Il governo dell’innovazione tecnologica in sanità. Il caso dell’impianto di valvola aortica transcatetere: stato dell’arte delle indicazioni e della rimborsabilità nelle regioni italiane

Journal title MECOSAN
Author/s Giuditta Callea, Maria Carterina Cavallo, Rosanna Tarricone, Guido Beccagutti, Rachele Busca, Mara Corbo
Publishing Year 2016 Issue 2015/95
Language Italian Pages 24 P. 137-160 File size 20718 KB
DOI 10.3280/MESA2015-095007
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Calcific degenerative aortic stenosis is the most frequent valvulopathy in Western Countries, and accounts for 5 million patients only in Europe. For about onethird of these inoperable patients, in 2007 a new technique came up to the market, Transcatheter Aortic Valve Implantation (TAVI). The goal of our study was to draw a picture of the policies devised by the Italian regions to govern the introduction of TAVI in Italy with the final aim of providing decision makers with recommendations. Both primary and secondary data, supplemented by interviews with institutional stakeholders, were used in conducting the analysis. Results highlighted the growing diffusion of TAVI but also the great variability across the existing regional policies focused on the technology assessment and its funding and reimbursement process.

Keywords: Transcatheter aortic valve implantation, Aortic stenosis, Health Technology, Reimbursement.

  1. Agenzia Sanitaria e Sociale Regionale – Commissione cardiologica e cardiochirurgia, Regione Emilia-Romagna (2009). Documento di indirizzo per l’impianto clinicamente appropriato delle protesi valvolari aortiche per via percutanea e trans apicale: http://assr.regione.emilia-romagna.it/it/servizi/pubblicazioni/rapporti-documenti/documento-di-indirizzo-per-l2019impianto-clinicamenteappropriato-delle-protesi-valvolari-aortiche-pervia-percutanea-e-transapicale, ultimo accesso marzo 2012.
  2. Bartoli S., Berti E., De Palma R. (2012). L’introduzione della Tavi (Transcatheter aortic valve implant) in Regione Emilia-Romagna: un’esperienza di Coverage with evidence development. Politiche Sanitarie, 13 (4): 247-252.
  3. BCIS, SCTS (2009). A position statement of the British Cardiovascular Intervention Society (BCIS) and the Society of Cardiothoracic Surgeons (SCTS). http://www.improvement.nhs.uk/heart/, ultimo accesso marzo 2012.
  4. Boothroyd L. et al. (2013). Transcatheter Aortic Valve Implantation: Recommendations for Practice Based on a Multidisciplinary Review Including Cost-Effectiveness and Ethical and Organizational Issues. Canadian Journal of Cardiology, 29 (6): 718-726. DOI: 10.1016/j.cjca.2012.09.002
  5. Cappellaro G., Ghislandi S., Anessi-Pessina E. (2011). Diffusion of medical technology: The role of financing. Health Policy, 100 (1): 51-59. DOI: 10.1016/j.healthpol.2010.10.004
  6. Cavallo A., Cerbo M., Jefferson T. et al. (2009). Sostituzione della valvola aortica per via transapicale. Agenzia Nazionale per i Servizi Sanitari Regionali (Age.na.s.), Roma. http://www.salute.gov.it/imgs/C_17_pagineAree_1394_listaFile_itemName_0_file.pdf.
  7. Ciani O., Tarricone R., Torbica A. (2012). Diffusion and use of health technology assessment in policy making: what lessons for decentralized healthcare systems?. Health Policy, 108 (2-3): 194-202. DOI: 10.1016/j.healthpol.2012.09.017
  8. D’Onofrio A., Rubino P., Fusari M., Salvador L., Musumeci F. et al. (2011). Clinical and hemodynamic outcomes of ‘all-comers’ undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). The Journal of Thoracic and Cardiovascular Surgery, 142 (4): 768-775. DOI: 10.1016/j.jtcvs.2011.06.026
  9. Giani E., Rivoiro C., Romano V. (2011). Sostituzione della Valvola Aortica per via Transapicale (TATAVI). Short Report A.Re.SS. http://www2.aress. piemonte.it/cms/short-report.html?download=11 88%3Asostituzione-della-valvola-aortica-per-viatransapicale-ta-tavi, ultimo accesso marzo 2012.
  10. Gilard M. et al. (2012). Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients. The New England Journal of Medicine, 366 (18): 1705-1715. DOI: 10.1056/nejmoa1114705.
  11. Haute Autorite de Sante-HAS (2008). Evaluation des bioprothèses valvulaires aortiques implantées par voie rétrograde transfémorale et transapicale. http://www.has-sante.fr/portail/upload/docs/application/pdf/rapport_valves_2008.pdf, ultimo accesso marzo 2012.
  12. Iung B., Baron G., Butchart E.G. et al. (2003). A prospective survey of patients with valvular heart disease in Europe: The Euro Heart Survey on Valvular Heart Disease. European Heart Journal, 24 (13): 1231-1243. DOI: 10.1016/s0195-668x(03)00201-x
  13. Kodali S.K., Williams M.R., Smith C.R. et al. (2012). Two-Year Outcomes after Transcatheter or Surgical Aortic-Valve replacement. The New England Journal of Medicine, 366 (18): 1686-1695. DOI: 10.1056/nejmoa1200384
  14. Laziosanita Agenzia di Sanita Pubblica Regione Lazio (2013). Documento di indirizzo per l’impianto di protesi valvolare aortica trans-catetere (TAVI). www.asplazio.it/asp_online/doc_indirizzo_TAVI. pdf, ultimo accesso gennaio 2013.
  15. Makkar R.R., Fontana G.P., Jilaihawi H. et al. (2012). Transcatheter Aortic-Valve Replacement for Inoperable Severe Aortic Stenosis. The New England Journal of Medicine, 366 (18): 1696-1704. DOI: 10.1056/nejmoa1202277
  16. Mylotte D., Osnabrugge R.L.J., Windecker S. et al. (2013). Transcatheter aortic valve replacement in Europe: adoption trends and factors influencing device utilization. Journal of the American College of Cardiology, 62: 210-219. DOI: 10.1016/j.jacc.2013.08.1504
  17. Neyt M., Van Brabandt H., Devriese S. et a.l (2012). A cost-utility analysis of transcatheter aortic valve implantation in Belgium: focusing on a well-defined and identifiable population. BMJ Open, 2(3): e001032. DOI: 10.1136/bmjopen-2012-00103
  18. Nishimura R.A. et al. (2014). Guideline for the Management of Patients with Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. Circulation, 129(23): 2440-2492. DOI: 10.1161/cir.0000000000000029
  19. Osnabrugge R.L.J., Mylotte D., Head S.J. et al. (2013). Aortic stenosis in the elderly: disease prevalence and number of candidates for transcatheter aortic valve replacement: a meta-analysis and modelling study. Journal of the American College of Cardiology, 62(11): 1002-1012. DOI: 10.1016/j.jacc.2013.05.015
  20. Reynolds M.R., Magnuson E.A., Lei Y. et al. (2012). Cost-effectiveness of transcatheter aortic valve replacement compared with surgical aortic valve replacement in high-risk patients with severe aortic stenosis. Results of the PARTNER (placement of aortic transcatheter valves) trial (Cohort A). Journal of the American College of Cardiology, 60 (25): 2685-2692. DOI: 10.1016/j.jacc.2012.09.018
  21. Reynolds M.R., Magnuson E.A., Wang K.J. et al. (2012). Cost-effectiveness of transcatheter aortic valve replacement compared with standard care among inoperable patients with severe aortic stenosis. Results from the placement of aortic transcatheter valves (PARTNER) trial (Cohort B). Circulation, 125(9): 1102-1109. DOI: 10.1161/circulationaha.111.054072
  22. Ross J. Jr, Braunwald E. (2012). Aortic stenosis. Circulation, 38 (1S5): V61-V67. DOI: 10.1161/01.cir.38.1s5.v-61.
  23. Santoro G., Vitali E., Tamburino C. et al. (2010). Impianto transcatetere di protesi valvolare aortica in pazienti con stenosi valvolare severa sintomatica. Giornale Italiano di Cardiologia, 11 (1): 45-53.
  24. Santoro G., Bedogni F., Ambrosini V. et al. (2011). Documento di posizione della Societa Italiana di Cardiologia Invasiva (SICI-SIGE) sui requisiti minimi per ospedali ed operatori che eseguono procedure di impianto transcatetere di protesi valvolare aortica in pazienti con stenosi valvolare severa sintomatica.
  25. Giornale Italiano di Cardiologia, 13 (11): 772-776. Schwarz F., Baumann P., Manthey J. et al. (1982). The effect of aortic valve replacement on survival. Circulation, 66 (5): 1105-1110. DOI: 10.1161/01.cir.66.5.1105
  26. Tarricone R. (a cura di) (2012). Politiche per la salute e scelte aziendali. Impatto sull’innovazione e diffusione delle tecnologie mediche. Milano: EGEA.
  27. Tarricone R., Drummond M. (2011). Challenges in the clinical and economic evaluation of medical devices: The case of transcatheter aortic valve implantation. Journal of Medical Marketing, 11 (3): 221-229. DOI: 10.1177/1745790411412242.1380.
  28. Vahanian A., Baungartner H., Bax J. et al. (2007). Guidelines on the management of valvular heart disease – The Task Force on the management of valvular heart disease of the European Society of Cardiology. European Heart Journal, 28 (2): 230-268. DOI: 10.1093/eurheartj/ehl428
  29. Vahanian A., Alfieri O., Al-Attar N. et al. (2008). Transcatheter valve implantation for patients with aortic stenosis: a position statement from the European Association of Cardio-Thoracic Surgery (EACTS) and the European Society of Cardiology (ESC), in collaboration with the European Association of Percutaneous Cardiovascular Interventions (EAPCI). European Heart Journal, 29 (11): 1463-1470. DOI: 10.1093/eurheartj/ehn183
  30. Vahanian A., Alfieri O., Andreotti F. et al. (2012). Guidelines on the management of valvular heart disease. The Joint Task Force on the Management of Valvular Heart Disease of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS). European Heart Journal, 33 (19): 2451-2496. DOI: 10.1093/eurheartj/ehs109
  31. Unita di Valutazione dell’Efficacia del Farmaco, Regione Veneto-UVEF (2010). Report di HTA Valvola Cardiaca Trans catetere, http://www.uvef.it/extfiles/10429/attachment/FILE1311340891948-pdf, ultimo accesso marzo 2012. Ussia G.P. ,Barbanti M., Petronio A. S. etal. (2012). For the core valve Italian Registry Investigators. Trans cathetera ortic valve implantation :3-year out comes of self-expanding Core-Valve prosthesis. European Heart Journal, 33 (8):969-976. DOI: 10.1093/eurheartj/ehr491

Giuditta Callea, Maria Carterina Cavallo, Rosanna Tarricone, Guido Beccagutti, Rachele Busca, Mara Corbo, Il governo dell’innovazione tecnologica in sanità. Il caso dell’impianto di valvola aortica transcatetere: stato dell’arte delle indicazioni e della rimborsabilità nelle regioni italiane in "MECOSAN" 95/2015, pp 137-160, DOI: 10.3280/MESA2015-095007