La valutazione dei benefici e dei costi dei dispositivi medici. Il caso degli stent medicati
Tóm tắt
From a regulatory viewpoint, medical devices are managed differently from drugs under several aspects, such as marketing authorisation, reimbursement procedures, price negotiations. In general, medical devices have a much lower degree of regulatory control as compared to drugs. To address these critical issues, in 2002 the Italian Ministry of Health has instituted a national committee (CUD, Commissione Unica sui Dispositivi Medici). This committee has carried out a variety of different activities including a number of health technology assessments focused on innovative and/or costly medical devices. The assessments completed thus far have considered drug-eluting stents, implantable cardioverter defibrillators, vertebroplastic and kiphoplastic interventions, and telethermography and have explored the cost-effectiveness profile of these techniques as well as the economic appropriateness of their price as compared to the amount of health gained. As an example of this activity of health technology evaluation, this paper presents the report that the Committee has produced about drug-eluting stents.
Tài liệu tham khảo
Costi e ricavi del SSN — Analisi per enti, funzioni di spesa e fonti di finanziamento — della D.G. Programmazione Sanitaria del Ministero della Salute, Roma 2005
Messori A, Santarlasci B, Trippoli S, Vaiani M. Controvalore economico del farmaco e beneficio clinico: stato dell’arte della metodologia e applicazione di un algoritmo farmacoeconomico. PharmacoEconomics-Italian Research Articles 2003; 5: 53–67
Bagust A, Grayson AD, Palmer ND, et al. Cost-effectiveness of drug-eluting coronary artery stenting in a UK setting: cost-utility study. Heart 2005 [Epub ahead of print]
(http://www.ministerosalute.it/dispositivi/paginainterna.jsp?id=88&menu=commissione) Stent coronarici a rilascio di farmaco
Morice M-C, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, et al.. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002; 346:1773–1780
Holmes DR Jr, Leon MB, Moses JW, Popma JJ, Cutlip D, et al. Analysis of 1-year clinical outcomes in the SIRIUS trial. Circulation 2004;109: 634–640
Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315–1323
Schofer J, Schluter M, Gershlick AH, Wijns W, Garcia E, et al. Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries: double-blind, randomised controlled trial (E-SIRIUS). Lancet 2003; 362: 1093–1099.
Schampaert E, Cohen EA, Schluter M, Reeves F, Traboulsi M, et al. The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS). J Am Coll Cardiol. 2004; 43: 1110–1115
Ardissino D, Cavallini C, Bramucci E, Indolfi C, Marzocchi A, et al. Sirolimus-eluting vs. uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA. 2004 Dec 8;292(22):2727–34
Colombo A, Drzewiecki J, Banning A, et al. Randomized study to assess the difference of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 2003; 108: 788–794.
Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, et al. One-year clinical results with the slow-release, polymer-based, paclitaxel-eluting TAXUS stent. The TAXUS-IV trial. Circulation 2004;109: 1942–7
Stone GW, Ellis SG, Cox DA, Hermiller J, O’Shaughnessy C, Mann JT, et al. A polymer-based paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004; 350: 221–231
Lemos PA, Serruys PW, van Domburg RT, et al. Unrestricted utilization of Sirolimus-eluting stents compared with conventional bare stent implantation in the “real world”. The RESEARCH registry. Circulation 2004; 109: 190–5.
Stone DG. 2005 ACC Scientific Sessions, Orlando, FL
Dawkins K. 2004 Euro PCR, Parigi
Windecker S. 2005 ACC Scientific Sessions, Orlando, FL
Kelbaek H. 2005 ACC Scientific Sessions, Orlando, FL
Morice MC. 2005 ACC Scientific Sessions, Orlando, FL
Kastrati A. 2005 ACC Scientific Sessions, Orlando, FL
Indolfi C, Berardi F, Bolognese L, et al. Consensus Conference Italiana sui “drug-eluting stents”. Ital Heart J Suppl 2004;5(1): 64–70
Pache J, Kastrati A, Mehilli J, Schuhlen H, Dotzer F et al. Intracoronary stenting and angiographic results: strut thickness effect on restenosis outcome (ISAR-STEREO-2) trial. J Am Coll Cardiol 2003;41(8):1283–8.
Cohen DJ, Bakhai A, Shi C, Githiora L, Lavelle T, et al. Cost-effectiveness of sirolimus-eluting stents for treatment of complex coronary stenoses: results from the Sirolimus-Eluting Balloon Expandable Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions(SIRIUS) trial. Circulation 2004;110(5):508–514
Shrive FM, Manns BJ, Galbraith PD, Knudtson ML, Ghali WA; APPROACH Investigators. Economic evaluation of sirolimus-eluting stents. CMAJ 2005;172(3):345–351
Bagust A, Grayson AD, Palmer ND, Perry RA, Walley T. Cost-effectiveness of drug-eluting coronary artery stenting in a UK setting: cost-utility study. Heart 2005 May 12 [Epub ahead of print]
Weintraub WS. Economics of sirolimus-eluting stents. Drug-eluting stents have really arrived. Circulation 2004;110:472–474
Grube E, Silber S, Hauptmann KE, Mueller R, Buellesfeld L, Gerckens U, Russell ME. TAXUS I: six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions. Circulation 2003;107(1):38–42.
Messori A, Santarlasci B, Trippoli S, Vaiani M. Controvalore economico del farmaco e beneficio clinico: stato dell’arte della metodologia e applicazione di un algoritmo farmacoeconomico. Pharmacoeconomics — Italian Research Articles 2003;5:53–67.
Andrea Messori. Markov models and hepatitis C. http://bmj.com/cgi/eletters/329/7468/733#76152, 28 Sep 2004
Arduini R, Colombo A, Gensini GF, Mapelli V, Peppa R e Wenk Lang A. L’impatto economico dell’innovazione tecnologica nelle malattie dell’apparato cardiovascolare. Quaderno 16. Economia e Sanità 2004;16:1–46
Gulizia M, Martelli E, Tamburino C, Tolaro S, Frascheri A, et al. Impatto potenziale dello stent medicato nella pratica clinica siciliana: risultati di una “survey” multicentrica e di un’analisi costo-beneficio rispetto alla stent metallico. Ital Heart J 2004;5:630–638.