reprint, amsmath,amssymb, aps, ]revtex4-2 Background: The rapid adoption of best-value biosimilars and generics improves cost-effectiveness of treatment and increases patient access. Despite this, adoption differs among hospitals. Objectives: To quantify variation in adoption among English teaching hospitals, estimate the financial impact of delays, and identify factors influencing uptake. Methods: Mixed-methods analysis across ten hospitals. Dispensing data were analysed for the ten highest-spend medicines switched between 2018 and 2024. The primary outcome was time to 80% best-value adoption. Lost opportunity costs were benchmarked against the fastest adopter per drug. Regression analysis was used to identify predictors of uptake. Semi-structured interviews were transcribed verbatim, inductively analysed, and mapped to the Behaviour Change Wheel. Results: On average, the ten hospitals switched to best-value medicines at a similar rate to the national average. Eighty-three percent of switches achieved 80% adoption within 12 months, though performance varied by hospital and drug. Had all hospitals adopted at the rate of the fastest per drug, £27.8 million would have been saved over the study period. Hospital and drug were statistically significant predictors of the time to switch, and switches with strong financial incentives occurred 3.2 (90% CI 1.7 - 6.1) months faster. Interviews (n=27) identified capability influences (dedicated roles, oversight groups, resource, volume), opportunity influences (commissioner support, regulation, supply continuity), and motivational influences (embedded clinical pharmacists, multidisciplinary engagement, organisational prioritisation). Conclusion: Adoption of best-value medicines in these hospitals was consistent with national averages but concealed inter-hospital variation with major financial implications. Accelerating uptake requires strong organisational infrastructure and incentive structures.

Health systems encourage switching from originators to biosimilars as biosimilars are more cost-effective. The speed and completeness of biosimilar adoption is a measure of efficiency. We describe the approach to biosimilar adoption at a single hospital and compare its efficiency against the English average. We additionally follow up patients who reverted to a previously used biologic, having switched to a biosimilar, to establish whether they benefitted from re-establishing prior treatment. The approach we describe resulted in a faster and more complete switch to biosimilars, which saved an additional £380,000 on drug costs in 2021/22. Of patients who reverted to their original biologic, 85% improved short-term where the concern was tolerability, and 90% where it was efficacy. Patients remained on treatment for a prolonged period after reverting. Our approach to biosimilar adoption outperformed the English average and permits patients to revert to their original biosimilar post-switch if appropriate.

● Pharmacogenomic testing has the potential to target medicines more effectively towards those who will benefit and avoid use in individuals at risk of harm. ● Implementation of testing into routine practice across a healthcare system requires consideration of the evidence, clinical utility, cost-effectiveness, and operational requirements. ● A national approach to providing pharmacogenomic test recommendations and centralised commissioning will reduce inequity and duplication, but must be transparent and evidence based

The initial purposes of regulation of medicines in England were principally to raise government revenue, to discourage murder by poisoning, and to regulate the activities of pharmacists. It was only much later that regulators sought to ensure that medicines were of good quality, reasonably safe, and at least somewhat effective, and to regulate misuse of drugs. Here we survey the history of the regulation of medicines and poisons in England from the perspective of clinicians with an interest in therapeutics.

Direct-acting oral anticoagulants (DOACs) are licensed for the prevention of thromboembolism in non-valvular atrial fibrillation amongst other indications. Prescribers use information derived from the summary of product characteristics which is based on the key trials supporting the DOAC’s market authorisation. However, prescribers may be aware of the limitations of these trials regarding underrepresentation of patient populations commonly encountered in clinical practice and how this may adversely impact them. This review highlights the gaps in the licensing evidence using 3 clinical vignettes that explore prescribing challenges in the elderly, obese and female patients.

Introduction: Free-of-charge (FoC) medicine schemes are increasingly available and allow access to investigational treatments outside clinical trials or in advance of licensing or NHS commissioning. Methods: We retrospectively reviewed FoC medicine schemes evaluated between 2013 and 2019 by a single NHS trust and a regional drug and therapeutics committee (DTC). The details of each locally reviewed FoC scheme, and any nationally available MHRA Early Access to Medicines Scheme (MHRA EAMS) in the same period, were recorded and categorised. Results: Most FoC schemes (95%) allowed access to medicines intended to address an unmet clinical need. Over 7 years, 90% were company-FoC schemes and 10% were MHRA EAMS that were locally reviewed. Phase 3 clinical trial data were available for 44% of FoC schemes; 37% had phase 2 data; and 19% were supported only by phase 1, retrospective observational studies, or pre-clinical data. Utilisation of company-FoC schemes increased on average by 50% per year, while MHRA EAMS showed little growth. Conclusion: Company-FoC medicine schemes are increasingly common. This may indicate a preference for pharmaceutical companies to independently co-ordinate schemes. Motivations for company-FoC schemes remain unclear and many provide access to treatments that are yet to be evaluated in appropriately conducted clinical trials, and whose efficacy and risk of harm remain uncertain. There is no standardisation of this practice and there is no regulatory oversight. Moreover, no standardised data collection framework is in place that could demonstrate the utility of such programmes in addressing unmet clinical need or allow generation of further evidence.