Preview

FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology

Advanced search

Health technology assessment and reimbursement of pharmaceuticals in Italy

https://doi.org/10.17749/2070-4909.2019.12.2.156-164

Full Text:

Abstract

The Italian healthcare system is historically structured by the difference in economic development between the northern and southern parts of this country. The Italian Medicines Agency (AIFA) is the national health technology assessment (HTA) authority in charge of the reimbursement and formulary-listing. Some regions have established their own HTA institutions to define the reimbursement policy for a specific region or organization. Because of that, the entire HTA system in Italy can be characterized by low inter-regional coherence and insufficient coordination. As a result, the access to medical services is not unified at the regional level; in addition, it is difficult to collect and analyze the data required for providing value-based healthcare. Although the cost-effectiveness of specific health technologies is taken into consideration for decision-making, in practice, the main focus rests on the budget impact and cost control. Along with that, the AIFA holds the leading positions in Europe in using such innovative approaches as the patient access schemes, early HTA and horizon scanning.

About the Authors

F. V. Gorkavenko
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation
Russian Federation

Filipp V. Gorkavenko - Leading Specialist, Department of Methodological Support of Comprehensive Health Technology Assessment.

10-5 Khokhlovskii pereulok, Moscow 109028



V. V. Omelyanovskiy
Research Institute of Finance, Ministry of Finance of the Russian Federation; Russian Presidential Academy of National Economy and Public Administration
Russian Federation

Vitaly V. Omelyanovskiy- MD, PhD, Professor, Head of the Healthcare Finance Center at the IFR, Researcher ID: P-6911-2018; Scopus Author ID: 6507287753.

3-2 Nastasyinsky pereulok, Moscow 127006; 82 Vernadskogo prospect, Moscow 119571



T. P. Bezdenezhnykh
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation; Research Institute of Finance, Ministry of Finance of the Russian Federation
Russian Federation

Tatiana P. Bezdenezhnykh - Leading Specialist, CHQAC; Junior Researcher at the Center for Healthcare Funding, IFR.

10-5 Khokhlovskii pereulok, Moscow 109028; 3-2 Nastasyinsky pereulok, Moscow 127006, Tel.: +7 (495) 783-19-05


G. R. Khachatryan
Center for Healthcare Quality Assessment and Control of the Ministry of Healthcare of the Russian Federation; Research Institute of Finance, Ministry of Finance of the Russian Federation
Russian Federation

Georgii R. Khachatryan - Head of the Department of Methodological Support of Comprehensive Health Technology Assessment, CHQAC; Junior Researcher at the Center for Healthcare Funding, FRI.

10-5 Khokhlovskii pereulok, Moscow 109028; 3-2 Nastasyinsky pereulok, Moscow 127006



References

1. Favaretti C., Cicchetti A., Guarrera G. et al. Health technology assessment in Italy. Int J Tech Assess Health Care. 2009; 25 (1): 12733.

2. PPRI Pharma Profile Italy 2007 [Electronic resource]. URL: https://ppri.goeg.at/Downloads/Results/Italy_PPRI_2007.pdf. Accessed: 07.04.2019.

3. Prada M., Ruggeri M., Sansone C. et al. Timeline of authorization and reimbursement for oncology drugs in Italy in the last 3 years. MedAccess@point care. 2017; 1 (1): e29-e36.

4. Catananti C., Cicchetti A., Marchetti M. Hospital-based health technology assessment: the experience of Agostino Gemelli University Hospital’s HTA Unit. Italian Journal of Public Health. 2005; 3: 23-8.

5. Garrido M. V., Kristensen F.B., Nielsen C. P., Busse R. Observatory Studies Series No 14 on Health Systems and Policies. European. Health technology. Assessment and health. Policy-making in europe. Current status, challenges and potential. [Electronic resource]. URL: http://www.euro.who.int/data/assets/pdf_file/0003/90426/E91922.pdf. Accessed: 11.11.2018.

6. Ciani O., Jommi C. The role of health technology assessment bodies in shaping drug development. Drug Design. Development and Therapy. 2014; 8: 2273-2281.

7. Musina N. Z., Fedyaeva V.K., Omelyanovskiy V.V., Khachatryan G.R., Gerasimova K.V., Lemeshko V.A., Konchits K.P. Review of the current approaches to the assessment of the drug innovative potential worldwide. Farmakoekonomika. Sovremennaya farmakoekonomika i farmakoepidemiologiya / Farmakoekonomika. Modern Pharmacoeco-nomics and Pharmacoepidemiology. 2017; 10 (3): 66-74 (in Russ.). DOI: 10.17749/2070-4909.2017.10.3.066-074.

8. Senatore P., Chalmers M., Cyrus A. The New AIFA Algorithm For Assessing ‘Innovativeness’ Of New Products In Italy: So What? 18 August 2017. [Electronic resource]. URL: http://cbpartners.com/blog/new-aifa-algorithm-assessinginnovativeness-new-products-italy.html. Accessed: 15.01.2019.

9. Montilla S., Xoxi E., Russo P. et al. Monitoring registries at italian Medicines agency: fostering access, guaranteeing sustainability. Int J Technol Assess Health Care. 2015 Jan; 31 (4): 210-3.

10. Capri S., Ceci A., Terranova L. et al. Guidelines for Economic Evaluations in Italy: Recommendations from the Italian Group of Phar-macoeconomic Studies. Drug Information Journal. 2001; 35: 189-201. DOI: 10.1177/009286150103500122.

11. Angelis A., Lange A. Using health technology assessment to assess the value of new medicines: results of a systematic review and expert consultation across eight European countries. P. Eur J Health Econ. 2017; DOI: https://doi.org/10.1007/s10198-017-0871-0.

12. Garattini L., van de Vooren K., Curto A. Regional HTA in Italy: Promising or confusing? Health Policy. 2012 Dec; 108 (2-3): 203-6. DOI: 10.1016/j.healthpol.2012.10.010.

13. Ciani O., Tarricone R., Torbica A. Diffusion and use of health technology assessment in policy making: What lessons for decentralised healthcare systems? Health Policy. 2012; 108 (2-3): 194-202.

14. The Economist Intelligence Unit: Value-based Health Assessment in Italy. A decentralised model. 2015.

15. Longhi S., Lazzari A., Fattore G. et al. Italy: Health system review. Health Systems in Transition. 2014; 16 (4): 1-168.

16. Bruno G., Valentino M., Oselin M. et al. Comparison between HTA Reports in Veneto and Emilia Romagna: Drugs Assessment Decision Criteria and Priorities. Value Health. 2015 Nov; 18 (7): A558. DOI: 10.1016/j.jval.2015.09.1811. Epub 2015 Oct 20.

17. Paris V., Belloni A. Value in Pharmaceutical Pricing. OECD Health Working Papers. 2013; 63. OECD Publishing. DOI: http://dx.doi.org/10.1787/5k43jc9v6knx-en.

18. Wilsdon T., Barron A. Managed Entry Agreements in the context of Medicines Adaptive Pathways to Patients. Final Report. November 2016. [Electronic resource]. URL: http://adaptsmart.eu/wp-content/uploads/2016/12/CRA-MEA-in-the-context-of-MAPPs-Final-Report-16-December-2016-STC.pdf. Accessed: 15.11.2018.

19. Pauwels K., Huys I., Vogler S., Casteels M., Simoens S. Managed Entry Agreements for Oncology Drugs: Lessons from the European Experience to Inform the Future. Frontiers in Pharmacology. 2017; 4 (8): 171. DOI: http://doi.org/10.3389/fphar.2017.00171.

20. Garattini L., Gianluigi C. Risk sharing agreements: What lessons from Italy? International journal of technology assessment in health care. 2011; 27 (2): 169-172.

21. Lepage-Nefkens I., Douw K., Mantjes G., de Graaf G., Leroy R., Cleemput I. Horizon scanning for pharmaceuticals: proposal for the BeNeLuxA collaboration. R283. Health Services Research (HSR). 2017; Report number: 283.


For citation:


Gorkavenko F.V., Omelyanovskiy V.V., Bezdenezhnykh T.P., Khachatryan G.R. Health technology assessment and reimbursement of pharmaceuticals in Italy. FARMAKOEKONOMIKA. Modern Pharmacoeconomic and Pharmacoepidemiology. 2019;12(2):156-164. (In Russ.) https://doi.org/10.17749/2070-4909.2019.12.2.156-164

Views: 69


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