Abstract

<h2>Abstract</h2><h3>Objectives</h3> Lung cancer is the leading cause of cancer death, and has the highest economic burden across Europe of all cancers. Early-stage disease is predominantly treated with surgery, and lung cancer resection using a video-assisted thoracoscopic surgery (VATS) approach has increased, despite limited randomised evidence of its effectiveness and cost-effectiveness compared to open lobectomy. The VIOLET randomised controlled trial compared VATS lobectomy with open surgery in participants with known or suspected (cT1-3, N0-1, M0) lung cancer recruited from nine UK centres. We report the trial cost-effectiveness analysis. <h3>Methods</h3> A within-trial cost-effectiveness analysis of VATS versus open lobectomy was conducted, with a one year time horizon, from a UK National Health Service and personal social services perspective. The primary outcome measure was quality-adjusted life years (QALYs), estimated using the EQ-5D-5L questionnaire. <h3>Results</h3> Mean QALYs to one year were 0.841 and 0.780 in the VATS and open groups respectively, (a statistically significant mean difference (MD) of +0.060, 95% CI +0.029, +0.092). Total costs of care were £10,879 and £13,581 in the VATS and open groups, (MD= -£2,702, 95% CI –£5,632, +£228). Differences in costs and QALYs favoured VATS, and when combined, resulted in VATS being clearly cost-effective. The probability that VATS is cost-effective at a willingness-to-pay threshold of £20,000 per QALY is >0.99, indeed VATS is considered cost-effective at any threshold, with negligible uncertainty around this finding. <h3>Conclusions</h3> VATS lobectomy provides good value for money. When considered alongside the published clinical findings from VIOLET that multiple outcomes were significantly improved with VATS, the policy implications are clear: VATS should be the first choice for suitable patients with early-stage lung cancer. ISRCTN13472721

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