The National Council on Disability (NCD)’s report to President Donald Trump on Quality-Adjusted Life Years and the Devaluation of Life with a Disability provides a timely understanding and perspective of the implications of QALYs. This report will be an essential tool for advocates, coming from an independent, nonpartisan federal agency charged with advising the President, Congress, and other federal agencies regarding policies, programs, practices, and procedures that affect people with disabilities.
In developing the report, the authors spoke to patients, advocates, bioethicists, payers, and value assessors. NCD came to its conclusions about the discriminatory nature of QALYs and its recommendations to ban their use in government decision-making after consulting a wide array of stakeholders including: Ari Ne’eman, a long-time disability advocate and consultant to PIPC; Eleanor Perfetto with the National Health Council; Bioethicist Professor Joseph Stramondo; and the President of the Institute for Clinical Economic Review (ICER) Steven Pearson. Ultimately, NCD recognized that all people — regardless of their health status or disability — are equally valuable and therefore rejected QALYs as a method of measuring cost-effectiveness for medical care.
Concerns About QALYs
In summary, the report raises concerns about the use of quality-adjusted life years (QALY) in government decision-making on health care and recommends that policymakers reject these metrics. NCD’s primary concern is the discriminatory effect of QALYs, which were found to place a lower value on the lives of people with chronic illnesses and disabilities and fail to fully measure health-related quality of life. Additionally, the report identified three primary ethical objections to the QALY: (1) that disability may not actually reduce quality of life; (2) that QALYs discriminate against people with disabilities; and (3) that QALYs fail to account for differences between what patients with the same condition value.
Many patients have medication responses that vary dramatically from the average —either in terms of medication efficacy or side effects — challenging the QALY to appropriately value a treatment for patients with atypical responses. The inability of QALYs to account for information that primarily exists within clinical knowledge but has not yet made it into the research literature constitutes a serious problem. In some cases, the report states, QALYs can inevitably lead to the conclusion that the person is “better off dead” and that treatments that prolong such a life are not cost-effective.
Patients Harmed by IPI
According to NCD, the experiences of patients in countries such as the United Kingdom were determined to foreshadow similar access issues in the United States if policymakers moved toward a similar QALY-based system. In other words, a reference price system would allow QALY-based decisions into the U.S through a back door. Therefore, NCD recommended CMS refrain from pursuing means of reducing Medicare and Medicaid prescription drug costs that attempt to model U.S. pricing after the pricing in other countries. The timing of this report comes as policymakers in Congress and the administration consider modeling aspects of the American health care system after those in other countries. Of particular concern to people with chronic illnesses and disabilities are proposals to adopt international reference pricing or “favored nation” requirements on purchasing prescription drugs. The countries whose prices would be imported base their coverage and pricing decisions in large part on QALY-based analysis or similar summary metrics.
No Existing Comprehensive Ban on QALYs
The report noted that there is no single American policy covering the use of QALYs in decision-making, either at the federal level or at the state level. However, it highlighted that use of the QALY has previously been found to violate the Americans with Disabilities Act. The report acknowledged that better alternatives to QALYs exist, reflecting methods such as the more nuanced and complex multi-criteria decision analysis (MCDA) which can take a more patient-centered approach to value assessments.
Patient rights groups believe that the best alternatives to QALYs allow patients with the condition being treated to define which treatments are of the highest “value,” and also what a “high-value” treatment is. The NCD noted that those interviewed did not support any single alternative to replace the QALY. As such, NCD recommended that Congress avoid creating provisions of any bill that would require the agency with management and oversight responsibilities (e.g. HHS) to cover only the most cost-effective drugs and treatments, or to require the agency to impose restrictions on less cost-effective treatments. The NCD report makes it clear that the federal government must act to unify policies across agencies that reject QALYs and protect people living with chronic diseases and disabilities. Varying treatment of QALYs by state and by program means that access to lifesaving treatments can be contingent on where a person lives, the person’s insurance provider, or federal program enrollment. The report called upon Congress to institute a comprehensive QALY ban in Medicare and Medicaid and to fund research into better decision-making tools. It also calls for a rejection of cost-effectiveness analyses which do not take patient preferences and experiences into account.
Time to Act
Unfortunately, QALY-based analyses are already on our shores. While Medicare does not currently use a QALY-based analysis to inform coverage and reimbursement decisions, plenty of private insurers and states do. In light of this, NCD recommended that insurance programs jointly run by the Federal Government and the States, such as Medicaid, should not rely on cost- effectiveness research or reports that gather input from the public on health preferences that do not include the input of people with disabilities and chronic illnesses.
PIPC is pleased for this new resource to help policymakers understand that the QALY-based analyses conducted by ICER and used by countries where people with disabilities are denied care have no place in the U.S. health care system. The NCD’s report shines a bright light on the QALY’s shortcomings and provides a valuable voice in the fight to ensure that people with disabilities get the care they deserve.
Concerns About QALYs
In summary, the report raises concerns about the use of quality-adjusted life years (QALY) in government decision-making on health care and recommends that policymakers reject these metrics. NCD’s primary concern is the discriminatory effect of QALYs, which were found to place a lower value on the lives of people with chronic illnesses and disabilities and fail to fully measure health-related quality of life. Additionally, the report identified three primary ethical objections to the QALY: (1) that disability may not actually reduce quality of life; (2) that QALYs discriminate against people with disabilities; and (3) that QALYs fail to account for differences between what patients with the same condition value.
Many patients have medication responses that vary dramatically from the average —either in terms of medication efficacy or side effects — challenging the QALY to appropriately value a treatment for patients with atypical responses. The inability of QALYs to account for information that primarily exists within clinical knowledge but has not yet made it into the research literature constitutes a serious problem. In some cases, the report states, QALYs can inevitably lead to the conclusion that the person is “better off dead” and that treatments that prolong such a life are not cost-effective.
Patients Harmed by IPI
According to NCD, the experiences of patients in countries such as the United Kingdom were determined to foreshadow similar access issues in the United States if policymakers moved toward a similar QALY-based system. In other words, a reference price system would allow QALY-based decisions into the U.S through a back door. Therefore, NCD recommended CMS refrain from pursuing means of reducing Medicare and Medicaid prescription drug costs that attempt to model U.S. pricing after the pricing in other countries. The timing of this report comes as policymakers in Congress and the administration consider modeling aspects of the American health care system after those in other countries. Of particular concern to people with chronic illnesses and disabilities are proposals to adopt international reference pricing or “favored nation” requirements on purchasing prescription drugs. The countries whose prices would be imported base their coverage and pricing decisions in large part on QALY-based analysis or similar summary metrics.
No Existing Comprehensive Ban on QALYs
The report noted that there is no single American policy covering the use of QALYs in decision-making, either at the federal level or at the state level. However, it highlighted that use of the QALY has previously been found to violate the Americans with Disabilities Act. The report acknowledged that better alternatives to QALYs exist, reflecting methods such as the more nuanced and complex multi-criteria decision analysis (MCDA) which can take a more patient-centered approach to value assessments.
Patient rights groups believe that the best alternatives to QALYs allow patients with the condition being treated to define which treatments are of the highest “value,” and also what a “high-value” treatment is. The NCD noted that those interviewed did not support any single alternative to replace the QALY. As such, NCD recommended that Congress avoid creating provisions of any bill that would require the agency with management and oversight responsibilities (e.g. HHS) to cover only the most cost-effective drugs and treatments, or to require the agency to impose restrictions on less cost-effective treatments. The NCD report makes it clear that the federal government must act to unify policies across agencies that reject QALYs and protect people living with chronic diseases and disabilities. Varying treatment of QALYs by state and by program means that access to lifesaving treatments can be contingent on where a person lives, the person’s insurance provider, or federal program enrollment. The report called upon Congress to institute a comprehensive QALY ban in Medicare and Medicaid and to fund research into better decision-making tools. It also calls for a rejection of cost-effectiveness analyses which do not take patient preferences and experiences into account.
Time to Act
Unfortunately, QALY-based analyses are already on our shores. While Medicare does not currently use a QALY-based analysis to inform coverage and reimbursement decisions, plenty of private insurers and states do. In light of this, NCD recommended that insurance programs jointly run by the Federal Government and the States, such as Medicaid, should not rely on cost- effectiveness research or reports that gather input from the public on health preferences that do not include the input of people with disabilities and chronic illnesses.
PIPC is pleased for this new resource to help policymakers understand that the QALY-based analyses conducted by ICER and used by countries where people with disabilities are denied care have no place in the U.S. health care system. The NCD’s report shines a bright light on the QALY’s shortcomings and provides a valuable voice in the fight to ensure that people with disabilities get the care they deserve.
