The recent draft Health Technology Assessment (HTA) methods report released by the Health Economics Methods Advisory group makes it crystal clear – policy grounded in conventional HTA methods (like the QALY) are willing to harm the individual for the sake of the formula-derived average.
The report was produced by a collaboration led by the Institute for Clinical and Economic Review (ICER) and health agencies in the UK and Canada. It underscores PIPC’s position on why policymakers must reject government policy based on national HTA, whether through direct use of ICER-style cost-effectiveness thresholds or indirect reliance on HTA-based decisions made in other countries.
Patients don’t experience “average health.” They experience their own illness, their own risks, and their own decisions. Yet many traditional health technology assessment (HTA) approaches still rely on methods that smooth those differences into a single representative patient. The Health Economics Methods Advisory’s (HEMA) recent draft report, “Defining Appropriate Benefits for Economic Evaluation of Health Care Technologies,” largely reinforces that mindset.
HEMA proposes a set of principles that, despite sounding neutral, effectively defend the QALY-based status quo. Their framework places population averages at the center of valuation and treats individual differences as secondary. They caution that any new value element must also account for what other patients lose when resources shift, assuming that tradeoffs among patients are an unavoidable part of the system.
In October, scholars from the USC Schaeffer Center pushed back, raising concerns that these principles don’t reflect how real patients make decisions or how societies define welfare. Their point is straightforward: “Healthcare resource allocation should serve the needs of the individual people in a society who benefited from it and paid for it — not the needs of HTA bodies or payers.”
At PIPC, we share that view. No patient is average, and no legitimate framework should accept harming some people so long as population averages improve.
HEMA’s Draft Report
HEMA’s draft report outlines three guiding principles intended to steer HTA organizations (including bodies like NICE, Canada’s Drug Agency, and ICER) as they consider new elements of value:
Taken together, these principles reinforce the QALY-based paradigm, where judgments hinge on average public preferences – not those of patients and people with disabilities – and where tradeoffs between patients are treated as acceptable features of the system.
USC Schaeffer’s Response
USC Schaeffer challenges this framework on theoretical, practical, and ethical grounds. They emphasize that HEMA’s approach centers the needs of decision-making organizations, even though those organizations are meant to reflect — not replace — patient judgment.
They also highlight what the draft report leaves out. Across administrations and Congresses, the U.S. has clearly rejected the use of QALYs in federal programs. “While HEMA treats the political processes that determine the level of healthcare spending in national health systems as “reflect[ing] the preferences of the general population,” it fails even to remark upon the preferences reflected by the US political processes that prohibited the QALY.”
PIPC has consistently argued that value assessments must reflect the outcomes, needs, and preferences of real people, not what is most convenient for a scoring system. If a method is rejected by the public and by Congress because it is discriminatory and inconsistent with patient-centered care, it cannot be treated as a “gold standard.”
Our Value Our Health principles put it plainly: All lives are valuable, and policy should reject methods that devalue or ration care for any group of Americans.
Where USC and PIPC Align on the Patient-Centered Critique of HEMA
1. HEMA ignores public and legal rejection of QALYs
USC points out that HEMA treats QALYs as settled practice despite decades of public and bipartisan opposition. PIPC’s work has documented this history extensively:
Americans consistently reject discriminatory rationing tools and expect decisions to be made by patients and clinicians, not by government scoring systems.
2. HEMA dismisses patient-centered decision-making by elevating “average preferences”
“HEMA’s focus on the QALY internally contradicts its claim that social decisions cannot be derived from individual preferences. This represents a fundamental error. By abandoning individual preferences, HEMA shifts decision making towards technocrats and away from patients, both current and future”
HEMA places substantial weight on general-population preferences. USC explains why this approach breaks down: legitimate social decision-making must start from individual preferences if it is to reflect real people’s welfare.
This aligns directly with the Senate’s intent when building comparative effectiveness research into U.S. law. In a colloquy on the Senate floor related advancing funding for comparative clinical effectiveness research, Senators stressed that research should focus on clinical effectiveness, not cost, reject “one size fits all,” and account for diversity in treatment response.
The takeaway is consistent: value assessment can inform care but should never override the needs or priorities of individual patients.
3. HEMA overstates “opportunity cost” in ways that defy patient logic
HEMA assumes that adding elements of value inherently harms others by consuming fixed resources. USC notes this ignores how health budgets actually evolve and how innovation expands what societies can afford.
PIPC has long emphasized that health spending is an investment in longer life, productivity, stability, and wellbeing — not merely a cost. Budgets change in response to innovation or when emergent needs, like COVID-19, demand more from our system.
4. HEMA ignores future generations by weakening incentives for innovation
USC notes that when pricing reflects what patients value, innovators naturally focus on developing treatments that meet those needs. HEMA’s framework breaks that link by anchoring valuation to population averages and HTA-defined metrics, signaling to developers that serving the model matters more than serving the patient.
“Neither HTA bodies, nor governments, nor private firms pay for medical technology. People do, in the form of insurance premiums, taxes, and out-of-pocket payments. Thus, HEMA’s approach would have individual people pay to serve the preferences of HTA bodies.”
PIPC has repeatedly highlighted that research and decision-making should reflect outcomes that matter to patients. When frameworks reward alignment with HTA metrics instead of patient priorities, innovation slows, especially for communities often overlooked in trial averages, such as people with rare diseases, disabilities, or rapidly progressing conditions.
Because the U.S. drives much of global pharmaceutical investment, these effects extend worldwide. Research shows that importing European-style HTA pricing — such as a Most Favored Nation (MFN) approach — would reduce longevity for patients abroad nearly as much as in the U.S. If innovators must tailor products to HTA bodies rather than to the individuals who pay for and rely on care, fewer breakthroughs follow.
5. HEMA’s “population portfolio” logic accepts individual harms for average gains
This is the ethical center of USC’s critique. HEMA assumes HTA decision makers can be “risk neutral,” because each reimbursement choice barely shifts population averages.
USC calls this out as both ethically and economically wrong. HEMA’s logic implicitly assumes losses to one patient can be offset by gains to others, as long as population averages rise. USC responds:
PIPC has been clear that there is no one-size-fits-all patient. Patients differ in severity, prognosis, family context, risk tolerance, and time sensitivity. Approaches that accept individual harms for the sake of improving population averages inevitably devalue some lives, which is why disability advocates have consistently opposed QALYs. A patient-centered system must recognize meaningful differences across patients, not treat health as a transferable asset.
6. HEMA’s idea of “group preferences” is undefined and dangerous
HEMA repeatedly appeals to “average preferences of the general population.” USC shows that HEMA never defines this properly and uses a vivid example: if two-thirds of patients need a blue pill and one-third need a red pill, an “average preference” approach might force everyone to take only one option — or even a “purple” compromise — harming the minority.
Congress barred QALYs in part to avoid these exact scenarios. Lawmakers were clear that comparative effectiveness research must not sideline patients whose needs differ from population means.
7. HEMA offers no solid basis for excluding patient preferences
USC concludes that HEMA offers no strong theoretical or budgetary justification for ignoring patient preferences, and that incorporating patient values can be done without destabilizing budgets.
PIPC shares this view. Improving methodologies is important, but never at the expense of fairness or patient voice. Tradeoffs will always exist, but they must be transparent, equitable, and aligned with real people’s needs.
Conclusion
USC Schaeffer’s response reinforces a principle that patients have always understood: health policy is legitimate only when it reflects the welfare and preferences of individual people.
HEMA’s draft report instead leans on population averages, QALY-centered valuation, and opportunity-cost narratives that presume some individual harms are acceptable for aggregate gains. That approach is not patient-centered, not aligned with U.S. law, and not consistent with a society that believes all lives are valuable.
PIPC will continue advocating for value assessment that:
If we want innovation that truly serves people today and in the future, evidence and decision frameworks must begin with patients.
Patients don’t experience “average health.” They experience their own illness, their own risks, and their own decisions. Yet many traditional health technology assessment (HTA) approaches still rely on methods that smooth those differences into a single representative patient. The Health Economics Methods Advisory’s (HEMA) recent draft report, “Defining Appropriate Benefits for Economic Evaluation of Health Care Technologies,” largely reinforces that mindset.
HEMA proposes a set of principles that, despite sounding neutral, effectively defend the QALY-based status quo. Their framework places population averages at the center of valuation and treats individual differences as secondary. They caution that any new value element must also account for what other patients lose when resources shift, assuming that tradeoffs among patients are an unavoidable part of the system.
In October, scholars from the USC Schaeffer Center pushed back, raising concerns that these principles don’t reflect how real patients make decisions or how societies define welfare. Their point is straightforward: “Healthcare resource allocation should serve the needs of the individual people in a society who benefited from it and paid for it — not the needs of HTA bodies or payers.”
At PIPC, we share that view. No patient is average, and no legitimate framework should accept harming some people so long as population averages improve.
HEMA’s Draft Report
HEMA’s draft report outlines three guiding principles intended to steer HTA organizations (including bodies like NICE, Canada’s Drug Agency, and ICER) as they consider new elements of value:
- Relevance: Benefits should align with HTA bodies’ remits and focus on population health rather than individual patient utility.
- Valuation: Benefits should reflect average preferences of the general population, not the diverse preferences of specific patients.
- Opportunity costs: Added benefits shouldn’t count unless HTA can also measure what other patients lose when resources shift to new care.
Taken together, these principles reinforce the QALY-based paradigm, where judgments hinge on average public preferences – not those of patients and people with disabilities – and where tradeoffs between patients are treated as acceptable features of the system.
USC Schaeffer’s Response
USC Schaeffer challenges this framework on theoretical, practical, and ethical grounds. They emphasize that HEMA’s approach centers the needs of decision-making organizations, even though those organizations are meant to reflect — not replace — patient judgment.
They also highlight what the draft report leaves out. Across administrations and Congresses, the U.S. has clearly rejected the use of QALYs in federal programs. “While HEMA treats the political processes that determine the level of healthcare spending in national health systems as “reflect[ing] the preferences of the general population,” it fails even to remark upon the preferences reflected by the US political processes that prohibited the QALY.”
PIPC has consistently argued that value assessments must reflect the outcomes, needs, and preferences of real people, not what is most convenient for a scoring system. If a method is rejected by the public and by Congress because it is discriminatory and inconsistent with patient-centered care, it cannot be treated as a “gold standard.”
Our Value Our Health principles put it plainly: All lives are valuable, and policy should reject methods that devalue or ration care for any group of Americans.
Where USC and PIPC Align on the Patient-Centered Critique of HEMA
1. HEMA ignores public and legal rejection of QALYs
USC points out that HEMA treats QALYs as settled practice despite decades of public and bipartisan opposition. PIPC’s work has documented this history extensively:
- Oregon Medicaid (1992): The federal government rejected Oregon’s QALY-based waiver, after controversy over ranking services with QALYs. Oregon later barred QALYs statewide.
- Affordable Care Act: Congress prohibited QALYs in Medicare decisions and PCORI-funded research, reflecting concerns about discriminatory rationing
- Inflation Reduction Act: Reinforced QALY prohibitions in federal pricing and reimbursement decisions.
Americans consistently reject discriminatory rationing tools and expect decisions to be made by patients and clinicians, not by government scoring systems.
2. HEMA dismisses patient-centered decision-making by elevating “average preferences”
“HEMA’s focus on the QALY internally contradicts its claim that social decisions cannot be derived from individual preferences. This represents a fundamental error. By abandoning individual preferences, HEMA shifts decision making towards technocrats and away from patients, both current and future”
HEMA places substantial weight on general-population preferences. USC explains why this approach breaks down: legitimate social decision-making must start from individual preferences if it is to reflect real people’s welfare.
This aligns directly with the Senate’s intent when building comparative effectiveness research into U.S. law. In a colloquy on the Senate floor related advancing funding for comparative clinical effectiveness research, Senators stressed that research should focus on clinical effectiveness, not cost, reject “one size fits all,” and account for diversity in treatment response.
The takeaway is consistent: value assessment can inform care but should never override the needs or priorities of individual patients.
3. HEMA overstates “opportunity cost” in ways that defy patient logic
HEMA assumes that adding elements of value inherently harms others by consuming fixed resources. USC notes this ignores how health budgets actually evolve and how innovation expands what societies can afford.
PIPC has long emphasized that health spending is an investment in longer life, productivity, stability, and wellbeing — not merely a cost. Budgets change in response to innovation or when emergent needs, like COVID-19, demand more from our system.
4. HEMA ignores future generations by weakening incentives for innovation
USC notes that when pricing reflects what patients value, innovators naturally focus on developing treatments that meet those needs. HEMA’s framework breaks that link by anchoring valuation to population averages and HTA-defined metrics, signaling to developers that serving the model matters more than serving the patient.
“Neither HTA bodies, nor governments, nor private firms pay for medical technology. People do, in the form of insurance premiums, taxes, and out-of-pocket payments. Thus, HEMA’s approach would have individual people pay to serve the preferences of HTA bodies.”
PIPC has repeatedly highlighted that research and decision-making should reflect outcomes that matter to patients. When frameworks reward alignment with HTA metrics instead of patient priorities, innovation slows, especially for communities often overlooked in trial averages, such as people with rare diseases, disabilities, or rapidly progressing conditions.
Because the U.S. drives much of global pharmaceutical investment, these effects extend worldwide. Research shows that importing European-style HTA pricing — such as a Most Favored Nation (MFN) approach — would reduce longevity for patients abroad nearly as much as in the U.S. If innovators must tailor products to HTA bodies rather than to the individuals who pay for and rely on care, fewer breakthroughs follow.
5. HEMA’s “population portfolio” logic accepts individual harms for average gains
This is the ethical center of USC’s critique. HEMA assumes HTA decision makers can be “risk neutral,” because each reimbursement choice barely shifts population averages.
USC calls this out as both ethically and economically wrong. HEMA’s logic implicitly assumes losses to one patient can be offset by gains to others, as long as population averages rise. USC responds:
- Health is not a transferable asset in a portfolio.
- Patients cannot “redeem” someone else’s survival to compensate for their own loss.
- HTA legitimacy cannot rest on accepting individual harms for better averages.
PIPC has been clear that there is no one-size-fits-all patient. Patients differ in severity, prognosis, family context, risk tolerance, and time sensitivity. Approaches that accept individual harms for the sake of improving population averages inevitably devalue some lives, which is why disability advocates have consistently opposed QALYs. A patient-centered system must recognize meaningful differences across patients, not treat health as a transferable asset.
6. HEMA’s idea of “group preferences” is undefined and dangerous
HEMA repeatedly appeals to “average preferences of the general population.” USC shows that HEMA never defines this properly and uses a vivid example: if two-thirds of patients need a blue pill and one-third need a red pill, an “average preference” approach might force everyone to take only one option — or even a “purple” compromise — harming the minority.
Congress barred QALYs in part to avoid these exact scenarios. Lawmakers were clear that comparative effectiveness research must not sideline patients whose needs differ from population means.
7. HEMA offers no solid basis for excluding patient preferences
USC concludes that HEMA offers no strong theoretical or budgetary justification for ignoring patient preferences, and that incorporating patient values can be done without destabilizing budgets.
PIPC shares this view. Improving methodologies is important, but never at the expense of fairness or patient voice. Tradeoffs will always exist, but they must be transparent, equitable, and aligned with real people’s needs.
Conclusion
USC Schaeffer’s response reinforces a principle that patients have always understood: health policy is legitimate only when it reflects the welfare and preferences of individual people.
HEMA’s draft report instead leans on population averages, QALY-centered valuation, and opportunity-cost narratives that presume some individual harms are acceptable for aggregate gains. That approach is not patient-centered, not aligned with U.S. law, and not consistent with a society that believes all lives are valuable.
PIPC will continue advocating for value assessment that:
- Measures outcomes meaningful to patients;
- Incorporates patient preferences directly;
- Protects against discrimination; and
- Makes tradeoffs explicit without sacrificing minorities to averages.
If we want innovation that truly serves people today and in the future, evidence and decision frameworks must begin with patients.
| pipc_data_mine_blog_--_hema__usc_3.pdf |
