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Med Tech-related technology assessments and clinical guidelines from NICE in November 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 November 2023, NICE published four new IPGs and made the following conclusions:
- Recommendations on percutaneous thrombectomy for intermediate-risk or high-risk pulmonary embolism (PE) differ depending on the clinical indications.For high-risk PE in people who cannot have thrombolysis or when there are no other suitable treatment options, or alternative treatments have failed, percutaneous thrombectomy should only be used with special arrangements for clinical governance, informed consent, and audit. For intermediate-risk PE or high-risk PE when alternative treatments are suitable, pulmonary thrombectomy should only be used in research;
- Percutaneous transarterial carotid artery stent placement for asymptomatic extracranial carotid stenosis should only be used with special arrangements for clinical governance, consent, and audit or research;
- Recommendations for biodegradable subacromial spacer insertion for rotator cuff tears depend on clinical indications. The procedure should not be used when debridement is a suitable option. When debridement is not a suitable option, the procedure should be used only in research;
- Recommendations for extracorporeal carbon dioxide removal for acute respiratory failure (ECCO2R) depend on clinical indications. For people with acute hypoxic respiratory failure, ECCO2R should not be used. For people with acute hypercapnic respiratory failure, ECCO2R should be used only in research.
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 November 2023, NICE published one new HTE virtual reality technologies for treating agoraphobia or agoraphobic avoidance and made the following recommendations:
- One technology (gameChangeVR) can be used in the NHS while more evidence is generated to treat severe agoraphobic avoidance in people with psychosis aged 16 and over. It should be used with the support of a mental health professional. NICE also developed the evidence generation plan for this technology. The company 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 (3 years, or sooner if enough evidence is available), the company should submit the evidence to NICE in a form that can be used for decision-making. NICE will review the evidence and assess if the technology can be routinely adopted in the NHS;
- The following VR technologies can only be used in research: gameChangeVR to treat mild to moderate agoraphobic avoidance in people with psychosis, Amelia Virtual Care, and XR Therapeutics to treat agoraphobia.
Five clinical guidelines were updated in November 2023. However, no MedTech-related changes were made:
- Familial breast cancer: classification, care and managing breast cancer and related risks in people with a family history of breast cancer;
- Suspected acute respiratory infection in over 16s: assessment at first presentation and initial management;
- Hypertension in adults: diagnosis and management;
- Transient loss of consciousness ('blackouts') in over 16s;
- COVID-19 rapid guideline: managing COVID-19.
See the full details here.
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