The Use of QALYs in Decision-Making in Europe, Canada, and the US: A Qualitative Review of Methodological Guidance

Author(s)

Edyta Ryczek, BSc, MSc, Hannah Baker, BSc, MSc, Hannah Gillies, BSc, MSc, Kaylie Metcalfe, BSc, MSc, Daniel James Scott Howard, BSc, MPhil, MSc, Calum Jones, BSc, MSc.
Petauri, Bicester, United Kingdom.

Presentation Documents

OBJECTIVES: The reimbursement of health technologies conventionally depends upon gaining favorable recommendations from health technology assessment (HTA) agencies, subject to the evaluation of manufacturer-submitted evidence. Some HTA agencies currently make use of the quality-adjusted life year (QALY) impact of health technologies to part formulate their recommendations. However, numerous HTA agencies to date have expressed ethical concerns regarding the use of QALYs in reimbursement decision-making, such that many only make limited use of the QALY, or forgo its use entirely. This research aimed to assess and compare the role of QALYs in the reimbursement decision-making process in selected countries, capturing HTA agencies’ rationale for either prominent, limited, or non-use of QALYs, where relevant.
METHODS: A qualitative review was conducted focusing on the current use of QALYs in decision-making processes in France, Germany, Italy, Spain, the UK, Canada, and the US. The review of methodological guidance from each HTA agency in the respective countries was supplemented by targeted desk research.
RESULTS: The formal assessment of new technologies varies between countries. QALYs were demonstrated to play an important role in decision-making processes in a subset of the countries reviewed. For other countries, QALYs were seen as complementary, and may be used alongside additional metrics, such as equal value life years, during the assessment of the evidence package. Some HTA agencies are actively working to address the equity concerns related to QALYs by introducing additional measures, such as the severity modifier applied in the UK.
CONCLUSIONS: The review highlighted a lack of standardized approach to QALY use during the assessment of new technologies across the countries assessed. The observed differences are in part due to heterogeneous societal preferences, but also reflect the substantial differences in health systems and legislative restrictions; particularly when assessing those systems less likely to utilise QALYs.

Conference/Value in Health Info

2025-05, ISPOR 2025, Montréal, Quebec, CA

Value in Health, Volume 28, Issue S1

Code

HTA4

Topic

Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes

Disease

No Additional Disease & Conditions/Specialized Treatment Areas

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