House Passes QALY Ban Bill

In a party line vote, the House Republicans passed legislation today that would prohibit federal agencies, Medicare Advantage plans, and Medicaid managed care organizations from using quality-adjusted life years (QALYs) and “similar measures” in coverage and payment determinations.

Cost-effectiveness groups such as the Institute for Clinical and Economic Review (ICER) and many academics use QALYs as a starting point, often with adjustments and additional factors, folded in, for assessing drugs and other medical interventions and their prices. Some disability rights advocates and others group have been strongly critical of QALYs because, they argue, QALYs undervalue and are discriminatory against people with disability and illness in the way they grade an intervention’s effect on health and functioning.

The QALY debate — sometimes polite and academic, other times combative and strident — has been going on for years, but the 211- 208 vote today in favor of Protecting Health Care for All Patients Act of 2023 (H.R. 485) may raise the stakes. Some experts are especially concerned about the “similar measures” language in the legislation stifling — or, at the very least, having a chilling effect — on all comparative effectiveness efforts.

Republicans favoring the bill spoke strongly. “QALY metrics intentionally devalue treatment for disabled and chronically ill patients in determining whether a treatment is cost effective. In other words, telling the patient, ‘you’re not worth it.’” Rep. Brad Wenstrup, one of the Republican co-sponsors of the bill, said today on the floor of the House before the vote. Wenstrup, a podiatrist, represents a district in in southern Ohio. Another sponsor, Rep. Buddy Carter, said the legislation will “expand access to life-saving treatments and prevent discrimination against American with disabilities.”

CMS is now negotiating prices that Medicare will pay for a set number of drugs. The Inflation Reduction Act (IRA) of 2022 gave CMS the authority to do so, and the IRA already prohibits the use of QALYs.

In a March 15, 2023, guidance about the price negotiations, CMS said the IRA directs it to consider comparative effectiveness but also referenced an IRA requirement that the CMS “not use evidence from comparative clinical effectiveness research in a manner that treats extending the life of an individual who is elderly, disabled, or terminally ill as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.”The guidance says when research uses QALYs in a life-extension context but has clearly separated this use of QALYs from other evidence, such as clinical effectiveness, risks and harms, CMS plans to consider that separate evidence in its price negotiations.

ICER did not respond today to a request for a comment on the QALY ban. In an opinion article published in June 2023 by JAMA, researchers at the Program on Regulation, Therapeutics, and the Law at Brigham and Women’s Hospital in Boston and the Harvard Medical School Center for Bioethics, argued that the critics of QALYs were mischaracterizing how they are used and that the analyses that do use them may show more benefit among people with a severe or disabling condition because they might experience the greatest health gains. They also warn about the “similar measures” leading to broad prohibition of comparative and cost-effectiveness research and sending a signal to drugmakers that don’t need to assess health-related quality of life in clinical trials.

Terry Wilcox, CEO and co-founder of Patients Rising, a patient advocacy group that has lists a number of pharmaceutical companies as supporters, issued a statement today applauding the passage of QALY ban legislation as “a long-awaited open door to equal value in the eyes of the federal government.”

“It is outrageous in 2024 that the federal government would be using a metric that devalues the lives of certain Americans,” Wilcox said in the statement. “The QALY inherently carries biases, lacks scientific rigor and lacks evidence to justify its widespread use in healthcare policy.”