Pharmacoeconomics: theory and practice
№3, 2021, Vol.9
The successful development of the economy of a modern state is directly related to the entry into the market of new advanced therapy medicinal products. For Russia, the process of developing and implementing biomedical cell products will become the basis for the successful transformation of the pharmaceutical market into a knowledge-intensive market economy. Biomedical cell products can act as one of the main tools of such a promising and capital-intensive direction as regenerative medicine. The field of biomedical cell products therapy is developing rapidly, but there are still questions about the safe use of biomedical cell products therapy. The growing need for effective recommendations for the participants of the biomedical cell products market has determined the relevance of this study. Multivariate analysis of the prospects and barriers to the development of the biomedical cell products market to justify and develop recommendations for investors, pharmaceutical manufacturers and distributors for the production and sale of biomedical cell products in Russia. Materials and methods. The materials were regulatory legal documents of regulatory bodies: the USA, the EU, the Russian Federation, the EAEU, as well as analytical materials of open access. Results. A comparative analysis of the production features and the formation of the cost of autologous and allogeneic biomedical cell products revealed the ways of development of the biomedical cell products market. Further, the key directions of the prospective development of the biomedical cell products market were identified and characterized, risk factors, drivers and barriers were identified. Conclusion. In the direction of regulatory support: – create a general register for monitoring the results of research and the use of biomedical cell products. – to develop an information environment for comparing large sets of biomedical cell products life cycle data obtained from different sources; – to develop regulatory approaches to the circulation of biomedical cell products in the market. In the direction of technological support: – plan the implementation of automation of all stages of the production process; – to provide for the development of technology transfer methods; – to maintain the pharmaceutical quality system in an up-to-date functioning state; – implement a platform for training qualified personnel for this field. In the direction of marketing support: – to create logistics chain systems, with the help of integration technologies, capable of ensuring uninterrupted supply of biomedical cell products with minimal risks to the quality of the supply chain reliability; – supply planning should take into account the stability and storage conditions of the biomedical cell products; – scaling up production leads to a reduction in cost, and an increase in the use of biomedical cell products in routine medical practice leads to an increase in the present value; – conduct training of production employees, distributors and medical personnel. – develop a commercialization strategy for each biomedical cell products separately.
The global pharmacoeconomic model of cost-effectiveness analysis of insulin degludec (Tresiba®) use in comparison with insulin glargine U300 in the treatment of type 2 diabetes mellitus, was validated. As the result, it was found that the model is relevant to local clinical practice, fully complies with the pharmacoeconomics methodology, takes into account the entire spectrum of costs relevant for the pharmacoeconomic evaluation of insulin in Russia, and the computations built in it is correct. Based on the actual cost data entered, the model calculated the ICER of degludec insulin, which was 214,714 rubles, which does not exceed the sum of three GDP per capita – 2,184,562 rubles and corresponds to the willingness to pay threshold in the Russian Federation. Thus, the insulin degludec (Tresiba®) can be considered as cost-effective from the standpoint of the conducted pharmacoeconomic analysis.
The article presents the results of predicting the dynamics of the spread of new cases of tuberculosis (TB) with multiple drug resistance (MDR) in the Republic of Karelia, as well as the costs of treating patients with tuberculosis, considering the different effectiveness of treatment. It has been demonstrated that while enhancing efficiency of treatment, due to the rapid determination of drug resistance by the method of polymerase chain reaction and a decrease in treatment gaps (using food kits), the effectiveness of treatment is significantly increased and the prevalence of MDR-TB decreases, which leads to significant budget savings.