Pharmaceutical innovativeness index: methodological approach for assessing the value of medicines - a case study of oncology drugs.

BACKGROUND: We propose a framework to assess the value of pharmaceutical innovations, with explicit clinical and methodological parameters, based on the therapeutic value and health needs. RESEARCH DESIGN AND METHODS: The study was based on the adaptation of health technology assessment methods documented in the literature, which was applied to a sample of oncological drugs. Difficulties and issues during the application of those tools were identified and addressed to develop a new framework with new and revised domains and clear classification criterion for each domain. Scores were assigned to each level and domain according to their relevance to generate the final score of innovativeness. RESULTS: The Pharmaceutical Innovation Index (PII) includes four domains, two related to clinical and social dimensions - Therapeutic Need and Added Therapeutic Value - and other two about methodological features - Study Design and Quality (risk of bias). The scores combined after assigned to each domain results Index of the Innovativeness of the medicines represents the degree of pharmaceutical innovation. CONCLUSION: This work proposes a transparent methodology with well-defined criteria and script; the algorithm developed with authors' weightings and criteria may be switched to best adjust to other applications, perspective or clinical indications, while keeping the transparency and objectiveness.

Pharmacoepidemiology of the elderly in Brazil: state of the art.

With improving socioeconomic conditions, longer life spans have become more common in developing countries-those with a growing economy increasing production, per capita consumption, and income. This has been the case in Brazil. If, on one hand, this phenomenon undoubtedly represents a major social achievement, there is also consensus that it provides a set of challenges for Brazilian society. Among these challenges: promoting rational drug use in the elderly. This article aims at presenting the current state of the pharmacoepidemiology of aging in Brazil. It describes the main components and needed advances in this field of knowledge. It also identifies areas that, if improved, will allow more consistent contributions to national drug policy and improve the quality of pharmacotherapy and other health conditions among Brazilian seniors.