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Med Tech-related technology assessments and clinical guidelines from NICE in February 2022
In February 2022, NICE published two Interventional Procedures Guidance (IPG) on stereotactic radiosurgery for trigeminal neuralgia and microwave ablation for treating primary lung cancer and metastases in the lung.
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 made the following conclusions in new IPGs:
- Evidence on the safety and efficacy is adequate to support using stereotactic radiosurgery for trigeminal neuralgia with standard arrangements for clinical governance, consent, and audit;
- Evidence on the safety of microwave ablation for treating primary lung cancer and metastases in the lung is adequate but shows it can cause infrequent serious complications. Evidence of its efficacy shows that the method reduces tumor size. But the evidence of improvement in survival, long-term outcomes, and quality of life is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
The Diagnostic Guidance (DG) program focuses on evaluating innovative medical diagnostic technologies to ensure that the NHS can adopt clinically and cost-effective technologies rapidly and consistently.
In February 2022, NICE published two new DG:
- EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules, which is a blood test (enzyme-linked immunosorbent assay). EarlyCDT Lung measures the presence of autoantibodies in a panel of seven lung cancer-associated antigens (p53, NY-ESO-1, CAGE, GBU4-5, HuD, MAGE A4, and SOX2);
- PredictSURE IBD and IBDX to guide treatment of Crohn's disease. PredictSURE IBD is a whole blood-based biomarker prognostic laboratory-based test combined with a proprietary algorithm to categorize people into a high or low risk of a severe course of Crohn's disease based on detecting CD8+ T‑cell exhaustion. IBDX is a panel of six indirect solid-phase enzyme-linked immunosorbent assay (ELISA) kits, each of which detects serum levels of specific antiglycan antibodies.
NICE made the following recommendations:
- There is not enough evidence to recommend routine use of EarlyCDT Lung for assessing the risk of lung cancer in solid lung nodules; further research is recommended;
- There is not enough evidence to recommend the use of the PredictSURE IBD and IBDX tests. They should only be used in the context of research to help identify people at high risk of a severe course of Crohn's disease and guide treatment. 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. The four new MIBs published in February 2022 are:
- The Insides System for managing intestinal failure, a chyme reinfusion system, used after bowel surgery in people with high-output fistulas or stomas by returning their intestinal fluid lost from the fistula or stoma back into the distal gut;
- d-Nav insulin management app for type 2 diabetes, which calculates and adjusts insulin dosage based on a person's current and historical blood glucose levels on a weekly basis and without healthcare professional approval;
- GaitSmart assessment and vGym personalized exercise rehabilitation program for people with gait and mobility issues, which can be provided by a healthcare assistant in any setting, and would be used in addition to current gait assessment in older people at risk of falling, people with hip or knee osteoarthritis and people with hip or knee replacements;
- AposHealth for knee osteoarthritis is a personalized non-invasive biomechanical device based on re-distribution of the loads and re-educating the neuromuscular system, thus correcting abnormal gait patterns. It can be used at home.
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