In this week's edition...
— CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. See details below.
— EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. See details below.
— Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. See details below.
— Reps. Cammack and Hern Introduce QALY Ban Bill. See details below.
-- Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. See details below.
-- COGI Reiterates Process Concerns for Maryland PDAB, Highlights NAACP Resolution. Click here to view the letter.
-- Webinar Series on Newborn Screening: A Vision for Sustaining and Advancing Excellence. Click here to learn more.
— PIPC Leads Comment Letter on Third Cycle of Medicare Drug Price Negotiation Program. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods. Click here to read the report.
— Update on the Texas v. Kennedy Lawsuit. See details below.
— Learn More About Alternative Measures for Value Assessment. Click here to learn more.
— 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.
— CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. See details below.
— EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. See details below.
— Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. See details below.
— Reps. Cammack and Hern Introduce QALY Ban Bill. See details below.
-- Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. See details below.
-- COGI Reiterates Process Concerns for Maryland PDAB, Highlights NAACP Resolution. Click here to view the letter.
-- Webinar Series on Newborn Screening: A Vision for Sustaining and Advancing Excellence. Click here to learn more.
— PIPC Leads Comment Letter on Third Cycle of Medicare Drug Price Negotiation Program. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods. Click here to read the report.
— Update on the Texas v. Kennedy Lawsuit. See details below.
— Learn More About Alternative Measures for Value Assessment. Click here to learn more.
— 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
PIPC welcomes new members to advance our efforts to assure patients and people with disabilities are at the center of research and policy! Please reach out to [email protected] for more information.
1. CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of value assessments that rely on the quality-adjusted life year (QALY) and the equal value of life year gained (evLYG), measures that are contrary to the laws governing Medicare and barring disability discrimination. In the explanations released on December 20, 2024, CMS explicitly listed studies that included reference to QALYs. View a recently published study highlighting the extent to which QALYs were referenced in CMS’ explanations last December here.
2. EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. The Ensuring Access through Collaborative Health and Patient Inclusion Council (EACH/PIC) has released the findings of its new report, Patient Experience Survey: Prescription Drug Affordability and Unaffordability, which captures how patients and caregivers define and experience prescription drug affordability. The results challenge conventional cost-review frameworks by showing that focusing on the affordability of individual drugs often misses critical patient context about patients’ broader challenges. Policymakers risk overlooking the burdens that make medications inaccessible, including insurance design, cumulative healthcare costs, and complex personal circumstances. The report highlights that affordability, as defined by patients, is not limited to drug price or out-of-pocket (OOP) costs. Rather, it reflects broader personal experiences, evolving circumstances, and individual interpretations. Results of the study indicate that insurance design, financial assistance, and the overall burden of managing chronic illness play a significant role in patient considerations of affordability. The survey findings point to clear areas for policy reform to reduce financial stress, improve adherence, and better align affordability efforts with patient needs. A companion policy brief offers actionable recommendations. Click here to read more.
3. Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. A new analysis by the Office of Health Economics (OHE) – the world’s oldest independent health economics research organization – sheds light on this crucial issue. To answer the question of how QALYs are used across countries to inform reimbursement and pricing decisions, OHE reviewed Health Technology Assessment (HTA) practices across Organisation for Economic Co-operation and Development (OECD) countries, with a goal of reporting on how QALYs are used in pricing and reimbursement decisions. OECD member countries have been the reference for prices included in proposed U.S. drug pricing policies such as “Most Favored Nation” pricing, a concept advanced by the current Trump administration, as well as Congressional legislative proposals. Click here to read more.
4. Reps. Cammack and Hern Introduce QALY Ban Bill. Representatives Kat Cammack (FL-03) and Kevin Hern (OK-01) introduced the Protecting Health Care for All Patients Act to ensure that Americans with disabilities, chronic illnesses, and rare conditions are not devalued in federal health care decisions. This legislation prohibits the use of Quality-Adjusted Life Years (QALYs)—a metric that assigns lower value to lives with disabilities— and similar measures in federal programs like Medicare, Medicaid, CHIP, and ACA exchanges. “The use of so-called cost-effective measures like QALYs threatens access to lifesaving care for the most vulnerable Americans,” said Congresswoman Cammack. “I am honored to lead this legislation alongside my colleague Rep. Kevin Hern to ensure that no patient is denied treatment simply because a mathematical formula decided their life is worth less. Every American—regardless of disability, chronic illness, or rare condition—deserves equal access to care.” View the press release here. View more information about the bill here. View PIPC's one pager here.
5. Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. In 2021, the Partnership to Improve Patient Care (PIPC), the American Association of People with Disabilities, and several organizations from the patient and disability communities partnered to publish an Open Letter that grounded our advocacy against policies that would reference QALYs and similar measures that devalue people with disabilities and older adults. Please join PIPC, ALS Association, Alliance for Aging Research, American Association of People with Disabilities, Epilepsy Foundation of America and Patients Rights Action Fund in signing a revised Open Letter! The threat for incorporating QALYs and similar measures into the American health system has grown with the last administration’s reference to QALY-based studies in the Medicare Drug Negotiation Program and in this administration's Executive Order seeking to model foreign countries that base drug prices on discriminatory value assessments. It is our goal to capitalize on the long history of robust, bipartisan opposition to QALY-based policies in Medicare and Medicaid that underscores America’s core belief that the lives of individuals with disabilities, older adults and infants are worth just as much as any other person.
The central theme of the updated letter is this: All lives are valuable, and our health care policy should adhere to this fundamental American belief. We strongly urge policymakers to reject policies that would devalue and ration care for any American whether modeled after foreign or domestic value assessment methodologies.
Click HERE to sign the updated Open Letter. Note we will add new signatories every few days to the updated letter which is available to share with policymakers here.
Click here to contact your Member of Congress.
6. COGI Reiterates Process Concerns for Maryland PDAB, Highlights NAACP Resolution. The Color of Gastrointestinal Illnesses (COGI) sent a new letter to the Maryland Prescription Drug Affordability Board raising concerns that the PDAB has been unresponsive to patients and people with disabilities. The letter highlights that the Board has not provided "assurances that setting Upper Payment Limits (UPL) will not impact patient access to care, that the affordability review process will not rely on value assessment measures known to discriminate against people with disabilities and serious chronic conditions such as quality-adjusted life years (QALYs) and similar measures, nor that there is a process to handle unintended consequences for patients in a timely and efficient manner.” COGI also highlighted that the NAACP recently passed a resolution as part of its 116th Convention calling on policymakers to reject determinations of care that are based on QALYs, underscoring the implications on health equity. View the letter here.
7. Webinar Series on Newborn Screening: A Vision for Sustaining and Advancing Excellence. In 2025, the National Academies of Sciences, Engineering, and Medicine released a consensus report, Newborn Screening: A Vision for Sustaining and Advancing Excellence, with actionable recommendations to strengthen newborn screening as an essential public health service. Genetic Alliance is hosting a three-part webinar series highlighting key findings from the report and inviting discussion among interest holders across the newborn screening ecosystem. The three webinars will cover the following topics: (1) Reflections on the Report from the Rare Disease Community; (2) Newborn Screening as a High-Quality Public Health Service for All; and (3) Newborn Screening as a High-Quality Public Health Service for All. Click here to learn more.
8. PIPC Leads Comment Letter on Third Cycle of Medicare Drug Price Negotiation Program. The Partnership to Improve Patient Care (PIPC) and 34 organizations representing patients, people with disabilities, and older adults submitted a comment letter to the Centers for Medicare and Medicaid Services (CMS) on the third cycle of the Medicare Drug Price Negotiation Program. The letter underscores the importance of patient engagement, particularly in decisions related to clinical effectiveness, unmet medical need, and therapeutic alternatives. The letter also urges CUS to avoid the use of value assessment metrics that restrict access to care.
Specifically, the letter offers the following recommendations: (1) CMS should avoid one-size fits all value metrics; (2) CMS should develop a formalized process to ensure continuous, robust engagement of patients and people with disabilities at multiple levels; (3) using patient insights, CMS should clearly communicate how it intends to use the input it receives, and how that input is reflected in the final negotiated prices; (4) CMS should solicit input from a variety of patients who rely on the treatments in question, including those in rural areas to ensure representation of the diversity of the patients and communities affected by the topic; (5) CMS should ensure that opportunities for patient engagement are accessible; and (6) to gauge both successes and challenges, CMS should establish a structured process for continuous review and assessment of its engagement strategy.
Click here to read the letter from PIPC and others. Click here to view the EACH/PIC Coalition letter expressing similar concerns.
9. National Minority Quality Forum Issue Brief Details MFN Consequences. The National Minority Quality Forum (NMQF) has released an issue brief examining the potential consequences of the Most Favored Nation (MFN) model recently introduced by President Trump in an executive order. The brief identifies five key concerns about MFN implementation: (1) creation of harmful timing mismatches between disease progression and bureaucratic processes; (2) disruption of innovation ecosystems for conditions affecting Americans; (3) the imposition of one-size-fits-all approaches that ignore unique biological needs; (4) importation of discriminatory evaluation tools that devalue vulnerable populations; and (5) legal and investment uncertainty that will immediately chill biomedical research.
Particularly concerning for NMQF is the model’s reliance on foreign pricing systems that often use quality-adjusted life year (QALY) metrics that systematically undervalue treatments for disabilities, rare diseases, and conditions disproportionately affecting communities of color.
Click here to read the issue brief.
10. Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods. A new report from No Patient Left Behind (NPLB) argues that faulty value assessments significantly underestimate the true societal benefits of innovative medicines. "Typically, HTAs have used what NPLB calls 'outdated' willingness-to-pay thresholds that tend to be built on “flawed” quality-adjusted life years. NPLB argues that these calculations do not adequately factor in benefits beyond those to the patient. '[T]hey ignore that new medicines not only benefit patients, but also their family members and society at large by enabling faster return to work, therefore increasing taxes paid and disability allowances not paid,' the report said." Click here to read the report.
11. Update on the Texas v. Kennedy Lawsuit. Texas v. Kennedy is a lawsuit brought by 17 states in federal court in the Northern District of Texas. The lawsuit challenges 2024 regulations from the U.S. Department of Health and Human Services (HHS), claiming that Section 504 of the Rehabilitation Act is unconstitutional.
As outlined by Bazelon, DREDF, The Arc, CPR and National Health Law Program, the Texas v. Kennedy case remains a significant threat to the rights of people with disabilities. The 17 states continue to challenge the updated Section 504 regulations, which include a ban on disability discrimination in medical treatment decisions including the use of discriminatory value assessments. The parties’ next filing is due on July 21, 2025. Advocates are urging the 17 state’s Attorneys General to withdraw from the case.
View the update here. Click here and scroll down to reach out to your State Attorney General.
12. Learn More About Alternative Measures for Value Assessment. PIPC has developed new resources about alternative methods and metrics for value assessment. It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. Click here to learn more.
Learn More About Emerging Threats in States for Use of Discriminatory Metrics
Several states are advancing policies that would reference quality-adjusted life years (QALYs) and similar measures known to discriminate and devalue people with disabilities and serious chronic conditions, despite laws barring their use. Contrary to the law, these measures are considered by some to be the “gold standard” for measuring cost effectiveness of treatments, including the Institute for Clinical and Economic Review (ICER) and by foreign countries. Their use as a reference for U.S. coverage and reimbursement decisions is concerning due to implications for access to care, as seen internationally where a focus on cost effectiveness disadvantages coverage of health care for people with conditions that are chronic or disabling. To keep track of state-based threats, several resources are available:
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.
View PIPC value assessment resources on gene therapies here, on health equity here and an analysis on lack of patient-centered outcomes in value assessment here.
Upcoming Events and Webinars
Webinar Series on Newborn Screening: Webinar #3
August 14, 2025
Click here to view.
Oregon PDAB Meeting
August 20, 2025
Click here to view.
Colorado PDAB Meeting
August 22, 2025
Click here to view.
Maryland PDAB Meeting
September 15, 2025
Click here to view.
Washington State PDAB Meeting
September 17, 2025
Click here to view.
ICHOM Conference
Sept. 29-Oct. 1, 2025
Click here to view.
PCORI Annual Meeting
Oct. 21-22, 2025
Click here to view.
PIPC welcomes new members to advance our efforts to assure patients and people with disabilities are at the center of research and policy! Please reach out to [email protected] for more information.
1. CMS Referenced QALYs in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of value assessments that rely on the quality-adjusted life year (QALY) and the equal value of life year gained (evLYG), measures that are contrary to the laws governing Medicare and barring disability discrimination. In the explanations released on December 20, 2024, CMS explicitly listed studies that included reference to QALYs. View a recently published study highlighting the extent to which QALYs were referenced in CMS’ explanations last December here.
2. EACH/PIC Releases Results from Patient-Led Survey on Drug Affordability. The Ensuring Access through Collaborative Health and Patient Inclusion Council (EACH/PIC) has released the findings of its new report, Patient Experience Survey: Prescription Drug Affordability and Unaffordability, which captures how patients and caregivers define and experience prescription drug affordability. The results challenge conventional cost-review frameworks by showing that focusing on the affordability of individual drugs often misses critical patient context about patients’ broader challenges. Policymakers risk overlooking the burdens that make medications inaccessible, including insurance design, cumulative healthcare costs, and complex personal circumstances. The report highlights that affordability, as defined by patients, is not limited to drug price or out-of-pocket (OOP) costs. Rather, it reflects broader personal experiences, evolving circumstances, and individual interpretations. Results of the study indicate that insurance design, financial assistance, and the overall burden of managing chronic illness play a significant role in patient considerations of affordability. The survey findings point to clear areas for policy reform to reduce financial stress, improve adherence, and better align affordability efforts with patient needs. A companion policy brief offers actionable recommendations. Click here to read more.
3. Data Mine Blog Analyzes a New Study from OHE on International Reference to QALYs. A new analysis by the Office of Health Economics (OHE) – the world’s oldest independent health economics research organization – sheds light on this crucial issue. To answer the question of how QALYs are used across countries to inform reimbursement and pricing decisions, OHE reviewed Health Technology Assessment (HTA) practices across Organisation for Economic Co-operation and Development (OECD) countries, with a goal of reporting on how QALYs are used in pricing and reimbursement decisions. OECD member countries have been the reference for prices included in proposed U.S. drug pricing policies such as “Most Favored Nation” pricing, a concept advanced by the current Trump administration, as well as Congressional legislative proposals. Click here to read more.
4. Reps. Cammack and Hern Introduce QALY Ban Bill. Representatives Kat Cammack (FL-03) and Kevin Hern (OK-01) introduced the Protecting Health Care for All Patients Act to ensure that Americans with disabilities, chronic illnesses, and rare conditions are not devalued in federal health care decisions. This legislation prohibits the use of Quality-Adjusted Life Years (QALYs)—a metric that assigns lower value to lives with disabilities— and similar measures in federal programs like Medicare, Medicaid, CHIP, and ACA exchanges. “The use of so-called cost-effective measures like QALYs threatens access to lifesaving care for the most vulnerable Americans,” said Congresswoman Cammack. “I am honored to lead this legislation alongside my colleague Rep. Kevin Hern to ensure that no patient is denied treatment simply because a mathematical formula decided their life is worth less. Every American—regardless of disability, chronic illness, or rare condition—deserves equal access to care.” View the press release here. View more information about the bill here. View PIPC's one pager here.
5. Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. In 2021, the Partnership to Improve Patient Care (PIPC), the American Association of People with Disabilities, and several organizations from the patient and disability communities partnered to publish an Open Letter that grounded our advocacy against policies that would reference QALYs and similar measures that devalue people with disabilities and older adults. Please join PIPC, ALS Association, Alliance for Aging Research, American Association of People with Disabilities, Epilepsy Foundation of America and Patients Rights Action Fund in signing a revised Open Letter! The threat for incorporating QALYs and similar measures into the American health system has grown with the last administration’s reference to QALY-based studies in the Medicare Drug Negotiation Program and in this administration's Executive Order seeking to model foreign countries that base drug prices on discriminatory value assessments. It is our goal to capitalize on the long history of robust, bipartisan opposition to QALY-based policies in Medicare and Medicaid that underscores America’s core belief that the lives of individuals with disabilities, older adults and infants are worth just as much as any other person.
The central theme of the updated letter is this: All lives are valuable, and our health care policy should adhere to this fundamental American belief. We strongly urge policymakers to reject policies that would devalue and ration care for any American whether modeled after foreign or domestic value assessment methodologies.
Click HERE to sign the updated Open Letter. Note we will add new signatories every few days to the updated letter which is available to share with policymakers here.
Click here to contact your Member of Congress.
6. COGI Reiterates Process Concerns for Maryland PDAB, Highlights NAACP Resolution. The Color of Gastrointestinal Illnesses (COGI) sent a new letter to the Maryland Prescription Drug Affordability Board raising concerns that the PDAB has been unresponsive to patients and people with disabilities. The letter highlights that the Board has not provided "assurances that setting Upper Payment Limits (UPL) will not impact patient access to care, that the affordability review process will not rely on value assessment measures known to discriminate against people with disabilities and serious chronic conditions such as quality-adjusted life years (QALYs) and similar measures, nor that there is a process to handle unintended consequences for patients in a timely and efficient manner.” COGI also highlighted that the NAACP recently passed a resolution as part of its 116th Convention calling on policymakers to reject determinations of care that are based on QALYs, underscoring the implications on health equity. View the letter here.
7. Webinar Series on Newborn Screening: A Vision for Sustaining and Advancing Excellence. In 2025, the National Academies of Sciences, Engineering, and Medicine released a consensus report, Newborn Screening: A Vision for Sustaining and Advancing Excellence, with actionable recommendations to strengthen newborn screening as an essential public health service. Genetic Alliance is hosting a three-part webinar series highlighting key findings from the report and inviting discussion among interest holders across the newborn screening ecosystem. The three webinars will cover the following topics: (1) Reflections on the Report from the Rare Disease Community; (2) Newborn Screening as a High-Quality Public Health Service for All; and (3) Newborn Screening as a High-Quality Public Health Service for All. Click here to learn more.
8. PIPC Leads Comment Letter on Third Cycle of Medicare Drug Price Negotiation Program. The Partnership to Improve Patient Care (PIPC) and 34 organizations representing patients, people with disabilities, and older adults submitted a comment letter to the Centers for Medicare and Medicaid Services (CMS) on the third cycle of the Medicare Drug Price Negotiation Program. The letter underscores the importance of patient engagement, particularly in decisions related to clinical effectiveness, unmet medical need, and therapeutic alternatives. The letter also urges CUS to avoid the use of value assessment metrics that restrict access to care.
Specifically, the letter offers the following recommendations: (1) CMS should avoid one-size fits all value metrics; (2) CMS should develop a formalized process to ensure continuous, robust engagement of patients and people with disabilities at multiple levels; (3) using patient insights, CMS should clearly communicate how it intends to use the input it receives, and how that input is reflected in the final negotiated prices; (4) CMS should solicit input from a variety of patients who rely on the treatments in question, including those in rural areas to ensure representation of the diversity of the patients and communities affected by the topic; (5) CMS should ensure that opportunities for patient engagement are accessible; and (6) to gauge both successes and challenges, CMS should establish a structured process for continuous review and assessment of its engagement strategy.
Click here to read the letter from PIPC and others. Click here to view the EACH/PIC Coalition letter expressing similar concerns.
9. National Minority Quality Forum Issue Brief Details MFN Consequences. The National Minority Quality Forum (NMQF) has released an issue brief examining the potential consequences of the Most Favored Nation (MFN) model recently introduced by President Trump in an executive order. The brief identifies five key concerns about MFN implementation: (1) creation of harmful timing mismatches between disease progression and bureaucratic processes; (2) disruption of innovation ecosystems for conditions affecting Americans; (3) the imposition of one-size-fits-all approaches that ignore unique biological needs; (4) importation of discriminatory evaluation tools that devalue vulnerable populations; and (5) legal and investment uncertainty that will immediately chill biomedical research.
Particularly concerning for NMQF is the model’s reliance on foreign pricing systems that often use quality-adjusted life year (QALY) metrics that systematically undervalue treatments for disabilities, rare diseases, and conditions disproportionately affecting communities of color.
Click here to read the issue brief.
10. Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods. A new report from No Patient Left Behind (NPLB) argues that faulty value assessments significantly underestimate the true societal benefits of innovative medicines. "Typically, HTAs have used what NPLB calls 'outdated' willingness-to-pay thresholds that tend to be built on “flawed” quality-adjusted life years. NPLB argues that these calculations do not adequately factor in benefits beyond those to the patient. '[T]hey ignore that new medicines not only benefit patients, but also their family members and society at large by enabling faster return to work, therefore increasing taxes paid and disability allowances not paid,' the report said." Click here to read the report.
11. Update on the Texas v. Kennedy Lawsuit. Texas v. Kennedy is a lawsuit brought by 17 states in federal court in the Northern District of Texas. The lawsuit challenges 2024 regulations from the U.S. Department of Health and Human Services (HHS), claiming that Section 504 of the Rehabilitation Act is unconstitutional.
As outlined by Bazelon, DREDF, The Arc, CPR and National Health Law Program, the Texas v. Kennedy case remains a significant threat to the rights of people with disabilities. The 17 states continue to challenge the updated Section 504 regulations, which include a ban on disability discrimination in medical treatment decisions including the use of discriminatory value assessments. The parties’ next filing is due on July 21, 2025. Advocates are urging the 17 state’s Attorneys General to withdraw from the case.
View the update here. Click here and scroll down to reach out to your State Attorney General.
12. Learn More About Alternative Measures for Value Assessment. PIPC has developed new resources about alternative methods and metrics for value assessment. It is now widely recognized that traditional methods and metrics of value assessment – including the quality-adjusted life year (QALY) – have significant shortcomings. This has led to well-intentioned development of other measures and approaches that developers assert to be nondiscriminatory and more patient-centered. However, each approach comes with tradeoffs, need for improvement, and inherent methodological flaws. No patient is average, and no measure of value should assume so. Click here to learn more.
Learn More About Emerging Threats in States for Use of Discriminatory Metrics
Several states are advancing policies that would reference quality-adjusted life years (QALYs) and similar measures known to discriminate and devalue people with disabilities and serious chronic conditions, despite laws barring their use. Contrary to the law, these measures are considered by some to be the “gold standard” for measuring cost effectiveness of treatments, including the Institute for Clinical and Economic Review (ICER) and by foreign countries. Their use as a reference for U.S. coverage and reimbursement decisions is concerning due to implications for access to care, as seen internationally where a focus on cost effectiveness disadvantages coverage of health care for people with conditions that are chronic or disabling. To keep track of state-based threats, several resources are available:
- Patient Access Project State-by-state tracker of QALY-based policies and legislation, including Prescription Drug Affordability Boards, P&T Committees, and reference to discriminatory policies in foreign countries.
- Value Of Care Coalition advocacy tracker of state PDAB comment opportunities.
- AIMED Alliance resources and tracker of state PDAB activities.
- PIPC resources on use of QALYs and similar measures internationally.
- EACH/PIC Coalition resources.
- Value Our Health toolkit and resources on implications for disability discrimination.
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. Prolonged government drug pricing negotiations are leading to patients in certain provinces and territories that not receiving access to certain medicines compared to others.
- New Zealand. An op-ed in the NZ Herald explains how the QALY doesn’t account for broader system benefits: medicines that prevent hospitalization, help people stay in work, reduce caregiving pressure or support mental wellbeing.
- United Kingdom. A woman with a rare life-shortening genetic disease is battling for treatment after being told access to help would not be a “cost-effective use of NHS resources.”
- United Kingdom. Barriers to patient access for rare cancer treatments means that a teenage patient must travel abroad to seek life-saving treatment, funded largely by crowd donations.
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.
View PIPC value assessment resources on gene therapies here, on health equity here and an analysis on lack of patient-centered outcomes in value assessment here.
- Launch Price and Access Report: Drug Approvals from 2023-2024: Protocol available.
- Smoking Cessation: Revised Scoping Document, Research Protocol available. Public meeting: January 2026.
- Obesity Management: Model Analysis Plan available. Public meeting: November 2025.
- Examining Strategies to Ensure Affordable Access for Obesity Medications: White Paper published on April 9, 2025.
- Non-Cystic Fibrosis Bronchiectasis: Draft Evidence report available. Public comments due August 19, 2025. Public meeting: September 2025.
- Spinal Muscular Atrophy: Evidence Report, Evidence Presentation available. Public meeting: August 2025.
- Multiple Sclerosis — SPMS: Final Evidence Report and Meeting Summary available.
- Retinitis Pigmentosa: Final Evidence Report and Meeting Summary available.
Upcoming Events and Webinars
Webinar Series on Newborn Screening: Webinar #3
August 14, 2025
Click here to view.
Oregon PDAB Meeting
August 20, 2025
Click here to view.
Colorado PDAB Meeting
August 22, 2025
Click here to view.
Maryland PDAB Meeting
September 15, 2025
Click here to view.
Washington State PDAB Meeting
September 17, 2025
Click here to view.
ICHOM Conference
Sept. 29-Oct. 1, 2025
Click here to view.
PCORI Annual Meeting
Oct. 21-22, 2025
Click here to view.
