MedTech-related technology assessments and clinical guidelines from NICE in June 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 June 2023, NICE published five new IPGs, which made the following conclusions:

• Evidence on the safety of intraoperative electron beam radiotherapy for locally advanced and locally recurrent colorectal cancer is adequate. Evidence on efficacy is inadequate in quality and quantity. Therefore, this procedure should only be used in the context of research;
• There is not enough good quality evidence on safety and efficacy for minimally invasive fusionless posterior-approach surgery to correct idiopathic scoliosis in children and young people. This procedure should be used only in research;
• Endoscopic ultrasound-guided gallbladder drainage for acute cholecystitis can be used with standard arrangements for clinical governance, consent, and audit when surgery is not an option. A disadvantage of this procedure, when compared with cholecystectomy, is that cholecystitis may reoccur;
• Radiofrequency denervation for osteoarthritic knee pain is recommended for use with standard arrangements for clinical governance, consent, and audit. There is good evidence to show that this procedure relieves pain in the short term. There are no major safety concerns, and the complications, including numbness, are well-recognized;
• Recommendations on Botulinum toxin type A injections into the urethral sphincter for idiopathic chronic non-obstructive urinary retention differ depending on its underlying cause: in external urethral sphincter dysfunction (also known as Fowler's syndrome in younger women and people with female anatomy, a primary disorder of urethral sphincter relaxation or high-tone non-relaxing urethral sphincter), the procedure should only be used with special arrangements for clinical governance, consent, and audit or research; in case of urinary retention from all other causes, the procedure should be used only in 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 June 2023, NICE published two new DGs and made the following recommendations:

• Transperineal biopsy for diagnosing prostate cancer
• FibroScan for assessing liver fibrosis and cirrhosis outside secondary and specialist care

The MedTech Innovation Briefings (MIBs) is the advice program by 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. NICE discontinued developing new MIBs in April 2023. The following two MIBs are published, as their development was launched before April 2023:

• MiraQ cardiac transit time flowmetry (TTFM) with high-frequency ultrasound probe for assessing graft flow during coronary artery bypass graft surgery;
• Proov Confirm for ovulation confirmation, a lateral flow test for at-home detecting of pregnanediol‑3a‑glucuronide (PdG). The test result can be read by eye or using a smartphone app.

Four clinical guidelines were updated in June 2023; however, only one update concerned MedTech:

• Early and locally advanced breast cancer: diagnosis and management. NICE reviewed the evidence and updated the recommendations on dose fractionation for external beam radiotherapy.

See the full details here and here.

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