Is dabigatran considered a cost-effective alternative to warfarin treatment: a review of current economic evaluations worldwide.

OBJECTIVE: Dabigatran was the first of a new generation of anticoagulation drugs for the indication of non-valvular atrial fibrillation (AF) to be approved. Evidence show that dabigatran 150 mg twice daily significantly reduces the risk of stroke and systemic embolism (RR = 0.65; p < 0.001) and shows a comparable rate of major bleedings (RR = 0.93; p = 0.32), whereas dabigatran 110 mg twice daily was associated with a comparable rate of stroke and systemic embolism (RR = 0.90; p = 0.30) and a significantly lower rate of major bleedings compared to warfarin treatment (RR = 0.80; p = 0.003). The purpose is to review current economic evaluations of these alternatives for healthcare professionals to include these findings in their decision-making. METHODS: A systematic literature search identified 43 economic evaluations, of which 10 were included and evaluated according to the Consensus Health Economic Criteria list (CHEC-list) and the Oxford model. RESULTS: Six economic evaluations concluded that dabigatran was a cost-effective alternative to warfarin. One evaluation concluded the same except when quality in warfarin treatment was excellent, with a mean time in therapeutic range (TTR) > 73%. Three evaluations concluded that dabigatran was a cost-effective alternative to warfarin in patient sub-groups; TTR ≤ 64%, congestive heart failure, hypertension, age ≥ 75, diabetes mellitus, prior stroke or transient ischemic attack (CHADS2 score) ≥3, or a CHADS2 score = 2 unless international normalized ratio (INR) control was excellent, and with high risk of stroke or in a low-quality warfarin treatment. Dabigatran 110 mg twice daily was in general dominated by dabigatran 150 mg twice daily. LIMITATIONS: The evaluations were not fully homogeneous, as some did not include loss of productivity, costs of dyspepsia, and annual costs of dabigatran patient management. CONCLUSIONS: In the majority of the economic evaluations, dabigatran is a cost-effective alternative to warfarin treatment. In some evaluations dabigatran is only cost-effective in sub-groups, such as patients with a low TTR-value in warfarin treatment and a CHADS2 score ≥2.

Cost-effectiveness of dabigatran etexilate for stroke prevention in non-valvular atrial fibrillation. Applying RE-LY to clinical practice in Denmark.

OBJECTIVE: To estimate the economic implications of introducing dabigatran etexilate ('dabigatran') for anti-coagulation therapy in Danish patients with non-valvular atrial fibrillation based on results of the RE-LY trial. METHODS: The lifetime cost and outcomes of dabigatran and warfarin were estimated using a previously published cost-effectiveness model. The model utilizes the data from the RE-LY study to estimate the costs and outcomes of stroke prevention in atrial fibrillation. Cost estimates were based on official Danish tariffs and prices, and published literature on the cost of stroke. In the base-case analysis a conservative approach was adopted applying tariffs from the lowest range for the cost of International Normalized Ratio (INR) monitoring associated with warfarin. The effectiveness measure of the analysis was quality-adjusted life-years (QALY). RESULTS: The model estimated that the mean cost per patient for the remaining life-time is euro 16,886 treated with warfarin and euro 18,752 treated with dabigatran. This was associated with mean QALYs per patient of 8.32 with warfarin and 8.59 with dabigatran. The resulting incremental cost-effectiveness ratio (ICER) of ∼ euro 7000 per QALY gained is regarded as cost-effective by Danish standards. This conclusion was seen to be robust to realistic variations in input parameters, including adjustment for the RE-LY centres achieving the best INR monitoring quality. Threshold analysis revealed that dabigatran would be cost-saving in settings where the cost of warfarin monitoring exceeds euro 744 per year. LIMITATIONS: The analysis does not include all aspects of Danish clinical practice anti-coagulation that will influence cost-effectiveness of dabigatran, e.g., this study did not attempt to model quality of anticoagulation monitoring and under-utilization in clinical practice. CONCLUSIONS: Based on the outcomes observed in the RE-LY trial, dabigatran represents a cost-effective alternative to warfarin in Denmark for all patients with atrial fibrillation within the licensed indication of dabigatran.

Costs and quality of life for prehabilitation and early rehabilitation after surgery of the lumbar spine.

UNLABELLED: During the recent years improved operation techniques and administrative procedures have been developed for early rehabilitation. At the same time preoperative lifestyle intervention (prehabilitation) has revealed a large potential for additional risk reduction. The aim was to assess the quality of life and to estimate the cost-effectiveness of standard care versus an integrated programme including prehabilitation and early rehabilitation. METHODS: The analyses were based on the results from 60 patients undergoing lumbar fusion for degenerative lumbar disease; 28 patients were randomised to the integrated programme and 32 to the standard care programme. Data on cost and health related quality of life was collected preoperatively, during hospitalisation and postoperatively. The cost was estimated from multiplication of the resource consumption and price per unit. RESULTS: Overall there was no difference in health related quality of life scores. The patients from the integrated programme obtained their postoperative milestones sooner, returned to work and soaked less primary care after discharge. The integrated programme was 1,625 euros (direct costs 494 euros + indirect costs 1,131 euros) less costly per patient compared to the standard care programme. CONCLUSION: The integrated programme of prehabilitation and early rehabilitation in spine surgery is more cost-effective compared to standard care programme alone.

Cost and utilization of blood transfusion associated with spinal surgeries in the United States.

The purpose of this study was to examine factors associated with the utilization and cost of blood transfusion during and post-spinal fusion surgery. A retrospective, observational study of 42,029 inpatients undergoing spinal fusion surgery in United States hospitals participating in the Perspective( Comparative Database for inpatient use was conducted. Descriptive analysis, logistic regression, and ordinary least squares (OLS) regression were used to describe the factors associated with the use and cost of allogeneic blood transfusion (ABT). Hospitalization costs were $18,690 (SD=14,159) per patient, erythropoietin costs were $85.25 (SD=3,691.66) per patient, and topical sealant costs were $414.34 (SD=1,020.06) per patient. Sub-analysis of ABT restricted to users revealed ABT costs ranged from $312.24 (SD=543.35) per patient with whole blood to $2,520 (SD=3,033.49) per patient with fresh frozen plasma. Patients that received hypotensive anesthesia (OR,1.61; 95% CI, 1.47-1.77), a volume expander (OR,1.95; 95% CI, 1.75-2.18), autologous blood (OR, 2.04; 95% CI, 1.71-2.42), or an erythropoietic agent (OR=1.64; 95% CI, 1.27-2.12) had a higher risk of ABT. Patients that received cell salvage had a lower risk of transfusion (OR=0.40; 95% CI, 0.32-0.50). Most blood avoidance techniques have low utilization or do not reduce the burden of transfusion associated with spinal fusion.

Resource utilization and costs of blood management services associated with knee and hip surgeries in US hospitals.

This article assesses the use and costs of blood transfusion during knee and hip surgery through a retrospective observational study of 92,223 discharged inpatients who had undergone knee or hip surgery from July 1, 2003, through June 30, 2004; a sample of US hospitals that participated in the Perspective Comparative Database (Premier Inc., Charlotte, NC) was used. Descriptive and multivariate analyses were performed to determine the use and costs of allogeneic blood transfusion (ABT). The average cost of ABT per user ranged from $387 (SD=$952) for red blood cells to $6585 (SD=$11,162) for cryoprecipitate. Utilization rates in the sample were as follows: antifibrinolytics, 0.14%; topical sealants, 3.24%; volume expanders, 3.89%; erythropoietin agents, 5.08%; and hypotensive anesthesia, 22.28%. Patients who were given volume expanders ($133.73, SD=$23.00, P<.01) or erythropoietin ($177.72, SD=$34.61, P<.01) had higher costs associated with ABT than did those who did not use volume expanders or erythropoietin. Patients who received hypotensive anesthesia (odds ratio [OR]=1.96; 95% confidence interval [CI], 1.87-2.06), a volume expander (OR=1.71; 95% CI, 1.57- 1.85), a topical sealant (OR=1.61; 95% CI, 1.45-1.79), or an erythropoietic agent (OR=2.30; 95% CI, 2.06-2.57) had a greater likelihood of ABT. Investigators concluded that most transfusion reduction techniques are underused, or they do not reduce the burden of ABT associated with knee or hip surgery.