OP223 A Semi-Automated Process To Monitor The Clinical Development And Regulatory Approval Pathway Of Innovative Medicines

Abstract

Introduction

Early identification of innovative medicines is crucial for timely health technology assessment (HTA) and efficient patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies, monitors and notifies key HTA stakeholders in England of ‘technologies’ (innovative medicines) within three to five years of regulatory approval. Increasing numbers of innovative medicines and significant uncertainties in clinical and regulatory pathways are major challenges in the monitoring and notification process. An active monitoring framework using pre-defined predictive criteria has previously been developed. This framework provides a standardized and consistent process, but is highly resource-intensive, requiring manual review of individual records.

Methods

Using the previous active monitoring framework, a scoring matrix was calculated and used to prioritize individual technologies using available data in the NIHRIO database: estimated regulatory timelines, regulatory awards/designations, innovative medicine type (for example gene therapies) and clinical trial phase, completion dates and results. A threshold for automatic and manual reviewing of technologies was developed and tested by NIHRIO analysts.

Results

The scoring system identified approximately ninety percent of technologies meeting the threshold for semi-automated reviewing. The review period for these technologies are set automatically according to predefined criteria depending on data availability. The review periods are updated automatically until the record reaches the threshold that triggers manual reviewing. The remaining ten percent had estimated regulatory timelines necessitating the need for manual reviewing and early engagement with companies to verify regulatory timelines and/or notify HTA stakeholders.

Conclusions

Preliminary analysis indicates that each technology is routinely and automatically updated. The semi-automatic updating represents a significant improvement in the efficiency of the monitoring of the large volume of technologies on the NIHRIO database. Ongoing work is being undertaken to further refine, pilot and test the system.

This project is funded by the NIHR [(HSRIC-2016-10009)/Innovation Observatory]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.