Cost analysis of "CEUS first" approach in the assessment of focal liver lesions.

Transcription

1 Cost analysis of "CEUS first" approach in the assessment of focal liver lesions. Poster No.: C-1152 Congress: ECR 2014 Type: Scientific Exhibit Authors: R. Dežman, D. Vidmar-Bracika, P. Gregoric, M. Gorenc, B. Cernelc; Ljubljana/SI Keywords: DOI: Economics, Technology assessment, Cost-effectiveness, Contrast agent-intravenous, Ultrasound, Liver, Contrast agents, Abdomen /ecr2014/C-1152 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply ECR's endorsement, sponsorship or recommendation of the third party, information, product or service. ECR is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold ECR harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies, ppt slideshows and any other multimedia files are not available in the pdf version of presentations. Page 1 of 19

2 Aims and objectives Ultrasonography is probably the most common imaging technique for the assessment of abdominal pathology. Patients with suspected abdominal pathology are often examined by US as part of their preliminary examination. Focal liver lesions (FLL) are common incidental findings during these examinations. The crucial part in the assessment of FLL is the differentiation of benign FLL from malignant FLL. Some of them may be characterized by the B-mode ultrasound alone. In others, however, the differentiation between benign and malignant lesion cannot be made on US findings alone and further characterization is required 1. In the past contrast enhanced computed tomography (CECT) or contrast enhanced magnetic resonance (CEMR) imaging were standard second-line examinations for routine evaluation of a FLL which could not be adequately characterized on US examination. The downsides of these imaging modalities are ionizing radiation exposure (CECT), relatively high cost (CECT and CEMR) and low accessibility (CEMR) 1. In the recent years contrast enhanced ultrasound (CEUS) has become a reliable method for the assessment of FLL. This has also been confirmed by The European Federation of Societies of Ultrasound in Medicine and Biology (EFSUMB) which issued the Guidelines regarding the use of CEUS in 2004, 2008 and CEUS characterization of FLL is based on contrast enhancement patterns of the FLL. These patterns are similar to those obtained with CECT or CEMR 3 and permit lesion characterization with comparable sensitivity and specificity to CECT 4. The use of CEUS has therefore been suggested as a valuable diagnostic alternative to CECT or CEMRI. If doubt persists, CECT or CEMRI would only be used as a possible third-line modality in the diagnostic workup. The cost of a single CEUS study is lower in comparison with a single CECT or CEMRI, but not all of the lesions can be characterized with CEUS and some of them still need to be referred further to CECT or CEMRI. Since the increase in the healthcare costs is the problem in the most of industrialized countries, reduction of costs by optimizing our clinical protocols is a reasonable option. Some studies have already confirmed the cost efficiency of CEUS in comparison with CECT or CEMRI 5,6, but were performed in non-comparable environment to ours from the economic point of view. Page 2 of 19

3 The aim of this study is therefore to analyze the impact on the total cost of characterization protocol for FLL with indeterminate appearance on baseline US if the CEUS is implemented as a second-line characterization method rather than CECT or CEMRI. We tried to evaluate the costs of radiology services from the point of view of the "payer" (the National health insurance fund (NHIF)) whose aim is to provide the patient with the best and most cost-effective clinical approach. Images for this section: Fig. 1: Hypoechoic lesion in the liver of a 30 year old female; B-mode ultrasound is inconclusive at lession charecterization Page 3 of 19

4 Fig. 2: Contrast enhanced ultrasound, early arterial phase - spoke-wheel like enhancement pattern is seen, which is characteristic for FNH. (the same patient as in Fig.1) Page 4 of 19

5 Fig. 3: FNH - CEUS showing arterial phase with characteristic spoke wheel enhancement pattern. (the same patients as in Fig.1 and Fig.2) Page 5 of 19

6 Fig. 4: Classic diagnostic pathway for charecterisation of focal liver lessions. Page 6 of 19

7 Page 7 of 19

8 Fig. 5: "CEUS first" diagnostic pathway for charecterisation of focal liver lessions. Page 8 of 19

9 Methods and materials We conducted a retrospective analysis of all CEUS evaluations of FLL performed at our department during a two year period (July 2011-July 2013). Patients referred to our department had a FLL discovered in one of the out-patient ultrasound practices. Only patients with non-cirrhotic liver were included in the analysis. Four experienced radiologists performed US scanning using Toshiba Aplio 500 and Toshiba Aplio XG ultrasound devices with a 3.5 MHz convex array probe. A baseline ultrasound examination was initially performed and was then followed by CEUS examination. The US contrast agent used was SonoVue (Bracco, Italy). For the purpose of characterization patient received an intravenous bolus injection of SonoVue (between 1.6 and 2.4 ml) via a 20-gauge intravenous catheter, placed in the cubital vein, followed by 10 ml saline flush. The examination lasted approximately 5 min after the bolus administration. All examinations were digitally recorded to the ultrasound device and were latter reviewed. To characterize the lesion, the vascularity and enhancement pattern (hypoenhancing, hyperenhancing, isoenhancing) during the arterial phase (15-30 seconds), portal venous ( seconds) and late vascular phases ( seconds), were evaluated. A CEUS examination was considered conclusive, if the FLL had a typical enhancement pattern according to the EFSUMB guidelines 1. Using these criteria, the lesions could be classified as hemangioma, FNH, adenoma, hepatocellular carcinoma, metastasis, area of focal fatty sparing or focal fatty infiltration or "others". For the cost analysis we formed two models: 1. classic diagnostic pathway: where the second-line (following B-mode ultrasound) investigation for the FLL characterization is either CECT or CEMRI. (fig. 4) 2. CEUS-first diagnostic pathway: where the second line (following B-mode ultrasound) investigation is CEUS. In case of inconclusive CEUS the thirdline investigation is either CECT or CEMRI. (fig. 5) We compared the costs of a classic diagnostic pathway verus a CEUS-first diagnostic pathway in the characterization of FLL. In the classic diagnostic pathway only CECT or CEMRI price was included. In the CEUS first diagnostic pathay the price of CEUS was included for all the patients and also the additional costs of CECT or CEMRI were included when CEUS was inconclusive. Page 9 of 19

10 Fig. 6: Reimbursement for imaging examinations by National health insurance fund. References: Institute of Radiology, UMC Ljubljana, UMC Ljubljana - Ljubljana/SI All costs were calculated as they are defined by the NHIF. The cost of CEUS was calculated as the cost of abdominal ultrasound and the cost of 1/2 vial of SonoVue (40EUR + 35EUR = 75 EUR). The costs of CECT scan and CEMRI were 197,85EUR and 222EUR. The study was approved by the national ethics committee. Images for this section: Page 10 of 19

11 Fig. 4: Classic diagnostic pathway for charecterisation of focal liver lessions. Page 11 of 19

12 Page 12 of 19

13 Fig. 5: "CEUS first" diagnostic pathway for charecterisation of focal liver lessions. Page 13 of 19

14 Results The study included 259 patients with FLL in non-cirrhotic liver. The CEUS examination alone was conclusive at the characterization in 201 patients (78%). Therefore 201 of 259 patients had a final diagnosis immediately following CEUS examination and only 58 of 259 patients had to undergo further investigation with CECT or CEMRI to obtain the diagnosis. If we were to follow the classic diagnostic pathway, all of the 259 patients would require CECT or CEMRI to obtain a final diagnosis. Fig. 7: Outcome of charecterization of focal liver lesions by CEUS; data based on 259 patients. References: Institute of Radiology, UMC Ljubljana, UMC Ljubljana - Ljubljana/SI In terms of cost, from the point of view of the payer (NHIF), the cost of classic diagnostic pathway with CECT as the second-line method would be With the CEMRI as the second-line method in the classic diagnostic pathway the total cost would be Page 14 of 19

15 Using our proposed "CEUS-first" diagnostic pathway with the CEUS as the second-line method the total costs would be (if all non-conclusive patients are reffered to CECT) or (when all non-conclusive patients are reffered to a CEMRI) respectively. The use of CEUS therefore results in significant savings - up to in total in two years - that is 98,1 per patient. Fig. 8: Cost analysis of "clasic diagnostic pathway" vs. "CEUS first diagnostic pathway", based on 259 consecutive patients References: Institute of Radiology, UMC Ljubljana, UMC Ljubljana - Ljubljana/SI Page 15 of 19

16 Images for this section: Fig. 7: Outcome of charecterization of focal liver lesions by CEUS; data based on 259 patients. Page 16 of 19

17 Fig. 8: Cost analysis of "clasic diagnostic pathway" vs. "CEUS first diagnostic pathway", based on 259 consecutive patients Page 17 of 19

18 Conclusion The introduction of US contrast media has improved the performance of US examinations for the characterization of FLLs. We have shown that the routine use of CEUS-first diagnostic pathway for the characterization of FLL with indeterminate appearance on baseline US reduced the number of CT and MRI examinations from potential 259 to 58 (reduction of 78%). In terms of cost, the CEUS-first diagnostic pathway has saved as much as (98,1 per patient) in the two year period. The hospitals receive the reimbursement for each diagnostic procedure by the NHIF. Therefore it is in the best interest of the NHIF, as a state owned fund, to promote the usage of a CEUS for the assessment of the FLL - we have shown that this protocol is cheaper as traditional protocol with CECT or CEMRI as the second-line modalities and has the potential to save the NHIF up to per year regarding the examinations performed at our institution alone. But there are also other benefits. We have shown, that the use of CEUS reduces the need for CT and MR examinations. This subsequently frees up the CT and MR machines and they become available for the studis of other pathologies. Therefore the use of CEUS achieves reduction in CT and MR waiting lists. Also a faster and simpler diagnostic algorithm is preferable for the patient - in the future a final diagnosis will be obrainet in the same session with the baseline US. This will result in greater savings in money, time and will reduce psychological stress to the patients 7. Personal information Dubravka B. Vidmar, MD, radiologist, head of ultrasound departement, Institute of radiology, UMC Ljubljana, Slovenia Rok Dežman, MD, radiology resident, Institute of radiology, UMC Ljubljana, Slovenia Primož Gregori#, MD, radiologist, ultrasound departement, Institute of radiology UMC Ljubljana, Slovenia Page 18 of 19

19 Milan Gorenc, MD, radiologist, ultrasound departement, Institute of radiology, UMC Ljubljana, Slovenia References 1. Bartolotta T V, Taibbi A, Midiri M, La Grutta L, De Maria M, Lagalla R. Characterisation of focal liver lesions undetermined at grey-scale US: contrast-enhanced US versus 64-row MDCT and MRI with liver-specific contrast agent. Radiol. Med. 2010;115(5): Claudon M, Dietrich CF, Choi BI, et al. Guidelines and good clinical practice recommendations for contrast enhanced ultrasound (CEUS) in the liver--update 2012: a WFUMB-EFSUMB initiative in cooperation with representatives of AFSUMB, AIUM, ASUM, FLAUS and ICUS. Ultraschall Med. 2013;34(1): Burns PN, Wilson SR. Focal Liver Masses#: Enhancement Patterns on Contrast-enhanced Images - Concordance of US Scans with CT Scans and MR Images 1 Methods#: Results#: Conclusion#: 2007;242(1). 4. Seitz K, Strobel D, Bernatik T, et al. Contrast-Enhanced Ultrasound (CEUS) for the characterization of focal liver lesions - prospective comparison in clinical practice: CEUS vs. CT (DEGUM multicenter trial). Parts of this manuscript were presented at the Ultrasound Dreiländertreffen 2008, Dav. Ultraschall Med. 2009;30(4): Sirli R, Sporea I, Martie A, Popescu A, D#nil# M. Contrast enhanced ultrasound in focal liver lesions--a cost efficiency study. Med. Ultrason. 2010;12(4): Romanini L, Passamonti M, Aiani L, et al. Economic assessment of contrastenhanced ultrasonography for evaluation of focal liver lesions: a multicentre Italian experience. Eur. Radiol. 2007;17 Suppl 6:F Edwards B, Clarke V. The psychological impact of a cancer diagnosis on families: the influence of family functioning and patients' illness characteristics on depression and anxiety. Psychooncology. 2004;13(8): Page 19 of 19