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Med Tech-related technology assessments and clinical guidelines from NICE in October 2023
The National Institute for Health and Care Excellence (NICE) develops Interventional Procedures Guidance (IPG) for most 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 October 2023, NICE published two new IPGs and made the following conclusions:
- Vaginal transluminal endoscopic hysterectomy and adnexal surgery for benign gynaecological conditions should only be used with special arrangements for clinical governance, consent, and audit or research. Evidence on the safety and efficacy of the procedure is limited. Given the high number of hysterectomy and adnexal procedures done in the NHS, further evidence is needed to better understand long-term safety and which patients this procedure will work best for;
- Percutaneous deep venous arterialisation for chronic limb-threatening ischaemia in people with limited treatment options should only be used with special arrangements for clinical governance, consent, and audit or research. The evidence is limited in quality and quantity; in particular, long-term data and quality-of-life data are lacking.
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 unmet national needs. NICE evaluates the available evidence to determine if earlier patient and system access in the NHS is appropriate while further evidence is generated.
In October 2023, NICE published two new HTEs and made the following recommendations:
- Five digital weight-management technologies can be used in the NHS while more evidence is generated to deliver specialist weight-management services for adults who are eligible for weight-management medicine: Gro Health W8Buddy, Liva, Oviva, Roczen, Second Nature. These technologies can only be used once they have met the standards within NHS England’s Digital Technology Assessment Criteria (DTAC). NICE also developed an evidence-generation plan. The companies must confirm that agreements are in place to generate the evidence and contact NICE annually to confirm that evidence is being generated and analyzed as planned. NICE may withdraw the guidance if these conditions are not met. At the end of the evidence generation period (4 years), NICE will review the evidence submitted by companies and assess if the technologies can be routinely adopted in the NHS;
- Virtual ward platform technologies can be used in the NHS while more evidence is generated to monitor people over 16 with acute respiratory infection in their usual place of residence. They can be used for people who have been referred for hospital admission or admitted to a hospital and whose condition is stable or improving but needs ongoing monitoring. These technologies can only be used once they have appropriate regulatory approval, including a CE mark, and meet the standards within NHS England’s DTAC. NICE identified 20 technologies during the scoping process. Of these, 13 companies provided information on their technology. NICE mentions that the list of technologies included in this evaluation is not exhaustive, and other virtual ward technology platforms may be available.
One new clinical guideline was published in October 2023:
- Stroke rehabilitation in adults - includes recommendations on the organization and delivery of rehabilitation in hospitals and the community. NICE made new and updated recommendations in multiple areas, including telerehabilitation, computer-based speech and language therapy, robot-assisted arm training, managing shoulder pain and spasticity (e.g., with neuromuscular electrical stimulation (NMES), functional electrical stimulation (FES) or transcutaneous electrical nerve stimulation (TENS)).
Eight clinical guidelines were updated in October 2023 (no significant MedTech-related changes):
- Pneumonia in adults: diagnosis and management;
- Jaundice in newborn babies under 28 days;
- Thyroid disease: assessment and management;
- Suspected cancer: recognition and referral;
- Suspected neurological conditions: recognition and referral;
- Hearing loss in adults: assessment and management;
- Urinary incontinence in neurological disease: assessment and management;
- Ovarian cancer: recognition and initial management.
See the full details here.
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