Background The concept of the regulatory sandbox—a safe space for testing new regulatory processes—was first used within the financial technologies (FinTech) sector, but has since expanded into other sectors, including healthcare. Objectives This review aims to describe the extent of use of sandboxes in healthcare and assess the potential for the sandbox approach to be used to test and develop emerging health technology assessment (HTA) methods, policies and processes for innovative technologies. Methods A systematic literature review was undertaken to identify published papers and reports that described and/or assessed the use of sandboxes in the healthcare sector. Searches were conducted in Medline, Embase, Econlit, Social Policy and Practice, and Health Management Information Consortium databases from inception to March 2020. Free-text Google search was also conducted to identify relevant grey literature. Only papers and reports discussing or evaluating the use of sandboxes in healthcare settings and published in English were included. Included studies were qualitatively summarised using a thematic analysis approach. Results Overall, 46 papers and reports were included. The topics covered were classified into 4 major themes: history of the regulatory sandbox, the sandbox as a testing environment, the sandbox as a regulatory approach, examples of using sandboxes in healthcare. Findings show that the use of regulatory sandboxes in healthcare is relatively new and primarily used in high-income countries to support the adoption of new technologies, particularly those related to digital health. Recommendations are made based on these findings to guide its use in HTA policy and methods development. Conclusions Sandboxes are increasingly used within healthcare regulation. Despite its potential, this approach has not been used in HTA policy and methodological developments to date. HTA agencies should consider this approach to facilitate developing policies, methods and processes for innovative and disruptive health technologies. Transferability to low- and middle-income countries’ settings, however, should be assessed.

In July 2019, the National Institute for Health and Care Excellence (NICE) initiated a major review of its health technology evaluation methods to update its methods guide. This update has recently concluded with the publication of its health technology evaluation manual in January 2022. This paper reports the methods and findings of the review in relation to the recommended approach to use for the measurement and valuation of health-related quality of life (HRQoL) in submissions to NICE. Issues related to (i) the methods to use when NICE’s preferred measure (EQ-5D) is not appropriate or not available; (ii) adjusting health state utility values over time to account for age; (iii) measuring and valuing HRQoL in children and young people; and (iv) including carers’ QoL in economic evaluations were included in this review. This commentary summarises the methods used to undertake the review, its findings, and the changes to NICE methods that were proposed based on these findings. It also outlines topics where further research is needed before definitive methods guidance can be issued. The broad proposals described here were subject to a public consultation in 2020 and a further consultation on the updated methods guidance was completed in October 2021 before the publication of the manual in January 2022.

Pharmacists play important role in ensuring timely care delivery at the ward level. The optimal level of pharmacist input, however, is not clearly defined. To systematically review the evidence that assessed the outcomes of ward pharmacist input for people admitted with acute or emergent illness. The protocol and search strategies were developed with input from clinicians. Medline, EMBASE, Centre for Reviews and Dissemination, The Cochrane Library, NHS Economic Evaluations, Health Technology Assessment and Health Economic Evaluations databases were searched. Inclusion criteria specified the population as adults and young people (age >16 years) who are admitted to hospital with suspected or confirmed acute or emergent illness. Only randomised controlled trials (RCTs) published in English were eligible for inclusion in the effectiveness review. Economic studies were limited to full economic evaluations and comparative cost analysis. Included studies were quality-assessed. Data were extracted, summarised. and meta-analysed, where appropriate. Eighteen RCTs and 7 economic studies were included. The RCTs were from USA (n = 3), Sweden (n = 2), Belgium (n = 2), China (n = 2), Australia (n = 2), Denmark (n = 2), Northern Ireland, Norway, Canada, UK and Netherlands. The economic studies were from UK (n = 2), Sweden (n = 2), Belgium and Netherlands. The results showed that regular pharmacist input was most cost effective. It reduced length-of-stay (mean = -1.74 days [95% CI: 2.76, -0.72], and increased patient and/or carer satisfaction (Relative Risk (RR) = 1.49 [1.09, 2.03] at discharge). At £20,000 per quality-adjusted life-year (QALY)-gained cost-effectiveness threshold, it was either cost-saving or cost-effective (Incremental Cost Effectiveness Ratio (ICER) = £632/QALY-gained). No evidence was found for 7-day pharmacist presence. Pharmacist inclusion in the ward multidisciplinary team improves patient safety and satisfaction and is cost-effective when regularly provided throughout the ward stay. Research is needed to determine whether the provision of 7-day service is cost-effective.