Robotic surgery

Dutch Organization for Health Research and Development, ZonMw awarded eight projects under the "Healthcare Evaluation and Appropriate Use" program, including two projects for geriatric care, two projects for cancer, per one project for cardiovascular, neurovascular, and dermatology care.

In late September 2021, the Clinical Coding and Schedule Development (CCSD) working group, which develops and maintains procedural and diagnostics nomenclature for private payers in England, has published Bulletins 0179 and 0076 with changes to be implemented no later than January 01, 2022. Four new procedure codes related to gynecology, robotic surgery in the pulmonology area, and orthopedics, and four new diagnostic codes were introduced.

In August 2021, the mini-HTA evaluation of the robot-assisted percutaneous coronary intervention was released. The method was described as safe and effective. After the introduction into the clinical practice, the method should be followed up for two years with a sufficient number of procedures to understand the real benefit. All procedures are to be registered in the Norwegian Registry for Invasive Cardiology.

In February 2021, the Health Technology Assessment Agency of the Health Institute Carlos III published the report for the efficacy and safety of robotic spinal surgery compared to manual surgery in spinal fusion.

On February 5, 2021, the French Ministry of Solidarity and Health published the results of the pre-selection of applications submitted in 2020 for participating in the coverage with evidence development programs. Regarding the Health Economic Research Program (PRME), 20 applications regarding various medical technologies were selected, including high throughput genome sequencing analysis in pediatric diagnostics, robotic thoracic surgery during lobectomy or segmentectomy in lung cancer, robotic gastric bypass for morbid obesity, mechanical thrombectomy techniques in the treatment of ischemic stroke, CAR-T cell therapy in the treatment of diffuse large B-cell lymphomas, creation of arteriovenous accesses for hemodialysis - the surgical technique and the endovascular technique, etc. Regarding the national Hospital Program of Clinical Research (PHRC-N), 205 applications were pre-selected.

In February 2021, Healthcare Improvement Scotland released a review of recently published evidence to inform the National Planning Robotic Review Group on the impact of the number of robotic-assisted procedures (gynecological, colorectal, urological) per treatment center/surgeon on the outcomes achieved and any related evidence on the learning curves for these procedures.

Norway established in 2013 a framework “New Method” for the introduction of innovations into the health care system through either a national or hospital-based health technology assessment. In this framework, all innovations should undergo HTA before being funded. In January 2020, four new mini-HTA projects of medical technologies were launched in Norway: robotic-assisted procedures, ear reconstruction, continuous electroencephalography, among others.

MTRC has developed three reports on the key market access topics, including innovation funding, health technology assessment and funding frameworks for medical devices. These reports help to understand the relevance of these frameworks to certain types of medical technologies, including robotic surgery technologies. This post provides some key facts about the HTA, funding and innovation payment landscape for robotic surgery devices in Europe.

In September 2019, the French High Authority for Health (HAS) has released an assessment report regarding the evaluation of total or partial robotic-assisted nephrectomy, compared to open surgery and conventional laparoscopic surgery. Due to the lack of any prospective comparative studies reporting robust results with relevant judgment criteria and collected with appropriate follow-up time, HAS could not comment on the expected service or the expected service improvement of robot-assisted nephrectomy compared to open surgery or conventional laparoscopic surgery.

In early May 2019, the Austrian HTA body, the Ludwig-Boltzmann Institute (LBI), has published a health technology assessment on robot-assisted surgery in thoracic and visceral indications as part of the EUnetHTA work.

In Sweden, the Centre for Assessment of Medical Technology (CAMTÖ) leads the development of HTA cooperation in healthcare region Uppsala-Örebro. Currently, CAMTÖ is working on several assessments related to the medical devices and technologies such as equipment for 3D Printing, robot Intuitive daVinci Xi etc. After the completion of assessment procedure, the reports will be published at the web-site of Örebro County Council.

The Clinical Coding and Schedule Development (CCSD) group develop and maintains procedural and diagnostics nomenclature for private payers in England. New diagnostic codes concern circulating tumor DNA profile for the different type of cancers, myriad Prolaris test, PET Scan with florbetapir, etc. and a procedure code for robotic-assisted radical hysterectomy and lymphadenectomy. The codes are introduced with a recommended adoption date being the 1st of May 2019. The documents also contain a list of textual changes in codes and an updated list of unacceptable combinations of codes.