 | This Letter to the Editor originally appeared in Bloomberg on October 5, 2023 The Bloomberg editorial board’s article calling the rationale for opposition from the disability community to the use of quality-adjusted life years, or QALYs, “dubious” dismisses decades of evidence that these types of measures discriminate. |
The countries that the article lauds as “solving this dilemma” of how to value health care do so at a cost to people with disabilities and chronic conditions whose needs are sacrificed to tailor coverage to the averages. There is nothing “fair” about it.
As an original author and sponsor of the Americans with Disabilities Act and a person with epilepsy, I feel I must set the record straight.
In 1992 – the ADA was signed into law in 1990 – the Department of Health and Human Services denied a state Medicaid waiver seeking to use QALYs to prioritize covered services over concerns that the metric devalues people with disabilities and therefore would lead to discriminatory coverage decisions. In 2010, the Affordable Care Act barred QALYs and similar measures in Medicare decisions. In 2019, the National Council on Disability, an independent federal agency, authored a report finding that QALYs discriminate, and recommended policymakers avoid their use. Last year, the Inflation Reduction Act doubled down by broadly barring the use of comparative clinical effectiveness research that devalued certain populations including people with disabilities and older adults. And most recently, a proposed rule described how value assessments devaluing people with disabilities may be used in violation of Section 504 of the Rehabilitation Act, a law ensuring people with disabilities are not excluded from the benefits of federally funded programs.
There is no question that QALYs and similar measures discriminate. And for 30-plus years, economists and researchers have had an opportunity to develop and test new measures. Yet, instead of doing so, the last decade saw millions of dollars invested in the Institute for Clinical and Economic Review, which embraces the QALY metric for its cost-effectiveness analyses, calling it the “gold standard.” Its new measure, the equal value of life year gained, or evLYG, still uses the same biased health utilities that underpin the QALYs’ failure to measure outcomes that matter to people with lived experience.
Just because the recently developed measures are not well tested is not an excuse to revert back to QALYs. Nor should we jump to a single untested alternative as a wholesale replacement of the QALY metric.
Instead, as in the Inflation Reduction Act, we should be relying on comparative clinical effectiveness research. This is not a new concept. The Patient-Centered Outcomes Research Institute was created for the sole purpose of advancing this type of research and is a great resource for best practices on how to ensure research is centered on the diverse voices of impacted patients and people with disabilities.
The problem lies in selecting a one-size-fits-all measure of clinical or cost-effectiveness to serve as a benchmark for coverage or even a fair price. Most of us don’t fit into an average. Yet traditional research doesn’t do a great job of analyzing how subgroups fare on treatment.
I was pleased to see the Medicare Drug Price Negotiation Program advance a series of patient listening sessions for selected drugs. Patients and people with disabilities are also urging the agency to provide opportunities for added patient feedback on the evidence informing their work to ensure it is truly representative of the diversity of patients needing treatment and their experiences.
As the article says, QALYs may be the most common cost-effectiveness metric – but that doesn’t make it good. With the development and use of high-quality comparative clinical effectiveness research to guide health-care decisions, we can steer away from what otherwise would be an inevitable discriminatory outcome.
Tony Coelho
Chairman, Partnership to Improve Patient Care
Former US representative (D-California)
Sept. 30, 2023
To read the article, go to Here’s How Medicare Should Negotiate Drug Prices: Editorial or click on Here’s How Medicare Should Negotiate Drug Prices
As an original author and sponsor of the Americans with Disabilities Act and a person with epilepsy, I feel I must set the record straight.
In 1992 – the ADA was signed into law in 1990 – the Department of Health and Human Services denied a state Medicaid waiver seeking to use QALYs to prioritize covered services over concerns that the metric devalues people with disabilities and therefore would lead to discriminatory coverage decisions. In 2010, the Affordable Care Act barred QALYs and similar measures in Medicare decisions. In 2019, the National Council on Disability, an independent federal agency, authored a report finding that QALYs discriminate, and recommended policymakers avoid their use. Last year, the Inflation Reduction Act doubled down by broadly barring the use of comparative clinical effectiveness research that devalued certain populations including people with disabilities and older adults. And most recently, a proposed rule described how value assessments devaluing people with disabilities may be used in violation of Section 504 of the Rehabilitation Act, a law ensuring people with disabilities are not excluded from the benefits of federally funded programs.
There is no question that QALYs and similar measures discriminate. And for 30-plus years, economists and researchers have had an opportunity to develop and test new measures. Yet, instead of doing so, the last decade saw millions of dollars invested in the Institute for Clinical and Economic Review, which embraces the QALY metric for its cost-effectiveness analyses, calling it the “gold standard.” Its new measure, the equal value of life year gained, or evLYG, still uses the same biased health utilities that underpin the QALYs’ failure to measure outcomes that matter to people with lived experience.
Just because the recently developed measures are not well tested is not an excuse to revert back to QALYs. Nor should we jump to a single untested alternative as a wholesale replacement of the QALY metric.
Instead, as in the Inflation Reduction Act, we should be relying on comparative clinical effectiveness research. This is not a new concept. The Patient-Centered Outcomes Research Institute was created for the sole purpose of advancing this type of research and is a great resource for best practices on how to ensure research is centered on the diverse voices of impacted patients and people with disabilities.
The problem lies in selecting a one-size-fits-all measure of clinical or cost-effectiveness to serve as a benchmark for coverage or even a fair price. Most of us don’t fit into an average. Yet traditional research doesn’t do a great job of analyzing how subgroups fare on treatment.
I was pleased to see the Medicare Drug Price Negotiation Program advance a series of patient listening sessions for selected drugs. Patients and people with disabilities are also urging the agency to provide opportunities for added patient feedback on the evidence informing their work to ensure it is truly representative of the diversity of patients needing treatment and their experiences.
As the article says, QALYs may be the most common cost-effectiveness metric – but that doesn’t make it good. With the development and use of high-quality comparative clinical effectiveness research to guide health-care decisions, we can steer away from what otherwise would be an inevitable discriminatory outcome.
Tony Coelho
Chairman, Partnership to Improve Patient Care
Former US representative (D-California)
Sept. 30, 2023
To read the article, go to Here’s How Medicare Should Negotiate Drug Prices: Editorial or click on Here’s How Medicare Should Negotiate Drug Prices
