OBJECTIVES: To establish a working definition of “quality” in the HTA context; to identify the key features of good-quality HTA submission and review performance. The outcome of the research will be used to facilitate the development and adoption of best practices in HTA submissions, assessment processes and decision making. METHODS:

The research was initiated by identifying common elements that underpin a quality submission dossier, and a set of key performance indicators (KPIs) of HTA review processes and procedures. International experts representing HTA/coverage agencies, academics and pharmaceutical companies were invited to discuss the identified parameters from diverse viewpoints. The key discussion points and recommendations for KPIs are outlined herein. RESULTS: Four elements of a quality dossier were identified: robustness and relevance of the scientific data; dossier completeness, that is, the inclusion of all relevant information; integrity or consistency; and logical structure and clear format. Quality of HTA review is most easily measured by assessing outcomes of tools designed to ensure or to support good-quality process such as internal and external peer reviews, audits, standard operating procedures and procedures for learning and feedback. Ten KPIs of the HTA review process considered important from a company’s perspective were identified as well the four main areas from HTA agencies perspective: timeliness, relevance, credibility and impact.  CONCLUSIONS:

A key outcome of this research was a clear understanding of “quality” in the context of HTA across stakeholders, and the identification of key factors, irrespective of the diversity of HTA agencies, which could be used to measure the quality of process.  The next phase of the research will be to develop an instrument to measure quality of HTA process based on identified KPIs and to be piloted and validated by key stakeholders.