Some Issues of Assessing Economic Efficiency of Innovative Products of Regenerative Medicine

The problem of assessing the economic efficiency of introducing innovative drugs slows down the development of the regenerative medicine industry. The lack of examples of biomedical products use makes it difficult to prove that the economic burden has been reduced. There are several main reasons for this situation. First, most studies are not considered as potential for further transfer to clinical practice. Secondly, the process of introducing new developments takes a very long time and at this moment it is not possible to make such estimates, since the cost of treatment with such drugs is unknown. Thirdly, it is extremely difficult to extrapolate estimates of the comparison of available and proposed methods of treatment in the West, since the cost formation is very different. The presented study provides information on epidemiology, available foreign drugs and domestic developments, the cost of treatment abroad and tariffs for current treatment options for such nosologies as cirrhosis of the liver, male infertility and damage to peripheral nerves. Information is also provided on the economic burden of these diseases for the Russian economy. Despite the obvious savings in budgetary funds when using innovative drugs compared to small molecules, their implementation requires infrastructure development, training of specialists in a new specialty, and changes to existing regulatory documents. The inclusion of high-tech drugs for these diseases in clinical practice takes a long time due to the lack of evidence of cost-effectiveness from their use. In this regard, the main objective of the presented study is to consider the issues and opportunities for assessing the economic effect of introducing innovative products of regenerative medicine into healthcare practice.

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