Med Tech-related technology assessments and clinical guidelines from NICE in June 2020

21

Jul 2020

In June 2020, the National Institute for Health and Care Excellence (NICE) published one new diagnostics guidance (tests to help assess the risk of acute kidney injury for people being considered for critical care admission), one new interventional procedure guidance (for intravascular lithotripsy for calcified coronary arteries during percutaneous coronary intervention), one new medical technologies guidance (for Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia), and four Medtech innovation briefings (for MolecuLight i:X for wound imaging and others).

In June 2020, NICE published one new Diagnostics Guidance for tests to help assess the risk of acute kidney injury for people being considered for critical care admission (ARCHITECT and Alinity i Urine NGAL assays, BioPorto NGAL test and NephroCheck test), which provides evidence-based recommendations on these tests.  There is not enough evidence to recommend the routine use of the ARCHITECT and Alinity i Urine neutrophil gelatinase-associated lipocalin (NGAL) assays, BioPorto NGAL test, or NephroCheck test to help assess the risk of acute kidney injury for people being considered for critical care admission. Further research is recommended.

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.

In June 2020, NICE published one new Interventional Procedure Guidance Intravascular lithotripsy for calcified coronary arteries during a percutaneous coronary intervention, which covers evidence-based recommendations on intravascular lithotripsy for calcified coronary arteries during percutaneous coronary intervention in adults. Evidence on the safety and efficacy of intravascular lithotripsy for calcified coronary arteries during percutaneous coronary intervention is limited in quantity and quality. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research.

Medical technologies guidance 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 June, NICE published one new Medical Technologies Guidance Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia covers evidence-based recommendations on Rezum for treating lower urinary tract symptoms secondary to benign prostatic hyperplasia. Evidence supports the case for adopting Rezum for treating lower urinary tract symptoms (LUTS) caused by benign prostatic hyperplasia (BPH) in the NHS. Rezum relieves LUTS and improves the quality of life. Cost modeling estimates that Rezum is cost-saving compared with standard treatments such as transurethral resection of the prostate (TURP) and holmium laser enucleation of the prostate (HoLEP) by more than £550 per person over four years. Savings compared with UroLift are uncertain. This is because of uncertainty about some of the assumptions in the cost modeling for that comparison.

MedTech Innovation Briefing is the NICE's advice program 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.

Four new Medtech Innovation Briefings for MolecuLight i:X for wound imaging (for imaging wounds to identify fluorescent bacteria), Actim Pancreatitis for diagnosing acute pancreatitis (rapid test to diagnose acute pancreatitis in people presenting to emergency departments with acute abdominal pain or in people who have had endoscopic retrograde cholangiopancreatography), FibroScan for assessing liver fibrosis and cirrhosis in primary care (is a non-invasive medical device that assesses liver fibrosis and cirrhosis by measuring the degree of liver stiffness) and Archimedes for biopsy of suspected lung cancer (used to take image-guided biopsies of lung lesions) have been published in June.

See the full details here.

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