OBJECTIVES: In England, medicines and devices not suitable for formal health technology assessment (HTA) by the National Institute for Health and Care Excellence (NICE) can be selected for a range of NICE advice products. NICE advice does not constitute formal guidance and does not provide recommendations, but rather informs local National Health Service decision making for medicines, devices, and digital apps. This study reviews differences between NICE advice products, the processes involved, and the areas of health care covered by published advice.
METHODS: Published NICE advice products and processes were reviewed up to 25 April 2018 and verified by consultation with NICE technical staff. For each product, the output was analyzed to record the type of technology, clinical area, and setting.
RESULTS: Of 295 NICE advice publications, products included: since 2012, 130 evidence summaries of new or unlicensed medicines; since 2014, 140 Medtech Innovation Briefings (MIBs) of devices, diagnostics, and digital apps; since 2015, 20 key therapeutic topics for medicines optimization; and since 2018, 5 Improving Access to Psychological Therapies Assessment Briefings (IABs) for digital psychological therapies. For MIBs and IABs, companies can directly submit their technology for consideration by NICE; however, evidence summaries and key therapeutic topics are selected by NHS England and NICE. All NICE advice is peer-reviewed and includes a summary and critical review of the best available clinical evidence and a cost/resource impact assessment. MIBs and IABs also include expert and/or patient commentary.
CONCLUSIONS: In addition to formal HTA, NICE now publish a suite of advice products to inform both clinicians and commissioners on medicines, devices, and apps, covering a broad range of clinical areas and care settings, including hospital, primary, and community care. NICE advice products on digital apps has been launched in the past year, with the introduction of a new product, IABs.
