Med Tech-related technology assessments and clinical guidelines from NICE in March 2021

In March 2021, NICE published four Interventional Procedures Guidance (IPG):

• Transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids
• Extracorporeal whole liver perfusion for acute liver failure
• Free-functioning gracilis transfer to restore upper limb function in brachial plexus injury
• Cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy for peritoneal carcinomatosis (update)

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.

Transcervical ultrasound-guided radiofrequency ablation for symptomatic uterine fibroids is recommended by NICE with special arrangements for clinical governance, consent, and audit or research. NICE stated that evidence on the safety of the procedure raises no major concerns. However, evidence on its efficacy is limited in quality. Further research should include comparative studies, preferably randomized controlled trials. It should report details of patient selection, disease-specific quality of life, and long-term outcomes.

NICE concluded that evidence on the safety of extracorporeal whole liver perfusion for acute liver failure shows serious but well-recognized complications, and evidence on its efficacy is inadequate in quantity and quality. Therefore, this procedure should only be used in the context of research.

NICE recommended free-functioning gracilis transfer to restore upper limb function in brachial plexus injury with standard arrangements for clinical governance, consent, and audit. NICE concluded that evidence on safety shows well-recognized complications and evidence on efficacy is adequate. This procedure should only be done in a specialist brachial plexus unit by a multidisciplinary team, with input from microvascular surgeons.

NICE updated IPG on cytoreduction surgery with hyperthermic intraoperative peritoneal chemotherapy for peritoneal carcinomatosis, initially published in 2009. NICE concluded that evidence on safety shows frequent and serious but well-recognized complications. 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.

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 March, NICE issued two new MTGs on Danis stent for acute oesophageal variceal bleeding and Alpha-Stim AID for anxiety disorders.

Danis stent for acute oesophageal variceal bleeding is a removable and self-expandable, silicone-covered nitinol stent that controls bleeding by direct compression of oesophageal varices. NICE concluded, that evidence supports the case for adopting the Danis stent.

• Danis stent improves the short-term control of bleeding compared with a balloon tamponade and can be left in place for longer, allowing time for stabilization
• Danis stent should be considered for people aged 16 and over with acute oesophageal variceal bleeding that does not respond to endoluminal therapy and whose oesophageal varices are being considered for definitive treatment. Also, Danis stent should be considered for people when definitive treatment is not appropriate and who are likely to be offered palliative care
• Cost modeling shows that Danis stent is cost-saving compared with balloon tamponade for acute oesophageal variceal bleeding being considered for definitive treatment. This is because having Danis stent results in a shorter stay in intensive care. Danis stent needs to decrease intensive care stay by approximately one day or more compared with balloon tamponade to be cost-saving

Alpha‑Stim AID for anxiety disorders is a compact electrotherapy device that uses a variable electric microcurrent to stimulate alpha wave activity. It delivers an electric current through a pair of small clips attached to the ear lobes. NICE concluded that Alpha-Stim AID shows promise for managing anxiety disorders; however, there is not enough good quality evidence to support the case for routine adoption. Further research is recommended to address uncertainties about the short- and long-term efficacy of Alpha-Stim AID, its position in the care pathway for treating anxiety disorders, and its resource impact.

MedTech Innovation Briefing (MIB) 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.

Two MIBs were published in March:

• Sonata system for diagnostic imaging and treatment of symptomatic uterine fibroids - an incision-less treatment option that combines a high‑resolution intrauterine ultrasound probe with a radiofrequency ablation handpiece in a single delivery system
• Butterfly iQ+ for diagnostic ultrasound imaging - is a pocket‑sized, handheld, single‑probe, whole‑body ultrasound system powered by a single silicon chip and connected to a smartphone

In March, NICE evaluated QAngio XA 3D quantitative flow ratio (QAngio QFR) and CAAS vessel fractional flow reserve (CAAS vFFR) imaging software for assessing coronary stenosis during invasive coronary angiography in the Diagnostic Guidance program. NICE does not recommend using QAngio QFR and CAAS vFFR during invasive coronary angiography to assess coronary stenosis in stable angina, as there is not enough evidence. QAngio QFR's diagnostic accuracy is considered acceptable for assessing coronary stenosis during invasive coronary angiography, but its clinical effectiveness is uncertain. CAAS vFFR's diagnostic accuracy and clinical effectiveness are uncertain. Further research is recommended in both diagnostic-only catheter labs and interventional catheter labs.

Further research is recommended on the following topics:

• People’s experiences of QAngio QFR and CAAS vFFR compared with the reference standards of FFR or an instantaneous wave-free ratio (iFR)
• Test failure rates of QAngio QFR and CAAS vFFR and how these affect whether revascularization is done in clinical practice
• The clinical benefit of using QAngio QFR and CAAS vFFR
• The diagnostic accuracy of CAAS vFFR

Also, five clinical guidelines were updated in March:

• Caesarean birth
• COVID-19 rapid guideline: rheumatological autoimmune, inflammatory and metabolic bone disorders
• Cannabis-based medicinal products
• Asthma: diagnosis, monitoring and chronic asthma management
• Atopic eczema in under 12s: diagnosis and management

See the full details here.

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