PROJECT TITLE:

Audit on hospital database to evaluate the impact of the company drug in the management of focal onset seizure drug-resistant patients (F-DRE)

ANGELINI AND NHS GGC POTENTIAL BENEFIT

• Evaluate the benefit of the company drug in the management and HCRU (healthcare resource utilisation) in patients living with drug resistant epilepsy, to identify areas for improvement on product use and communication.
• Ultimately, this joint working project is for the benefit of patients, to improve the quality of care.

EXPECTED OUTCOMES AND HOW WILL BE USED

• This project will help evaluate the impact of the company drug has had in the management of patients with drug resistant epilepsy and identify areas for improvement.
• We aim to obtain valuable insight into the early experience of clinicians using the company drug, with objective audit data collected in a large real-world cohort. Objective measures of response, retention, rates of adherence and HCRU will be undertaken in a well described clinical cohort. By updating the analysis at 12 months we will evaluate whether clinicians are using the company drug earlier and the effect that has on response.
• The results of the project will be used by NHS GGC and Angelini to shape decisions to help improving the quality of care for patients with F-DRE

PROJECT RATIONALE

• NHS GGC has a relevant experience on data collection and analysis.
• The data will be in fact collected as part of a Regional Epilepsy Register, supported by the Scottish Government. Much of the outcome data is routinely generated health data eg, Dispensing data, ED attendance data. This is supplemented by more granular data, collected as part of routine good clinical practice eg. Following attendance at out-patients.
• The data is transferred to a secure NHS server, anonymised and analysed by a data analyst with previous experience using this methodology. 

GOVERNANCE

• University of Glasgow will be responsible for the protocol definition, data extraction and collection, data analysis and final reporting.
• Angelini Pharma will provide clinical and pharmacoeconomic advice for the protocol definition and data analysis plan, and financial support.

TIMELINE

• Contracting and project set-up – by Dec '23
• Interim analysis – by end of April '24
• Final reporting – by Dec ‘24