International Regulations and Recommendations for Utility Data for Health Technology Assessment

Abstract

Recommendations and guidelines for the collection, generation, source and usage of utility data for health technology assessment (HTA) vary across different countries, with no international consensus. Many international agencies generate their own guidelines providing details on their preferred methods for HTA submissions, and there is variability in both what they recommend and the clarity and amount of detail provided in their guidelines. This article provides an overview of international regulations and recommendations for utility data in HTA for a selection of key HTA countries: Australia, Canada, France, Germany, the Netherlands, Spain (Catalonia), Sweden and the UK (England/Wales and Scotland). International guidelines are typically clear and detailed for the selection of countries assessed regarding the source description of health states (e.g. generic preference-based measure) and who should provide preference weights for these health states (e.g. general population for own country). Many guidelines specify the use of off-the-shelf generic preference-based measures, and some further specify a measure, such as EQ-5D. However, international guidelines are either unclear or lack detailed guidance regarding the collection (e.g. patients report own health), source (e.g. clinical trial) and usage (e.g. adjusting for comorbidities) of utility values. It is argued that there is a need for transparent and detailed international guidelines on utility data recommendations to provide decision makers with the best possible evidence. Where this is not possible it is recommended that best practice should be used to inform the collection, source and usage of utility values in HTA.

Incorporating Quantitative Patient Preference Data into Healthcare Decision Making Processes: Is HTA Falling Behind?

“…Several influential HTA agencies in countries such as the UK, Australia, the Netherlands, and Canada recommend the use of generic MAUIs such as the EQ-5D rather than condition-specific measures [32]. A major benefit of these generic measures is that they help improve the consistency of HTA decisions.…”

“…Key HTA agencies in countries such as the UK, Australia, the Netherlands, and Canada recommend that the general population are the source for health state utilities [32]. If this stance changes, patient preferences could be incorporated within the QALY.…”

An Educational Review About Using Cost Data for the Purpose of Cost-Effectiveness Analysis

“…In the UK, CEA, particularly CUA as the National Institute for Health and Care Excellence (NICE) economic evaluation reference case [2], has become the most common form of economic evaluation. This is also reflected within reimbursement agency guidance internationally [3]. Therefore, this paper focuses specifically on CEA, although many of the aspects described and discussed are relevant to other forms of economic evaluation, such as CBA.…”

Heath State Utility Values for Cost-Effectiveness Models

“…Rowen et al [3] provide an overview of international regulations and recommendations for the collection, analysis and use of utility data. Their paper provides a starting point at which it is useful to differentiate between issues for which best practice can be defined and issues for which alternative regulatory bodies may have legitimately different preferences, such as the use of public or patient preference values.…”