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A525 estimate was based on prevalence data for URDs for which patented drugs are currently available and for which drugs are in clinical development and hence may be expected to be launched in the foreseeable future. A power function was used to estimate the relation between (decreasing) prevalence and (increasing) cost per patient. For drugs in development, we applied phase duration data and attrition rates from the Tufts Center for the Study of Drug Development database. Results: A total of 18 drugs under patent protection for non-oncological URDs were identified. Furthermore, 29 drugs for non-oncological URDs under development that have the potential of reaching the market by 2021 were found. Total budget impact over 10 years was estimated to be € 14,112 and € 4,965 million for approved and pipeline URD drugs, respectively (total: € 19,077 million). Relative to total pharmaceutical expenditures in Europe, spending on drugs for URDs is estimated to rise from 0.7% at present to 1.6% in 2021. Univariate sensitivity analyses and extreme scenario analyses suggesting robustness of this projection will be presented. ConClusions: Our analysis does not support concerns regarding an uncontrolled growth in expenditures for drugs for URDs. Nevertheless, continuous monitoring of the budget impact as an input to rational policy making is recommended.

Aleksei Sergeevich Kolbin, PhD, Professor, head of the clinical pharmacology and evidencebased medicine department at the First Pavlov Saint Petersburg State Medical University, Professor of the pharmacology department of the medical faculty at the Saint Petersburg State University Topicality of the issueThe authors touch upon an issue critical for children in neonatality and the first years of lifeimmune prevention of respiratory syncytial virus (RSV) infection [1]. It not only features severe course in the setting of no evidence-based effective and safe etiotropic therapy, but also lays a heavy disease burden (DB) on the society. DB may be numerically represented with a WHO indicator DALY (disability-adjusted life year). This indicator characterizes the disease burden in years of life in relation to disability. In other words, it is equivalent to losing 1 healthy life year. It is known that DALY (Score/1,000) for RS infection is 67.7, whereas for adenovirus it is 49.7, for herpes -34.4, for influenza A -6.8 [2, 3]. RS infection burden is comprised of two main components -high hospitalization frequency in children with RSV and consumption of healthcare resources by children under 2 years of age. At the same time, there are technologies of controlling this medical and social issue -immune prevention of RS infections with monoclonal antibodies. Palivizumab is considered to be such a vaccine. There is evidence (meta-analysis of clinical trials) that immune prevention has reduced mortality more than 4 times in the group of children born before the 32 nd gestation week [4]. Prevention of RS infection is a standard practice in children born before the 30 th gestation week regardless of the economic development level. Unfortunately, the Russian Federation does not partake in this process (unlike, say, Ecuador), although preservation and rehabilitation of children's health is proclaimed the priority of Russian healthcare. Advantages of the articleThe article by V.I. Ignatyeva et al. is set forth according to the traditional scheme of clinical economic analysis (standards of "Clinical economic analysis", general provision of OST 91500.14. . The author substantiates topicality of the issue, scientific novelty and practical implications of the work, defines the aim of the study and lists methods of pharmacoepidemiological and clinical economic analysis. The obtained data were statistically manipulated using difference significance criteria. The study involved detailed analysis of palivizumab immune prevention results in Moscow in the season of 2012/2013. The article features detailed calculation of expenses per 1 disability-adjusted life year and proves that the taken measures prevented economic loss due to infantile mortality decrease. The results demonstrate that use of palivizumab for preventing RS infection ought to be considered clinically and economically sound. The article is a complete scientific study; it is well illustrated, written in the literary language and is rather readable despite complicated nature of ...

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