Objectives: In the Veneto Region, a centralized Regional Pharmacy and Therapeutics Committee (RP&TC) has been nominated and its main task is to define and update the Regional Drug Formulary (RDF). The Drug Effectiveness Evaluation Unit (UVEF) of the Veneto Region is a HTA Centre and one of its functions is to produce assessments for the RP&TC. Dabigatran and Rivaroxaban are two new drugs recently approved by EMEA for the prevention of thromboembolism in adult patients undergoing elective hip or knee replacement surgery. They are the first two oral drugs approved for this indication. Objectives: The objective is to present the HTA reports and the budget impact analysis (BIA) about Rivaroxaban and Dabigatran produced by UVEF for the appraisal by the RP&TC. Methods: The mini-HTA report contains these main sections: • Disease; • Clinical efficacy and safety; therapeutic guidelines; • Other HTA reports; • Economic evaluations and BIA with regard to the Regional economic context; • Organizing regional context. The BIA considers the following parameters: • number of patients discharged after elective hip or knee replacement surgery from the 2005 discharge records; • drug costs in hospital and selling price based on different distribution models (e.g. from the hospital pharmacy or from outpatient pharmacies) of the new drugs and the alternative treatments (e.g. LMWH and fondaparinux); • length of treatment. Results: The RP&TC introduced the new antithrombotics in the RDF in therapeutic substitution. The HTA reports and the RP&TC appraisals are published in the UVEF website (http://www.uvef.it). Conclusions: New antithrombotic drugs are at least efficacy as the alternative treatments and presents the advantage of the oral administration, but are more expensive than the alternative treatments. The BIA shows that in Veneto Region these drugs are not much more expensive than alternative treatments, depending on the distribution model.

New oral antithrombotic drugs for the VTE prevention in orthopaedic surgery: the HT assessment and appraisal process of the Veneto Region in Italy

ALBERTI, CAMILLA;VENTURINI, FRANCESCA;VISENTIN, Elena;SCROCCARO, GIOVANNA
2010

Abstract

Objectives: In the Veneto Region, a centralized Regional Pharmacy and Therapeutics Committee (RP&TC) has been nominated and its main task is to define and update the Regional Drug Formulary (RDF). The Drug Effectiveness Evaluation Unit (UVEF) of the Veneto Region is a HTA Centre and one of its functions is to produce assessments for the RP&TC. Dabigatran and Rivaroxaban are two new drugs recently approved by EMEA for the prevention of thromboembolism in adult patients undergoing elective hip or knee replacement surgery. They are the first two oral drugs approved for this indication. Objectives: The objective is to present the HTA reports and the budget impact analysis (BIA) about Rivaroxaban and Dabigatran produced by UVEF for the appraisal by the RP&TC. Methods: The mini-HTA report contains these main sections: • Disease; • Clinical efficacy and safety; therapeutic guidelines; • Other HTA reports; • Economic evaluations and BIA with regard to the Regional economic context; • Organizing regional context. The BIA considers the following parameters: • number of patients discharged after elective hip or knee replacement surgery from the 2005 discharge records; • drug costs in hospital and selling price based on different distribution models (e.g. from the hospital pharmacy or from outpatient pharmacies) of the new drugs and the alternative treatments (e.g. LMWH and fondaparinux); • length of treatment. Results: The RP&TC introduced the new antithrombotics in the RDF in therapeutic substitution. The HTA reports and the RP&TC appraisals are published in the UVEF website (http://www.uvef.it). Conclusions: New antithrombotic drugs are at least efficacy as the alternative treatments and presents the advantage of the oral administration, but are more expensive than the alternative treatments. The BIA shows that in Veneto Region these drugs are not much more expensive than alternative treatments, depending on the distribution model.
Thrombosis; Drugs
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/11562/391886
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