Industry sponsorship bias in cost effectiveness analysis: registry based analysis

Abstract

Objective: To assess the association between industry sponsorship (drug, medical device, and biotechnology companies) and cost effectiveness results in cost effectiveness analysis (CEA).

Design: Registry based analysis DATA SOURCE: The Tufts Cost-Effectiveness Analysis Registry was used to identify all CEAs published in Medline between 1976 and 2021.

Eligibility criteria for selecting studies: CEAs that reported incremental cost effectiveness ratio (ICER) using quality adjusted life year and provided sufficient information about the magnitude or location of the ICER.

Methods: Descriptive analyses were used to describe and compare the characteristics of CEAs with and without industry sponsorship. Logistic regression was used to identify the association between industry sponsorship and the cost effective conclusion using selected threshold values ($50 000 (£40 511; €47 405), $100 000, and $150 000). Robust linear regression was used to assess the association between industry sponsorship and the magnitude of ICER. All regression analyses were adjusted for disease and study design characteristics.

Results: 8192 CEAs were eligible and included in the analysis, with 2437 (29.7%) sponsored by industry. Industry sponsored CEAs were more likely to publish ICERs below $50 000 (adjusted odds ratio 2.06, 95% confidence interval 1.82 to 2.33), $100 000 (2.95, 2.52 to 3.44), and $150 000 (3.34, 2.80 to 3.99) than non-industry sponsored studies. Among 5877 CEAs that reported positive incremental costs and quality adjusted life years, ICERs from industry sponsored studies were 33% lower (95% confidence interval -40 to -26) than those from non-industry sponsored studies.

Conclusions: Sponsorship bias in CEAs is significant, systemic, and present across a range of diseases and study designs. Use of CEAs conducted by independent bodies could provide payers with more ability to negotiate lower prices. This impartiality is especially important for countries that rely on published CEAs to inform policy making for insurance coverage because of limited capacity for independent economic analysis.

Fig 1

Distributions of incremental cost effectiveness ratios (ICERs). 190 ICERs with both negative incremental cost and negative incremental quality adjusted life years (QALYs) were excluded because the interpretation of the magnitude of these ICERs, according to a threshold, is in the opposite direction compared with other positive ICERs. Cost saving=intervention was better and cheaper than the comparator. Dominated=intervention was less effective but more expensive than the comparator

Fig 2

Association between industry sponsorship and reported incremental cost effectiveness ratios below $50 000 (£40 511, €47 405) per quality adjusted life year. CI=confidence interval

Fig 3

Association between industry sponsorship and reported incremental cost effectiveness ratios below $100 000 (£81 023, €94 810) per quality adjusted life year. CI=confidence interval

Fig 4

Association between industry sponsorship and reported incremental cost effectiveness ratios below $150 000 (£121 535, €142 215) per quality adjusted life year. CI=confidence interval

Fig 5

Association between industry sponsorship and magnitude of incremental cost effectiveness ratios (ICERs). ICERs with positive incremental cost and positive incremental quality adjusted life years were included (n=5877). CI=confidence interval