Med Tech-related technology assessments and clinical guidelines from NICE in November 2022

Interventional Procedures Guidance (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.

In November 2022, NICE published five new IPGs and made the following conclusions:

• Evidence on the safety of extracorporeal shockwave therapy for calcific tendinopathy in the shoulder shows no major safety concerns in the short term. Evidence on efficacy is inadequate. Therefore, this procedure should only be used in the context of research;
• Evidence on the safety and efficacy of balloon disimpaction of the baby’s head at emergency caesarean during the second stage of labor is adequate to support using this procedure with standard arrangements for clinical governance, consent, and audit;
• Evidence on the safety of percutaneous ultrasound-guided microwave ablation for symptomatic benign thyroid nodules shows some well-recognized complications. Evidence on efficacy is adequate. Therefore, this procedure can be used with standard arrangements for clinical governance, consent, and audit;
• Evidence on the safety of ab interno canaloplasty for open-angle glaucoma shows no major safety concerns. Evidence on efficacy is limited in quality and quantity, particularly in the long term. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research;
• Evidence on the safety of long-term tunnelled peritoneal drainage catheter insertion for refractory ascites in cirrhosis is limited but shows well-recognized complications. Evidence on efficacy is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

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, give greater independence to patients, or detect or monitor medical conditions.

In November 2022, NICE issued two new MTGs:

• GreenLight XPS for treating benign prostatic hyperplasia, a minimally invasive procedure with photoselective vaporization of prostatic tissue (PVP);
• Optilume for treating recurrent bulbar urethral strictures is a novel drug-coated balloon. The technology combines balloon dilation to expand or widen the strictured area and the delivery of an anti-proliferative drug (paclitaxel) intended to reduce the rate of stricture recurrence.

NICE made the following conclusions:

• GreenLight XPS is recommended as an option to treat benign prostatic hyperplasia (BPH) in adults. Data should continue to be collected on cost-saving outcomes for GreenLight XPS compared with other treatments in people who may be considered high-risk. This includes people with larger prostates and a higher risk of bleeding. The cost modeling suggests GreenLight XPS is likely cost-saving compared with TURP and holmium laser enucleation of the prostate (HoLEP). The amount of savings depends on day case proportions, length of stay, and procedure length;
• Optilume is recommended as an option to treat recurrent bulbar urethral strictures in adults only if comparative data is collected on patient-reported outcome measures and reintervention rates. The cost analysis shows that Optilume is cost-saving at five years compared with standard care (urethral dilatation, urethrotomy, and urethroplasty). The uncertainty about the likelihood of recurrence in the long term limits the reliability of the long-term cost savings.

One new clinical guideline, “Subarachnoid hemorrhage caused by a ruptured aneurysm: diagnosis and management”, was published in November 2022. Recommendations were made for assessment, diagnosis, and managing the culprit aneurysm, complications, and non-culprit (unruptured) aneurysms. A treatment plan for the culprit aneurysm should consider the following options: endovascular coiling, neurosurgical clipping, or no interventional procedure, with monitoring to check for clinical improvement and reassess the options for treatment.

One clinical guideline, “Fractures (complex): assessment and management”, was updated in November 2022. NICE reviewed the evidence on negative pressure wound therapy and made a new recommendation for using a temporary dressing.

See the full details for guidance here.

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