Budget Impact of Restrictive Strategy Versus Usual Care for Cholecystectomy (SECURE-Trial)

Carmen S.S Latenstein,Aafke H Van Dijk,Sarah Z Wennmacker,Joost P.H Drenth,Gert P Westert,Cornelis J.H.M Van Laarhoven,Marja A Boermeester,Marcel G.W Dijkgraaf,Philip R De Reuver

doi:10.1016/j.jss.2021.06.033

Abstract

ObjectivesA cost-effectiveness analysis of a multicenter randomized-controlled trial comparing restrictive strategy versus usual care in patients with gallstones showed that savings by restrictive strategy could not compensate for the lower proportion of pain-free patients. However, four subgroups based on combined stratification factors resulted in less cholecystectomies and more pain-free patients in restrictive strategy (female-low volume-BMI > 30, female-low volume-BMI25-30, female-high volume-BMI25-30, and male-low volume-BMI < 25). The aim of this study was to explore the budget impact from a hospital healthcare perspective of implementation of restrictive strategy in these subgroups. MethodsData of the SECURE-trial were used to calculate the hospital budget impact with a time horizon of four years. Based on a study into practice variation, about 19% of hospitals treat patients according restrictive strategy. This represents the proportion of patients treated according restrictive strategy at the start of budget period. Three subanalyses were performed: a scenario analysis in which 30% of patients fall under a restrictive strategy in clinical practice, a sensitivity analysis in which we calculated the budget impact with the low and high 95% confidence limits of the expected future number of patients, a subgroup analysis in which restrictive strategy was also implemented in two additional subgroups (male-high volume-BMI < 25 and female-high volume-BMI >30). ResultsBudget impact analysis showed savings of €6.7-€15.6 million (2.2%-5.6%) for the period 2021-2024/2025 by implementing the restrictive strategy in the four subgroups and provision of usual care in other patients. Sensitivity analysis with 30% of patients already in the restrictive strategy at the start of the budget period, resulted in savings between €5.4 million and €14.0 million (1.7%-5.0%). ConclusionPerforming a restrictive strategy for selection of cholecystectomy in subgroups of patients and provision of usual care in other patients will result in a lower overall hospital budget needed to treat patients with abdominal pain and gallstones. Trial registrationThe Netherlands National Trial Register NTR4022. Registered on June 5, 2013.

Highlights

In the SECURE-trial we explored the clinical trajectory for cholecystectomy
The cost-effectiveness analysis (CEA) parallel to the trial revealed that, generally, a restrictive selection strategy for cholecystectomy results in lower costs compared to usual care, and in fewer pain-free patients
This study explored the long-term impact of a restrictive selection strategy for cholecystectomy in patients with abdominal pain and gallstones on the health care budget

Summary

Introduction

700,000 cholecystectomies are performed in the United States (US) with subsequent direct and indirect costs of US$ 9.9 billion.[1,2] the optimal indication for cholecystectomy is unclear and varies globally, resulting in persistent postoperative symptoms in many patients and in variation in cholecystectomies performed amongst and within countries.[3,4] In the SECURE-trial we explored the clinical trajectory for cholecystectomy. This multicenter randomized controlled trial (RCT) compared usual care and a restrictive strategy (strict criteria for surgery) for triage of patients with gallstones and abdominal pain for cholecystectomy. A higher societal willingness to pay for one extra pain-free patient, reduces the probability that a restrictive strategy becomes cost-effective.[6]

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