A model for the clinical management of the introduction of new medicines in a large University Hospital in Spain.

BACKGROUND: New medicines offer therapeutic opportunities but also challenge healthcare system organisation and sustainability. This study aims to describe a model based on regular multidisciplinary meetings to manage and monitor the introduction of new medicines for Hospital Outpatient Treatments (HOT) in a Spanish tertiary hospital, and the observed results after its implementation. METHODS: Meetings held during 2016-2023 and related documents were retrospectively reviewed. The meeting agenda and minutes included information on new drugs, follow-up of compliance with data collection in the Register of Patients and Treatments, drug expenditure, number of treated patients, quality/efficiency indicators, and agreements. An observational, descriptive study with a mixed approach (quantitative analysis of expenditure and activity data and qualitative documentary analysis) was performed. Percentage changes are expressed as relative changes. RESULTS: During this period, 242 meetings with 12 selected clinical departments/units were held. A total of 284 agreements were reached, most of them related to the need to improve registry data (37.7%), and promoting the use of generic/biosimilar drugs (18.3%). A 40.2% increase in HOT expenditure, a 55.4% increase in the number of treated patients, and a 9.7% decrease in the cost per patient were documented in these departments from 2016 to 2023. The greatest HOT expenditure was observed in Haematology and Oncology (reaching around 39 and 28 million euros annually in 2023, respectively). The most marked increases occurred in Pneumology and Allergology. The use of generic/biosimilar drugs in Infectious diseases and Rheumatology departments had a more noticeable impact, with decreases in HOT expenditure of 15.8% and 6.6%, respectively. While caution is needed when interpreting the data, a lower increase in HOT expenditure was observed in the departments/units in which meetings were held. CONCLUSION: Having a consolidated method for the introduction and monitoring of new medications helps to set up an organised and reasoned decision-making process.