with disabilities urging ICER to abandon their use in favor of measures that better capture outcomes that matter to patients. PIPC will fully analyze the new value assessment framework to better understand the extent to which comments from patients and people with disabilities were incorporated. Click here to view the 2023 framework from ICER. Click here to view the comments from over 75 organizations to ICER.
3. Comments on Proposed Rule on Accessibility of Web Information and Services of State and Local Government Entities Due October 3. Digital inaccessibility presents huge barriers to people with disabilities. Therefore, the Department of Justice has proposed a rule that would require state and local government entities, including schools and transit agencies, to make their websites and apps accessible. However, this rule proposes massive carve outs for schools and universities in addition to 5 other exceptions for pdf documents and third-party information. A letter from the disability community is calling for the Department to remove those exceptions. These regulations will set the standard for state and local government website and app accessibility. In the comments CCD calls for the Department to adopt the most recent WCAG standard and to eliminate unnecessary exceptions to the rule, especially those that exempt educational class materials. The letter is being led by the Consortium for Constituents with Disabilities (CCD), but welcomes any national, state, territorial, and local disability organizations in the United States to show the breadth and commitment of the community on this issue. Only organizations can sign on. Signatures are due by 2 pm ET on Monday, October 2, 2023. Please complete this form to sign your organization on to the joint CCD and friends comments on the Department of Justice Title II regulations. If you have difficulty accessing this form for any reason, please email Sarah Malaier at [email protected]. Click here to view the comments submitted by Tony Coelho.
4. PCORI Seeks Nominations for Advisory Panels. PCORI is currently seeking nominations for appointments to its advisory panels. These multi-stakeholder advisory panels must include patients, caregivers, or patient advocates. PCORI advisory panels do not serve in an official decision-making capacity, but their recommendations and advice will be taken into consideration by PCORI. PIPC encourages patients, caregivers, and patient advocates to apply or to submit nominations to serve on PCORI's five advisory panels on: Clinical Effectiveness and Decision Science, Clinical Trials, Healthcare Delivery & Disparities Research, Patient Engagement, and Rare Disease. The application is open through March 29, 2024. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
5. CMS Process Should Provide Robust and Ongoing Engagement of Patients and People with Disabilities in Negotiation Process. The June 30, 2023 guidance from the Centers for Medicare and Medicaid Services (CMS) stated that CMS will be holding “patient-focused listening sessions in Fall 2023 after the October 2, 2023 deadline for patients and other interested parties to share patient-focused input on therapeutic alternatives and other section 1194(e)(2) data regarding selected drugs.” In its guidance, CMS referenced these listening sessions as a resource for understanding unmet medical need, acquiring new information from patients, identifying relevant outcomes from patients and caregivers and related to therapeutic alternatives. Recently, more information was provided by CMS regarding the patient-focused listening sessions for the selected drug list. Recently, CMS provided further clarification about the listening sessions, stating, "CMS expects a high level of interest in the Listening Sessions. CMS will use a process to randomly select speakers from among the individuals who register for the chance to speak. Approximately 20 speakers will be selected for each Listening Session. A confirmation email will be sent to selected speakers the week of October 9, 2023.” Registration will close October 2, 2023. Click here to view more information about the listening sessions. Click here to view the recommendations from PIPC developed in consultation with other organizations representing patients and people with disabilities.
6. Letter from Over 1900 Researchers, Organizations and Individuals Opposing NIMHD Exclusion of People with Disabilities. On September 8, 2023, letters signed by over 1900 researchers, organizations and individuals expressed opposition to the NIMHD Advisory Committee decision to reject a recommendation to add people with disabilities as a health disparity population. The NIMHD Advisory Committee did not include people with disabilities. Additionally, several people have weighed in about exponential health equity barriers that disabled people from intersecting marginalized groups face - including people of color, people from the LBGTQ+ community, people who live in rural areas, and people who have low incomes. The 2 letters urged the administration to advance a swift course correction on this issue and move to designate people with disabilities as a health disparity population. Click here to view the letter from the disability research community sharing an in-depth analysis about the flaws in this decision-making process. Click here to view the letter from organizations and individuals sharing this analysis and similarly expressing concerns and calling for the recommendation to be reversed.
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.
Michigan
A group of Michigan State Senators on Tuesday introduced a suite of bills that would create a Prescription Drug Affordability Board (PDAB). S. 483, S.484, and S.485 would establish a PDAB to institute upper payment limits for certain prescription drugs used by people with disabilities and chronic conditions. The Board, which is appointed and does not maintain spots specifically for patient representatives, would have the authority to review and comment on all prescription drug costs impacting residents of Michigan. The bill includes some language related to the QALY and cost-effectiveness metrics, but it is not a broad QALY ban. The language does not address how the QALY may be used to discriminate by setting QALY-based cost thresholds. Any finalized upper payment limits established by the PDAB would apply to all purchases of the drug intended for sale in Michigan. If enacted, Michigan would become the seventh state to establish a PDAB.
Colorado
Colorado passed legislation in 2021 creating a Prescription Drug Affordability Review Board. The legislation included language stating that the Upper Payment Limit for selected drugs "shall not consider research or methods that employ a dollars-per-quality adjusted life year, or similar measure, that discounts the value of a life because of an individual's disability or age.” However, this limitation did not clearly extend to the process for determining the selected drugs. Presentations related to cost effectiveness analyses to the Colorado Board have referenced the use of a cost-per-QALY or the equal value of life-year gained (evLYG) in estimating cost effectiveness of treatments. This indicates that these metrics may have influenced how Colorado selected the drugs for review.
Pennsylvania
In the last legislative session, the legislature introduced, HB 1722, a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a third party that could include ICER. The bill has not been reintroduced in 2023. The Pennsylvania legislature held an informational meeting on Prescription Drug Boards in the House Health Committee on April 12 at 10am. Click here to learn more about Prescription Drug Affordability Boards and the implications of discriminatory measures of cost effectiveness. Click here to learn more about the committee chair, Rep. Dan Frankel.
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. On September 20, 2023, the Massachusetts Joint Committee on Health Care Financing considered the legislation, including provisions that would prohibit reliance on discriminatory measures, including quality-adjusted life years (QALYs) to determine whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs. PIPC Chair Tony Coelho testified in support of this legislation, alongside the ALS Foundation and the Epilepsy Foundation of New England.
Oregon
The Oregon legislature held a hearing on March 27, 2023 on SB 492, legislation that would address the use of biased measures of quality of life, such as quality-adjusted life years or QALYs. PIPC Chairman Tony Coelho submitted testimony stating, "This legislation reflects decades of work to advance disability rights and to end the use of discriminatory measures of the effectiveness of health care that too often drive barriers to care for people with disabilities. In the past this may have been considered just a disability issue, but today we recognize the implications of these biased algorithms for health equity more broadly.” Click here to view testimony from PIPC Chairman Tony Coelho. Click here to view testimony submitted by the Caring Ambassadors Program. Click here to view the list of organizations in Oregon supporting the bill.
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) discussed a proposed plan for using QALYs. 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 their use of QALYs but has not made a decision as to whether they will adjust their methodology. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act. 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
2023 PCORI Annual Meeting
October 4-5, 2023
Click here to view.
Real World Evidence Conference
October 16-17, 2023
Click here to view.
2023 Annual Meeting - National Forum for Heart Disease & Stroke Prevention
October 26, 2023
Click here to view.
Medical Journal Articles
NEW: A Clinical Pathway to Well-Being: Putting Patient Priorities at the Center of Care. Click here to read the article.
Comparative Effectiveness of Treatments for Rheumatoid Arthritis in Clinical Practice: A Systematic Review. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials. Click here to view.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes. Click here to view.
Patient-Reported Outcomes for People with Diabetes: What and How to Measure? A Narrative Review. Click here to view.
Patient Engagement in Research; Benefits, Challenges, Importance, and Implications. Click here to view.
The Opportunity for Greater Patient and Public Involvement and Engagement in Drug Development and Regulation. Click here to view.
AHRQ Effective Program Updates
Technical Brief: Measuring Healthcare Organization Characteristics in Cancer Care Delivery Research. Click here to view.
Systematic Review: Postpartum Care up to 1 Year After Pregnancy: A Systematic Review and Meta-analysis. Click here to view.
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.
1. PIPC Chair Tony Coelho Testifies to Massachusetts Legislature Supporting Statewide QALY Ban, Michigan Bill Threatens Expanded Use of QALYs and Similar Measures. On September 20, 2023, the Massachusetts Joint Committee on Health Care Financing considered legislation, H. 1183 and S. 730, that would prohibit reliance on discriminatory measures, including quality-adjusted life years (QALYs) to determine whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs. PIPC Chair Tony Coelho testified in support of this legislation.
"We have a 30-year track record of public opposition to QALYs and similar measures. Research from the National Council on Disability, an independent federal agency advising on disability policy, found that the use of the QALY is discriminatory and recommended that policy makers and insurers reject its use. I authored the ADA to counter disability bias and stigma for future generations. Combined with existing laws including the Affordable Care Act, the Inflation Reduction Act and Section 504 of the Rehab Act, there is no question that metrics like QALYs are not fit for use in our health system.”
In Michigan, legislators introduced a suite of bills, S. 483, S.484, and S.485, that would create a Prescription Drug Affordability Board (PDAB) and institute upper payment limits for certain prescription drugs. The bill received a hearing on September 20, 2023 in the Senate Committee on Finance, Insurance, and Consumer Protection, but patient advocates that attended to testify were unable to do so due to "time constraints” as noted here. Click here to view testimony from Laura Bonnell, Bonnell Foundation.
2. ICER Finalizes 2023 Updates to Value Assessment Framework. Today, the Institute for Clinical and Economic Review published its 2023 update. ICER continues to favor a health system perspective in its cost effectiveness analyses, and continues to use the quality-adjusted life year (QALY) and a similar measure called the equal value of life year gained (evLYG), despite advocacy from patients and people with disabilities urging ICER to abandon their use in favor of measures that better capture outcomes that matter to patients. PIPC will fully analyze the new value assessment framework to better understand the extent to which comments from patients and people with disabilities were incorporated. Click here to view the 2023 framework from ICER. Click here to view the comments from over 75 organizations to ICER.
3. Comments on Proposed Rule on Accessibility of Web Information and Services of State and Local Government Entities Due October 3. Digital inaccessibility presents huge barriers to people with disabilities. Therefore, the Department of Justice has proposed a rule that would require state and local government entities, including schools and transit agencies, to make their websites and apps accessible. However, this rule proposes massive carve outs for schools and universities in addition to 5 other exceptions for pdf documents and third-party information. A letter from the disability community is calling for the Department to remove those exceptions. These regulations will set the standard for state and local government website and app accessibility. In the comments CCD calls for the Department to adopt the most recent WCAG standard and to eliminate unnecessary exceptions to the rule, especially those that exempt educational class materials. The letter is being led by the Consortium for Constituents with Disabilities (CCD), but welcomes any national, state, territorial, and local disability organizations in the United States to show the breadth and commitment of the community on this issue. Only organizations can sign on. Signatures are due by 2 pm ET on Monday, October 2, 2023. Please complete this form to sign your organization on to the joint CCD and friends comments on the Department of Justice Title II regulations. If you have difficulty accessing this form for any reason, please email Sarah Malaier at [email protected]. Click here to view the comments submitted by Tony Coelho.
4. PCORI Seeks Nominations for Advisory Panels. PCORI is currently seeking nominations for appointments to its advisory panels. These multi-stakeholder advisory panels must include patients, caregivers, or patient advocates. PCORI advisory panels do not serve in an official decision-making capacity, but their recommendations and advice will be taken into consideration by PCORI. PIPC encourages patients, caregivers, and patient advocates to apply or to submit nominations to serve on PCORI's five advisory panels on: Clinical Effectiveness and Decision Science, Clinical Trials, Healthcare Delivery & Disparities Research, Patient Engagement, and Rare Disease. The application is open through March 29, 2024. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
5. CMS Process Should Provide Robust and Ongoing Engagement of Patients and People with Disabilities in Negotiation Process. The June 30, 2023 guidance from the Centers for Medicare and Medicaid Services (CMS) stated that CMS will be holding “patient-focused listening sessions in Fall 2023 after the October 2, 2023 deadline for patients and other interested parties to share patient-focused input on therapeutic alternatives and other section 1194(e)(2) data regarding selected drugs.” In its guidance, CMS referenced these listening sessions as a resource for understanding unmet medical need, acquiring new information from patients, identifying relevant outcomes from patients and caregivers and related to therapeutic alternatives. Recently, more information was provided by CMS regarding the patient-focused listening sessions for the selected drug list. Recently, CMS provided further clarification about the listening sessions, stating, "CMS expects a high level of interest in the Listening Sessions. CMS will use a process to randomly select speakers from among the individuals who register for the chance to speak. Approximately 20 speakers will be selected for each Listening Session. A confirmation email will be sent to selected speakers the week of October 9, 2023.” Registration will close October 2, 2023. Click here to view more information about the listening sessions. Click here to view the recommendations from PIPC developed in consultation with other organizations representing patients and people with disabilities.
6. Letter from Over 1900 Researchers, Organizations and Individuals Opposing NIMHD Exclusion of People with Disabilities. On September 8, 2023, letters signed by over 1900 researchers, organizations and individuals expressed opposition to the NIMHD Advisory Committee decision to reject a recommendation to add people with disabilities as a health disparity population. The NIMHD Advisory Committee did not include people with disabilities. Additionally, several people have weighed in about exponential health equity barriers that disabled people from intersecting marginalized groups face - including people of color, people from the LBGTQ+ community, people who live in rural areas, and people who have low incomes. The 2 letters urged the administration to advance a swift course correction on this issue and move to designate people with disabilities as a health disparity population. Click here to view the letter from the disability research community sharing an in-depth analysis about the flaws in this decision-making process. Click here to view the letter from organizations and individuals sharing this analysis and similarly expressing concerns and calling for the recommendation to be reversed.
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.
Michigan
A group of Michigan State Senators on Tuesday introduced a suite of bills that would create a Prescription Drug Affordability Board (PDAB). S. 483, S.484, and S.485 would establish a PDAB to institute upper payment limits for certain prescription drugs used by people with disabilities and chronic conditions. The Board, which is appointed and does not maintain spots specifically for patient representatives, would have the authority to review and comment on all prescription drug costs impacting residents of Michigan. The bill includes some language related to the QALY and cost-effectiveness metrics, but it is not a broad QALY ban. The language does not address how the QALY may be used to discriminate by setting QALY-based cost thresholds. Any finalized upper payment limits established by the PDAB would apply to all purchases of the drug intended for sale in Michigan. If enacted, Michigan would become the seventh state to establish a PDAB.
Colorado
Colorado passed legislation in 2021 creating a Prescription Drug Affordability Review Board. The legislation included language stating that the Upper Payment Limit for selected drugs "shall not consider research or methods that employ a dollars-per-quality adjusted life year, or similar measure, that discounts the value of a life because of an individual's disability or age.” However, this limitation did not clearly extend to the process for determining the selected drugs. Presentations related to cost effectiveness analyses to the Colorado Board have referenced the use of a cost-per-QALY or the equal value of life-year gained (evLYG) in estimating cost effectiveness of treatments. This indicates that these metrics may have influenced how Colorado selected the drugs for review.
- The PDAB offers several opportunities for patients to engage and ensure their voice is heard on these topics:
- Patient and caregiver surveys will be available between September 12 - October 3
- Patient and Caregiver meetings on each selected drug will be held through September:
- Enbrel: Tuesday, September 19 from 6 - 8 pm
- Genvoya: Wednesday, September 20 from 6 - 8 pm
- Cosentyx: Thursday, September 21 from 6 - 8 pm
- Stelara: Tuesday, September 26 from 6 - 8 pm
- Trikafta: Wednesday, September 27 from 6 - 8 pm
Pennsylvania
In the last legislative session, the legislature introduced, HB 1722, a bill creating a Prescription Drug Affordability Board that would not bar reference to QALYs and would explicitly authorize the Board to contract with a third party that could include ICER. The bill has not been reintroduced in 2023. The Pennsylvania legislature held an informational meeting on Prescription Drug Boards in the House Health Committee on April 12 at 10am. Click here to learn more about Prescription Drug Affordability Boards and the implications of discriminatory measures of cost effectiveness. Click here to learn more about the committee chair, Rep. Dan Frankel.
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. On September 20, 2023, the Massachusetts Joint Committee on Health Care Financing considered the legislation, including provisions that would prohibit reliance on discriminatory measures, including quality-adjusted life years (QALYs) to determine whether a particular health care treatment is cost effective, recommended, the value of a treatment, or in determining coverage, reimbursement, appropriate payment amounts, cost-sharing, or incentive policies or programs. PIPC Chair Tony Coelho testified in support of this legislation, alongside the ALS Foundation and the Epilepsy Foundation of New England.
Oregon
The Oregon legislature held a hearing on March 27, 2023 on SB 492, legislation that would address the use of biased measures of quality of life, such as quality-adjusted life years or QALYs. PIPC Chairman Tony Coelho submitted testimony stating, "This legislation reflects decades of work to advance disability rights and to end the use of discriminatory measures of the effectiveness of health care that too often drive barriers to care for people with disabilities. In the past this may have been considered just a disability issue, but today we recognize the implications of these biased algorithms for health equity more broadly.” Click here to view testimony from PIPC Chairman Tony Coelho. Click here to view testimony submitted by the Caring Ambassadors Program. Click here to view the list of organizations in Oregon supporting the bill.
On October 6, 2022, the Oregon Health Evidence Review Commission (HERC) discussed a proposed plan for using QALYs. 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 their use of QALYs but has not made a decision as to whether they will adjust their methodology. Click here to view the letter from almost 50 advocacy groups asking the HERC to stop using QALYs. Click here to view testimony from PIPC Chairman Coelho to the Oregon HERC expressing his support for the Americans with Disabilities Act. 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: MS patients in Australia face limited choices with respect to effective treatments covered, and some are forced to raise money for treatment overseas.
- U.K: The family of a patient with MS has had to turn to crowdfunding for treatment that is not funded through the NHS.
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.
- Paroxysmal Nocturnal Hemoglobinuria: Draft Scoping Document Available. Comments due August 14, 2023.
- Schizophrenia: Draft Scoping Document available. Comments due on July 26, 2023.
- Metachromatic Leukodystrophy: Draft Evidence Report now available.
- Pulmonary Arterial Hypertension: Draft Scoping Document available. Open for comments until June 5, 2023.
- Sickle Cell Disease: Evidence Report Available. California Technology Assessment Forum (CTAF) to meet on July 27, 2023, to review.
- Non-Alcoholic Steatohepatitis: Final Evidence Report now available.
Upcoming Events and Webinars
2023 PCORI Annual Meeting
October 4-5, 2023
Click here to view.
Real World Evidence Conference
October 16-17, 2023
Click here to view.
2023 Annual Meeting - National Forum for Heart Disease & Stroke Prevention
October 26, 2023
Click here to view.
Medical Journal Articles
NEW: A Clinical Pathway to Well-Being: Putting Patient Priorities at the Center of Care. Click here to read the article.
Comparative Effectiveness of Treatments for Rheumatoid Arthritis in Clinical Practice: A Systematic Review. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Perspectives on Patient-Reported Outcome Data After Treatment Discontinuation in Cancer Clinical Trials. Click here to view.
The Implementation of Value-Based Frameworks, Clinical Care Pathways, and Alternative Payment Models for Cancer Care in the United States. Click here to view.
Federal Data for Conducting Patient-Centered Outcomes Research on Economic Outcomes. Click here to view.
Patient-Reported Outcomes for People with Diabetes: What and How to Measure? A Narrative Review. Click here to view.
Patient Engagement in Research; Benefits, Challenges, Importance, and Implications. Click here to view.
The Opportunity for Greater Patient and Public Involvement and Engagement in Drug Development and Regulation. Click here to view.
AHRQ Effective Program Updates
Technical Brief: Measuring Healthcare Organization Characteristics in Cancer Care Delivery Research. Click here to view.
Systematic Review: Postpartum Care up to 1 Year After Pregnancy: A Systematic Review and Meta-analysis. Click here to view.
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.
