Objective In 2018, the UK National Institute for Health and Care Excellence (NICE), in partnership with Public Health England, NHS England, NHS Improvement and others, developed an evidence standards framework (ESF) for digital health and care technologies (DHTs). The ESF was designed to provide a standardised approach to guide developers and commissioners on the levels of evidence needed for the clinical and economic evaluation of DHTs by health and care systems. Methods The framework was developed using an agile and iterative methodology that included a literature review of existing initiatives and comparison of these against the requirements set by NHS England; iterative consultation with stakeholders through an expert working group and workshops; and questionnaire-based stakeholder input on a publicly available draft document. Results The evidence standards framework has been well-received and to date the ESF has been viewed online over 55,000 times and downloaded over 19,000 times. Conclusions In April 2021 we published an update to the ESF. Here, we summarise the process through which the ESF was developed, reflect on its global impact to date, and describe NICE’s ongoing work to maintain and improve the framework in the context for a fast moving, innovative field.

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Context The quality improvement involved development of a follow up service for patients presenting to a busy district general hospital with Henoch Schoelein Purpura (HSP). Follow up is recommended as the rare but important renal sequelae of the condition can be silent initially. Problem In our department no follow up pathway existed for HSP. Patients were seen in either consultant outpatient clinics, with the majority of children being well, or discharged for primary care follow up which relies on general practitioners and families to organise ill defined follow up creating the potential to miss any renal sequelae Assessment of problem and analysis of its causes The problem was identified during the acute assessment of patients presenting. Following discussion with senior staff about absence of evidence based local follow up procedures and subsequent literature review a structured pathway was proposed. It was felt that all children should have hospital review with consultant follow up focusing on children with complications Intervention The aim was to standardise and rationalise care thereby improving department efficiency without compromising patient safety. A pathway for nurse led follow up which had been piloted elsewhere (1) was used as a model. Children were assessed at presentation and guidance was given for those needing admission or investigation. Otherwise they should be discharged home with urine dipsticks to check early morning urine and information about what concerning features should lead them to seek reassessment. All children were seen seven days later and stratified according to absence or presence of proteinuria, as a marker for renal involvement, to standard follow up (four in the year) and more frequent visits (seven in the year) if proteinuria present. If proteinuria developed in the standard group, they moved to more frequent follow up. Urinalysis was undertaken at each follow up visit and criteria for consultant review were clearly defined. (1) Henoch Schonlein Purpura – A 5-Year Review and Proposed Pathway. Louise Watson, et al Strategy for change During the development stage senior nursing and medical staff were consulted about the practicalities and possibilities of developing a similar pathway and a guideline was produced with department ratification. Only limited information about the pathway was disseminated to junior staff before its introduction. Measurement of improvement Sixteen months on, an audit and service evaluation was undertaken with feedback from patients, their families and staff. Effects of changes Of 22 children followed up none developed renal sequelae at any time. Almost half did not use consultant clinic appointments for follow up with seven completing the pathway appropriately, two having extra nurse follow up and one who had nurse follow up at different intervals to those recommended. Ten children had consultant follow up, which was not clinically indicated. Staff feedback was positive. Parents expressed the benefit of more flexible and quicker appoin...

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none of them includes the cost of caregivers. The ICERs proposed by the manufacturers can range from V 6,111 to V 2,661,514 / QALY. The efficiency frontier of the best therapeutic strategies is presented in only 32% of cases. Uncertainty analysis is often problematic, with only 64% of models presenting both deterministic and probabilistic sensitivity analysis. CONCLUSIONS: In France, there are no benchmarks for willingness to pay, but the CEESP is increasingly making a value judgment on the amount of ICER. A decision support tool is beginning to emerge: a proportionality between the price and the ICER.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 peerreviewed 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.