Med Tech-related technology assessments and clinical guidelines from NICE in April 2023

In April 2023, NICE published seven new Interventional Procedures Guidance (IPG). IPG is developed for most of the 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.

NICE recommended the following procedures to be used with standard arrangements for clinical governance, consent, and audit, as evidence of their safety and efficacy is adequate:

• Maximal cytoreductive surgery for advanced ovarian cancer;
• Radiofrequency ablation as an adjunct to balloon kyphoplasty or percutaneous vertebroplasty for palliation of painful spinal metastases.

Recommendations for endoscopic ultrasound-guided biliary drainage (EUS-BD) for biliary obstruction differ depending on the clinical condition leading to obstruction:

• EUS-BD for biliary obstruction caused by distal malignant disease is recommended for use with standard arrangements for clinical governance, consent, and audit, as evidence on the safety and efficacy is adequate;
• EUS-BD for biliary obstruction caused by the malignant hilar or benign disease should be used only in research, as evidence on the safety and efficacy is inadequate in quality and quantity.

NICE recommended the following procedures to be used with special arrangements for clinical governance, consent, and audit or research:

• Percutaneous thoracic duct embolisation for persistent chyle leak, as evidence of its safety and efficacy is limited in quantity and quality;
• Radiofrequency ablation for palliation of painful spinal metastases, as evidence of the safety and efficacy is limited in quantity and quality;
• Focal therapy using high-intensity focused ultrasound for localised prostate cancer, as evidence of its safety is adequate, but evidence of its efficacy is limited.

One procedure, Daytime intraoral neuromuscular electrical tongue stimulation using a removable device for obstructive sleep apnoea, is recommended to be used only in research, as evidence of the safety and efficacy is inadequate in quantity and quality.

Medical Technologies Guidance (MTG) evaluates new, innovative medical devices and diagnostics. It looks at medical technologies that deliver treatment, like those implanted during surgical procedures, gives greater independence to patients, or detect or monitor medical conditions.

In April 2023, NICE issued one new MTG on AposHealth for knee osteoarthritis. NICE recommended it as a cost-saving option to manage knee osteoarthritis in adults if non-surgical standard care has not worked well enough and their condition meets the referral criteria for total knee replacement surgery, but they do not want surgery, and data is collected (on quality of life, health resource use and knee replacement surgery in the long term). Further research is recommended.

The MedTech Innovation Briefings (MIBs) is the advice program of NICE for innovative technologies. It provides an overview of clinical effectiveness, safety, and cost. It does not offer formal guidance, and it, therefore, does not provide any recommendations.

One new MIB published in April 2023 concerned Fasciotens for abdominal wall closure. It uses controlled traction and allows the closure of complex hernias and the open abdomen, reducing the need for mesh bridging or component separation.

Three clinical guidelines were updated in April 2023:

• Metastatic malignant disease of unknown primary origin in adults: diagnosis and management - recommendations on gene-expression-based profiling were removed, and the link was added to the national genomic test directory;
• Hypertension in pregnancy: diagnosis and management - recommendations were updated on when to offer placental growth factor (PLGF)-based testing for pre-eclampsia, in line with new diagnostics guidance;
• Early and locally advanced breast cancer: diagnosis and management - recommendations on arm and shoulder mobility were updated.

See the full details for guidance here and for MIBs here.

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