Genetic screening for the predisposition to venous thromboembolism: a cost-utility analysis of clinical practice in the Italian health care system.

Objectives: In the Italian health care system, genetic tests for factor V Leiden and factor II are routinely prescribed to assess the predisposition to venous thromboembolism (VTE) of women who request oral contraception. With specific reference to two subpopulations of women already at risk (i.e., familial history or previous event of VTE), the study aimed to assess whether current screening practices in Italy are cost-effective.

Methods: Two decisional models accrued costs and quality-adjusted life-years (QALY) annually from the perspective of the National Health Service. The two models were derived from a decision analysis exercise concerning testing practices and consequent prescribing behavior for oral contraception conducted with 250 Italian gynecologists. Health care costs were compiled on the basis of 10-year hospital discharge records and the activities of a thrombosis center. Whenever possible, input data were based on the Italian context; otherwise, the data were taken from the international literature.

Results: Current testing practices on women with a familial history of VTE generate an incremental cost-effectiveness ratio of €72,412/QALY, which is well above the acceptable threshold of cost-effectiveness of €40,000 to €50,000/QALY. In the case of women with a previous event of VTE, the most frequently used testing strategy is cost-ineffective and leads to an overall loss of QALY.

Conclusions: This study represents the first attempt to conduct a cost-utility analysis of genetic screening practices for the predisposition to VTE in the Italian setting. The results indicate that there is an urgent need to better monitor the indications for which tests for factor V Leiden and factor II are prescribed.