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PRICING, REIMBURSEMENT, AND HEALTH TECHNOLOGY ASSESSMENT OF MEDICINAL PRODUCTS IN BULGARIA

Published online by Cambridge University Press:  23 August 2017

Tatyana Benisheva-Dimitrova
Affiliation:
Faculty of Public Health, Medical Universitybenicheva_tb@yahoo.com
Dobriana Sidjimova
Affiliation:
Faculty of Public Health, Medical University
Daniela Cherneva
Affiliation:
Faculty of Public Health, Medical University
Nikolay Kralimarkov
Affiliation:
Faculty of Public Health, Medical University

Abstract

Objectives: The aim of this study was to investigate the analysis, discussion, and challenges of the price and reimbursement process of medicinal products in Bulgaria in the period 2000–15 and health technology assessment (HTA) role in these processes.

Methods: The dynamics of the reform, with respect to the healthcare and pharmaceutical sectors, are tracked by documentary review of regulations, articles, and reports in the European Union (EU), as well as analytical and historical analysis.

Results: Pricing and reimbursement processes have passed through a variety of committees between 2003 and 2012. Separate units for pricing and reimbursement of medicinal products were established in Bulgaria for the first time, in 2013, when an independent body, the National Council at Prices and Reimbursement of Medicinal Products, was set up to approve medicinal products with new international nonproprietary names (INN) for reimbursement in Bulgaria. Over the course of 2 years (2013–14), thirty-three new INNs were approved for reimbursement. In December 2015, a new HTA body was introduced, and assigned to the National Centre for Public Health and Analyses.

Conclusions: Although Bulgaria has current legislation on pricing and reimbursement which is in accordance with the EU rules, there is no mechanism for reporting and monitoring these processes or the financial resources annually, so as to provide an overall objective assessment and analysis by year. Therefore, this financial assessment should become a national policy objective for the future.

Type
Theme Submissions
Copyright
Copyright © Cambridge University Press 2017 

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References

REFERENCES

1. Dimova, A, Rohova, M, Moutafova, E, et al. Bulgaria: Health system review. Health Syst Transit. 2012;14:1-186.Google ScholarPubMed
2. Country rankings using data from official sources. http://www.theglobaleconomy.com/Bulgaria/Health_spending_as_percent_of_GDP/ (accessed December 19, 2016).Google Scholar
3. Health Insurance in Bulgaria-National Health Insurance Fund. http://www.nhif.bg/web/guest/73 (accessed December 19, 2016).Google Scholar
4. Law on Health Insurance SG. 70 from 19 June 1998; last changes and amend. SG 108 from 25.12. 2016Google Scholar
5. Reports of the Health Insurance 2004 -2013. http://www.nhif.bg/web/guest/74 (accessed December 19, 2016).Google Scholar
6. Law on Medicinal Products in Human Medicine (LMPHM in Bulgaria) SG31 from 13.04.2007, in force 13.04.2007, last amend, SG 43 from 7.06.2016.Google Scholar
7. Council Directive 89/105/EС, Of 21 December 1988, (OJL 40, 11.02.1989 P.8-11; Chapter 15 Volume 9).Google Scholar
8. Positive Drug List - Annexes of National Council on prices and reimbursement of Medicinal Products In Bulgaria. http://www.ncpr.bg/en/ncprmp (accessed December 16, 2016).Google Scholar
9. Ordinance of the term, rules and procedure for the regulation and registration of prices for medicinal products Effective 30 April 2013 Adopted by Council of Ministers Decree No. 97 of 19 April 2013 Promulgated in the State Gazette No. 40 of 30 April 2013; Amended, last amended and supplemented, SG No 74 of 24 September 2016. http://ncpr.bg/bg/нормативни-актове/българско-законодателство/наредби (accessed December 19, 2016).Google Scholar
10. Ordinance № 10 of 24 March 2009 on terms and conditions for payment of medicinal products under Art. 262, para. 6 para. 1 of the Law on Medicinal Products in Human Medicine, medical devices and dietary foods for special medical purposes, as well as medicines for health activities under Art. 82, para. 2 p. 3 of the Health Act last amended and supplemented SG. 44 of June 10, 2016 Google Scholar
11. Report № 0000000112/01.11. AUDIT OFFICE of the implementation of the regulating the prices of medicinal products included in the positive list of medicines and paid with public funds 01.01.2008 Г. till 31.12.2011 Г. http://www.bulnao.government.bg/files/_bg/Doklad_ceni_lekarstva_last_1112.doc (accessed December 19, 2016).Google Scholar
12. Benisheva-Dimitrova, T, Petrova, G, Stoimenova, A, et al. HTA Methodologies of novel treatments in Bulgaria in 2013/2014. Paris, 13-16 April: DIA Euro-Meeting 2015.Google Scholar
13. Benisheva-Dimitrova, TV, Christoff, GC, Stoyanova, R. Medical University – Sofia Bulgaria. Bulgarian Association of Drug Information, Sofia Critical analysis of pricing and reimbursement process on the basis of the new Pharmacoeconomic guidelines in Bulgaria, Bulgaria Milan, Italy November, 2015. http://www.ispor.org/ScientificPresentationsDatabase/Presentation/60735 (accessed December 19, 2016).Google Scholar
14. Annual Report for the activities of the NCPR 2013 and Annexes. http://www.ncpr.bg/bg/нсцрлп/годишни-доклади (accessed December 16, 2016).Google Scholar
15. Annual Report for the activities of the NCPR 2014. http://www.ncpr.bg/bg/нсцрлп/годишни-доклади (accessed December 16, 2016).Google Scholar
16. Annual Report for the activities of the NCPR 2015. http://www.ncpr.bg/bg/нсцрлп/годишни-доклади (accessed December 19, 2016).Google Scholar
17. Regulation № 9 from 1st 2015 г. for the conditions and rules of HTA SG 97 of 11 December 2015. http://www.mh.government.bg/media/filer_public/2015/12/11/naredba9-1-12-2015.pdf (accessed December 19, 2016).Google Scholar