Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

Advanced search

INTERNATIONAL APPROACHES TO THE GOVERNMENT PRICE CONTROL OVER GENERICS AND BIOSIMILARS: A REVIEW

https://doi.org/10.17749/2070-4909.2017.10.4.015-024

Full Text:

Abstract

Objective. In this review, we analyzed the policies for price controls on generics and biosimilars in the European Union.

Materials and methods. We conducted a literature review regarding government price controls on generics and biosimilars in 28 EU countries and in the Russian Federation.

Results. Most of the reviewed countries have policies controlling prices for generic drugs and employ the internal reference pricing. Prices are predominantly determined by setting a discount on the generic price as compared to the price of the original drug. In some countries, the price is set through free competition within the reference group of drugs. However, today’s control of biosimilar pricing in Europe is just building up. A number of countries have no defined procedure for pricing biosimilars, while others utilize the same mechanism as they use for generics, yet with a lower discount. In the Russian Federation, the price control policy is focused on promoting the development and manufacture of generics and biosimilars and, therefore, the discount is lower than the average discount level set in Europe.

About the Authors

D. G. Tolkacheva
JSC BIOCAD
Russian Federation

Tolkacheva Daria Georgievna – Head of Health Economics.

34-A, Ulitsa Svyazi, Strelna, St. Petersburg, 198515



A. V. Torgov
JSC BIOCAD
Russian Federation

Torgov Aleksei Vladimirovich – GR Director.

34-A, Ulitsa Svyazi, Strelna, St. Petersburg, 198515



A. S. Margazova
JSC BIOCAD
Russian Federation

Margazova Anna Sergeevna – International Marketing Specialist.

34-A, Ulitsa Svyazi, Strelna, St. Petersburg, 198515



References

1. WHO Guideline on Country Pharmaceutical Pricing Policies. Geneva: World Health Organization; 2013. Режим доступа: https://www.ncbi.nlm.nih.gov/books/NBK258629/. Дата обращения: 28.11.2017.

2. Espin J., Rovira J. Analysis of differences and commonalities in pricing and reimbursement systems in Europe. 2007. Режим доступа: https://ec.europa.eu/DocsRoom/documents/7605/attachments/1/translations/en/renditions/pdf. Дата обращения: 28.11.2017.

3. Study on enhanced cross-country coordination in the area of pharmaceutical product pricing. Final report. Gesundheit O¨sterreich Forschungs- und Planungs GmbH; 2015. Режим доступа: https://ec.europa.eu/health/sites/health/files/systems_performance_assessment/docs/pharmaproductpricing_frep_en.pdf. Дата обращения: 28.11.2017.

4. Espin J., Rovira J., de Labry A. O. Working paper 1: External price referencing – review series on pharmaceutical pricing policies and interventions. Geneva: World Health Organization and Health Action International, 2011. Режим доступа: http://haiweb.org/wpcontent/uploads/2015/08/ERP-final-May2011a1.pdf. Дата обращения: 28.11.2017.

5. Ferrario A., Reinap M., Pedersen H. B., Kanavos P. Availability of medicines in Estonia: an analysis of existing barriers and options to address them. Copenhagen: WHO, Regional Office for Europe; 2016. Режим доступа: http://www.euro.who.int/__data/assets/pdf_file/0006/306186/Availability-medicines-Estonia-analysis-existingbarriers-options-address-them.pdf?ua=1. Дата обращения: 28.11.2017.

6. Toumi M., Remuzat C., Vataire A.-L., Urbinati D. External reference pricing of medicinal products: simulation-based considerations for cross-country coordination. Final Report. European Commission, 2014. Режим доступа: https://www.redaccionmedica.com/contenido/images/erp_reimbursement_medicinal_products_ en-1.pdf. Дата обращения: 28.11.2017.

7. Vogler S., Paris V., Ferrario A. et al. How Can Pricing and Reimbursement Policies Improve Affordable Access to Medicines? Lessons Learned from European Countries. Appl Health Econ Health Policy. 2017; 15: 307-321. Режим доступа: http://whocc.goeg.at/Literaturliste/Dokumente/Articles/Vogler%20et%20al_PR_Europe_AHEHP_2017.pdf. Дата обращения: 28.11.2017.

8. Association of British Pharmaceutical Industry. Understanding the 2014 Pharmaceutical Pricing Regulation Scheme. Режим доступа: http://www.abpi.org.uk/our-work/policy-parliamentary/Documents/understanding_pprs2014.pdf. Дата обращения: 28.11.2017

9. Bouvy J., Vogler S. Background Paper 8.3 Pricing and Reimbursement Policies: Impacts on Innovation. In: World Health Organization, editor. Priority Medicines for Europe and the World ‘‘A Public Health Approach to Innovation’’ Update on 2004 Background Paper. Geneva 2013. Режим доступа: http://www.who.int/medicines/areas/priority_medicines/BP8_3_pricing.pdf. Дата обращения: 28.11.2017.

10. Vogler S. The impact of pharmaceutical pricing and reimbursement policies on generics uptake: implementation of policy options on generics in 29 European countries – an overview. GaBI Journal. 2012; 1 (2): 44-51. Режим доступа: http://whocc.goeg.at/Literaturliste/Dokumente/Articles/GJ2%2009j%20Vogler%20European%20focus%20generics.pdf. Дата обращения: 28.11.2017.

11. Godman B., Bennie M., Baumgartel C., Sovic-Brkicic L., Burkhardt T., Furst J. et al. Essential to increase the use of generics in Europe to maintain comprehensive health care? Farmeconomia Health Econ Ther Pathw. 2012; 13 (3S): 5-20. Режим доступа: https://journals.edizioniseed.it/index.php/FE/article/view/312/558. Дата обращения: 28.11.2017.

12. Heinze G., Hronsky M., Reichardt B., Baumgartel C., Mullner M., Bucsics A. et al. Potential savings in prescription drug costs for hypertension, hyperlipidemia, and diabetes mellitus by equivalent drug substitution in Austria: a nationwide cohort study. Appl Health Econ Health Policy. 2014; 13 (2): 1-13. Режим доступа: https://link.springer.com/article/10.1007%2Fs40258-014-0143-4. Дата обращения: 28.11.2017.

13. Simoens S., De Coster S. Sustaining generic medicines markets in Europe. J Generic Med. 2006; 3 (4): 268. Режим доступа: http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.584.2538&rep=rep1&type=pdf. Дата обращения: 28.11.2017.

14. Final Report with Recommendations for Reforming Bulgaria’s Pharmaceutical Sector. Режим доступа: https://www.mh.government.bg/media/filer_public/2015/06/16/final-report-withrecommendations-for-reforming_bulgarias_pharmaceutical_sector.pdf Дата обращения: 28.11.2017.

15. WHO, Austria. Режим доступа: http://who.int/health-laws/countries/aut-en.pdf?ua=1 Дата обращения: 28.11.2017.

16. WHO, Croatia. Режим доступа: http://www.who.int/healthlaws/countries/hrv-en.pdf. Дата обращения: 28.11.2017.

17. Pricing and Reimbursement. Режим доступа: www.sukl.eu/file/74580_1_2. Дата обращения: 28.11.2017.

18. Health Systems in Transition (HiT) profile of Hungary. Режим доступа: http://www.hspm.org/countries/hungary25062012/livinghit.aspx?Section=2.8%20Regulation&Type=Section Дата обращения: 28.11.2017.

19. PPRI, Slovakia. Режим доступа: http://whocc.goeg.at/Literaturliste/Dokumente/CountryInformationPosters/10k_SK_Poster_JanaSlusna_2012.pdf Дата обращения: 28.11.2017.

20. Wouters O. J., Kanavos P. G. Transitioning to a national health system in Cyprus: a stakeholder analysis of pharmaceutical policy reform. Bull World Health Organ. 2015 Sep 1; 93 (9): 606-613. Режим доступа: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4581641/.Дата обращения: 28.11.2017.

21. Consenso sobre las medidas para la reactivación de los medicamentos genéricos en España. Режим доступа: https://www.sefac.org/sites/default/files/2017-07/consenso-medidas-reactivacionmedicamentos-genericos-en-Espana.pdf. Дата обращения: 28.11.2017.

22. Atribuição de preços. Режим доступа: http://www.infarmed.pt/web/infarmed/entidades/medicamentos-uso-humano/avaliacaoeconomica/regulamentacao-preco-medicamentos/atribuicao_precos Дата обращения: 28.11.2017.

23. Enjeux autour du médicament générique. Режим доступа: http://solidarites-sante.gouv.fr/soins-et-maladies/medicaments/professionnels-de-sante/medicaments-generiques-a-l-usage-desprofessionnels/article/enjeux-autour-du-medicament-generique. Дата обращения: 28.11.2017.

24. PwC, Calculation methodology of maximal prices for medicinal products. Режим доступа: http://www.pwc.ro/en/tax-legal/alerts/calculation-methodology-prices-medicinal-products.html. Дата обращения: 28.11.2017.

25. WHO, Pharmaceutical pricing and reimbursement policies in the in- and out-patient sector. Режим доступа: http://whocc.goeg.at/Literaturliste/Dokumente/CountryInformationPosters/Poland_new2015.pdf . Дата обращения: 28.11.2017.

26. Pricing and Reimbursement Questions. Режим доступа: http://www.arthurcox.com/wp-content/uploads/2015/06/Pricing-andReimbursement-Questions.pdf. Дата обращения: 28.11.2017.

27. Market review – European generic medicines market, 2016. Режим доступа: http://www.medicinesforeurope.com/wp-content/uploads/2016/11/Market-Review-2016-Generic-medicines-policies.pdf Дата обращения: 28.11.2017.

28. The Netherlands. Policy and Legislation. Режим доступа: http://www.gabionline.net/Country-Focus/The-Netherlands/Policies-andLegislation Дата обращения: 28.11.2017.

29. Kyriakides I. Production, Circulation and Pricing of Drugs-Brand Name and Generic, 2016. Режим доступа: http://www.greeklawdigest. gr/topics/health-life-sciences/item/253-production-circulation-andpricing-of-drugs-brand-name-and-generic. Дата обращения: 28.11.2017.

30. IPHA and the Government finally reach agreement on the supply and pricing of medicines in Ireland, 2016. Режим доступа: http://www.arthurcox.com/wp-content/uploads/2016/08/IPHA-State-agreepricing-of-medicines-in-Ireland-Aug-2016.pdf. Дата обращения: 28.11.2017.

31. Kawalec P., Stawowczyk E., Tesar T. et al. Pricing and Reimbursement of Biosimilars in Central and Eastern European Countries. Front Pharmacol. 2017; 8: 288. Режим доступа: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5463127/pdf/fphar-08-00288.pdf. Дата обращения: 28.11.2017.

32. Vogler S., Schneider P. Do pricing and usage-enhancing policies differ between biosimilars and generics? Findings from an international survey. GaBI Journal. 2017; 6 (2): 79-88. Режим доступа: http://gabi-journal.net/do-pricing-and-usage-enhancing-policiesdiffer-between-biosimilars-and-generics-findings-from-aninternational-survey.html. Дата обращения: 28.11.2017.

33. Reinaud F., Ando G. Price Differences Triggered by the Availability of Biosimilars in Developed Countries. Value in Health. 2013; 16 (7): A329. Режим доступа: http://www.valueinhealthjournal.com/article/S1098-3015(13)01943-8/fulltext. Дата обращения: 28.11.2017.

34. Jha A., Upton A., Dunlop WC., Akehurst R. The Budget Impact of Biosimilar Infliximab (Remsima®) for the Treatment of Autoimmune Diseases in Five European Countries. Adv Ther. 2015; 32 (8): 742-756. Режим доступа: https://www.ncbi.nlm.nih.gov/pubmed/26343027. Дата обращения: 28.11.2017.

35. Database data monitoring auctions "Headway Company". Режим доступа: http://www.hwcompany.ru/ Дата обращения: 20.11.2017.

36. Трякин А. А., Рудакова А. В., Фогт С. Н. и др. Фармакоэкономические аспекты применения биоаналогов. Современная Онкология. 2017; 19 (1): 43-48 [Tryakin A.A., Rudakova A. V., Fogt S. N. Et al. Sovremennaya Onkologiya. 2017; 19 (1): 43-48 (in Russian)]


For citation:


Tolkacheva D.G., Torgov A.V., Margazova A.S. INTERNATIONAL APPROACHES TO THE GOVERNMENT PRICE CONTROL OVER GENERICS AND BIOSIMILARS: A REVIEW. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2017;10(4):15-24. (In Russ.) https://doi.org/10.17749/2070-4909.2017.10.4.015-024

Views: 357


ISSN 2070-4909 (Print)
ISSN 2070-4933 (Online)