hta_ knee intro.qxp - Ministero della Salute

More documents

Recommendations

Info

58 8.4 Conclusions Regardless of whether we included effectiveness data from RIPO or AOAJRR registers, NEX- GEN LPS (ZIMMER) is the most cost-effective among the prostheses with a multiradius femoral design while SCORPIO (STRYKER) is the most cost-effective among the prostheses with a singleradius design. ICERs were calculated comparing only prostheses in the same femoral design class. Using a different approach, ICERs could be calculated comparing prostheses with different biomechanical designs. ICERs of other prostheses are sensitive to the source of effectiveness estimates. The main limitations of our analysis and conclusions are mentioned in the Discussion (chapter 9).
9. Discussion The present report was designed to assess whether the prostheses for TKR currently used in the Italian clinical practice are supported by evidence, and if implant performance can be correlated to implant price. We addressed these issues first by performing a context-specific analysis (to identify which knee systems are currently in use and their prices), a systematic review of the evidence from formal studies and an analysis of implant performance from the arthroplasty registers (to identify performance by knee system). Finally with the cost and the effectiveness data so far assembled, we carried out an economic evaluation to help decision making by the Italian MLHSP. The context-specific analysis was necessary since the central inventory of medical devices was not yet operative at the start of the study (and is not completed yet at the time of writing). The survey allowed us to identify a list of knee systems that are probably representative of all the devices used in Italy, together with their mean purchasing prices. These prices can be assumed as “real prices”, i.e. the true amount that purchasers have to pay in the transaction. “Real price” is sometimes different from the price reported in the manufacturer’s list price as, to our knowledge, bulk purchase discounts are common. Manufactures of knee prostheses were involved in our HTA project as stakeholders. We contacted several companies with a formal letter sent to the main association of manufacturers of medical technology in Italy (ASSOBIOMEDICA) but elicited scarce interest from manufacturers. Only 6 companies collaborated with us: BIOMET, DEPUY, LIMA, LINK, MEDACTA, and STRYKER out of the 25 or more which to our knowledge are active in Italy. No reply or reasons for non-response were received by the others. We attempted to identify and synthesise evidence of performance (expressed as survival rate or revision rate for each knee system) from published literature. Unfortunately, literature in this field seems to be too generic for our particular research questions. Very few studies met our inclusion criteria and those that did were poorly reported. For this reason we decided to give more weight to performance estimates contained in the periodic reports of the arthroplasty registers. We were forced to refer to national registers of foreign countries, as Italy does not yet have a national knee prostheses register. At present a National hip arthroplasty register project is running and will start collecting data in the next months. In the near future, there is the intention to extend the same protocol to the knee arthroplasty registration. However, we used regional Italian data thanks to the collaboration and data-sharing spirit of the RIPO (regional register of Emilia- Romagna). We noted high variation among the periodic reports published and decided to conduct an enquiry among the “key-persons” (e.g. the register’s coordinator) of the arthroplasty registers to obtain collaboration in our project by data-sharing. Unfortunately, few collaborated. Some key persons reported that the data we asked for were not available for “third party” analysis, sometimes the data were not available at all as they were not collected on a regular basis. However we greatly benefited from the collaboration with the AOAJRR (the Australian register) and the RIPO. Their key persons sent all data we requested rapidly, sometimes performing ad hoc queries and handling. 59
Page 1 and 2:
HTA REPORT Prostheses for primary t
Page 3 and 4:
Contributions Authors Marina Cerbo,
Page 5 and 6:
HTA REPORT Prostheses for primary t
Page 7 and 8:
10. Recommendations . . . . . . . .
Page 9:
Prefazione Quest’anno l’Agenas
Page 12 and 13:
XII Results Literature in this fiel
Page 14 and 15:
XIV Obiettivi del report L’interv
Page 16 and 17:
XVI formati e delle variabili racco
Page 18 and 19:
2 The procedures were identified ac
Page 21 and 22:
2. Technology, procedure and altern
Page 23: 3. The marketing status of knee pro
Page 27 and 28: 5. Context-specific analysis Contex
Page 29 and 30: Figure 5.1: Type of centres in the
Page 31 and 32: Figure 5.2: Percentage of respondin
Page 33 and 34: Table 5.3: Volume of purchased pros
Page 35 and 36: 5.2.5 Analysis on purchasing price
Page 37: Table 5.6: Distribution of mean wei
Page 40 and 41: 24 6.1.3 Evidence synthesis After t
Page 42 and 43: 26 Survival rate as “revision for
Page 44: 28 Table 6.1: Evidence table for si
Page 49 and 50: 7. Assessing the evidence from arth
Page 51 and 52: Only four reports out of the 9 repo
Page 53 and 54: Table 7.3: Variables used in each r
Page 55 and 56: Table 7.4: Replies from the key-per
Page 57 and 58: Table 7.6: Data from the Australian
Page 59 and 60: Table 7.8: Data from Registro dell
Page 61 and 62: Table 7.11: Data from the Australia
Page 63 and 64: Table 7.15: Data from Registro dell
Page 65: Table 7.18: Revision rates of uncem
Page 68 and 69: 52 We calculated ICERs only for cla
Page 70 and 71: 54 Figure 8.1 shows prostheses ICER
Page 72 and 73: 56 Table 8.3: ICER (AOAJRR data) fo
Page 76 and 77: 60 The gross heterogeneity of repor
Page 79: 10. Recommendations We recommend th
Page 83: 12. Competing interests declaration
Page 86 and 87: 70 22. http://www.agenas.it/monitor
Page 88 and 89: 72 • a tibial component: a metall
Page 90 and 91: 74 Retention or sacrifice of the po
Page 92 and 93: 76 Figure A1.2: Examples of femoral
Page 94 and 95: 78 Suggested readings Bronzino JD.
Page 97 and 98: Appendix 2 Survey of Medical device
Page 103 and 104: Appendix 3 Sampling methodology The
Page 105: Table A2.2: Sample and total centre
Page 108 and 109: 92 Veneto: 050017 Ospedale Sacro Cu
Page 110 and 111: 94 Basilicata: 170011 Presidio Ospe
Page 113 and 114: Appendix 6 Search strategy The sear
Page 115 and 116: #50. (hls AND noetos) AND tornier A
Page 117 and 118: #108. (prime) AND (exatech) AND pri
Page 119 and 120: #166. (vanguard AND ps) AND ('biome
Page 121 and 122: Select 6 document(s) Search ("1998-
Page 123 and 124: Search ("1998-01-01"[Publication Da
Page 125 and 126:
Appendix 7 Data extraction form for
Page 127 and 128:
Common characteristics: Manufacture
Page 129 and 130:
Conclusions: Assessment of generali
Page 131 and 132:
Appendix 8 Data extraction form for
Page 133 and 134:
Appendix 9 Quality assessment tool
Page 135 and 136:
Appendix 10 List of excluded studie
Page 137 and 138:
Studies excluded for short follow-u
Page 139 and 140:
Robinson RP. Five-year follow-up of
Page 141 and 142:
Regnér L, Carlsson L, Kärrholm J,
Page 143 and 144:
Appendix 11 List of included studie
Page 145 and 146:
Acronyms and abbreviations Agenas A
show all

hta_ knee intro.qxp - Ministero della Salute

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?