In this week's edition...
— Oregon Legislature Passes SB 1508. See details below.
— Khrystal Davis testifies at House E&C Rare Disease Hearing. Click here to view Khrystal’s testimony.
— New Year, New Opportunities: Looking Ahead to 2024 and Beyond. Click here to read the PCORI blog.
— Health Affairs Call for Papers on Inflation Reduction Act. See details below.
— Chairman Tony Coelho's Statement on Final Passage of H.R. 485. See details below.
— PIPC Patient Blog: Access Delayed is Access Denied. Click here to read the blog.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
— 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.
— Oregon Legislature Passes SB 1508. See details below.
— Khrystal Davis testifies at House E&C Rare Disease Hearing. Click here to view Khrystal’s testimony.
— New Year, New Opportunities: Looking Ahead to 2024 and Beyond. Click here to read the PCORI blog.
— Health Affairs Call for Papers on Inflation Reduction Act. See details below.
— Chairman Tony Coelho's Statement on Final Passage of H.R. 485. See details below.
— PIPC Patient Blog: Access Delayed is Access Denied. Click here to read the blog.
— PCORI Seeks Nominations for Advisory Panels. Click here to learn more, to apply to serve on an advisory panel, or submit a nomination.
— 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. Oregon Legislature Passes SB 1508. SB 1508 now bars the Health Evidence Review Commission from using generalized quality of life measures in ranking health care priorities. PIPC Chairman Tony Coelho provided testimony to the Oregon House Committee on Behavioral Health and Health Care supporting SB 1508. "The bill you are discussing today represents over 30 years of advocacy from the disability community. By banning generic measures of quality of life, the most well-known being QALYs, Oregon will be a leader in advancing disability rights. These measures are known to devalue disabled lives by failing to represent how people with disabilities experience quality of life and what they most need to optimize their health.” The bill is waiting for the Governor’s signature.
Disability Rights Oregon strongly advocated for this legislation, and petitioned to ban quality adjusted life years (QALYs) by payers in Oregon, a flawed scoring system economists use to determine cost-effectiveness of proposed medical treatments. Payers—including the Oregon Health Plan—use QALY scores to determine who is eligible for healthcare resources. The problem is the scores are calculated in inherently discriminatory ways. DRO states in their petition, "QALY violates both the Rehabilitation Act and the Americans with Disabilities Act. These types of scores have no place influencing what conditions and treatments the Oregon Health Plan will cover.”
2. Khrystal Davis testifies at House E&C Rare Disease Hearing. Khrystal Davis is the President of Texas Rare Alliance, a rare disease mom to her son with spinal muscular atrophy, and a widow having recently lost her husband to glastioblastoma, a rare brain cancer. Her testimony highlighted the unmet need and burden of rare disease and the need for investment in new treatments, including repurposing rare disease therapeutics. Khrystal stated, "The IRA significantly threatens repurposing existing rare disease treatments to additional rare conditions by making orphan drugs designated for more than one indication eligible for price negotiation.” She also expressed concerns about the potential implications for increased use of utilization management. Having testified in the past on banning the use of QALYs, she thanked the Chair for her work to pass H.R. 485 out of the House, stating, "The legislation is a 'must do' for people with rare diseases, disabilities, chronic illnesses, elderly patients, and really for all patients. Click here to view Khrystal’s testimony.
3. PCORI Blog — New Year, New Opportunities: Looking Ahead to 2024 and Beyond. PCORI Executive Director Nakela Cook has penned a blog outlining PCORI's top priorities for this year. "One of the expectations is for research teams to formally assess the effectiveness of the engagement approaches used in CER studies, which will complement our Science of Engagement initiative in building the evidence base on engagement in research. The Foundational Expectations will also accelerate our efforts to help move the locus of health research out of the ivory tower closer to the community by encouraging, and dedicating resources to, full partnership and co-leadership of community and research organizations, similar to the model built into our Partner funding opportunity.”
4. Health Affairs Call for Papers on Inflation Reduction Act. Health Affairs announced a new series of journal articles focusing on implementation of pharmaceutical-related provisions of the Inflation Reduction Act (IRA). "We are seeking new empirical research, commentaries, reviews, and analyses that address the impact of any of the IRA’s drug-related provisions on: prices/spending; utilization; prescribing patterns; health outcomes; the research and innovation pipeline – investments, drug developments, clinical trials, comparative effectiveness, etc.”
5. Chairman Tony Coelho's Statement on Final Passage of H.R. 485. In response to the final passage of H.R. 485, PIPC Chairman Tony Coelho is pleased to share this statement.
It is disappointing that a bill to simply extend current law protections to all people with disabilities did not pass the House unanimously and instead passed on a partisan vote. Yet, it is important to note that Republicans and Democrats both stated support for the current law protections against use of QALYs & similar measures that devalue people with disabilities, and they support banning their use more broadly. This is the critical issue for those of us with disabilities. We expect both parties to keep that view and work with the disability community to act on the recommendations of the National Council on Disability, the independent federal agency that identified for policymakers how QALYs & similar measures discriminate and called for a consistent policy across federal programs to address it.
For additional information, you may click here to view the CCD letter supporting H.R. 485, click here to view the statement from supporting organizations and click here to view the letter from supportive organizations. You may view the White House Statement of Administration Policy here, which opposed how the bill would be paid for, while underscoring continued Democratic support for the current law barring QALYs and similar measures.
6. PIPC Patient Blog: Access Delayed is Access Denied. Beth Vanstone has published penned a post for the PIPC Patient Blog explaining why the U.S. should not adopt foreign drug pricing models. "As a parent who was one of the “lucky” ones, having accessed a lifesaving drug after 2 years, I would strongly recommend supporting methods of improving access to therapies for patients. Canada continues to fall behind many of the developed countries around the world when it comes to providing access to lifesaving drugs due to a process that is not patient centered. The science and innovation used to develop these drugs had the sole purpose of saving and improving lives. Please make sure they get to the patients that so desperately need them before it’s too late. Don’t let patients die waiting."
7. 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.
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.
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 or the affordability review. Presentations to the Colorado Board from entities such as the Program on Regulation, Therapeutics, and Law (PORTAL) related to cost effectiveness analyses have referenced the merits of using of a cost-per-QALY or the equal value of life-year gained (evLYG) in estimating cost effectiveness of treatments, indicating that these discriminatory measures may have influenced how Colorado selected the drugs and may influence the affordability review. Concerns about the potential for discrimination were described in a letter to the Board from 16 patient and disability organizations. The PDAB offers several opportunities for patients to engage and ensure their voice is heard on these topics.
At the PDAB meeting held Friday, February 16, the Board voted that an injectable drug for arthritis is unaffordable to patients in the state. On Friday, February 23, the Board voted to consider the drug for an upper payment limit. The PDACC has also noticed that it is currently accepting applications for new council members. Click here to apply.
Connecticut
The Governor’s bill No. 5054 would establish a Prescription Drug Affordability Board with authority to "(1) explore strategies to reduce out-of-pocket drug costs to consumers while supporting innovations in biotechnology and scientific discovery; (2) study the prescription drug supply chain and pharmaceutical pricing strategies to identify opportunities for consumer savings; (3) monitor prescription drug prices in the state; (4) promote innovative strategies for the use of more affordable drugs; and (5) recommend a range of options of prescription drug cost affordability tools to the executive director of the Office of Health Strategy.” The Board is to report on “cost effectiveness evaluations” among the topics to be covered, but is not precluded from referencing evaluations using quality-adjusted life years (QALYs) and similar measures. The board members "shall have an advanced degree and experience or expertise in health care economics, health services research, pharmoeconomics, pharmacology or clinical medicine. At least one such member shall have direct experience with consumer advocacy and health equity.” While one board member is to have experience with consumer advocacy and health equity, it is not clearly stated that the person represent the patient perspective, nor does the legislation create an advisory process for patients and people with disabilities. Click here to view comments from the International Cancer Advocacy Network. Click here to view the bill. Click here to view comments from the Value of Care Coalition.
Illinois
Legislation was introduced in the Illinois House (HB 4472) on January 17, 2024 creating a Health Care Availability and Access Board, using a model aligned with the NASHP template legislation for creation of Prescription Drug Affordability Boards. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Illinois. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures.
Maine
A bill introduced in the Maine legislature, LD 1829, would create a Prescription Drug Affordability Board with 6 members. The board is not required to include patients or people with disabilities. The 12-member advisory council includes a consumer representative appointed by the Governor, but does not require patient and disability participation. The process for assessing affordability and establishing payment limits does not bar the use of quality-adjusted life years (QALYs) and similar measures. The board is authorized to establish upper payment limits and to reference Medicare prices. Click here to view the bill.
Massachusetts
The Massachusetts Senate Ways and Means Committees was referred the “PACT Act”, reported favorably on October 30, 2023 by the Joint Committee on Health Care Financing. The legislation includes a provision calling for the health policy commission not to base its determinations on measures such as QALYs. The Senate rejected an amendment (#19) pushed by Massachusetts advocates calling for transparency related to the use of cost effectiveness analyses by the commission, as well as increased requirements for stakeholder engagement. The Senate passed the bill on November 15, 2023. Massachusetts advocates will work with the House toward language that more clearly provides for public transparency of the evidence under consideration and opportunities for engagement from patients and people with disabilities.
Oregon
The Oregon legislature passed SB 844 in 2021 creating a Prescription Drug Affordability Board, which was updated based on the Board’s recommendations in 2023 by SB 192. While the legislation included language barring consideration of QALYs and similar formulas, the Board has engaged the Program on Regulation, Therapeutics, and Law (PORTAL), per their meeting agenda for November 15. PORTAL has a subcontract with the Institute for Clinical and Economic Review (ICER) for its work with the Massachusetts Health Policy Commission and has presented on the merits of the QALY and evLYG measures to the Colorado Prescription Drug Affordability Board. This raises concerns about the evidentiary basis for the Board’s decisions and the potential for reference to discriminatory measures of cost effectiveness.
The Oregon Board voted to advance an affordability review of 26 drugs at the October 18, 2023 meeting, with an ambitious plan to conduct the reviews by February. The Board’s rules for conducting an affordability review does not include a robust process for engaging patients and people with disabilities in their decisions. In response to the Board’s deliberations, advocates sent a letter to the Board in advance of their December public meeting, available here. Guidance for providing public testimony is available here. The Oregon PDAB will hold its next meeting on March 20, 2024.
Click here to join Disability Rights Oregon in advocating for legislation banning use of QALYs. The bill SB 1508 was passed by the Senate Committee on Health Care on February 13, 2024, and will advance.
Vermont
On January 4, 2024, the Vermont Senate Health and Welfare Committee raised S. 98, legislation that would direct the Green Mountain Care Board to conduct an affordability review using cost-effectiveness studies. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)). Advocates that want to weigh in may reach out to the committee assistant Kiki Carasi-Schwartz at [email protected].
Virginia
Legislation creating a Prescription Drug Affordability Board was reintroduced in the Virginia legislature (HB 570 and SB 274). The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Virginia. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)).
Washington State
At its December, 2023 meeting, the Washington State Prescription Drug Affordability Board acknowledged the limitation in its statute on using quality adjusted life years (QALYs) to establish an upper payment limit, yet also raised the possibility of contracting with the Institute for Clinical and Economic Review (ICER) as a consultant to the Board for its methodologies and analysis (1:03:25). At its October, 2023 meeting, the Board discussed partnering the Program on Regulation, Therapeutics, and Law (PORTAL), acknowledging its education of the Colorado Board and collaboration with the National Association of State Health Policy (NASHP) in development of the legislation creating Washington’s PDAB and supporting materials, further underscoring the potential influence of entities that view QALYs and evLYG measures as useful to the affordability review process (47:55). PIPC is following the PDAB’s implementation in Washington State closely for potential use of discriminatory measures of effectiveness.
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
5th Annual IVI Methods Summit
March 14, 2024
Click here to view.
PCORI Board of Governors Meeting
March 18-19, 2024
Click here to view.
Medical Journal Articles
Policy Symposium: Ensuring Equity in Implementation of Ira Drug Price Negotiations: Convening Proceedings Report. Click here to read the report.
Comparative Effectiveness Research Using Claims Data: Meticulous Methods Don’t Solve Old Problems. Click here to read the article.
The Impact of The House Proposed IRA Expansion on the US Biopharma Ecosystem. Click here to view the report.
Using A Patient-Centered Value Assessment to Optimize Fair Prices for Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Click here to read the article.
Alternative approaches to measuring value: an update on innovative methods in the context of the United States Medicare drug price negotiation program. Click here to read the article.
Economic Outcomes in Patient-Centered Outcomes Research: A Paradigm Shift. Click here to read the article.
Visualization of Evidence for Shared Decision Making. Click here to read the article.
Avenues for Strengthening PCORnet’s Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research. Click here to read the article.
Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries. Click here to read the article.
Gene Therapies for Sickle Cell Disease: Effectiveness and Value. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
AHRQ Effective Program Updates
Systematic Review: Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
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. Oregon Legislature Passes SB 1508. SB 1508 now bars the Health Evidence Review Commission from using generalized quality of life measures in ranking health care priorities. PIPC Chairman Tony Coelho provided testimony to the Oregon House Committee on Behavioral Health and Health Care supporting SB 1508. "The bill you are discussing today represents over 30 years of advocacy from the disability community. By banning generic measures of quality of life, the most well-known being QALYs, Oregon will be a leader in advancing disability rights. These measures are known to devalue disabled lives by failing to represent how people with disabilities experience quality of life and what they most need to optimize their health.” The bill is waiting for the Governor’s signature.
Disability Rights Oregon strongly advocated for this legislation, and petitioned to ban quality adjusted life years (QALYs) by payers in Oregon, a flawed scoring system economists use to determine cost-effectiveness of proposed medical treatments. Payers—including the Oregon Health Plan—use QALY scores to determine who is eligible for healthcare resources. The problem is the scores are calculated in inherently discriminatory ways. DRO states in their petition, "QALY violates both the Rehabilitation Act and the Americans with Disabilities Act. These types of scores have no place influencing what conditions and treatments the Oregon Health Plan will cover.”
2. Khrystal Davis testifies at House E&C Rare Disease Hearing. Khrystal Davis is the President of Texas Rare Alliance, a rare disease mom to her son with spinal muscular atrophy, and a widow having recently lost her husband to glastioblastoma, a rare brain cancer. Her testimony highlighted the unmet need and burden of rare disease and the need for investment in new treatments, including repurposing rare disease therapeutics. Khrystal stated, "The IRA significantly threatens repurposing existing rare disease treatments to additional rare conditions by making orphan drugs designated for more than one indication eligible for price negotiation.” She also expressed concerns about the potential implications for increased use of utilization management. Having testified in the past on banning the use of QALYs, she thanked the Chair for her work to pass H.R. 485 out of the House, stating, "The legislation is a 'must do' for people with rare diseases, disabilities, chronic illnesses, elderly patients, and really for all patients. Click here to view Khrystal’s testimony.
3. PCORI Blog — New Year, New Opportunities: Looking Ahead to 2024 and Beyond. PCORI Executive Director Nakela Cook has penned a blog outlining PCORI's top priorities for this year. "One of the expectations is for research teams to formally assess the effectiveness of the engagement approaches used in CER studies, which will complement our Science of Engagement initiative in building the evidence base on engagement in research. The Foundational Expectations will also accelerate our efforts to help move the locus of health research out of the ivory tower closer to the community by encouraging, and dedicating resources to, full partnership and co-leadership of community and research organizations, similar to the model built into our Partner funding opportunity.”
4. Health Affairs Call for Papers on Inflation Reduction Act. Health Affairs announced a new series of journal articles focusing on implementation of pharmaceutical-related provisions of the Inflation Reduction Act (IRA). "We are seeking new empirical research, commentaries, reviews, and analyses that address the impact of any of the IRA’s drug-related provisions on: prices/spending; utilization; prescribing patterns; health outcomes; the research and innovation pipeline – investments, drug developments, clinical trials, comparative effectiveness, etc.”
5. Chairman Tony Coelho's Statement on Final Passage of H.R. 485. In response to the final passage of H.R. 485, PIPC Chairman Tony Coelho is pleased to share this statement.
It is disappointing that a bill to simply extend current law protections to all people with disabilities did not pass the House unanimously and instead passed on a partisan vote. Yet, it is important to note that Republicans and Democrats both stated support for the current law protections against use of QALYs & similar measures that devalue people with disabilities, and they support banning their use more broadly. This is the critical issue for those of us with disabilities. We expect both parties to keep that view and work with the disability community to act on the recommendations of the National Council on Disability, the independent federal agency that identified for policymakers how QALYs & similar measures discriminate and called for a consistent policy across federal programs to address it.
For additional information, you may click here to view the CCD letter supporting H.R. 485, click here to view the statement from supporting organizations and click here to view the letter from supportive organizations. You may view the White House Statement of Administration Policy here, which opposed how the bill would be paid for, while underscoring continued Democratic support for the current law barring QALYs and similar measures.
6. PIPC Patient Blog: Access Delayed is Access Denied. Beth Vanstone has published penned a post for the PIPC Patient Blog explaining why the U.S. should not adopt foreign drug pricing models. "As a parent who was one of the “lucky” ones, having accessed a lifesaving drug after 2 years, I would strongly recommend supporting methods of improving access to therapies for patients. Canada continues to fall behind many of the developed countries around the world when it comes to providing access to lifesaving drugs due to a process that is not patient centered. The science and innovation used to develop these drugs had the sole purpose of saving and improving lives. Please make sure they get to the patients that so desperately need them before it’s too late. Don’t let patients die waiting."
7. 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.
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.
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 or the affordability review. Presentations to the Colorado Board from entities such as the Program on Regulation, Therapeutics, and Law (PORTAL) related to cost effectiveness analyses have referenced the merits of using of a cost-per-QALY or the equal value of life-year gained (evLYG) in estimating cost effectiveness of treatments, indicating that these discriminatory measures may have influenced how Colorado selected the drugs and may influence the affordability review. Concerns about the potential for discrimination were described in a letter to the Board from 16 patient and disability organizations. The PDAB offers several opportunities for patients to engage and ensure their voice is heard on these topics.
At the PDAB meeting held Friday, February 16, the Board voted that an injectable drug for arthritis is unaffordable to patients in the state. On Friday, February 23, the Board voted to consider the drug for an upper payment limit. The PDACC has also noticed that it is currently accepting applications for new council members. Click here to apply.
Connecticut
The Governor’s bill No. 5054 would establish a Prescription Drug Affordability Board with authority to "(1) explore strategies to reduce out-of-pocket drug costs to consumers while supporting innovations in biotechnology and scientific discovery; (2) study the prescription drug supply chain and pharmaceutical pricing strategies to identify opportunities for consumer savings; (3) monitor prescription drug prices in the state; (4) promote innovative strategies for the use of more affordable drugs; and (5) recommend a range of options of prescription drug cost affordability tools to the executive director of the Office of Health Strategy.” The Board is to report on “cost effectiveness evaluations” among the topics to be covered, but is not precluded from referencing evaluations using quality-adjusted life years (QALYs) and similar measures. The board members "shall have an advanced degree and experience or expertise in health care economics, health services research, pharmoeconomics, pharmacology or clinical medicine. At least one such member shall have direct experience with consumer advocacy and health equity.” While one board member is to have experience with consumer advocacy and health equity, it is not clearly stated that the person represent the patient perspective, nor does the legislation create an advisory process for patients and people with disabilities. Click here to view comments from the International Cancer Advocacy Network. Click here to view the bill. Click here to view comments from the Value of Care Coalition.
Illinois
Legislation was introduced in the Illinois House (HB 4472) on January 17, 2024 creating a Health Care Availability and Access Board, using a model aligned with the NASHP template legislation for creation of Prescription Drug Affordability Boards. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Illinois. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures.
Maine
A bill introduced in the Maine legislature, LD 1829, would create a Prescription Drug Affordability Board with 6 members. The board is not required to include patients or people with disabilities. The 12-member advisory council includes a consumer representative appointed by the Governor, but does not require patient and disability participation. The process for assessing affordability and establishing payment limits does not bar the use of quality-adjusted life years (QALYs) and similar measures. The board is authorized to establish upper payment limits and to reference Medicare prices. Click here to view the bill.
Massachusetts
The Massachusetts Senate Ways and Means Committees was referred the “PACT Act”, reported favorably on October 30, 2023 by the Joint Committee on Health Care Financing. The legislation includes a provision calling for the health policy commission not to base its determinations on measures such as QALYs. The Senate rejected an amendment (#19) pushed by Massachusetts advocates calling for transparency related to the use of cost effectiveness analyses by the commission, as well as increased requirements for stakeholder engagement. The Senate passed the bill on November 15, 2023. Massachusetts advocates will work with the House toward language that more clearly provides for public transparency of the evidence under consideration and opportunities for engagement from patients and people with disabilities.
Oregon
The Oregon legislature passed SB 844 in 2021 creating a Prescription Drug Affordability Board, which was updated based on the Board’s recommendations in 2023 by SB 192. While the legislation included language barring consideration of QALYs and similar formulas, the Board has engaged the Program on Regulation, Therapeutics, and Law (PORTAL), per their meeting agenda for November 15. PORTAL has a subcontract with the Institute for Clinical and Economic Review (ICER) for its work with the Massachusetts Health Policy Commission and has presented on the merits of the QALY and evLYG measures to the Colorado Prescription Drug Affordability Board. This raises concerns about the evidentiary basis for the Board’s decisions and the potential for reference to discriminatory measures of cost effectiveness.
The Oregon Board voted to advance an affordability review of 26 drugs at the October 18, 2023 meeting, with an ambitious plan to conduct the reviews by February. The Board’s rules for conducting an affordability review does not include a robust process for engaging patients and people with disabilities in their decisions. In response to the Board’s deliberations, advocates sent a letter to the Board in advance of their December public meeting, available here. Guidance for providing public testimony is available here. The Oregon PDAB will hold its next meeting on March 20, 2024.
Click here to join Disability Rights Oregon in advocating for legislation banning use of QALYs. The bill SB 1508 was passed by the Senate Committee on Health Care on February 13, 2024, and will advance.
Vermont
On January 4, 2024, the Vermont Senate Health and Welfare Committee raised S. 98, legislation that would direct the Green Mountain Care Board to conduct an affordability review using cost-effectiveness studies. The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)). Advocates that want to weigh in may reach out to the committee assistant Kiki Carasi-Schwartz at [email protected].
Virginia
Legislation creating a Prescription Drug Affordability Board was reintroduced in the Virginia legislature (HB 570 and SB 274). The language limiting the use of quality-adjusted life years (QALYs) is modeled on language used in other states to allow for use of cost effectiveness measures such as the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and only focuses on discrimination related to life extension, raising concerns that the state could partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care.
ICER acknowledges that it developed the language for use in Washington State that is now being used across states, including Virginia. While the legislative language is touted as restricting QALYs, it is not modeled on the Affordable Care Act’s ban on use of QALYs and similar measures in Medicare, which comprehensively bans discriminatory measures. The Value Our Health template for state legislatures includes a provision banning use of discriminatory measures that is modeled on the ACA language (see section (d)).
Washington State
At its December, 2023 meeting, the Washington State Prescription Drug Affordability Board acknowledged the limitation in its statute on using quality adjusted life years (QALYs) to establish an upper payment limit, yet also raised the possibility of contracting with the Institute for Clinical and Economic Review (ICER) as a consultant to the Board for its methodologies and analysis (1:03:25). At its October, 2023 meeting, the Board discussed partnering the Program on Regulation, Therapeutics, and Law (PORTAL), acknowledging its education of the Colorado Board and collaboration with the National Association of State Health Policy (NASHP) in development of the legislation creating Washington’s PDAB and supporting materials, further underscoring the potential influence of entities that view QALYs and evLYG measures as useful to the affordability review process (47:55). PIPC is following the PDAB’s implementation in Washington State closely for potential use of discriminatory measures of effectiveness.
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: The Medical Services Advisory Committee has deferred a decision to approve public funding for a type of CAR-T cell therapy for multiple myeloma, leaving hundreds of terminally ill patients in limbo.
- Canada: While treatments for ataxia have been approved elsewhere, none have been approved in Canada where patients must pay hundreds of thousands of dollars to access treatment abroad.
- New Zealand: Cancer patients are rallying for the government to support equal access to treatments so that the out-of-pocket burden is lesser.
- United Kingdom: An analysis by London School of Economics and Political Science experts reveals two thirds of decisions to reject or roll out drugs on the NHS are backed by poor clinical evidence.
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.
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- Schizophrenia: Evidence Report available. Public meeting: February 9, 2024.
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Upcoming Events and Webinars
5th Annual IVI Methods Summit
March 14, 2024
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PCORI Board of Governors Meeting
March 18-19, 2024
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Medical Journal Articles
Policy Symposium: Ensuring Equity in Implementation of Ira Drug Price Negotiations: Convening Proceedings Report. Click here to read the report.
Comparative Effectiveness Research Using Claims Data: Meticulous Methods Don’t Solve Old Problems. Click here to read the article.
The Impact of The House Proposed IRA Expansion on the US Biopharma Ecosystem. Click here to view the report.
Using A Patient-Centered Value Assessment to Optimize Fair Prices for Inflation Reduction Act’s Medicare Drug Price Negotiation Program. Click here to read the article.
Alternative approaches to measuring value: an update on innovative methods in the context of the United States Medicare drug price negotiation program. Click here to read the article.
Economic Outcomes in Patient-Centered Outcomes Research: A Paradigm Shift. Click here to read the article.
Visualization of Evidence for Shared Decision Making. Click here to read the article.
Avenues for Strengthening PCORnet’s Capacity to Advance Patient-Centered Economic Outcomes in Patient-Centered Outcomes Research. Click here to read the article.
Linking Medicare-Medicaid Claims for Patient-Centered Outcomes Research Among Dual-Eligible Beneficiaries. Click here to read the article.
Gene Therapies for Sickle Cell Disease: Effectiveness and Value. Click here to read the article.
QALYs: The Math Doesn’t Work. Click here to read the article.
AHRQ Effective Program Updates
Systematic Review: Healthcare Algorithms on Racial and Ethnic Disparities in Health and Healthcare. Click here to view.
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.
