In this week's edition...
— PIPC Calls on Policymakers to Avoid Devaluing Patients, People with Disabilities and Older Adults. See details below.
— Make Your Voice Heard in the Oregon PDAB. Click here to watch the video.
— 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— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods.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.
— Maryland Matters: It’s Time to Hit Pause on the PDAB. See details below.
— Use of QALYs and Similar Measures Deemed Acceptable in MD, Considered in Congress. See details below.
— The Protecting Health Care for All Patients Act Has No Budget Impact. 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.
— PIPC Calls on Policymakers to Avoid Devaluing Patients, People with Disabilities and Older Adults. See details below.
— Make Your Voice Heard in the Oregon PDAB. Click here to watch the video.
— 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— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods.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.
— Maryland Matters: It’s Time to Hit Pause on the PDAB. See details below.
— Use of QALYs and Similar Measures Deemed Acceptable in MD, Considered in Congress. See details below.
— The Protecting Health Care for All Patients Act Has No Budget Impact. 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. PIPC Calls on Policymakers to Avoid Devaluing Patients, People with Disabilities and Older Adults. The Partnership to Improve Patient Care (PIPC) has issued the following statement calling on the Trump administration to avoid policies that discriminate against patients and people with disabilities.
Since its founding, the Partnership to Improve Patient Care (PIPC) has been at the forefront of the fight to put patients first in our nation’s healthcare system and ensure individual patients with different health care needs – including people with disabilities and older adults – are not ignored and devalued. In this fight, we have always opposed use of cost effectiveness measures and standards that deem certain populations as unworthy of treatment in government programs. As Congress and the administration seek policies to improve patient care and health care affordability, we urge all policymakers to again reject any policy that relies on quality-adjusted life years (QALYs) or similar measures. Instead, PIPC supports approaches that ensure patients, people with disabilities and older adults are valued in the U.S. health care system – a key differentiator between our country and countries that openly embrace utilitarian models of health care and care rationing, dictating the care provided based on its cost effectiveness and the value placed on those receiving care in those countries.
We were pleased that the first administration under President Trump enforced disability nondiscrimination laws against the implementation of Crisis Standards of Care in several states that would have explicitly put people with disabilities and older adults at the back of the line for care in a shortage, openly recognizing that every American is worth treating regardless of age or disability. In the last Congress, every House Republican voted to ban the use of QALYs in a bill advanced by the Energy and Commerce Committee and lauded by disability and patient advocates across the country.
We have begun to see increasing use of QALYs and similar measures that devalue people with disabilities and older adults as the basis for reimbursement and coverage decisions that impact access to care and undermine clinicians. This is inconsistent with efforts of the President’s first administration and existing federal laws specifically enacted to protect the most vulnerable patients.
We look forward to working with the Congress and administration on policies that build on the President’s first term efforts to assure every person is valued in America’s health system, starting with a commitment to ban the use of discriminatory value assessments across federal programs. We look forward to working together to put America’s patients and providers in charge of healthcare.
2. Make Your Voice Heard in the Oregon PDAB. The Oregon PDAB will meet next on May 21, 2025, during which it will receive testimony related to the drugs selected for review. The Patient Inclusion Council is a resource for patients seeking to testify at the hearing - reach out here. Patients are strongly encouraged to testify so that the PDAB is aware of the impact and value of the selected drugs for patients, whether alternatives are (or are not) interchangeable, and how formulary placement impacts affordability (as advocates push for explicit protections against adverse formulary placement resulting from this process). Caring Ambassadors and PIPC Executive Director Sara van Geertruyden recently did a deep dive on the Oregon PDAB ahead of upcoming drug reviews. Watch the video to learn more about OR PDAB, their drug review process, and the implications of their use of discriminatory value assessments. Click here to watch the video. Click here to view the selected drugs. Click here to register to testify at the May 21 PDAB meeting.
3. Patient Groups Call Attention to Payer’s Discriminatory Policy. 57 patient advocacy organizations led by Little Hercules Foundation sent a letter 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.
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. Maryland Matters: It’s time to hit pause on the PDAB. An op-ed from Melodie Narain-Blackwell, founder of the Color of Gastrointestinal Illnesses, urges the Maryland Prescription Drug Affordability Board (PDAB) to put patients first and not adopt discriminatory, one-size-fits-all coverage decisions. "Based on my experience and so many like me, I worry the activities of the Maryland Prescription Drug Affordability Board will exacerbate existing health disparities. In this age of personalized medicine, clinicians can prescribe treatment based on evidence of clinical effectiveness based on personal characteristics. Drugs do not have the same impact on different patients, and policies should not allow physicians to be steered by payers into prescribing decisions. Insurers are not doctors." Click here to read the op-ed. Please share a survey by and for patients to ensure that PDABs have accurate information from patients on why a prescription drug is affordable, unaffordable, accessible, or not accessible.
7. Use of QALYs and Similar Measures Deemed Acceptable in MD, Considered in Congress. PIPC is closely monitoring the ongoing consideration of importing the use of QALYs and similar measures from foreign countries as part of state-based affordability reviews and setting reimbursement. PIPC has provided a series of comments to entities known as Prescription Drug Affordability Boards (PDAB) in states including Maryland, Oregon, Washington, and Colorado to share and explain how discriminatory value assessments are used internationally to establish coverage and reimbursement policies. Washington State has chosen to collect data reflecting QALYs from other countries, and other state PDABs have regulations allowing them to do so. Oregon’s PDAB is openly considering the equal value and life year gained, a measure derived from the QALY and therefore using the same biased health utility data.
On Feb. 26, 2025, the Maryland PDAB openly considered PIPC’s comments opposing the use of QALY-based studies from other countries. In concluding not to take action to limit the Board’s use of QALYs and similar measures, one board member stated, "I don't think we should take data off the table. I think we should use as much data as we possibly can use. Some of us are good fans of QALY, some of us are not good fans of the QALYs. So I think having as much data as possible to make a decision is always a good thing.” The Maryland legislature passed SB357, a bill to expand the reach of the state’s PDAB to the commercial insurance market despite patient and disability concerns.
8. The Protecting Health Care for All Patients Act Has No Budget Impact. Last Congress, the Protecting Health Care for All Patients Act (H.R. 485) passed the House of Representatives on Feb. 7, 2024. Since finalization of the Section 504 rules barring disability discrimination in May 2024, Congressional staff have been informed that the House-passed bill has no budget impact. When considered in the House, the Biden administration's concerns about the bill were limited to the use of a budget offset from the CDC, which is no longer needed. As highlighted by the previous administration, Democrats supported the original QALY ban in the Affordable Care Act and the nondiscrimination provisions in the IRA. The bill has not yet been reintroduced. Without the need for an offset, this bipartisan policy change has a stronger chance of consideration this year. People with disabilities and serious chronic conditions continue to support this legislation extending the law barring Medicare’s use of quality-adjusted life years (QALYs) and similar measures to other programs.
As CBO stated when the bill was introduced, current law already prohibits the Secretary from using QALYs and similar measures in Medicare, giving it no impact on the Medicare Drug Price Negotiation Program, which is subject to both the nondiscrimination provisions in the IRA and in the ACA. Entities receiving federal financial assistance (i.e. all the entities impacted by the bill) are also subject to the rules governing Section 504 of the Rehabilitation Act that similarly bar the use of use any measure, assessment, or tool that discounts the value of life extension on the basis of disability (i.e. QALYs) to deny or afford an unequal opportunity to qualified individuals with disabilities, with the agency also clarifying that methods of utility weight generation are also subject to Section 504 when they are used in a way that discriminates. The Protecting Health Care for All Patients Act would explicitly make the statute governing use of QALYs and similar measures also clear and consistent across federal and state programs.
We urge advocates to call on Congress to take action to pass The Protecting Health Care for All Patients Act this year. Click here to view a one-pager about the bill. The National Down Syndrome Society has updated their FAQ on the legislation here.
9. 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.
10. 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.
ICHOM Conference
Sept. 29-Oct 1. 2025
Click here to view.
PCORI Annual Meeting
Oct. 21-22, 2025
Click here to view.
AHRQ Effective Program Updates
Systematic Review: Behavioral Interventions for Migraine Prevention. Click here to view.
Systematic Review: Healthcare Delivery of Clinical Preventive Services for People With Disabilities. Click here to view.
Systematic Review: Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents. Click here to view.
Research Protocol: Making Healthcare Safer IV: Programs for Responding to Harms Experienced by Patients during Clinical Care. Click here to view.
Research Protocol: Making Healthcare Safer IV: High Reliability Organization (HRO) as a Patient Safety Practice Click here to view.
Research Protocol: Making Healthcare Safer IV: Supply Chain Disruption Monitoring Programs Click here to view.
1. PIPC Calls on Policymakers to Avoid Devaluing Patients, People with Disabilities and Older Adults. The Partnership to Improve Patient Care (PIPC) has issued the following statement calling on the Trump administration to avoid policies that discriminate against patients and people with disabilities.
Since its founding, the Partnership to Improve Patient Care (PIPC) has been at the forefront of the fight to put patients first in our nation’s healthcare system and ensure individual patients with different health care needs – including people with disabilities and older adults – are not ignored and devalued. In this fight, we have always opposed use of cost effectiveness measures and standards that deem certain populations as unworthy of treatment in government programs. As Congress and the administration seek policies to improve patient care and health care affordability, we urge all policymakers to again reject any policy that relies on quality-adjusted life years (QALYs) or similar measures. Instead, PIPC supports approaches that ensure patients, people with disabilities and older adults are valued in the U.S. health care system – a key differentiator between our country and countries that openly embrace utilitarian models of health care and care rationing, dictating the care provided based on its cost effectiveness and the value placed on those receiving care in those countries.
We were pleased that the first administration under President Trump enforced disability nondiscrimination laws against the implementation of Crisis Standards of Care in several states that would have explicitly put people with disabilities and older adults at the back of the line for care in a shortage, openly recognizing that every American is worth treating regardless of age or disability. In the last Congress, every House Republican voted to ban the use of QALYs in a bill advanced by the Energy and Commerce Committee and lauded by disability and patient advocates across the country.
We have begun to see increasing use of QALYs and similar measures that devalue people with disabilities and older adults as the basis for reimbursement and coverage decisions that impact access to care and undermine clinicians. This is inconsistent with efforts of the President’s first administration and existing federal laws specifically enacted to protect the most vulnerable patients.
We look forward to working with the Congress and administration on policies that build on the President’s first term efforts to assure every person is valued in America’s health system, starting with a commitment to ban the use of discriminatory value assessments across federal programs. We look forward to working together to put America’s patients and providers in charge of healthcare.
2. Make Your Voice Heard in the Oregon PDAB. The Oregon PDAB will meet next on May 21, 2025, during which it will receive testimony related to the drugs selected for review. The Patient Inclusion Council is a resource for patients seeking to testify at the hearing - reach out here. Patients are strongly encouraged to testify so that the PDAB is aware of the impact and value of the selected drugs for patients, whether alternatives are (or are not) interchangeable, and how formulary placement impacts affordability (as advocates push for explicit protections against adverse formulary placement resulting from this process). Caring Ambassadors and PIPC Executive Director Sara van Geertruyden recently did a deep dive on the Oregon PDAB ahead of upcoming drug reviews. Watch the video to learn more about OR PDAB, their drug review process, and the implications of their use of discriminatory value assessments. Click here to watch the video. Click here to view the selected drugs. Click here to register to testify at the May 21 PDAB meeting.
3. Patient Groups Call Attention to Payer’s Discriminatory Policy. 57 patient advocacy organizations led by Little Hercules Foundation sent a letter 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.
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. Maryland Matters: It’s time to hit pause on the PDAB. An op-ed from Melodie Narain-Blackwell, founder of the Color of Gastrointestinal Illnesses, urges the Maryland Prescription Drug Affordability Board (PDAB) to put patients first and not adopt discriminatory, one-size-fits-all coverage decisions. "Based on my experience and so many like me, I worry the activities of the Maryland Prescription Drug Affordability Board will exacerbate existing health disparities. In this age of personalized medicine, clinicians can prescribe treatment based on evidence of clinical effectiveness based on personal characteristics. Drugs do not have the same impact on different patients, and policies should not allow physicians to be steered by payers into prescribing decisions. Insurers are not doctors." Click here to read the op-ed. Please share a survey by and for patients to ensure that PDABs have accurate information from patients on why a prescription drug is affordable, unaffordable, accessible, or not accessible.
7. Use of QALYs and Similar Measures Deemed Acceptable in MD, Considered in Congress. PIPC is closely monitoring the ongoing consideration of importing the use of QALYs and similar measures from foreign countries as part of state-based affordability reviews and setting reimbursement. PIPC has provided a series of comments to entities known as Prescription Drug Affordability Boards (PDAB) in states including Maryland, Oregon, Washington, and Colorado to share and explain how discriminatory value assessments are used internationally to establish coverage and reimbursement policies. Washington State has chosen to collect data reflecting QALYs from other countries, and other state PDABs have regulations allowing them to do so. Oregon’s PDAB is openly considering the equal value and life year gained, a measure derived from the QALY and therefore using the same biased health utility data.
On Feb. 26, 2025, the Maryland PDAB openly considered PIPC’s comments opposing the use of QALY-based studies from other countries. In concluding not to take action to limit the Board’s use of QALYs and similar measures, one board member stated, "I don't think we should take data off the table. I think we should use as much data as we possibly can use. Some of us are good fans of QALY, some of us are not good fans of the QALYs. So I think having as much data as possible to make a decision is always a good thing.” The Maryland legislature passed SB357, a bill to expand the reach of the state’s PDAB to the commercial insurance market despite patient and disability concerns.
8. The Protecting Health Care for All Patients Act Has No Budget Impact. Last Congress, the Protecting Health Care for All Patients Act (H.R. 485) passed the House of Representatives on Feb. 7, 2024. Since finalization of the Section 504 rules barring disability discrimination in May 2024, Congressional staff have been informed that the House-passed bill has no budget impact. When considered in the House, the Biden administration's concerns about the bill were limited to the use of a budget offset from the CDC, which is no longer needed. As highlighted by the previous administration, Democrats supported the original QALY ban in the Affordable Care Act and the nondiscrimination provisions in the IRA. The bill has not yet been reintroduced. Without the need for an offset, this bipartisan policy change has a stronger chance of consideration this year. People with disabilities and serious chronic conditions continue to support this legislation extending the law barring Medicare’s use of quality-adjusted life years (QALYs) and similar measures to other programs.
As CBO stated when the bill was introduced, current law already prohibits the Secretary from using QALYs and similar measures in Medicare, giving it no impact on the Medicare Drug Price Negotiation Program, which is subject to both the nondiscrimination provisions in the IRA and in the ACA. Entities receiving federal financial assistance (i.e. all the entities impacted by the bill) are also subject to the rules governing Section 504 of the Rehabilitation Act that similarly bar the use of use any measure, assessment, or tool that discounts the value of life extension on the basis of disability (i.e. QALYs) to deny or afford an unequal opportunity to qualified individuals with disabilities, with the agency also clarifying that methods of utility weight generation are also subject to Section 504 when they are used in a way that discriminates. The Protecting Health Care for All Patients Act would explicitly make the statute governing use of QALYs and similar measures also clear and consistent across federal and state programs.
We urge advocates to call on Congress to take action to pass The Protecting Health Care for All Patients Act this year. Click here to view a one-pager about the bill. The National Down Syndrome Society has updated their FAQ on the legislation here.
9. 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.
10. 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: Patients with rate forms of cancer were forced to wait years to gain affordable access to treatment due to arbitrary, drawn-out coverage decisions.
- Canada: “Canadians are fortunate to be able to access high quality cancer care, [but] cost is a barrier that leaves a huge psychological impact on people.”
- United Kingdom: The families of children suffering with Duchenne Muscular Dystrophy say it's “unfair” and “completely frustrating” that they're being denied access to free drugs that will slow its progression.
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.
- Obesity Management: Draft Scoping Document available. Public comments due May 19, 2025.
- Examining Strategies to Ensure Affordable Access for Obesity Medications: White Paper published on April 9, 2025.
- Non-Cystic Fibrosis Bronchiectasis: Draft Scoping Document, Research Protocol available. Public meeting: September 2025.
- Spinal Muscular Atrophy: Research Protocol, Model Analysis Plan available. Public meeting: August 2025.
- Multiple Sclerosis — SPMS: Draft Evidence Report available. Comments due May 13, 2025. Public meeting: June 2025.
- Retinitis Pigmentosa: Public meeting held on April 11, 2025. Final evidence report to be released on May 15, 2025.
Upcoming Events and Webinars
PCORI Board of Governors Meeting
June 17-18, 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.
AHRQ Effective Program Updates
Systematic Review: Behavioral Interventions for Migraine Prevention. Click here to view.
Systematic Review: Healthcare Delivery of Clinical Preventive Services for People With Disabilities. Click here to view.
Systematic Review: Psychosocial and Pharmacologic Interventions for Disruptive Behavior in Children and Adolescents. Click here to view.
Research Protocol: Making Healthcare Safer IV: Programs for Responding to Harms Experienced by Patients during Clinical Care. Click here to view.
Research Protocol: Making Healthcare Safer IV: High Reliability Organization (HRO) as a Patient Safety Practice Click here to view.
Research Protocol: Making Healthcare Safer IV: Supply Chain Disruption Monitoring Programs Click here to view.
