Med Tech-related technology assessments from NICE in April 2025

The National Institute for Health and Care Excellence (NICE) develops Interventional Procedures Guidance (IPG) for most novel interventional procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit." Recommendations are not binding, although they are followed by providers and commissioners.

In April 2025, NICE published one new IPG on Balloon disimpaction of the baby’s head at emergency cesarean during the second stage of labor and recommended the procedure only as a part of a formal research study approved by the NHS Research Ethics Committee. Further research is needed to compare this procedure with alternative options, assess patient selection criteria, including characteristics of women, transmen, or non-binary individuals giving birth, and to evaluate risk factors, as well as long-term safety and efficacy outcomes for the person giving birth and the baby.

Health Technology Evaluations (HTE) using the Early Value Assessment (EVA) approach are the new type of NICE guidance to provide rapid conditional recommendations on promising health technologies that have the potential to address unmet national needs. NICE evaluates the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.

In April 2025, NICE published two new EVAs and made the following conclusions:

• According to the Robot-assisted surgery for soft tissue procedures: early value assessment, five technologies (Da Vinci SP and Da Vinci X and Xi by Intuitive Surgical, Hugo robotic-assisted surgery system by Medtronic, Senhance Surgical System by Asensus, Versius Surgical System by CMR Surgical) can be used in the NHS during the evidence-generation period. Additional research is needed to better understand the learning curve for surgeons and centers and resource utilization associated with robot-assisted surgery services. Furthermore, studies should explore the cost structures involved in procuring and implementing robotic systems, along with their impact on procedure’s outcomes;
• Based on the Robot-assisted surgery for orthopedic procedures: early value assessment, NICE concluded that six technologies (ApolloKnee by Corin, CORI Surgical System by Smith+Nephew, MAKO SmartRobotics System by Stryker, ROSA Knee System by Zimmer Biomet, SkyWalker by MicroPort MedBot, VELYS Robotic-Assisted Solution by Johnson & Johnson) can be used in the NHS during the evidence-generation period. More evidence needs to be generated on health-related quality of life, encompassing patient-reported outcome measures, the immediate consumables and resources involved in surgery, post-operative treatments, and service utilization, as well as the characteristics of individuals undergoing the procedure. Furthermore, studies should consider population subgroups and the geographical distribution of centers offering the procedure.

Furthermore, in April 2025, NICE published one new clinical guideline on Falls: assessment and prevention in older people and in people 50 and over at higher risk. One clinical guideline on Early and locally advanced breast cancer: diagnosis and management was updated.

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