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Drug provision and health technology assessment in France

https://doi.org/10.17749/2070-4909.2020.13.1.71-83

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Abstract

The article presents the description of structural, organizational and methodological issues of health technology assessment (HTA) of French drugs as well as the state-reimbursable list of drugs. The HTA is conducted by an independent public body – French National Authority for Health (HAS). HAS evaluates medical products, procedures, services and technologies from a medical and economic points of view to make cost recovery decisions. HAS consists of two committees providing HTA: Transparency Committee and the Economic and Public Health Assessment Committee. Thus, the French HTA consists of two separate components within the same agency. The result of HAS evaluation of a drug is a conclusion on the level of clinical value and clinical added value, as well as the methodological quality of the studies and the size of the target patient population. Based on the evaluation results, HAS gives recommendations for the National Union of Health Insurance Funds, the Economic Committee for Healthcare Products and Ministry of Health and publishes its opinion on the HAS website. HAS decisions are of a recommendatory nature – the final decision whether to include the drug in reimbursement lists are made by the Ministry of Health and published in the Official Journal of French republic.

About the Authors

V. V. Omelyanovskiy
Research Financial Institution of the Ministry of Finance of the Russian Federation ; Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Russian Federation

Vitaly V. Omelyanovskiy – MD, Dr Sci Med, Professor, General Director ; Head of the Center for Healthcare Funding

Researcher ID: P-6911-2018; Scopus Author ID: 6507287753



A. V. Nikitina
Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Russian Federation
Anna V. Nikitina – Chief Specialist at the Department of Methodological Support of Comprehensive Health Technology Assessment


V. A. Lemeshko
Research Financial Institution of the Ministry of Finance of the Russian Federation ; Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation; Sechenov First Moscow State Medical University
Russian Federation
Valeriya A. Lemeshko – Deputy Head of the Department of Methodological Support of Comprehensive Health Technology Assessment;  Research assistant at the Center for Healthcare Funding; Post-graduate student at the Department of Pharmacology


G. R. Khachatryan
Research Financial Institution of the Ministry of Finance of the Russian Federation ; Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation
Russian Federation
Georgii R. Khachatryan – Head of the Department of Methodological Support of Comprehensive Health Technology Assessment; Junior Researcher at the Center for Healthcare Funding


References

1. T’erri G., Ani O. Comparative analysis of health care reforms in France and Russia. Vestnik Rossiiskogo universiteta druzhby narodov. Seriya: Ekonomika. 2014; №. 3. (in Russ.).

2. Health system in France [Electronic resource]. URL: https://ru.ambafrance.org/IMG/pdf/systeme_de_sante_ru_1_.pdf?24120/7e3f5299ceef57e00db948fd814b92b0701efa16. Accessed: 12.03.2020.

3. International Profiles of Health Care Systems, 2012 [Electronic resource]. URL: http://apps.who.int/medicinedocs/documents/s19988en/s19988en.pdf. Accessed: 12.03.2020.

4. The French Social Security System. [Electronic resource]. URL: http://www.cleiss.fr/docs/regimes/regime_france/an_1.html. Accessed: 12.03.2020.

5. Healthcare expenditure statistics. Eurostat. [Electronic resource]. URL: https://ec.europa.eu/eurostat/statistics-explained/index. php/Healthcare_expenditure_statistics#Healthcare_expenditure_by_ financing_scheme. Accessed: 12.03.2020.

6. The French Health Care System. [Electronic resource]. URL: http://international.commonwealthfund.org/countries/france. Accessed: 10.03.2020.

7. Health system: time for change. [Electronic resource]. URL: http://www.euro.who.int/__data/assets/pdf_file/0003/155550/ E94856sumR.pdf. Accessed: 12.03.2020.

8. Solodkii V.A., Perkhov V.I., Stebunova R.V. Review of France’s health care reform over the past twenty years. Menedzher zdravookhraneniya. 2012; 1: 36-48. (in Russ.).

9. Chevreul K., Brigham B., Durand-Zaleski I., et al. France: health system review 2015. Health systems in transition. 2015;17(3):1-218.

10. Garrido M., Kristensen F., Busse R., et al. Health technology assessment and health policy-making in Europe: current status, challenges and potential. WHO Regional Office Europe. 2008; 14: 1-197.

11. National Authority for Health: France.2009, [Electronic resource] URL: https://pdfs.semanticscholar.org/92b7/27ce2c33e71434d9d6c16281fc2b3f0107ab.pdf. Accessed: 12.03.2020.

12. Haute Autoritе` de Santе` [Electronic resource] URL: https:// www.has-sante.fr/portail/. Accessed: 12.03.2020.

13. Lopes S., Marty Ch., Berdai B.: PHIS Pharma Profile France 2011. Pharmaceutical Health Information System; Commissioned by the European Commission, Executive Agency for Health and Consumers and the Austrian Federal Ministry of Health, 2011. [Electronic resource] URL: https://ppri.goeg.at/sites/ppri.goeg.at/files/inline-files/PHIS_Pharma%20Profile%20FR_2011_final_1.pdf. Accessed: 12.03.2020.

14. Doctrine de la commission de la transparence. Principes d’е`valuation de la CT relatifs aux mе`dicaments en vue de leur accе`s au remboursement. [Electronic resource] URL: https://www.has-sante.fr/upload/docs/application/pdf/2018-10/doctrine_10102018.pdf. Accessed: 12.03.2020.

15. General method for assessing health technologies [Electronic resource]. URL: https://www.has-sante.fr/portail/upload/docs/application/pdf/general_method_eval_techno.pdf. Accessed: 10.03.2020.

16. Les modalitе`s actuelles de remboursement des anticancе`reux – Quelles е`volutions possibles ? [Electronic resource]. URL: https://oncocdn.keeo.com/les-modalites-actuelles-de-remboursement-antic-22202.pdf. Accessed: 10.03.2020.

17. Rе`muzat C., Toumi M., Falissard B. New drug regulations in France: what are the impacts on market access? Part 1–overview of new drug regulations in France. Journal of Market Access & Health Policy. 2013; 1 (1): 20891.

18. Toumi M., Motrunich A., Millier A., et al. Analysis of health economics assessment reports for pharmaceuticals in France–understanding the underlying philosophy of CEESP assessment. Journal of market access & health policy. 2017; 5 (1): 1344088.

19. Toumi M., Rе`muzat S., Hammi E., et al. Current process and future path for health economic assessment of pharmaceuticals in France. Journal of market access & health policy. 2015; 3 (1): 27902.

20. Zorginstituut Nederland [Electronic resource]. URL: https:// www.zorginstituutnederland.nl/. Accessed: 10.03.2020.

21. Introduction to HTA. Educational Seminar ISPOR Dubai – September 19, 2018 [Electronic resource]. URL: https://www.ispor.org/ docs/default-source/default-document-library/3-sept-19_educational-seminar-introduction-to-hta8ec28fed4b0246089d84e40684dcf2d9. pdf?sfvrsn=62f34682_0. Accessed: 10.03.2020.

22. Akehurst R.L., Abadie E., Renaudin N., et al. Variation in health technology assessment and reimbursement processes in Europe. Value in Health. 2017; 20 (1): 67-76.

23. Horscroft J.A., Chapman A., Philips Z., et al. Variation In Health Technology Assessment And Reimbursement Decisions In England, France, And Germany: Spotlight On The Impact Of Uncertainty. Value in Health. 2017; 20 (9): A468-A468.

24. Choices in Methods for Economic Evaluation [Electronic resource]. URL: https://www.has-sante.fr/portail/upload/docs/application/pdf/2012-10/choices_in_methods_for_economic_evaluation.pdf. Accessed:10.03.2020.

25. Vlachaki I., Ovcinnikova O., Storck C., et al. Comparison of Early Scientific Advice Processes in UK, France and Germany (HTA Only): Tips and Tricks. Value in Health, Vol. 20, No. 9 (October 2017) [Electronic resource]. URL: https://www.ispor.org/docs/default-source/ispor-20th-annual-european-congress/php267--strong-u-vlachaki-i-u-sup-1-sup-strong-ovcinnikova-o-sup-1-sup-storck-c-sup-2-sup-el-mouaddin-n-sup-3-sup-shah-msup-4-sup-br-sup-1-sup-mapi-london-uk-sup-2-sup-mapi-munich-germany-sup-3-sup-m.pdf?sfvrsn=97410100_0. Accessed: 12.03.2020.


For citation:


Omelyanovskiy V.V., Nikitina A.V., Lemeshko V.A., Khachatryan G.R. Drug provision and health technology assessment in France. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2020;13(1):71-83. (In Russ.) https://doi.org/10.17749/2070-4909.2020.13.1.71-83

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