We did a cost-utility analysis for the new oral anticoagulants (NOACs) in the German population based on the quality-adjusted life years (QALY), total costs, and incremental cost-effectiveness ratios (ICER). The aim of our investigation was to examine cost-utility for current German drug market costs and compared to other countries. Outcome data were taken from dabigatran's RE-LY, rivaroxaban's ROCKET AF, and apixaban's ARISTOTLE trials. A Markov decision model, the Monte Carlo simulation (MCS), and further sensitivity analyses were used to simulate comparisons between NOACs over a follow up period of 20 years. The main perspective used for the analyses is from a German public health care insurance perspective. The base-case analyses of a 65 years old person with a CHADS2 score >1 resulted in 7.56-7.64 QALYs gained for warfarin. NOACs added 0.04-0.19 QALYs. Total costs for warfarin ranged from 7622 to 9069
New direct and indirect acting factor Xa (FXa) and thrombin inhibitors are being developed to overcome the downsides of the conventional anticoagulants -unfractionated and low molecular weight heparins and vitamin K antagonists. Ximelagatran and idraparinux failed to demonstrate an acceptable safety profile. Rivaroxaban and dabigatran are approved for the post-operative prevention of thromboembolic complications after elective hip or knee replacement surgery; dabigatran is approved for the prevention of embolism in patients with atrial fibrillation in an increasing number of countries. Several novel indirect antithrombin-dependent anticoagulants as well as antithrombin-independent oral direct FXa and thrombin inhibitors are investigated in multiple indications for the prophylaxis and treatment of venous thromboembolism and the prophylaxis of arterial thrombotic disorders. Quality-adjusted life years costs and incremental cost-effectiveness ratios are relatively high at present, but may decrease after approval of more new anticoagulants for additional indications.
We compared the cost-utility analysis for edoxaban at both doses with that of dabigatran at both doses, rivaroxaban, and apixaban (non vitamin K antagonist oral anticoagulants, NOAC) in a German population. Data of clinical outcome events were taken from edoxaban's ENGAGE-AF, dabigatran's RE-LY, rivaroxaban's ROCKET, and apixaban's ARISTOTLE trials. The base-case analyses of a 65-year-old person with a CHADS2 score >1 gained 0.17 and 0.21 quality-adjusted life years over warfarin for 30 mg od and 60 mg od edoxaban, respectively. The incremental cost-effectiveness ratio was 50.000 and 68.000 euro per quality-adjusted life years for the higher and lower dose of edoxaban (Monte Carlo simulation). These findings were also similar to those for apixaban and more cost-effective than the other NOAC regimens. The current market costs for direct oral anticoagulants are high in relation to the quality of life gained from a German public health care insurance perspective. The willingness-to-pay threshold was lowest for 60 mg edoxaban compared to all direct oral anticoagulants and for 30 mg edoxaban compared to dabigatran and rivaroxaban.
1164 The three new oral anticoagulants (NOAC) dabigatran 110mg bid and 150mg bid, investigated in the RE-LY trial, rivaroxaban 20mg od of the ROCKET trial, and apixaban 5mg bid of the ARISTOTLE trial showed equivalent or superior efficacy and safety compared to warfarin in these patients. We performed a cost-effectiveness analysis for these NOACs in Germany and compared the quality of life (QALY), incremental cost effectiveness ratios (ICER), and total costs across those countries form where these data are published. The base case population was a hypothetical cohort of patients 65 years or older with AF who were at increased risk for stroke (CHADS2-score >1) and had no contraindications to anticoagulation. The time horizon was based on the life expectancy of the German population. The QALYs, health insurance costs, and ICER for the NOACs compared with warfarin were calculated for each study. The sensitivity analysis was performed for different base case prices. The Markov decision model was adopted using the TreeAge Pro 2011 program. The data of the outcomes of ischemic stroke and cerebral embolism, major and intracerebral haemorrhage, myocardial infarction, and mortality were taken from the 3 studies comparing the NOAC with INR-adjusted warfarin. Prices for clinical events and for outpatient care were taken from the institute for payment regulations in German hospitals (InEK). The base-case analysis of a 65 years old person with a >2 CHADS2 score using the data from the RE-LY study resulted in 11.41 QALYs for warfarin, 11.53 QALYs for dabigatran 110mg bid, 11.66 QALYs for dabigatran 150 mg bid. ICERs per QALY were 49640€ for dabigatran 110 mg bid and 49590€ for dabigatran 150 mg bid versus warfarin. The same base-case analysis using the data from the ROCKET AF study resulted in 10.79 QALYs for warfarin versus 11.05 QALYs for rivaroxaban. ICERs per QALY were 48980€ for rivaroxaban versus warfarin. The base-case analysis using the data from the ARISTOTLE study resulted and 11.04 QALYs for warfarin versus 11.38 QALYs for apixaban. ICERs per QALY were 49720€ for apixaban versus warfarin. According the Markov Model the daily value based daily prices were 1.25€ for dabigatran 110 mg bid, 2.50€ for dabigatran 150 mg bid, 2.60€ for rivaroxaban, and 3.10€ for apixaban in Germany. The model was highly sensitive to the daily costs for the NOACs but relatively insensitive to other model inputs. Calculating the range of NOAC prices from 0.2 to 10 Euro versus the ICERs dabigatran 110 mg bid produced the highest increase of ICERs over this range of daily costs (Tukey-Kramer test, p<0.05) Comparing these data across countries using the published data shows that the willingness to pay per QALY as well as differences in treatment costs between substantially influences the daily prices of the NOACs. The data demonstrate the necessity to analyse the cost-effectiveness separately for every study due to differences in the INR-adjusted warfarin treated control group. The better the outcome during treatment with warfarin the lower is the benefit of the NOAC. The tendency of the cost-effectiveness calculated by the Markov model is comparable across countries. Disclosures: No relevant conflicts of interest to declare.
Background Several treatment options for chronic periprosthetic joint infections have been published in the current literature, with an on-going discussion to determine effective management algorithms. Objectives To compare outcomes of the two-stage exchange procedure in revision TKA prior to and after implementation of the PRO-IMPLANT Foundation treatment algorithm. The primary endpoints were defined as (i) revisions during the interval time, (ii) duration of the interval time and (iii) successful PJI eradication. Material and Methods Between 02/2013 and 09/2016, 122 patients were included in a single-centre cohort analysis. 55 patients were treated according to the previously used algorithm (K1) and 67 according to the PRO-IMPLANT Foundation algorithm (K2). A minimum follow-up period of 3 years was set as the inclusion criterion. Successful eradication of infection was defined in accordance with the consensus criteria by Diaz-Ledezma et al. Results Successful eradication was achieved in 42 (67%) patients in K1 and 47 (85.5%) in K2 (p ≤ 0.005). The mean interval time was 88 days (range 51 – 353) in K1 and 52 days (range 42 – 126) in K2 (p ≤ 0.005). In K1, a mean of 0.8 (range 0 – 6) revisions were necessary during the interval period compared with 0.5 (range 0 – 4) in K2 (p = 0.066). Conclusion Implementation of the PRO-IMPLANT treatment algorithm led to significant improvement in the outcome of periprosthetic joint infections. During mid-term follow-up, infection eradication was highly successful, with decreases in the interval time as well as the number of revisions.
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