Clinical guidelines and Med Tech-related technology assessments from NICE in the second half of September 2017

The following new clinical guidelines have been published by the National Institute for Health and Care Excellence in the second half of September:

• Faltering growth: recognition and management of faltering growth in children. This guideline covers recognition, assessment and monitoring of faltering growth in infants and children. It includes a definition of growth thresholds for concern and identifying the risk factors for, and possible causes of faltering growth. It also covers interventions, when to refer, service design, and information and support.
• Endometriosis: diagnosis and management. This guideline covers diagnosing and managing endometriosis. It aims to raise awareness of the symptoms of endometriosis, and to provide clear advice on what action to take when women with signs and symptoms first present in healthcare settings. It also provides advice on the range of treatments available.

The following clinical guidelines have been updated:

• Urinary tract infection in under 16s. This guideline covers diagnosing and managing first or recurrent upper or lower urinary tract infections in infants, children and young people. In September 2017 the evidence for urine testing strategies for infants and children under 3 years has been reviewed.
• Depression in children and young people: identification and management. This guideline covers identifying and managing depression in children and young people aged between 5 and 18 years. Based on the stepped care model, it aims to improve recognition and assessment and promote effective treatments for mild, moderate and severe depression. In September 2017, recommendation to clarify the training needed for therapists and to delete reference to a preferred questionnaire, as this is no longer relevant, have been updated. Footnotes 3, 5 and 6 were also updated to clarify the advice on marketing authorisation and licensed indications.
• Sepsis: recognition, diagnosis and early management. This guideline covers the recognition, diagnosis and early management of sepsis for all populations. In September 2017, NICE has updated recommendation 1.4.3 to properly divide 2 bullet points. Table 3 and recommendations 1.4.9 and 1.9.2 were corrected to give oxygen saturation as less than 92% in air. Table 2 was amended to include tympanic temperature as a moderate risk factor. Table 3 was amended to add pallor of skin, lips or tongue as an intermediate to high risk factor, and recommendation 1.4.9 was amended to remove pale or flushed as an intermediate risk factor.

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. Interventional Procedures Guidance for the following procedures have been published:

• Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by motor neurone disease: NICE concluded that on intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by motor neurone disease suggests that there are serious long-term safety concerns. Evidence on efficacy is limited and therefore, this procedure should not be used to treat this condition.
• Intramuscular diaphragm stimulation for ventilator-dependent chronic respiratory failure caused by high spinal cord injuries: NICE recommended to use this procedure only in the context of research due to limited quantity and quality of evidence on the safety and efficacy.
• Ab externo canaloplasty for primary open-angle glaucoma: NICE supports the use of this procedure because current evidence on its safety and efficacy is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit.
• High-intensity focused ultrasound for symptomatic breast fibroadenoma: NICE recommended to use this procedure only with special arrangements for clinical governance, consent and audit or research due to limited quantity and quality of evidence on the safety and efficacy.

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 a formal guidance and it therefore does not provide any recommendations.

Three new Medtech Innovation Briefings for Farco-fill Protect (a solution used to inflate Foley urinary catheter balloons), Caris Molecular Intelligence for guiding cancer treatment (used to help guide future management of locally advanced or metastatic cancer) and Aptiva for painful diabetic neuropathy (frequency rhythmic electrical modulation system (FREMS) to treat painful diabetic neuropathy) have been published.

Subscribe to our newsletter delivered every second week not to miss important reimbursement information.