In this week's edition...
— PIPC Calls on Policymakers to Avoid Devaluing Patients, People with Disabilities and Older Adults, Modeling Countries that Ration Care. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— PIPC to Hold a Webinar on Protecting Patient Access in Nevada. 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— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods.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.
— 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, Modeling Countries that Ration Care. See details below.
— National Minority Quality Forum Issue Brief Details MFN Consequences. Click here to read the issue brief.
— PIPC to Hold a Webinar on Protecting Patient Access in Nevada. 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— Report: Foreign Countries Rely on Flawed and Outdated HTA or Value Assessment Methods.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.
— 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.
1. PIPC Calls on Policymakers to Avoid Devaluing Patients, People with Disabilities and Older Adults, Modeling Countries that Ration Care.
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. Therefore, we urge that the Most Favored Nation policy be reconsidered to ensure that the United States does not import quality-adjusted life years (QALYs) and similar measures into the U.S. pricing structure.
We are grateful that President Trump took an important step forward to protect people with disabilities and older adults from policies that would otherwise make them less worthy of health care when taking a stand against state Crisis Standards of Care that violated federal law. These standards would have explicitly put people with disabilities and older adults at the back of the line for care in a shortage. Instead, President Trump openly recognized that every American is worth treating regardless of age or disability. President Trump’s bulletin to states stated, “As such, persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative ‘worth’ based on the presence or absence of disabilities or age. Decisions by covered entities concerning whether an individual is a candidate for treatment should be based on an individualized assessment of the patient based on the best available objective medical evidence.”
Consistent with the President’s first term, we hope the administration will reconsider looking to foreign nations that do not share his commitment to valuing the lives of all people, including those with disabilities and older adults. We remain concerned that the pricing, reimbursement and coverage policies in other countries rely on measures of cost effectiveness to ration care that devalue people with disabilities and older adults, contrary to federal law and policy. Therefore, we urge Congress and the administration to reconsider a Most Favored Nation policy that would import foreign standards for health care where disabled lives are too often not considered worth saving. In this moment, we are especially concerned about giving states more tools to restrict access to care for people with disabilities and older adults, as CMS had acknowledged to be the impact of a similar policy proposed in 2020. In the 2020 proposal, CMS acknowledged that a portion of the Most Favored Nation model’s savings “is attributable to beneficiaries not accessing their drugs through the Medicare benefit, along with the associated lost utilization.”
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 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 appreciate that 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 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. 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. PIPC to Hold a Webinar on Protecting Patient Access in Nevada. The Partnership to Improve Patient Care (PIPC) and the Value of Care Coalition will host a webinar on May 29 at 12:00pm PST (3:00pm EST) to educate people with disabilities, older adults and patients with serious chronic conditions about legislation that is under consideration in the Nevada legislature, AB 259. AB 259 automatically sets Medicare’s maximum fair price as the upper payment limit (UPL) for drugs whose price has been negotiated at the federal level. By doing so, the legislation removes opportunities for public input on potential access issues, raising concerns that treatment options will be limited without guaranteed cost savings for beneficiaries. The bill references certain Medicare drug prices, for which CMS has indicated a reliance on quality-adjusted life years (QALYs) and similar measures that discriminate against people with disabilities and older adults. Click here to register for the webinar.
4. 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 by the morning of May 20 to testify at the May 21 PDAB meeting.
5. 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.
6. 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.
7. 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.
8. 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.
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
Maryland PDAB Board Meeting
May 19, 2025
Click here to view.
Washington PDAB Board Meeting
May 21, 2025
Click here to view.
PAF Innovation Summit
May 22, 2025
Click here to view.
Colorado PDAB Board Meeting
May 23, 20
Click here to view.
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.
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. Therefore, we urge that the Most Favored Nation policy be reconsidered to ensure that the United States does not import quality-adjusted life years (QALYs) and similar measures into the U.S. pricing structure.
We are grateful that President Trump took an important step forward to protect people with disabilities and older adults from policies that would otherwise make them less worthy of health care when taking a stand against state Crisis Standards of Care that violated federal law. These standards would have explicitly put people with disabilities and older adults at the back of the line for care in a shortage. Instead, President Trump openly recognized that every American is worth treating regardless of age or disability. President Trump’s bulletin to states stated, “As such, persons with disabilities should not be denied medical care on the basis of stereotypes, assessments of quality of life, or judgments about a person’s relative ‘worth’ based on the presence or absence of disabilities or age. Decisions by covered entities concerning whether an individual is a candidate for treatment should be based on an individualized assessment of the patient based on the best available objective medical evidence.”
Consistent with the President’s first term, we hope the administration will reconsider looking to foreign nations that do not share his commitment to valuing the lives of all people, including those with disabilities and older adults. We remain concerned that the pricing, reimbursement and coverage policies in other countries rely on measures of cost effectiveness to ration care that devalue people with disabilities and older adults, contrary to federal law and policy. Therefore, we urge Congress and the administration to reconsider a Most Favored Nation policy that would import foreign standards for health care where disabled lives are too often not considered worth saving. In this moment, we are especially concerned about giving states more tools to restrict access to care for people with disabilities and older adults, as CMS had acknowledged to be the impact of a similar policy proposed in 2020. In the 2020 proposal, CMS acknowledged that a portion of the Most Favored Nation model’s savings “is attributable to beneficiaries not accessing their drugs through the Medicare benefit, along with the associated lost utilization.”
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 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 appreciate that 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 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. 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. PIPC to Hold a Webinar on Protecting Patient Access in Nevada. The Partnership to Improve Patient Care (PIPC) and the Value of Care Coalition will host a webinar on May 29 at 12:00pm PST (3:00pm EST) to educate people with disabilities, older adults and patients with serious chronic conditions about legislation that is under consideration in the Nevada legislature, AB 259. AB 259 automatically sets Medicare’s maximum fair price as the upper payment limit (UPL) for drugs whose price has been negotiated at the federal level. By doing so, the legislation removes opportunities for public input on potential access issues, raising concerns that treatment options will be limited without guaranteed cost savings for beneficiaries. The bill references certain Medicare drug prices, for which CMS has indicated a reliance on quality-adjusted life years (QALYs) and similar measures that discriminate against people with disabilities and older adults. Click here to register for the webinar.
4. 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 by the morning of May 20 to testify at the May 21 PDAB meeting.
5. 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.
6. 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.
7. 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.
8. 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.
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: Despite having top-tier insurance, cancer patients and their families are still forced to spend hundreds for medications that are not covered by the PBS.
- Australia: A new survey shows that more Australians are skipping medical care because of the cost or languish on public wait lists.
- New Zealand: An independent board released a review that found Pharmac's current approach is not fit for purpose and has called for an overhaul of both strategy and culture to support innovation and access.
- United Kingdom: Despite freezing charges on prescriptions, advocates warn that this will do little to tackle the deep inequalities in the U.K.’s outdated prescription drug program.
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: Revised 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. Public meeting: June 2025.
- Retinitis Pigmentosa: Final Evidence Report and Meeting Summary available.
Upcoming Events and Webinars
Maryland PDAB Board Meeting
May 19, 2025
Click here to view.
Washington PDAB Board Meeting
May 21, 2025
Click here to view.
PAF Innovation Summit
May 22, 2025
Click here to view.
Colorado PDAB Board Meeting
May 23, 20
Click here to view.
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.
