EARLY HEALTH TECHNOLOGIES ASSESSMENT — NEW APPROACH TO IMPROVING THE EFFICIENCY OF THE MEDICAL TECHNOLOGY DEVELOPMENT PROCESS
Abstract
Early health technologies assessment (HTA) is a form of HTA, which takes place at early stages of the life cycle of medical technology. This method allows us to optimize the design of clinical trials to prove the economic benefits of new technologies, to assess the need for follow-up phases of clinical trials, to predict the probability of formulary inclusion, and to define socially acceptable price.
About the Authors
N. Z. Musina
FSBEI HE I.M. Sechenov First MSMU MOH Russia
Center of Expertise and Quality Control of Medical Care, Ministry of Health of the Russian Federation, Moscow, Russia
Russian Federation
Russian Federation
PhD, lecturer of the Department of Pharmacology, Pharmaceutical Faculty First Moscow Medical Sechenov University. Address: ul. Trubetskaya, 8-2, Moscow, Russia, 119048; Chief of development and communications, Center of Healthcare Quality Assessment and Control, The Ministry of Health of Russian Federation. Address: Khokhlovsky per., 10-5, Moscow, Russia, 109028
V. V. Omelyanovskiy
Russian Presidential Academy of National Economy and Public Administration, Moscow
Research Institute of Finance, Ministry of Finance of the Russian Federation, Moscow
Center of Expertise and Quality Control of Medical Care, Ministry of Health of the Russian Federation, Moscow, Russia
Russian Federation
Russian Federation
MD, Professor, Director of the Center for Technology Assessment in Health Care of the Institute of Applied Economic Research of RANEPA, Head of the Health Care Finance Center of the Research Financial Institute of the Ministry of Finance of the Russian Federation. Address: Nastasiinsky lane d. 3 p. 2, Moscow, Russia, 127006. Tel.: +74999569528
A. V. Krasheninnikova
Center of Expertise and Quality Control of Medical Care, Ministry of Health of the Russian Federation, Moscow, Russia
Russian Federation
Russian Federation
specialist Department of the methodological support for a comprehensive assessment in health care technology, Center of Healthcare Quality Assessment and Control, The Ministry of Health of Russian Federation. Address: Khokhlovsky per., 10-5, Moscow, Russia, 109028
References
1. Kostina D. V. V.S. INFO – Budget funding of innovation in the medical industry [V.S. INFO – Byudzhetnoe finansirovanie innovatsionnykh razrabotok v meditsinskoi promyshlennosti. 2011 (in Russian)]. http://www.vipstd.ru/nauteh/index.php/---ep13-09/970-a.Accessed: 20.04. 2016.
2. Omelyanovskiy V. V. Meditsinskie tekhnologii. Otsenka i vybor. 2014; 2 (16): 23-29.
3. Peskov K. V. Vestnik Roszdravnadzora. 2013; 1: 57-60.
4. Peskov K., Shulgin B., Aksenov S., Khelmlinger G., Stanski D. Mathematical modeling in research and development of medicines in Russia. 2011. [Matematicheskoe modelirovanie pri issledovanii i razrabotke lekarstvennykh sredstv v Rossii. 2011. (in Russian)]. http://ipheb.ru/netcat_files/userfiles/prezentatsiya-ipheb-Peskov.pdf. Data obrashcheniya: 20.04. 2016.
5. Programma «Razvitie farmatsevticheskoi i meditsinskoi promyshlennosti Rossiiskoi Federatsii na period do 2020 goda i dal’neishuyu perspektivu». http://fcpfarma.ru/. Accessed: 20.04. 2016.
6. Andersson F. Why is the pharmaceutical industry investing increasing amounts in health economic evaluations? International journal of technology assessment in health care. 1995; 11 (5): 750-761.
7. Annemans L., Genesté B., Jolain B. Early Modelling for assessing health and economic outcomes of drug therapy. Value in Health. 2000; 3 (6): 427-434.
8. Avksentyeva M. V., Omelyanovsky V. V. Perspectives of Health Technology Assessment in the Russian Federation. Journal of Internal Medicine. 2015; 12-16.
9. Clemens K., Garrison L. P., Jones A., Macdonald F. Strategic use of Pharmacoeconomic research in early drug development and global pricing. PharmacoEconomics. 1993; 4 (5): 315-322.
10. De Ridder F. Predicting the outcome of phase III trials using phase II data: a case study of clinical trial simulation in late stage drug development. Basic & clinical pharmacology & toxicology. 2005; 96 (3): 235-241.
11. Dimasi J. A., Caglarcan E., Wood-Armany M. Emerging role of Pharmacoeconomics in the research and development decisionmaking process. PharmacoEconomics. 2001; 19 (7): 753-766.
12. DiMasi J.A., Hansen R. W., Grabowski H. G ., Lasagna L. Cost of innovation in the pharmaceutical industry. Journal of Health Economics. 1991; 10 (2): 107-142.
13. DiMasi J. A. The value of improving the productivity of the drug development process. PharmacoEconomics. 2002; 20 (3): 1-10.
14. G irard P., Cucherat M., Guez D. Clinical trial simulation in drug development. Thérapie. 2004; 59 (3): 297-304.
15. H artz S., John J. Contribution of economic evaluation to decision making in early phases of product development: a methodological and empirical review. International Journal of Technology Assessment in Health Care. 2008; 24 (4): 465- 472.
16. H ughes D. A., Walley T. Economic evaluations during early (phase II) drug development. PharmacoEconomics. 2001; 19 (11): 1069-1077.
17. Matthew Taylor, Health Economics and Decision-Making in the Pharmaceutical Industry.
18. Miller P. Role of Pharmacoeconomic analysis in R&D decision making. PharmacoEconomics. 2005; 23 (1): 1-12.
19. Noyce R. The smart organization: creating value through strategic R&D. Boston. 1998.
20. Sculpher M., Drummond M., Buxton M. Economic evaluation in health care research and development: undertake it early and often. HERG discussion paper No 12. Brunel University, Uxbridge. 1995.
Review
For citations:
Musina N.Z., Omelyanovskiy V.V., Krasheninnikova A.V. EARLY HEALTH TECHNOLOGIES ASSESSMENT — NEW APPROACH TO IMPROVING THE EFFICIENCY OF THE MEDICAL TECHNOLOGY DEVELOPMENT PROCESS. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology. 2016;9(3):53-59. (In Russ.) https://doi.org/10.17749/2070-4909.2016.9.3.053-059
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