Alex Diamantopoulos

An indirect comparison, via enoxaparin, of rivaroxaban with dabigatran in the prevention of venous thromboembolism after hip or knee replacement.

Abstract Objective: To compare the efficacy, in the prevention of venous thromboembolism (VTE), and safety, of rivaroxaban and dabigatran relative to the common comparator enoxaparin. Methods: Two randomized clinical trials of dabigatran, one after total hip replacement (THR), RE-NOVATE, and one after total knee replacement (TKR), RE-MODEL, were identified as using the same enoxaparin regimen (40 mg once daily given the evening before surgery) and being of comparable duration to two rivaroxaban trials, RECORD1 and RECORD3. Indirect comparisons were performed on both efficacy and safety endpoints. To enable comparisons, symptomatic VTE results were based on the total study duration period, i.e. including the follow-up period. Major bleeding included surgical-site bleeding events. Results: After THR, rivaroxaban 10 mg once daily significantly reduced total VTE and symptomatic VTE relative to dabigatran 220 mg once daily (relative risk 0.34 and 0.19, respectively). After TKR, rivaroxaban significantly reduced total VTE versus dabigatran (relative risk 0.53); symptomatic VTE was not different between dabigatran and rivaroxaban. There was no significant difference in the rates of major bleeding for patients receiving rivaroxaban or dabigatran. Conclusions: Based on the indirect comparisons, rivaroxaban was estimated to be more efficacious than dabigatran in the prevention of total VTE after THR and TKR. Our analysis relied upon published data for dabigatran and did not have the advantages of more detailed comparative data obtained directly from a randomized trial, as was the case with rivaroxaban. Further comparative research may be of value, but until available our conclusions represent the best available evidence.

Cost-effectiveness of rivaroxaban in the prevention of venous thromboembolism: A Canadian analysis using the Ontario Ministry of Health Perspective

Abstract Objectives: A cost-effectiveness model for rivaroxaban evaluated the cost-effectiveness of prophylaxis with rivaroxaban (a once-daily, orally administered Factor Xa inhibitor) vs enoxaparin in the prevention of venous thromboembolism (VTE) after total hip replacement (THR) and total knee replacement (TKR). This Canadian analysis was conducted using the Ontario Ministry of Health perspective over a 5-year time horizon. The model combined clinical data and builds upon existing economic models. Methods: The model included both acute VTE (represented as a decision tree) and long-term complications (represented as a Markov process with 1-year cycles) phases. The model allowed VTE event rates, quality-adjusted life expectancy and direct medical costs to be estimated over a 5-year time horizon, based on current approved practice patterns in Canada. A number of one-way sensitivity analyses were performed on the baseline assumptions, including a comparison of rivaroxaban with dalteparin, and probabilistic sensitivity analyses were performed to address any uncertainty concerning model inputs. Results: When comparing equal durations of therapy, rivaroxaban dominated enoxaparin in the prevention of VTE events in patients undergoing THR and TKR, providing more benefit at a lower cost. Rivaroxaban was cost-effective when comparing 35 days’ prophylaxis with 14 days’ prophylaxis with enoxaparin following THR. One-way and probabilistic sensitivity analyses demonstrated that the results of the economic analysis were robust to variations in key inputs. Rivaroxaban remained dominant during one-way sensitivity analyses comparing rivaroxaban with dalteparin after THR or TKR. Limitations: Although clinical trial data were used in the prophylaxis module, assumptions and values used in the post-prophylaxis and long-term complication (LTC) modules were based on several different literature sources; it was not always possible to source Canadian data. Conclusions: This economic analysis suggests that the use of rivaroxaban for the prophylaxis of VTE after THR or TKR in Canada was cost-effective.

PHC7 COST-EFFECTIVENESS OF RIVAROXABANVERSUS ENOXAPARIN FORTHROMBOPROPHYLAXIS AFTER TOTAL HIP REPLACEMENT IN CANADA

requires additional surgery and leads to increased co-morbidity, blood loss, infection rate, and pelvic instability. We assessed the cost-effectiveness of rhBMP-2 compared with autograft in spine fusion surgery over two years from both a health care payer’s and societal perspectives in The Netherlands. METHODS: An economic model was developed to evaluate differences in results between spine-fusion surgery with rhBMP-2 and fusion with bone autograft. The cost and health-related quality-of-life associated with both treatment options were estimated for two years after surgery. Data were obtained from a previously published analysis of pooled data, in which patients in the rhBMP-2 arm showed significant clinical improvements after surgery compared to standard therapy. Costs were obtained according to the Dutch costing manual, and are reported in 2007 values. RESULTS: In The Netherlands, from the health care payer’s perspective, using rhBMP-2 lead to extra cost of €1,520 per case, and incremental cost-effectiveness ratio (ICER) of €27,260/QALY. Significant reduction in secondary interventions, and better fusion rates associated with rhBMP-2 treatment resulted in faster return to work and reduced productivity loss. CONCLUSIONS: The standard use of rhBMP-2 in ALIF surgery is a cost-effective treatment option in The Netherlands from the payer’s perspective, and a cost-saving option from the societal perspective.

PHC8 COST-EFFECTIVENESS OF RIVAROXABANVERSUS ENOXAPARIN FORTHROMBOPROPHYLAXIS AFTER TOTAL KNEE REPLACEMENT IN THE UK AND SPAIN

Objective Venous thromboembolism (VTE: the composite of deep vein thrombosis [DVT] and pulmonary embolism [PE]) is the outcome of a clot, which forms within a vein and then travels through the blood vessels to a different site Total knee replacement (TKR) surgery is an important risk factor for VTE1 With more than 66,000 TKRs being performed in the UK2 and almost 17,000 being performed in Spain annually, the potential impact is large3