MedTech-related technology assessments and clinical guidelines from NICE in May 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 May 2023, NICE published one IPG on intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure from high spinal cord injuries. NICE recommended that the procedure should only be used with special arrangements for clinical governance, consent, and audit or 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 May 2023, NICE published two new DGs and made the following conclusions:

• There is not enough evidence to recommend the routine adoption of MRI fusion biopsy systems for diagnosing prostate cancer. Centers already using MRI fusion biopsy systems to diagnose prostate cancer may continue to do so but are encouraged to collect data or do further research;
• There is not enough evidence to recommend the routine adoption of automated ankle brachial pressure index (ABPI) measurement devices to detect peripheral arterial disease in people with leg ulcers. They should only be used in the context of research for these people. Centers already using automated ABPI measurement devices to detect peripheral arterial disease in people with leg ulcers can continue to use them only if specific requirements are fulfilled.

Health Technology Evaluations (HTE) are the new type of NICE guidance that uses the Early Value Assessment (EVA) approach to provide rapid conditional recommendations on promising health technologies that have the potential to address the unmet national need. NICE evaluate the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.

In May 2023, NICE published three new HTEs and made the following recommendations:

• Six digitally enabled therapies for adults with anxiety disorders can be used as treatment options while further evidence is generated on their clinical and cost-effectiveness (once they have appropriate regulatory approval). Recommended technologies are: Beating the Blues (365 Health Solutions), iCT-PTSD (OxCADAT) for post-traumatic stress disorder, iCT-SAD (OxCADAT) for social anxiety disorder, Space from Anxiety (SilverCloud) for generalized anxiety symptoms or unspecified anxiety disorder;
• Three digitally enabled therapies for adults with depression can be used as treatment options while further evidence is generated on their clinical and cost-effectiveness (once they have appropriate regulatory approval). The therapies should be used with support from a trained practitioner or therapist in NHS Talking Therapies for anxiety and depression services. Recommended technologies are: Beating the Blues (365 Health Solutions), Deprexis (Ethypharm Digital Therapy), Space from Depression (SilverCloud);
• Two point-of-care tests for urinary tract infections to improve antimicrobial prescribing were not recommended for early routine use in primary or community care settings in the NHS while further evidence is generated: Astrego PA-100 analyzer with the PA AST panel U-0501 (Sysmex Astrego) and Uriscreen (Savyon Diagnostics). NICE made recommendations for further research. Three other assessed culture-based tests were not recommended for early use or further research, as they are not expected to give results quickly enough to improve antimicrobial prescribing in these settings.

Four clinical guidelines were updated in May 2023:

• Head injury: assessment and early management includes new or updated recommendations on assessment in the emergency department, investigating clinically important traumatic brain injuries, investigating injuries to the cervical spine, and others;
• Diabetes (type 1 and type 2) in children and young people: diagnosis and management includes new recommendations on real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM, commonly referred to as 'flash') for children and young people with type 2 diabetes;
• Cardiovascular disease: risk assessment and reduction, including lipid modification;
• Acne vulgaris: management;

See the full details here.

This news is just one of about 300 market access news collected by our team in the subscription services "HTA Alerts" and "Reimbursement Alerts" every two weeks from more than 80 organizations. Access our paid subscription services to stay on top of all developments specifically for your products in Europe (reimbursement news) and globally (HTA news). Contact us to get a free, three-month, no-obligation trial.