For several decades, the QALY has been widely recognized as being inappropriate for use in the U.S. In 1992, the Bush administration prevented use of QALYs to prioritize services available under a state Medicaid waiver. The Affordable Care Act (ACA) included a prohibition on use of QALYs or similar metrics in Medicare coverage and reimbursement decisions, reflecting concerns about the discriminatory implications of these approaches. These patient-focused safeguards are not present in many of the countries whose pricing systems are now being referenced in U.S. policy discussions. Further, the QALY is only one component of a broader set of health technology assessment (HTA) practices used internationally to evaluate treatments and determine access.
This paper examines how HTA processes in the UK diverge from the U.S.’ patient-centered principles, including key shortcomings such as:
- Failure to meaningfully capture the full range of outcomes (health and quality of life) that matter
- to patients and caregivers;
- Imposition of evidence standards that disadvantage patients with serious diseases and
- conditions;
- Lack of transparency and flexibility in HTA processes;
- Failure of patient input to meaningfully shape decision outcomes.
Together, these features can result in patients in the UK encountering long delays in access to new tests and treatments and reduced flexibility for physicians to tailor care to the needs of different patients. As U.S. policymakers consider approaches such as MFN pricing, understanding how these underlying systems shape access and decision-making is critical to ensuring that efforts to lower costs do not come at the expense of patient-centered care.
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