European Journal of Radiology 81S1 (2012) S69–S71
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Economic aspects of MR-mammography in dense breasts a Clemens G. Kaisera, *, Cornelia Reichb , Klaus Wassera , Stefan O. Schonberg ¨ , Werner A. Kaiserb a Institute of Clinical Radiology and Nuclear Medicine, University Medical Centre Mannheim, Medical Faculty Mannheim-University of Heidelberg, Theodor-Kutzer-Ufer 1–3, 68167 Mannheim, Germany b Institute of Diagnostic and Interventional Radiology Jena I, Friedrich-Schiller-University Hospital Jena, Erlanger Allee 101, 07740 Jena, Germany
1. Aim The role of MRI in comparison to other imaging modalities of the breast has become increasingly important over the last 20 years. Up to this day, the indications for MR-mammography (MRM) are highrisk patients, CUP-Syndrome (Cancer of unknown primary) and preoperative staging as well as implant indications. “Dense breasts” as an indication have not yet been evaluated. In an agreement between one of the major German insurance companies and our university hospital administration, patients with dense breasts, in
1488 patients included (2279 follow-up exams over 5 years)
142 patients with BX
1346 patients without BX
124 BX / Op (with MRM+) 18 BX /Op (with MRM–)*
0 BX / Op
761 MRM
585 questionnaires to be sent
(follow-ups)
(397 sent, 192 returned: 0 FN)
Fig. 1. Patient collective of our study. *18 Patients received biopsy upon external request, despite negative MR-findings. Table 1 Results: MR diagnosis vs. histological correlation and follow-ups for 1488 patients Histology
Patients
Results
Sensitivity
76/76
100%
Specificity
971/1019
95.20%
PPV
76/124
61.30%
NPV
971/971
100%
Accuracy
1047/1095
95.60%
Table 3 Results “Dense breast” study – malignant lesions (1488 patients, 393 lost)
1492 patients (before drop-out – 4 patients excluded due to claustrophobia)
MRM
Table 2 Results “dense breast” study (04/06 – 12/11)
Follow-up
Diagnoses
Number
CA/DCIS
Ben.
Mal.
Ben.
Cancer
90
63
27
0
0
Lost
0
DCIS
34
13
21
0
0
0
Benign
2148
0
18
0
1737
393
Total
2272
76
66
0
1737
393
* Clemens Kaiser, MD, University Medical Centre Mannheim, Medical Faculty Mannheim, University of Heidelberg, Theodor-Kutzer-Ufer 1–3, D-68167 Mannheim, Germany. Tel.: +49 0621 383 2067. E-mail address:
[email protected] (C.G. Kaiser). 0720-048X/$ – see front matter © 2012 Elsevier Ireland Ltd. All rights reserved.
Type of lesion
Number of lesions
TP
63
FP
27
TN
971
FN
0
which a biopsy would, according to guidelines, have been elsewise the necessary next step without MRM, were included. Figure 1 and tables 1 through 3 display patient collective and results. Patients were openly referable through the insurance company by external gynecologists or surgeons. The subjects of this study are the economic aspects (cost vs. savings) of the use of MRM in dense breasts. 2. Methods The study was aimed to define the role of breast MR in dense breasts in terms of medical and economical aspects. In a specific arrangement with the participating insurance company (one of the major German insurance companies), the cost of a MRM examination was negotiated to be set to the amount of €418.5, which is rather inexpensive compared to the German average price of a MRM examination. According to the pharmaceutical as well as administrative department of our University hospital, the cost of biopsy (biopsy needle, histological evaluation) was estimated to the amount of €1,000, an inextensive surgery (for small cancers with hospitalization not longer than 3 days) to the amount of €4,000 and an extended surgical procedure (extended surgery, hospitalization time 3–7 days) to the amount of €10,000 (see table 4). For chemotherapy average costs of €30,000 were considered, while radiotherapy was estimated to the amount of €10,000. The costs of an additional therapy with Herceptin and aromatase
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inhibitors were so far not included into the calculation (varying in dose application and duration of application between €100,000 and €400,000 for Herceptin and for the application aromatase inhibitors from €10,000 to €15,000). Table 4 Cost estimate interventions Intervention
Cost (€)
MRM
418.50
Biopsy total
~1,000
Inextensive surgery
~4,000
Extensive surgery
~10,000
Chemotherapy
~30,000
Radiotherapy
~10,000
Regarding savings, the following estimates were calculated with: In case of a negative finding, a biopsy was avoided. Instead, an MRM follow-up examination within the next 2 years and/or patient questionnaires by mail about the patient’s health status were used in order to confirm a non-malignant finding. In case of a positive finding, its was assumed, that the cancer would have elsewise been detected later (sometimes years) in a rather more advanced stage and size, causing additional cost due to more necessary extensive surgeries and advanced application of treatment. 3. Results The overall costs for patients (MRM examinations, biopsies and costs of limited surgeries) included in this study resulted in expenses to the amount of €1.53 million (€1.187 million. MRM cost + €304,000 for further treatment of true positive findings + €48,000 for the biopsy of 48 false positive findings). On the contrary, the estimate amount of savings (prevented biopsies, reduced surgeries) ranged from €2.65 million to €4.15 million (€2.15 million in prevented biopsies and treatment + 76 true positive findings, resulting in a total of €0.5–2 million. in less extensive treatment). This results in a net profit for the insurance company of €1.1–2.6 million, i.e. an economic benefit of at least 100% could be achieved, in case MRM was performed under high quality conditions (i.e. high specificity through reader experience) in dense breasts (see table 5).
BIRADS guidelines as the specificity of MRM is considered to be extremely variable, depending on reader experience and acquisition technique. Big studies like this Dutch one [1] emphasize, that generalized uncoordinated use of MRM without reader experience (the application of all diagnostic signs) and technical standards, MRM led to twice as many additional follow-up exams with various diagnostic modalities and three times as many biopsies than X-Ray mammography, resulting in tremendous amounts of lost profit. The estimated figures in the economic evaluation of this study represent the standard costs of our European University hospital. All hospitals or healthcare systems have individually listed costs and numbers, which is why these figures may vary, depending on country and local conditions. However, the overall findings should not be affected dramatically. In the future costs for therapeutic measures (surgery and chemotherapy) are likely to increase, while the costs for MRM will supposedly rather decrease, intensifying the tendency to increase savings by reducing costs, resulting in further increased profits. Increasing progress, sensitivity and specificity in ultrasound or X-Ray, especially the use of highly sophisticated tomosynthesis might result beneficiary towards the conventional techniques. However, previous data so far [2,3] suggest, that in case X-Ray mammography, Ultrasound and MRM had been used, the additional benefit from X-Ray or Ultrasound did not result in any additional medical benefit i.e. no additional invasive cancer could be detected. Our study concludes, that MRM might economically be the most cost-effective diagnostic tool in patients with dense breasts. However, an immediate recommendation for MRM in dense breasts has to carefully be proposed. Variable specificity of MRM across the world, due to variable diagnostic experience (consideration and application of all signs) of readers as well as missing standards in technique and diagnostics seems to represent the most important hurdle. This is why the MRM indication “dense breasts” might still be premature demand today. It rather seems, that intensive teaching and training is more important in the present state, than an immediate expansion of MR indications in the direction of dense breasts. However, to our knowledge, this study is the first to prove the conditional outstanding cost-effectiveness of MRM in dense breasts. Further studies in an effort to confirm this data in a multicentric setting are nevertheless necessary. 5. Conclusion
Table 5 Costs and savings in MRM of “dense” breasts Amount (€) Costs
1.53 million
Savings
~2.65–4.15 million
Profit
~1.1–2.6 million
Despite higher operational costs of MR-examinations in comparison to X-Ray and Ultrasound, there is substantial strategic, long-term overall cost saving, in case “MRM-only” is performed. This is owed to the high sensitivity and high NPV of 100%, as well as a relatively high specificity of 95%. 6. Clinical relevance
4. Discussion The overall strategic cost reduction through the economic evaluation of long-term effects can be considered severe (profit of a minimum of 100%), despite the actual higher operative costs of MRM in contrast to a diagnostic scenario, including only X-Ray and Ultrasound. In our study we had no false negative cases, due to the high sensitivity and negative predictive value of locally performed accuracy of MRM. Reader experience (the maximization of specificity, i.e. the minimization of false negatives through the inclusion and application of all morphologic and kinetic signs like e.g. intact ligament sign, destroyed ligament sign, blooming sign, perifocal edema, drapery sign, etc.) as a prerequisite of this study has not yet been included into the
The economic aspects of an addition of “dense breasts” to standard MRM indications have not yet been evaluated. Our study shows the economic value and monetary benefits for insurance companies by analyzing cost reduction through the alteration of diagnostics and treatment. Competing interests: The authors have no conflict of interest to declare. References 1. Kriege M, Brekelmans CT, Boetes C, et al. Efficacy of MRI and mammography for breast-cancer screening in women with a familial or genetic predisposition. N Eng J Med 2004;351(5):427–37.
C.G. Kaiser et al. / European Journal of Radiology 81S1 (2012) S69–S71 2. Kuhl C, Weigel S, Schrading S, et al. Prospective multicenter cohort study to refine management recommendations for women at elevated familial risk of breast cancer: the EVA trial. J Clin Oncol 2010;28(9):1450–7. 3. Sardanelli F, Podo F, Santoro F, et al. Multicenter surveillance of women at high
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genetic breast cancer risk using mammography, ultrasonography, and contrastenhanced magnetic resonance imaging (the high breast cancer risk Italian 1 study): final results. Invest Radiol 2011 Feb;46(2):94–105.