Abstract

IntroductionWhile horizon-scanning systems aim to identify innovative and potentially disruptive health technologies in development, a key challenge is variation in information collation and tracking of the pace of change prior to regulatory approval. An active and efficient monitoring process is crucial for timely notification of health technology assessment (HTA) stakeholders to enhance faster market and patient access. The National Institute for Health Research Innovation Observatory (NIHRIO) identifies and notifies its key HTA stakeholders in England of technologies that are within three to five-year timeframe to regulatory approval. Regular review of each technology is required to meet this remit.MethodsA standardized monitoring framework was developed based on the knowledge and experience of the evidence synthesis specialists in NIHRIO, supplemented by literature to ensure consistency of setting review periods. This framework used predefined criteria that integrated the technology innovation (advanced therapies, orphan status, regulatory awards), trial data (phase, status, completion date, preliminary results) and estimated approval timelines obtained from the company or other sources (for example, press releases).ResultsThe framework has been piloted and early findings showed improved consistency in the monitoring process between different analysts. It ensures that each technology is reviewed at least once a year; review timelines are set at three, six, nine or twelve months based on the predefined criteria. Estimated timeframes obtained from the companies are used to triangulate and streamline review periods, improving efficiency of the monitoring process.ConclusionsFindings from the pilot work with the framework demonstrated improved consistency and efficiency of the technology monitoring process, which can be easily implemented to provide early awareness in an accurate and timely manner for HTA. This framework was designed using a systematic and transparent approach that integrated different data sources to set review periods. While most of the data used in defining the criteria are publicly available, commercially sensitive information provided by companies were also used which may not always be readily available. Implications for horizon-scanning organizations will be discussed.

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