MedTech-related technology assessments and clinical guidelines from NICE in August 2023

NICE develops Interventional Procedures Guidance (IPG) 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.

In August 2023, NICE published one new IPG on aortic valve reconstruction with glutaraldehyde-treated autologous pericardium for aortic valve disease, which recommended the procedure to be used only in the context of research. Recommendations were based on the following conclusions:

• Short-term and medium-term evidence suggests that the procedure works well, with survival rates of around 90% after ten years and only a small proportion of people needing another operation within five years;
• However, there is a lack of long-term evidence (more than 20 years), which is important because mechanical valve alternatives can last for over 25 years;
• It is also not clear how well the procedure works or how safe it is in different groups of people with aortic valve disease.

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 August 2023, NICE published one new DG on quantitative faecal immunochemical testing (FIT) to guide colorectal cancer pathway referral in primary care. NICE concluded that there is clear evidence of the diagnostic accuracy of the HM‑JACKarc and OC‑Sensor and recommended these tests to guide referral for suspected colorectal cancer in adults with the following clinical indications:

• Abdominal mass or change in bowel habit or, iron-deficiency anemia, or
• Aged 40 and over with unexplained weight loss and abdominal pain, or
• Aged under 50 with rectal bleeding and either of the following unexplained symptoms: abdominal pain, weight loss, or
• Aged 50 and over with any of the following unexplained symptoms: rectal bleeding, abdominal pain, weight loss, or
• Aged 60 and over with anemia even in the absence of iron deficiency.

The evidence is less clear for other tests (FOB Gold, IDK Hemoglobin ELISA, IDK, IDK TurbiFIT,  Hemoglobin/Haptoglobin Complex ELISA, NS‑Prime, QuikRead go iFOBT), and the estimates of diagnostic accuracy are more uncertain, so further research is needed.

Five clinical guidelines were updated in August 2023:

• Otitis media with effusion in under 12s with new recommendations on the management of hearing loss (air conduction hearing aids and bone conduction devices), and surgical management (grommets, adenoidectomy);
• Suspected cancer: recognition and referral – was updated in line with the new DG on quantitative FIT to guide colorectal cancer pathway referral in primary care;
• Caesarean birth – recommendations for surgical opening technique were updated;
• Ectopic pregnancy and miscarriage: diagnosis and initial management – updates only concerned medication;
• Venous thromboembolic diseases: diagnosis, management, and thrombophilia testing - recommendations were updated on the use of Wells score and D-dimer in the diagnostic pathways for pulmonary embolism and deep vein thrombosis.

See the full details here.

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