Med Tech-related technology assessments and clinical guidelines from NICE in July 2019

In July 2019, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance for therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis, two new interventional procedure guidance (for transurethral laser ablation for recurrent non-muscle-invasive bladder cancer and ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids), and one new MedTech innovation briefing for HemaClear for bloodless surgical field during limb surgery.

In July 2019, NICE published one new Diagnostics Guidance for therapeutic monitoring of TNF-alpha inhibitors in rheumatoid arthritis. Enzyme-linked immunosorbent assay (ELISA) tests for therapeutic monitoring of tumor necrosis factor (TNF)-alpha inhibitors (drug serum levels and anti-drug antibodies) show promise, but there is currently insufficient evidence to recommend their routine adoption in rheumatoid arthritis. The ELISA tests covered by this guidance are Promonitor, IDKmonitor, LISA-TRACKER, RIDASCREEN, MabTrack, and tests used by Sanquin Diagnostic Services. Further research is recommended on the clinical effectiveness of using ELISA tests for therapeutic monitoring of TNF‑alpha inhibitors in rheumatoid arthritis.

Interventional Procedure Guidance 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 July 2019, NICE published two new Interventional Procedure Guidance:

• Interventional Procedure Guidance Transurethral laser ablation for recurrent non-muscle-invasive bladder cancer, which covers evidence-based recommendations on transurethral laser ablation for recurrent non-muscle-invasive bladder cancer in adults. The evidence on the safety of transurethral laser ablation for recurrent non-muscle-invasive bladder cancer shows that there are no major safety concerns. However, current evidence on its efficacy is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.
• Interventional Procedure Guidance Ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids, which covers evidence-based recommendations on ultrasound-guided high-intensity transcutaneous focused ultrasound for symptomatic uterine fibroids in adults. Current evidence on the safety of ultrasound-guided high‑intensity transcutaneous focused ultrasound for symptomatic uterine fibroids shows there are well-recognized complications including skin burns. The evidence on efficacy is limited in quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

MedTech Innovation Briefing is the NICE's advice program 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 Medtech Innovation Briefing for HemaClear for bloodless surgical field during limb surgery (a single-use sterile device, used for limb exsanguination during limb surgery to provide a bloodless surgical field) has been published in July.

See full details here.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.