A report by the Office of Health Economics (OHE) – the world’s oldest health economics research organization – confirms what we’ve been warning about for years. If the U.S. references prices in other countries, we’ll be embracing decisions that employ the quality adjusted life year (QALY). In fact, OHE’s analysis shows that 18 of the 19 countries referenced in CMS’ GLOBE and GUARD models make use of QALYs in their decisions about value and pricing.
There’s no denying that these two major new policy changes – proposed under the guise of “models” or “demonstrations” by the Center for Medicare and Medicaid Innovation (CMMI) – will import the use foreign value standards that devalue people with disabilities, older adults, and other groups.
The Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model would impact drugs in Medicare Part D. The Global Benchmark for Efficient Drug Pricing (GLOBE) Model would impact drugs in Medicare Part B. Both models would reference the values and pricing established in 19 foreign countries as the determination of value that America places on specialized treatments for patients with disabling and chronic conditions, as well as older adults. This move is inconsistent with what Americans value in medicine – like making sure people with rare, life-threatening diseases have early access to treatment, and empowering patients and people with disabilities to make the treatment decision best for them as individuals. It also conflicts with hard-fought bipartisan laws like the prohibition against use of QALYs in Medicare and safeguards in the Americans with Disabilities Act (ADA) that protect people with disabilities from being devalued in American society.
In their analysis, OHE reviewed Health Technology Assessment (HTA) practices across Organisation for Economic Co-operation and Development (OECD) countries and reported on how QALYs are used in pricing and reimbursement decisions. According to their findings, 18 of the 19 countries referenced by the GLOBE and GUARD models reference QALYs in their decisions about value and pricing. That means each of these countries either use a QALY-based benchmark of whether a drug is “cost effective,” or they reference QALYs in a more general way without setting a formal threshold in deciding whether to pay for it or cover its cost for patients. Either way, nearly all the countries referenced by the GLOBE and GUARD models reference this measure, which is widely known to devalue disabled lives – and barred from use in American health programs – to make decisions.
We know that use of QALYs in government decision-making has real consequences for patients. Patients in other countries do not have timely access to many new treatments. In most other countries, drugs take two years or more after being approved in the U.S. to be approved there, and many drugs may not ever get approved and marketed in those countries. Health systems abroad reflect cultures that do not value improving or extending the lives of people with disabilities or older adults. The is not the American ethos.
This fact raises serious questions and concerns about how these new models will change the ethic of the American health system, in which bipartisan legal safeguards exist to protect people with disabilities from being denied or given limited health care based on public perceptions or judgements about their quality of life and whether it is worth saving. American policymakers have consistently sought to protect people with disabilities against discrimination in our health system. In 1992, the Bush administration determined Medicaid programs would be in violation of the ADA by referencing QALYs. In 2010, the Affordable Care Act (ACA) barred QALYs and similar measures from being used in reimbursement and coverage decisions in Medicare.
In 2019, the National Council on Disability (NCD), an independent federal agency advising Congress and the administration on disability policy, published a report further recommending policymakers avoid use of the QALY both directly and by importing its use from other countries due to known implications for access to care. In 2020, the Trump administration fought against state-based Crisis Standards of Care that would put people with disabilities at the back of the line for care in a shortage, a move contributing to the 2024 updated regulations governing Section 504 of the Rehabilitation Act barring medical discrimination and use of value assessments devaluing disabled lives.
The problems associated with Most Favored Nation injecting QALYs into U.S. health decisions is gaining recognition. On February 18, researchers published a commentary on the “QALY Paradox: An Unintended Consequence Of Most Favored Nation Drug Pricing.” These researchers evaluated use of QALYs in a separate Medicaid proposal, the so-called GENEROUS Model, and found that seven of the eight foreign countries referenced in this model “employ formal [HTAs] that incorporate the QALY as a central or a supporting metric.” The authors raise a crucial question: “When Congress explicitly prohibits a particular methodology in statute, can the executive branch effectively circumvent that prohibition by adopting foreign prices derived from the banned methodology?”
Other countries using QALYs do not share our values. Just look at the story of Alice, a Canadian mom who has had to stand by as her children with Wilson disease are denied access to treatments that are widely available in America. Or the story of Paula, an Irish mother of seven children who cannot access the treatment acknowledged to be indicated for her liver disease, if only she lived in America. The laws that protect equal access to health care in America do not exist there.
Have American politics become so divisive that we no longer agree on a most basic American value – that we will give equal access to health care to people with disabilities, complex diseases, and older adults? I have genuine concerns about taking this dangerous step toward modeling foreign countries that do not share this American value and what it will mean for people in America with disabilities or chronic conditions and older adults. It has been my life’s ministry to promote equal rights for people with disabilities. I fear adopting foreign prices based on foreign values will undermine our work toward this goal.
I hope you will join the fight by reaching out to your Member of Congress to weigh in against advancing health policies modeled on foreign values.
GLOBE and GUARD Model Countries: Importing QALYs and Devaluing People with Disabilities
Modeling foreign prices has long concerned disability advocates as it would, in effect, import quality-adjusted life years (QALYs) from other countries. QALYs are a measure of cost effectiveness placing a lower value on lives of people with disabilities, chronic illnesses and older adults which results in treatments for these individuals being valued less than treatments for people who are “healthy.” In countries using QALYs, people with complex health needs are often unable to access treatments they need and which their doctors prescribe.
The Guarding U.S. Medicare Against Rising Drug Costs (GUARD) Model would impact drugs in Medicare Part D. The Global Benchmark for Efficient Drug Pricing (GLOBE) Model would impact drugs in Medicare Part B. Both models would reference the values and pricing established in 19 foreign countries as the determination of value that America places on specialized treatments for patients with disabling and chronic conditions, as well as older adults. This move is inconsistent with what Americans value in medicine – like making sure people with rare, life-threatening diseases have early access to treatment, and empowering patients and people with disabilities to make the treatment decision best for them as individuals. It also conflicts with hard-fought bipartisan laws like the prohibition against use of QALYs in Medicare and safeguards in the Americans with Disabilities Act (ADA) that protect people with disabilities from being devalued in American society.
In their analysis, OHE reviewed Health Technology Assessment (HTA) practices across Organisation for Economic Co-operation and Development (OECD) countries and reported on how QALYs are used in pricing and reimbursement decisions. According to their findings, 18 of the 19 countries referenced by the GLOBE and GUARD models reference QALYs in their decisions about value and pricing. That means each of these countries either use a QALY-based benchmark of whether a drug is “cost effective,” or they reference QALYs in a more general way without setting a formal threshold in deciding whether to pay for it or cover its cost for patients. Either way, nearly all the countries referenced by the GLOBE and GUARD models reference this measure, which is widely known to devalue disabled lives – and barred from use in American health programs – to make decisions.
We know that use of QALYs in government decision-making has real consequences for patients. Patients in other countries do not have timely access to many new treatments. In most other countries, drugs take two years or more after being approved in the U.S. to be approved there, and many drugs may not ever get approved and marketed in those countries. Health systems abroad reflect cultures that do not value improving or extending the lives of people with disabilities or older adults. The is not the American ethos.
This fact raises serious questions and concerns about how these new models will change the ethic of the American health system, in which bipartisan legal safeguards exist to protect people with disabilities from being denied or given limited health care based on public perceptions or judgements about their quality of life and whether it is worth saving. American policymakers have consistently sought to protect people with disabilities against discrimination in our health system. In 1992, the Bush administration determined Medicaid programs would be in violation of the ADA by referencing QALYs. In 2010, the Affordable Care Act (ACA) barred QALYs and similar measures from being used in reimbursement and coverage decisions in Medicare.
In 2019, the National Council on Disability (NCD), an independent federal agency advising Congress and the administration on disability policy, published a report further recommending policymakers avoid use of the QALY both directly and by importing its use from other countries due to known implications for access to care. In 2020, the Trump administration fought against state-based Crisis Standards of Care that would put people with disabilities at the back of the line for care in a shortage, a move contributing to the 2024 updated regulations governing Section 504 of the Rehabilitation Act barring medical discrimination and use of value assessments devaluing disabled lives.
The problems associated with Most Favored Nation injecting QALYs into U.S. health decisions is gaining recognition. On February 18, researchers published a commentary on the “QALY Paradox: An Unintended Consequence Of Most Favored Nation Drug Pricing.” These researchers evaluated use of QALYs in a separate Medicaid proposal, the so-called GENEROUS Model, and found that seven of the eight foreign countries referenced in this model “employ formal [HTAs] that incorporate the QALY as a central or a supporting metric.” The authors raise a crucial question: “When Congress explicitly prohibits a particular methodology in statute, can the executive branch effectively circumvent that prohibition by adopting foreign prices derived from the banned methodology?”
Other countries using QALYs do not share our values. Just look at the story of Alice, a Canadian mom who has had to stand by as her children with Wilson disease are denied access to treatments that are widely available in America. Or the story of Paula, an Irish mother of seven children who cannot access the treatment acknowledged to be indicated for her liver disease, if only she lived in America. The laws that protect equal access to health care in America do not exist there.
Have American politics become so divisive that we no longer agree on a most basic American value – that we will give equal access to health care to people with disabilities, complex diseases, and older adults? I have genuine concerns about taking this dangerous step toward modeling foreign countries that do not share this American value and what it will mean for people in America with disabilities or chronic conditions and older adults. It has been my life’s ministry to promote equal rights for people with disabilities. I fear adopting foreign prices based on foreign values will undermine our work toward this goal.
I hope you will join the fight by reaching out to your Member of Congress to weigh in against advancing health policies modeled on foreign values.
GLOBE and GUARD Model Countries: Importing QALYs and Devaluing People with Disabilities
Modeling foreign prices has long concerned disability advocates as it would, in effect, import quality-adjusted life years (QALYs) from other countries. QALYs are a measure of cost effectiveness placing a lower value on lives of people with disabilities, chronic illnesses and older adults which results in treatments for these individuals being valued less than treatments for people who are “healthy.” In countries using QALYs, people with complex health needs are often unable to access treatments they need and which their doctors prescribe.
GLOBE/GUARD Model Country |
QALY Use |
Australia |
Formal QALY use |
Austria |
Informal QALY use |
Belgium |
Formal QALY use |
Canada |
Formal QALY use |
Czech Republic |
Formal QALY use |
Denmark |
Formal QALY use |
France |
Informal QALY use |
Germany |
Informal QALY use |
Ireland |
Formal QALY use |
Israel |
No QALY use |
Italy |
Informal QALY use |
Japan |
Formal QALY use |
The Netherlands |
Formal QALY use |
Norway |
Formal QALY use |
South Korea |
Formal QALY use |
Spain |
Formal QALY use |
Sweden |
Formal QALY use |
Switzerland |
Formal QALY use |
United Kingdom |
Formal QALY use |
Learn more: https://www.pipcpatients.org/international.html;
https://www.ohe.org/insights/how-widely-are-qalys-used-in-oecd-countries-a-snapshot-of-international-practices/
https://www.ohe.org/insights/how-widely-are-qalys-used-in-oecd-countries-a-snapshot-of-international-practices/
| pipc_oecd_chairman_blog.pdf |
