Development of a core evaluation framework of value-added medicines: report 1 on methodology and findings.

Background: Medicines that are based on known molecules and are further developed to address healthcare needs and deliver relevant improvement for patients, healthcare professionals and/or payers are called value-added medicines (VAMs). The evaluation process of VAMs is heterogeneous across countries, and it has been primarily designed for originator pharmaceuticals with confirmatory evidence collected alongside pivotal clinical trials. There is a mismatch between evidence requirements by public decision-makers and evidence generated by manufacturers of VAMs.

Development of a core evaluation framework of value-added medicines: report 2 on pharmaceutical policy perspectives.

Background: A core evaluation framework that captures the health care and societal benefits of value added medicines (VAMs, also often called repurposed medicines) was proposed in Report 1, aiming to reduce the heterogeneity in value assessment processes across countries and to create incentives for manufacturers to invest into incremental innovation. However, this can be impactful only if the framework can be adapted to heterogeneous health care financing systems in different jurisdictions, and the cost of evidence generation necessitated by the framework takes into account the anticipated benefits for the health care system and rewards for the developers.

Areas Covered: The framework could potentially improve the pricing and reimbursement decisions of VAMs by adapting it to different country specific decision-contexts such as deliberative processes, augmented cost-effectiveness frameworks or formal multi-criteria decision analysis (MCDA); alternatively, some of its domains may be added to current general evaluation frameworks of medicines.

Vitamin C, E and A levels in maternal and fetal blood for Czech and Gypsy ethnic groups in the Czech Republic.

Vitamin C, E and A levels in maternal and cord blood sera were examined at delivery in two districts of the Czech Republic. Information on personal and social characteristics, health, ethnicity, and lifestyle was also collected. A highly significant correlation between ascorbate levels in maternal and cord blood was found.

The exposure of nonsmoking and smoking mothers to environmental tobacco smoke during different gestational phases and fetal growth.

We studied the impact of maternal exposure to environmental tobacco smoke (ETS) on birth weight (BW), low birth weight (LBW), and intrauterine growth retardation (IUGR) according to self-reported maternal smoking habits in a sample of 6,866 singleton births. We obtained data about parental characteristics and maternal active smoking (AS) and passive smoking at delivery via maternal questionnaires and medical records. We used three categories of smoking habits (nonsmokers and those who smoked 1-10 or >10 cigarettes per day) and defined ETS exposure as greater than or equal to 5 cigarettes per day smoked by others in the mother's presence.