Diagnostics guidance evaluates new, innovative diagnostic technologies. It includes all types of measurements and tests that are used to assess a patient's condition. The guidance helps people in the NHS make efficient, cost-effective and consistent decisions about adopting new products. It supports innovation, transformation and improves healthcare delivery.
In December 2018, NICE published one new Diagnostics Guidance for tumor profiling tests to guide adjuvant chemotherapy decisions in early breast cancer. EndoPredict (EPclin score), Oncotype DX Breast Recurrence Score and Prosigna are recommended as options for guiding adjuvant chemotherapy decisions for people with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative and lymph node (LN)-negative (including micrometastatic disease) early breast cancer, only if:
- they have an intermediate risk of distant recurrence using a validated tool such as PREDICT or the Nottingham Prognostic Index
- information provided by the test would help them choose, with their clinician, whether or not to have adjuvant chemotherapy taking into account their preference
- the companies provide the tests to the NHS with the discounts agreed in the access proposals, and
- clinicians and companies make timely, complete and linkable record-level test data available to the National Cancer Registration and Analysis Service as described in the data collection arrangements agreed with NICE
MammaPrint is not recommended for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2‑negative, and LN-negative early breast cancer because it is not cost-effective. IHC4+C is not recommended for guiding adjuvant chemotherapy decisions for people with ER-positive, HER2-negative, and LN‑negative early breast cancer because the analytical validity of the test is uncertain.
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 December 2018, NICE published two new Interventional Procedure Guidance documents:
- Interventional Procedure Guidance for transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults, which covers evidence-based recommendations on transcutaneous neuromuscular electrical stimulation for oropharyngeal dysphagia in adults that is aimed to strengthen the muscles involved in swallowing. For adults with dysphagia after a stroke, the evidence on efficacy suggests a potential benefit but is limited in quality and quantity. Therefore, this procedure should only be used with special arrangements for clinical governance, consent, and audit or research. For adults with dysphagia not caused by a stroke, there is insufficient evidence on efficacy to support the use of this procedure. Therefore, this procedure should only be used in the context of research
- Interventional Procedure Guidance for bronchial thermoplasty for severe asthma, which covers evidence-based recommendations on bronchial thermoplasty for severe asthma in adults with applying heat to the inside walls of the airways. Current evidence on the safety and efficacy of bronchial thermoplasty for severe asthma is adequate to support the use of this procedure provided that standard arrangements are in place for clinical governance, consent and audit
MedTech Innovation Briefing is the advice program for innovative technologies by NICE. 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 were published in December 2018:
- for Axonics sacral neuromodulation system for overactive bladder and faecal incontinence (rechargeable sacral neuromodulation system for use in overactive bladder syndrome and faecal incontinence)
- For Cerebrotech Visor for detecting stroke (the device that uses bioimpedance measurements for early detection of stroke subtypes to allow appropriate management, including mechanical thrombectomy)
- For Galaxy UNYCO for temporary stabilization of lower limb fractures (a single-use device used for temporary stabilization of lower limb fractures of the femur, tibia, ankle, and foot)
- For video laryngoscopes to help intubation in people with difficult airways (11 video laryngoscopes that are used to support the placement of breathing tubes in people with difficult airways)
See full details here.
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