HTA Report – Using knee prostheses on the basis of evidence – Correlation between implant performance and costs

Presenter: Antonio Migliore, AGE.NA.S., Agenzia Nazionale per i Servizi Sanitari Regionali

Abstract

Rationale: Knee prostheses are often used without an adequate assessment of their clinical performance or without any a priori analysis of their cost-effectiveness. The main complication of knee replacement is implant failure. When failure occurs, further surgery is necessary with considerable monetary and social costs. The number of implant revisions may be reduced through an accurate evaluation of implant performance prior to their clinical use.

Objectives: To assess if the knee prostheses used in Italian clinical practice are supported by evidence. Comparative cost-effectiveness analysis will be applied to the different models identified.

Methodology: There will be a survey of the orthopaedic facilities in Italy to collect device data (product name and manufacturer of the prostheses, device costs, number purchased) and activity volume (number of procedure performed, total cost for the primary procedure, total cost for the revision procedure). A systematic review of the evidence will be conducted to obtain performance data for each prosthesis model. Implant survival rate, possibly long-term, will be the main outcome. Safety data and adverse events related to the prostheses will also be considered and reported. In addiction to the systematic review, arthroplasty registers will be also consulted and analysed to obtain performance data by specific prosthesis model. A comparative analysis between different devices will be conducted considering the performance of each implant at a defined follow-up period (e.g. 5 and 10 years), the devices costs and the consequences of their use in terms of number of revisions avoided.

Results: In Italian clinical practice very low attention is devoted to the link between the cost of knee prostheses and the evidence of their performance. Often the choice of the prosthesis is driven by personal considerations or marketing strategies.

Conclusions: We hope to suggest that the National Health System must explicitly use performance evidence to manage the reimbursement policy of prostheses and to promote the use of those with well documented good performance. Ideally, reimbursement for knee prostheses should be primarily targeted towards those systems that have the greatest evidence base proving with the highest performance in terms of revisions avoided and cost containment. However, not to stifle progress, we may recommend that new or newer knee prostheses should be used and assessed as part of an adequately powered clinical trial or, alternatively, they should be reimbursed only if evidence of good performance is reported by arthroplasty registers.