HEALTH INNOVATIVE TECHNOLOGY ASSESMENT IN THE FEDERAL MEDICAL BIOLOGICAL AGENCY OF RUSSIA

Author(s)

Vorobiev P1, Pimenova A2, Krasnova L3, Samoylov A4, Vorobiev A3
1First Sechenov Moscow State Medical University, Moscow, Russia, 2Federal State Unitary Enterprise Research & Production Center, Khimki, Russian Federation, 3Russian Society for Pharmacoeconomics and Outcomes Research, Moscow, Russia, 4FGBU "State Scientific Center of the Russian Federation - A.I. Burnazyan Federal Medical Biophysical Center" FMBA of Russia, Moscow, Russian Federation

In Russian health care system there are several sectors that are not regulated directly by the Ministry of Health of the Russian Federation and regional authorities. They include healthcare fpr the military and for the Ministry of Internal Affairs, healthcare associated with the nuclear industry and space projects. The last sector is subject to the Federal Medical Biological Agency. There are large number of health care organizations and academic institutions, which have developed over the course of over 50 years new medical technologies, by the scientists and doctors, both for specific and for general applications. One of the most well-known example of such technology is treatment of acute radiation syndrome. However, many of Agency’s technologies show lack of scientific, clinical and/or economical evidence. Because of that, a special structure in the Agency is being set up for evaluation and setting up standards of innovative healthcare technologies, applying international approaches to the clinical and economic studies. Technology assessment process is based on the Russia’s current standard for health technology assessment, which was developed by our team. The evaluation is a three-step process. The first step is formal evaluation of the documents submitted by the applicant. The second step is assessment of the credibility of the available scientific results and feasibility studies, performed by means of formal database search. Results are exposed to a public discussion on the website. The third step is the decision about application of innovative technology and about making it a standard. All activities will be transparent and the evaluation process is openly exposed to the public discussion in the web. Evaluation outcome is either suggestion for implementation in health care (as a medical standard) or suggestions for further research, or decision to reject the technology.

Conference/Value in Health Info

2016-05, ISPOR 2016, Washington DC, USA

Value in Health, Vol. 19, No. 3 (May 2016)

Code

PHP208

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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