Modern Trends in Pharmaceutical Scientific Research
Dr. Antal István
Dr. Kaló Zoltán Dr. Inotai András
Dr. Rencz Fanni
Dr. Nagy Balázs
Dr. Zelkó Romána
Dr. Babarczy Balázs
Dr. Varga Orsolya
SUMMARY
It has become unassailable that the currently dual world of pharmaceutical innovation (original versus generic) cannot keep up with the rapid pace of the growing therapeutic needs of the 21st century. Incremental innovation of off-patent medicines could complement both generic and original drug development approaches in a fast, affordable, and sustainable manner. However, at present, there is no viable business model for value-added medicines, therefore – because of the lack of incentives for investors – the market share of these medicines is negligible in the European market. The establishment of a predictably functioning business model is hindered by various factors. From these, my doctoral research focuses on issues related to health technology assessment and reimbursement. The main problem in this area is that the potential value of VAMs is limitedly comprehensible within the currently used technology assessment frameworks, which were primarily developed for original medicines. To take the first step in tackling these issues, we developed an evaluation framework that – when adapted to national needs – can facilitate the value assessment processes and reimbursement decisions of VAMs. The development of the evaluation framework was based on a comprehensive systematic literature review, through which we collected the potential value propositions of VAMs. From these value propositions, we created value domains through an iterative process, resulting in the first version of the framework. To be internationally adaptable, we engaged an external panel of international experts to critically review the evaluation framework. Following two virtual expert panels, the final core evaluation framework was developed, consisting of 5 clusters and 11 value domains. Subsequently, we examined the opportunities and potential barriers to the adaptation of the framework in different countries and potential intervention points. We conducted structured interviews with recognised health policy experts and pharmaceutical managers in three European countries. To achieve a broad application and adaptation of the framework, further national-level health policy research is required. The research carried out and presented in this dissertation provides a suitable starting point for such additional policy work. Ultimately, the research results can contribute to the entry of high-quality, off-patent medicines to the market and finally, the establishment of a more sustainable, patient-centered healthcare delivery system in Europe.
