Rethinking health technology assessment in robotic surgery: an EFISDS-TROGSS position paper. Official position paper of the European Federation - International Society for Digestive Surgery (EFISDS) and The Robotic Global Surgical Society (TROGSS).

Clinical Snapshot

Key Findings

• P Value: Not reported

• Effect Size: Not applicable — no quantitative effect sizes are reported; this is a qualitative policy position paper

• Primary Outcome: The paper argues that conventional HTA frameworks are methodologically insufficient for evaluating robotic surgical platforms as integrated digital ecosystem technologies, and proposes a multidimensional assessment model encompassing procedural outcomes, organisational sustainability, digital interoperability, workforce implications, and longitudinal healthcare value

• Nnt Or Sensitivity: Not applicable — no NNT, sensitivity/specificity, or hazard ratio data are presented; the paper does not conduct a primary or secondary quantitative analysis

• Confidence Interval: Not reported — no quantitative data synthesis performed

Clinical Application

The conceptual framework proposed is aspirational and requires substantial operationalisation before practical implementation. Adoption of multidimensional HTA approaches would necessitate new data collection infrastructure, revised DRG coding structures, longitudinal outcome registries, and cross-sector collaboration between surgical societies, health economists, payers, and digital health regulators. Feasibility in resource-constrained health systems is not addressed. In Australia, robotic-assisted surgery is evaluated through the Medical Services Advisory Committee (MSAC) process, which assesses safety, clinical effectiveness, and cost-effectiveness prior to Medicare Benefits Schedule (MBS) listing. Several robotic procedures (e.g., robotic prostatectomy, robotic colorectal resection) have been assessed by MSAC with mixed reimbursement outcomes. The paper's critique of comparator-based HTA models is directly relevant to MSAC methodology. The Therapeutic Goods Administration (TGA) regulates robotic surgical devices as Class IIb or Class III medical devices, but TGA approval does not guarantee MBS reimbursement. The RACGP and relevant surgical colleges (RACS) have not yet published unified positions on robotic surgery HTA reform. The paper's arguments regarding DRG misalignment are pertinent to the Australian Refined Diagnosis Related Groups (AR-DRG) system, where robotic procedures are not consistently differentiated from laparoscopic equivalents, creating reimbursement disincentives for public hospitals. Australian public hospital access to robotic surgery remains inequitable, with most platforms concentrated in metropolitan private and tertiary public centres. Surgical departments, hospital administrators, health technology assessment bodies, and health policymakers considering the adoption, reimbursement, or evaluation of robotic-assisted surgical platforms across digestive surgery and other surgical specialties

Abstract

Robotic-assisted surgery (RAS) has evolved from a procedural innovation into an increasingly integrated component of contemporary digital surgical ecosystems. Nevertheless, most current Health Technology Assessment (HTA) frameworks continue to evaluate robotic systems primarily through comparator-based models focused on isolated perioperative and oncological outcomes. In this EFISDS-TROGSS position paper, we critically examine the methodological limitations of conventional HTA paradigms when applied to robotic surgical platforms, using the recent Italian AGENAS appraisal as a representative case study. While the AGENAS document represents one of the most comprehensive national evaluations of RAS performed to date, its heterogeneous recommendations across procedures highlight unresolved tensions regarding perioperative benefit, real-world implementation, learning curves, organizational impact, and long-term healthcare value. We argue that RAS should increasingly be interpreted not simply as a surgical device, but as a platform technology interacting with simulation-based training, digital infrastructure, surgical data science, artificial intelligence, telecommunication systems, and institutional organization. Rather than a surgical device alone, RAS should be interpreted and regarded as a combination of technological advances and approaches that integrate various degrees of artificial intelligence autonomy, image navigation, telesurgery, and other benefits to empower the surgical team. Conventional HTA models, originally developed for relatively discrete therapeutic interventions, may incompletely capture the multidimensional interaction between robotic technologies and modern healthcare systems. Particular attention is dedicated to real-world evidence, implementation maturity, reimbursement limitations, and the growing mismatch between current Diagnosis-Related Group (DRG) structures and technologically integrated surgical care. Finally, we propose more flexible and multidimensional assessment frameworks integrating procedural outcomes with organizational sustainability, digital interoperability, workforce implications, and longitudinal healthcare value.

References

1. 1.Marano, L., Oviedo, R. J., Nappo, G., Prete, F. P., Pascotto, B., Abou-Mrad, A., & Vashist, Y. (2026). Rethinking health technology assessment in robotic surgery: an EFISDS-TROGSS position paper. Official position paper of the European Federation - International Society for Digestive Surgery (EFISDS) and The Robotic Global Surgical Society (TROGSS). Journal of Robotic Surgery. Advance online publication. https://doi.org/10.1007/s11701-025-02456-7