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The Use of QALY Weights for QALY Calculations

A Review of Industry Submissions Requesting Listing on the Australian Pharmaceutical Benefits Scheme 2002–4

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Abstract

Background

QALYs combine survival and health-related quality of life (QOL) into a single index, enabling judgements about the relative value for money of healthcare interventions.

Objective

To investigate the methods used for estimating QALY weights included in submissions by industry for listing of their products on the Australian Pharmaceutical Benefits Scheme.

Study design

Retrospective descriptive review of submissions considered by the Pharmaceutical Benefits Advisory Committee (PBAC) 2002–4.

Data sources

The database of submissions considered at PBAC meetings was obtained from the Pharmaceutical Evaluation Section of the Australian Government Department of Health and Ageing. Further information on each included submission was obtained in the form of the Pharmaceutical Evaluation Section commentary (expert report) on the submission.

Methods

Submissions to the PBAC over 2002–4 presenting QALYs as an outcome measure were reviewed to identify the methods used to obtain preference-based QALY weights. Information was analyzed according to the approach taken to obtain QALY weights (multi-attribute utility instrument [MAUI], health state valuation [HSV] experiment for scaling the health states, or non-preference-based approach); the population from whom the QALY weights were obtained; the appropriateness of the population for the instrument; the recommendation made by the PBAC; and the main indicated category for use of the pharmaceutical.

The approach and the population were classified as ‘more appropriate’ and ‘less appropriate’. The ‘more appropriate’ approaches were where a MAUI was administered to patients who were currently experiencing the health states being valued, or when an HSV experiment was undertaken in either the general population to value a health state derived from clinical and QOL studies or a population of patients to value their own health state. All other approaches were considered ‘less appropriate’.

Results

MAUIs were used in 39% of approaches reporting QALYs; the most frequently used MAUI was the EQ-5D. HSV experiments were used in 36% of the approaches and generally drawn from the published literature. Non-preference based approaches (24%) included rating scales, mapping transformations and consensus opinions. Responses from patients were used in 58% of the approaches, followed by healthcare professionals and investigators (24% and 9%, respectively). Healthcare professionals and investigators’ responses were frequently used in non-preference-based approaches. Submissions for nervous system, infectious disease and neoplasms disease areas were less likely to have presented QALY weights derived from a ‘more appropriate’ approach. Of the approaches using ‘more appropriate’ populations and techniques, 56% were rejected by the PBAC compared with 66% of those using ‘less appropriate’ approaches.

Conclusions

The variability in the quality of QALY weights is troubling. The PBAC guidelines that applied over the period studied neither encouraged nor discouraged cost-utility analyses and provided only brief guidance on how QALY studies should be conducted. A consistent approach to the application of standard methods should be used when the QALY is used to inform decisions on resource allocation. The new PBAC guidelines released in 2006 provide more extensive guidance on derivation of QALY estimates and are more encouraging of the presentation of cost-utility analysis. MAUIs offer a straightforward approach to obtaining QALY weights, and ideally should be used routinely in relevant comparative randomized trials to assess patients’ health states.

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Notes

  1. We use the term ‘QALY weight’ to distinguish the weights used to estimate QALYs from the scoring systems commonly used in QOL instruments, such as the Short-Form 36-item health survey (SF-36). The scores for the latter are not based on any direct measurement of individual preferences, and hence there is no indication of strength of preference for different health states, or for the trade-offs individuals may make between dimensions of HR-QOL that contribute to the instrument. Elsewhere, QALY weights are sometimes referred to as utilities or utility weights, and are claimed to have a basis in Von Neumann Morgenstern expected utility. However, QALYs are only a measure of utility if additional strong restrictions are imposed on the utility function.

  2. A resubmission is a submission that was previously rejected by the PBAC; the sponsor may choose to resubmit to provide additional information and/or make other appropriate amendments. The main reasons for rejections typically include insufficient evidence on the clinical benefit (e.g. from a different target population from that described in the evidence provided), too much residual uncertainty around the clinical benefit or cost-effectiveness estimate, or an unacceptable cost-effectiveness ratio.

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Acknowledgements

No sources of funding were used to assist in the preparation of this study. The authors have no conflicts of interest that are directly relevant to the content of this study. At the time the data were collected, Andrew Mitchell was the Secretary and Rosalie Viney was a member of the Economics Subcommittee of the Pharmaceutical Benefits Advisory Committee.

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Correspondence to Paul A. Scuffham.

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Scuffham, P.A., Whitty, J.A., Mitchell, A. et al. The Use of QALY Weights for QALY Calculations. Pharmacoeconomics 26, 297–310 (2008). https://doi.org/10.2165/00019053-200826040-00003

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