In this week's edition...
-- Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— Patient Groups Call Attention to Payer’s Discriminatory Policy. Click here to read the letter.
— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods.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.
— Follow the Medicaid Debate. See details below.
— CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. 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.
-- Opportunity: Sign an Open Letter Rejecting Use of QALYs and Similar Measures. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— Patient Groups Call Attention to Payer’s Discriminatory Policy. Click here to read the letter.
— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods.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.
— Follow the Medicaid Debate. See details below.
— CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. 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
1. 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 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 view and sign the Open Letter.
Click here to contact your Member of Congress.
2. 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.
3. Patient Groups Call Attention to Payer’s Discriminatory Policy. A Substack article on May 6, 2025 highlighted the “Dangerous Delay” posed by insurer policies that substitute their judgements for the FDA’s approval of breakthrough medications. “This shows how plans are moving away from care optimization and toward revenue optimization,” said Peter Rubin, the executive director of No Patient Left Behind. The article highlighted a letter from 57 patient advocacy organizations led by Little Hercules Foundation to Independence Blue Cross Blue Shield (IBX) regarding their policy to exclude coverage of treatments approved via FDA's accelerated approval pathway for the first 18 months of approval. This policy excludes treatments for oncology, creating an explicitly discriminatory policy against patients with rare diseases who have few treatment options. The groups called on IBX to immediately overturn this discriminatory policy. Click here to read the letter. Click here to view the article.
4. 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.
5. 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.
6. Follow the Medicaid Debate: Patients and people with disabilities are actively engaged with Congress and the White House in efforts to protect Medicaid. Resources for people with disabilities are available from NCIL and AAPD, for rare disease patients from EveryLife Foundation for Rare Diseases, as well as from Modern Medicaid Alliance.
7. CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of ICER’s 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 from the Institute for Clinical and Economic Review (ICER) in its explanations for the calculation of Maximum Fair Prices (MFPs) for the drugs Eliquis, Enbrel, Farxiga, and Xarelto. The explanation for Xarelto report also cites data from the National Institute for Health and Care Excellence (NICE) in the United Kingdom which is know for its explicit reliance on QALYs. In its public comments to CMS, ICER defends the use of the evLYG, calling it a nondiscriminatory alternative and highlighting its use by the Veterans Administration, Medicaid programs and private insurers. CMS did not acknowledge that the evLYG is a similar measure to the QALY that is barred under Section 1182 of the Affordable Care Act and under §84.56 of the rules governing Section 504 of the Rehabilitation Act barring disability discrimination. Click here to view the explanations from CMS.
8. 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.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
June 17-18, 2025
Click here to view.
Oregon PDAB Meeting
June 18, 2025
Click here to view.
New Hampshire PDAB Meeting
June 30, 2025
Click here to view.
Colorado PDAB Meeting
July 11, 2025
Click here to view.
Washington State PDAB Meeting
July 15, 2025
Click here to view.
Maryland PDAB Meeting
July 28, 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.
1. 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 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 view and sign the Open Letter.
Click here to contact your Member of Congress.
2. 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.
3. Patient Groups Call Attention to Payer’s Discriminatory Policy. A Substack article on May 6, 2025 highlighted the “Dangerous Delay” posed by insurer policies that substitute their judgements for the FDA’s approval of breakthrough medications. “This shows how plans are moving away from care optimization and toward revenue optimization,” said Peter Rubin, the executive director of No Patient Left Behind. The article highlighted a letter from 57 patient advocacy organizations led by Little Hercules Foundation to Independence Blue Cross Blue Shield (IBX) regarding their policy to exclude coverage of treatments approved via FDA's accelerated approval pathway for the first 18 months of approval. This policy excludes treatments for oncology, creating an explicitly discriminatory policy against patients with rare diseases who have few treatment options. The groups called on IBX to immediately overturn this discriminatory policy. Click here to read the letter. Click here to view the article.
4. 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.
5. 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.
6. Follow the Medicaid Debate: Patients and people with disabilities are actively engaged with Congress and the White House in efforts to protect Medicaid. Resources for people with disabilities are available from NCIL and AAPD, for rare disease patients from EveryLife Foundation for Rare Diseases, as well as from Modern Medicaid Alliance.
7. CMS References ICER and NICE in Explanations for Medicare Drug Price Negotiation Program. PIPC has long advocated against the reference of ICER’s 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 from the Institute for Clinical and Economic Review (ICER) in its explanations for the calculation of Maximum Fair Prices (MFPs) for the drugs Eliquis, Enbrel, Farxiga, and Xarelto. The explanation for Xarelto report also cites data from the National Institute for Health and Care Excellence (NICE) in the United Kingdom which is know for its explicit reliance on QALYs. In its public comments to CMS, ICER defends the use of the evLYG, calling it a nondiscriminatory alternative and highlighting its use by the Veterans Administration, Medicaid programs and private insurers. CMS did not acknowledge that the evLYG is a similar measure to the QALY that is barred under Section 1182 of the Affordable Care Act and under §84.56 of the rules governing Section 504 of the Rehabilitation Act barring disability discrimination. Click here to view the explanations from CMS.
8. 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.
- Australia: Restrictive pricing controls for a Cystic Fibrosis treatment has resulted in patients paying $250,000 a year for treatment that is widely available elsewhere.
- United Kingdom: A news investigation found that England hospitals are either delaying or are refusing to give the new treatment for a form of muscular dystrophy because of a complex “lottery” system.
- United Kingdom: "Some boys who were eligible for this drug six months ago are no longer eligible, because they've stopped walking."
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.
- Launch Price and Access Report: Drug Approvals from 2023-2024: Protocol available.
- Smoking Cessation: Draft Scoping Document available. Comments due June 10, 2025. Public meeting: January 2026.
- Obesity Management: Revised Scoping Document, Research Protocol 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: Model Analysis Plan available. Public meeting: September 2025.
- Spinal Muscular Atrophy: Draft Evidence Report available. Comments due June 24, 2025. Public meeting: August 2025.
- Multiple Sclerosis — SPMS: Evidence Report available. Public meeting: June 2025.
- Retinitis Pigmentosa: Final Evidence Report and Meeting Summary available.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
June 17-18, 2025
Click here to view.
Oregon PDAB Meeting
June 18, 2025
Click here to view.
New Hampshire PDAB Meeting
June 30, 2025
Click here to view.
Colorado PDAB Meeting
July 11, 2025
Click here to view.
Washington State PDAB Meeting
July 15, 2025
Click here to view.
Maryland PDAB Meeting
July 28, 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.
