title: Some inconsistencies in NICE's consideration of social values.
abstract: The UK's National Institute for Health and Care Excellence (NICE) recently proposed amendments to its methods for the appraisal of health technologies. Previous amendments in 2009 and 2011 placed a greater value on the health of patients at the "end of life" and in cases where "treatment effects are both substantial in restoring health and sustained over a very long period". Drawing lessons from these previous amendments, we critically appraise NICE's proposals. The proposals repeal "end of life" considerations but add consideration of the "proportional" and "absolute" quality-adjusted life-year (QALY) loss from illness. NICE's cost-effectiveness threshold may increase from £20,000 to £50,000 per QALY on the basis of these and four other considerations: the "certainty of the ICER [incremental cost-effectiveness ratio]"; whether health-related quality of life is "inadequately captured"; the "innovative nature" of the technology; and "non-health objectives of the NHS". We demonstrate that NICE's previous amendments are flawed; they contain logical inconsistencies which can result in different values being placed on health gains for identical patients, and they do not apply value weights to patients bearing the opportunity cost of NICE's recommendations. The proposals retain both flaws and are also poorly justified. Applying value weights to patients bearing the opportunity cost would lower NICE's threshold, in some cases to below £20,000 per QALY. Furthermore, this baseline threshold is higher than current estimates of the opportunity cost. NICE's proposed threshold range is too high, for empirical and methodological reasons. NICE's proposals will harm the health of unidentifiable patients, whilst privileging the identifiable beneficiaries of new health technologies.
authors.affiliation: Department of Emergency Medicine, University of Alberta, 736 University Terrace, 8303 112 St, Edmonton, AB, T6G 2T4, Canada, paulden@ualberta.ca.
authors.forename: Mike
authors.initials: M
authors.lastname: Paulden
authors.forename: James F
authors.initials: JF
authors.lastname: O'Mahony
authors.forename: Anthony J
authors.initials: AJ
authors.lastname: Culyer
authors.forename: Christopher
authors.initials: C
authors.lastname: McCabe
mesh_terms: D003362:Cost-Benefit Analysis / Q000379:methods*; D006801:Humans; D019057:Quality-Adjusted Life Years; D012945:Social Values; D013673:Technology Assessment, Biomedical / Q000191:economics / Q000379:methods*; D006113:United Kingdom