Cássia Rita Pereira da Veiga

MORE THAN ONE DECADE OF VIAGRA: WHAT LESSONS CAN BE LEARNED FROM INTELLECTUAL PROPERTY RIGHTS IN THE ERECTILE DYSFUNCTION MARKET?

The general objective of this study is to investigate the erectile dysfunction pharmaceutical market over the past two decades (1990–2010) through patent data analysis. The study of the erectile dysfunction market allows the analysis of the technological trajectory of Viagra® in its several phases, since the launching of a radical innovation, going through the accommodation of incremental innovations and eventually the release of generic versions of that product. This is a descriptive, documentary, longitudinal research that analyses five research hypotheses. The results show how the erectile dysfunction market has developed over the years and the lessons that can be extracted regarding Intellectual Property Rights for countries, companies and governments, including political and social considerations about how much should a patent protect innovation.

Concern over cost of and access to cancer treatments: A meta-narrative review of nivolumab and pembrolizumab studies

BACKGROUND A better understanding of the modulation of the immune system has resulted in the development of new classes of antitumor agents such as nivolumab and pembrolizumab. Despite the proven effectiveness and tolerability of these new drugs for specific types of cancer, the high cost of treatment has affected their accessibility. OBJECTIVE The aim of this study is to conduct a meta-narrative review of studies that have addressed the concerns that have been voiced regarding the cost of and access to nivolumab and pembrolizumab in oncology health care. This meta-narrative review attempts to answer the following questions: (1) which papers have considered this broad topic area?; (2) what are the main empirical/theoretical findings?; and (3) what insights can be drawn by combining and comparing findings from different papers? METHODS AND DATA SOURCE A meta-narrative review has been conducted in 5 research databases (Web of Science, Science Direct, Scopus, Embase and Pubmed) without time limitations up to January of 2017 to address concerns related to the cost of and access to nivolumab and pembrolizumab in oncology health care. From each research base, articles were selected that had a key word related to the theme of pharmacoeconomics and nivolumab or pembrolizumab in any field of scientific work. The research questions were analyzed through the application of a meta-narrative review approach and the use of a convergence-coding matrix to summarize similarities and differences directly related to the research topic between the different papers. KEY FINDINGS The first contribution of this meta-narrative review is that it summarizes economic-based works on the use of nivolumab and pembrolizumab, particularly for three therapeutic indications: melanoma, NSCLC and RCC. In general, despite the clinical benefit of nivolumab and pembrolizumab being well accepted and proven by scientific works, the published studies show that there are contradictory results with regard to the cost-effectiveness of these anti-PD-1s. The regulatory, economic and epidemiological variations mean that healthcare costs for cancer patients vary greatly from country to country and according to the type of tumor. The second contribution has to do with the recommendations for the development of high quality process for pharmacoeconomic analyses, especially in the new field of immuno-oncology. Finally, the third contribution is with regard to recommendations for the sustainable use of immunotherapies. CONCLUSIONS Given the revolution in cancer therapy in recent years, the efficient allocation of existing resources is essential for healthcare systems to meet the evolving needs of populations and remain sustainable in the long term. The application of high quality information that stems from scientific evidence and economic modeling can help considerably to make the healthcare system sustainable over time mainly due to a higher number of therapeutic indications or more countries giving regulatory approval for the use of new and expensive cancer drugs.