In this week's edition...
— Canadian Study Finds Americans Get Better and Faster Access to Innovative Drugs. See details below.
— CMS Finalizes Requirement for a Patient Representative on Exchange P&T Committees. See details below.
— Oregon Advocates Highlight Engagement Challenges get with PDAB, Patient Forums Scheduled. See details below.
— View PCORI’s April Panel Meetings, Get PCORI Updates. See details below.
— Oregon Governor Signs SB 1508. See details below.
— PIPC In the News: State Level Action on QALYs Needed. Click here to read the article.
— Chairman Tony Coelho's Statement on Final Passage of H.R. 485. 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.
— Canadian Study Finds Americans Get Better and Faster Access to Innovative Drugs. See details below.
— CMS Finalizes Requirement for a Patient Representative on Exchange P&T Committees. See details below.
— Oregon Advocates Highlight Engagement Challenges get with PDAB, Patient Forums Scheduled. See details below.
— View PCORI’s April Panel Meetings, Get PCORI Updates. See details below.
— Oregon Governor Signs SB 1508. See details below.
— PIPC In the News: State Level Action on QALYs Needed. Click here to read the article.
— Chairman Tony Coelho's Statement on Final Passage of H.R. 485. 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.
What We're Reading
1. Canadian Study Finds Americans Get Better and Faster Access to Innovative Drugs. A recent study published by the Canadian Health Policy Institute found that Americans get better and faster access to innovative medicines compared to Europeans and Canadians. "Data showed that the United States was the top priority market for new drug launches. More than two out of every three new drug applications submitted across the jurisdictions from 2018 to 2022 were launched first in the United States. Of the marketing authorizations for new drugs that accrued during the same timeframe, the US Food and Drug Administration approved 45% more than Health Canada, and 13% more than the European Medicines Agency."
2. CMS Finalizes Requirement for a Patient Representative on Exchange P&T Committees. CMS is finalizing requirements that P&T committees must include at least one patient representative, responding to PIPC’s comments requesting the final requirement to use the terminology “patient representative” as opposed to “consumer representative.” This new policy will ensure that patient experience and input is considered in the design of formulary benefits for plan years beginning on or after January 1, 2026. Specifically, the final rule requires that patient representatives must: (1) represent the patient perspective; (2) have relevant experience or participation in patient or community-based organizations; (3) be able to demonstrate the ability to integrate data interpretations with practical patient considerations; (4) have no fiduciary obligation to a health facility; (5) have a broad understanding of one or more conditions or diseases and associated treatment options, and; (6) disclose any financial conflicts of interest. Click here to view PIPC’s comments. Click here to view similar comments from Global Liver Institute.
3. Oregon Advocates Highlight Engagement Challenges get with PDAB, Patient Forums Scheduled. Lorren Sandt with Caring Ambassadors authored an opinion for the Oregon Capitol Chronicle highlighting that Oregon's new Prescription Drug Affordability Board has failed to engage patients and people with disabilities in its process, raising concerns about whether the board will use discriminatory measures of cost effectiveness in its decisions. She stated "But since Oregon’s board doesn’t have a single representative from the patient or disability community among its ranks, its members could easily default to using these unfeeling, inhumane analyses in their decision-making process…No amount of formal training or education can make up for neglecting the perspective of someone living with a chronic illness or navigating the world with a disability.” She also stated, "both state law and the board’s discretionary authority have failed to prioritize sincere engagement with the patient community and clinicians.” Click here to view the opinion. Click here to view the letter from advocates to the legislature requesting pause of the board’s activites and legislative oversight.
4. View PCORI’s April Panel Meetings, Get PCORI Updates. PCORI's multi-stakeholder advisory panels are convening in April 2024 for their Spring 2024 meetings. These research advisory panels are an important way we bring voices from across the healthcare community into our work. They focus on clinical effectiveness and decision science, clinical trials, healthcare delivery and disparities research, patient engagement, and rare diseases. Members of the public are invited to tune in to the meetings via webinar/teleconference. Click here to learn more and register.
PCORI also has evidence updates available for multiple sclerosis, type 2 diabetes, stroke and urinary incontinence. Click here to view. Learn more about upcoming PCORI funding announcements on May 7, 2024 related to rare disease, substance use, pragmatic studies, science of engagement and methods here.
5. Oregon Governor Signs 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. After final passage, he stated, “Thank you Disability Rights Oregon for your persistence to ban generalized quality of life measures like QALYs to restrict access to care, demonstrating to other states and the nation it can be done!” Click here for more information.
6. PIPC In the News: State Level Action on QALYs Needed. PIPC Chairman Tony Coelho was featured in an article for Show Me State Times to discuss the need to pass the Protecting Healthcare for All Patients Act. "Former U.S. Rep. Tony Coelho (D-Calif.), chairman of the Partnership to Improve Patient Care (PIPC), said that until this federal bill is passed, "state-level action" is needed. 'Without a consistent federal policy across federal programs, state-level action to ban QALYs and similar measures is needed to protect people with disabilities and serious chronic conditions from discrimination.'" Click here to read the article.
7. 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.
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 PDACC has also noticed that it is currently accepting applications for new council members. Click here to apply.
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. Patients reviewed the survey referenced in the affordability decision, providing insights as to how the survey was flawed or misleading, indicating the need for patient engagement in future development of questions.
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. The bill was discussed in a public hearing on February 23, 2024.
View the letter opposing the bill from Boomer Esiason Foundation here. You may view comments from International Cancer Advocacy Network here and the Value Our Care Coalition here. Contact information for the committee is here.
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. An amended version of the legislation was referred to the legislative committees on 2/28/24. The amended version continues to include language related to the use of quality-adjusted life years (QALYs) that was originally developed by the Institute for Clinical and Economic Review (ICER) for other states where it has not precluded boards from referencing QALYs and the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and focuses on discrimination related to life extension, raising concerns that the legislation would allow the PDAB to partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care, as seen in other states. It was referred to the Health Care Availability & Accessibility Committee in the Illinois General Assembly. The lead sponsors are Representative Nabeela Syed (D) and Representative Emanuel "Chris" Welch (D).
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 board would be authorized to establish upper payment limits and to reference Medicare prices, yet the process for assessing affordability and establishing payment limits does not bar the use of quality-adjusted life years (QALYs) and similar measures. The bill received a “divided report” on February 1, 2024, in the Committee on Health Coverage, Insurance and Financial Services with 7 legislators favoring passage and 4 legislators opposing passage. Click here to view the bill. View Laura Bonnell’s testimony here. Contact information for Committee members and staff is here.
Maryland
The next meeting of the Maryland Prescription Drug Affordability Board’s stakeholder council is April 29. Comments provided to the board at the March meeting may be viewed here and include concerns similar to those shared in Colorado related to concerns about health equity and access to care. Drugs potentially referred to the council for review include Biktarvy for HIV, Dupixent for eczema and asthma, Farxiga for chronic kidney disease (CKD), Jardiance or CKD and health failure, Ozempic for obesity, Skyriza for arthritis, psoriasis and Crohn’s disease, Trulicity for disabetes and heart disease, and Vyvance for ADHD. Register for the upcoming stakeholder meeting here. Learn more about the next May 20 Board meeting here.
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.
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].
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
2024 Science of Patient Engagement Symposium
May 8-9, 2024
Click here to view.
PCORI Board of Governors Meeting
June 17-18, 2024
Click here to view.
Medical Journal Articles
Studying How Patient Engagement Influences Research: A Mixed Methods Study. Click here to read the article.
Principles for Stakeholder Engagement in Observational Health Research. Click here to read the article.
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.
AHRQ Effective Program Updates
Research Protocol: Fiber Intake and Laxation Outcomes. Click here to view.
Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: 2024 Update of the Evidence Base for the PTSD Trials Standardized Data Repository. Click here to view.
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.
1. Canadian Study Finds Americans Get Better and Faster Access to Innovative Drugs. A recent study published by the Canadian Health Policy Institute found that Americans get better and faster access to innovative medicines compared to Europeans and Canadians. "Data showed that the United States was the top priority market for new drug launches. More than two out of every three new drug applications submitted across the jurisdictions from 2018 to 2022 were launched first in the United States. Of the marketing authorizations for new drugs that accrued during the same timeframe, the US Food and Drug Administration approved 45% more than Health Canada, and 13% more than the European Medicines Agency."
2. CMS Finalizes Requirement for a Patient Representative on Exchange P&T Committees. CMS is finalizing requirements that P&T committees must include at least one patient representative, responding to PIPC’s comments requesting the final requirement to use the terminology “patient representative” as opposed to “consumer representative.” This new policy will ensure that patient experience and input is considered in the design of formulary benefits for plan years beginning on or after January 1, 2026. Specifically, the final rule requires that patient representatives must: (1) represent the patient perspective; (2) have relevant experience or participation in patient or community-based organizations; (3) be able to demonstrate the ability to integrate data interpretations with practical patient considerations; (4) have no fiduciary obligation to a health facility; (5) have a broad understanding of one or more conditions or diseases and associated treatment options, and; (6) disclose any financial conflicts of interest. Click here to view PIPC’s comments. Click here to view similar comments from Global Liver Institute.
3. Oregon Advocates Highlight Engagement Challenges get with PDAB, Patient Forums Scheduled. Lorren Sandt with Caring Ambassadors authored an opinion for the Oregon Capitol Chronicle highlighting that Oregon's new Prescription Drug Affordability Board has failed to engage patients and people with disabilities in its process, raising concerns about whether the board will use discriminatory measures of cost effectiveness in its decisions. She stated "But since Oregon’s board doesn’t have a single representative from the patient or disability community among its ranks, its members could easily default to using these unfeeling, inhumane analyses in their decision-making process…No amount of formal training or education can make up for neglecting the perspective of someone living with a chronic illness or navigating the world with a disability.” She also stated, "both state law and the board’s discretionary authority have failed to prioritize sincere engagement with the patient community and clinicians.” Click here to view the opinion. Click here to view the letter from advocates to the legislature requesting pause of the board’s activites and legislative oversight.
4. View PCORI’s April Panel Meetings, Get PCORI Updates. PCORI's multi-stakeholder advisory panels are convening in April 2024 for their Spring 2024 meetings. These research advisory panels are an important way we bring voices from across the healthcare community into our work. They focus on clinical effectiveness and decision science, clinical trials, healthcare delivery and disparities research, patient engagement, and rare diseases. Members of the public are invited to tune in to the meetings via webinar/teleconference. Click here to learn more and register.
PCORI also has evidence updates available for multiple sclerosis, type 2 diabetes, stroke and urinary incontinence. Click here to view. Learn more about upcoming PCORI funding announcements on May 7, 2024 related to rare disease, substance use, pragmatic studies, science of engagement and methods here.
5. Oregon Governor Signs 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. After final passage, he stated, “Thank you Disability Rights Oregon for your persistence to ban generalized quality of life measures like QALYs to restrict access to care, demonstrating to other states and the nation it can be done!” Click here for more information.
6. PIPC In the News: State Level Action on QALYs Needed. PIPC Chairman Tony Coelho was featured in an article for Show Me State Times to discuss the need to pass the Protecting Healthcare for All Patients Act. "Former U.S. Rep. Tony Coelho (D-Calif.), chairman of the Partnership to Improve Patient Care (PIPC), said that until this federal bill is passed, "state-level action" is needed. 'Without a consistent federal policy across federal programs, state-level action to ban QALYs and similar measures is needed to protect people with disabilities and serious chronic conditions from discrimination.'" Click here to read the article.
7. 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.
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 PDACC has also noticed that it is currently accepting applications for new council members. Click here to apply.
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. Patients reviewed the survey referenced in the affordability decision, providing insights as to how the survey was flawed or misleading, indicating the need for patient engagement in future development of questions.
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. The bill was discussed in a public hearing on February 23, 2024.
View the letter opposing the bill from Boomer Esiason Foundation here. You may view comments from International Cancer Advocacy Network here and the Value Our Care Coalition here. Contact information for the committee is here.
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. An amended version of the legislation was referred to the legislative committees on 2/28/24. The amended version continues to include language related to the use of quality-adjusted life years (QALYs) that was originally developed by the Institute for Clinical and Economic Review (ICER) for other states where it has not precluded boards from referencing QALYs and the equal value of life year gained (evLYG). As drafted, the language limits the use of QALYs only to identifying subpopulations and focuses on discrimination related to life extension, raising concerns that the legislation would allow the PDAB to partner with entities such as PORTAL and ICER that support the use of QALYs and evLYGs to value health care, as seen in other states. It was referred to the Health Care Availability & Accessibility Committee in the Illinois General Assembly. The lead sponsors are Representative Nabeela Syed (D) and Representative Emanuel "Chris" Welch (D).
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 board would be authorized to establish upper payment limits and to reference Medicare prices, yet the process for assessing affordability and establishing payment limits does not bar the use of quality-adjusted life years (QALYs) and similar measures. The bill received a “divided report” on February 1, 2024, in the Committee on Health Coverage, Insurance and Financial Services with 7 legislators favoring passage and 4 legislators opposing passage. Click here to view the bill. View Laura Bonnell’s testimony here. Contact information for Committee members and staff is here.
Maryland
The next meeting of the Maryland Prescription Drug Affordability Board’s stakeholder council is April 29. Comments provided to the board at the March meeting may be viewed here and include concerns similar to those shared in Colorado related to concerns about health equity and access to care. Drugs potentially referred to the council for review include Biktarvy for HIV, Dupixent for eczema and asthma, Farxiga for chronic kidney disease (CKD), Jardiance or CKD and health failure, Ozempic for obesity, Skyriza for arthritis, psoriasis and Crohn’s disease, Trulicity for disabetes and heart disease, and Vyvance for ADHD. Register for the upcoming stakeholder meeting here. Learn more about the next May 20 Board meeting here.
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.
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].
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.
- Canada: A young neuroblastoma patient must travel to Mexico to receive treatment that is not funded through the Canadian health system.
- New Zealand: Cancer experts are urging Pharmac to fund a life-saving treatment that is targeted at a deadly form of breast cancer.
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.
- Transthyretin Amyloidosis Cardiomyopathy: Draft Scoping Document Available. Public meeting: September 2024
- Myelodysplastic Syndrome: Revised Scoping Document available. Public meeting: July 2024.
- Chronic Obstructive Pulmonary Disease: Revised Scoping Document available. Public meeting: June 2024
- Post-Traumatic Stress Disorder: Draft Evidence Report available. Main review: May 30, 2024.
Upcoming Events and Webinars
2024 Science of Patient Engagement Symposium
May 8-9, 2024
Click here to view.
PCORI Board of Governors Meeting
June 17-18, 2024
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Medical Journal Articles
Studying How Patient Engagement Influences Research: A Mixed Methods Study. Click here to read the article.
Principles for Stakeholder Engagement in Observational Health Research. Click here to read the article.
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.
AHRQ Effective Program Updates
Research Protocol: Fiber Intake and Laxation Outcomes. Click here to view.
Pharmacologic and Nonpharmacologic Treatments for Posttraumatic Stress Disorder: 2024 Update of the Evidence Base for the PTSD Trials Standardized Data Repository. Click here to view.
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.
