Gesundheitsökonomische Evaluation der Magnetresonanzbildgebung im Staging von Prostatakarzinomen für Österreich und Deutschland

Zusammenfassung

Ziel: Ziel dieser Studie war eine gesundheitsökonomische Analyse der Anwendung der MR-Bildgebung (MRT) im präoperativen Staging des Prostatakarzinoms (PCa).

Material und Methoden: Die gesundheitsökonomische Analyse umfasste folgende Schritte: Erstellung des entscheidungsanalytischen Modells, Bestimmung von Wahrscheinlichkeiten und Parametern basierend auf einer detaillierten Literaturrecherche, Evaluierung des Modells mit den Mittelwerten der Parameter und Sensitivitätsanalysen der Ergebnisse über die entsprechenden Wertebereiche. Es wurde eine Kosten-Nutzwert-Analyse aus Sicht der Krankenkassen für Österreich und Deutschland durchgeführt. Die Zielpopulation waren Patienten mit gesichertem PCa, die Handlungsalternativen waren die Therapiewahl ohne bzw. mit Staging mittels MRT. Therapieoptionen waren eine Prostatektomie bei lokal begrenztem PCa und eine Strahlen-/Hormontherapie bei lokalfortgeschrittenem PCa. Die Ergebnisparameter waren Quality Adjusted Life Years (QALYs) und Kosten pro Patient.

Ergebnisse: Die Evaluierung zeigte, dass die Durchführung einer MRT vor einer relativ teuren und folgenschweren Therapiemaßnahme wie der radikalen Prostatektomie aus Sicht des Kostenträgers sowohl hinsichtlich der Kosten wie auch der Nutzwerte sinnvoll ist. Die Kosten pro Patient waren um € 2635 niedriger, die Nutzwerte um 0,099 QALYs höher. Die Strategie ohne MRT war nicht nur bei der Evaluation mit den Basiswerten, sondern auch bei fast allen Sensitivitätsanalysen hinsichtlich der Kosten wie auch der Nutzwerte der Strategie eines vorherigen Stagings mit MRT unterlegen.

Schlussfolgerung: Unser entscheidungsanalytisches Modell hat für die gewählten Rahmenbedingungen und fast alle Szenarien innerhalb der Sensitivitätsanalyse ein besseres Kosten-Nutzwert-Verhältnis für die Strategie mit MRT zum Staging des PCas aufgezeigt.

Abstract

Purpose: The aim of this study was the health economics analysis of MR imaging in the preoperative staging of patients with prostate carcinoma (PCa).

Materials and Methods: The health economics analysis consisted of the following steps: modeling, determination of probabilities and parameters based on a detailed literature search, evaluation using the averages of the parameters, and sensitivity analyses of the results over the ranges of values. We performed a cost-utility analysis from health insurance’s perspective for Austria and Germany. The population under investigation included patients with confirmed PCa. The alternative was a decision for therapy with or without staging using MR imaging. A localized PCa was treated by prostatectomy and locally advanced PCa by radiation/hormone therapy. The result parameters were quality adjusted life years (QALYs) and costs per patient.

Results: The evaluation showed that MR imaging is useful regarding costs and utilities prior to radical prostatectomy which is expensive and may be associated with serious clinical consequences. The costs per patient were lower by € 2635 and the utilities were higher by 0.099 QALYs. The strategy without MR imaging for staging was dominated by the strategy using MR imaging for staging in the evaluation using the base values and in almost all sensitivity analyses.

Conclusion: For the parameters used and almost all scenarios of the sensitivity analysis, our decision-analytic model revealed a higher cost-utility ratio for the strategy using MR imaging for the staging of PCa.

Key words

prostate - cost-effectiveness - health policy and practice

• Literatur

• 1 Robert Koch-Institut, Gesellschaft der epidemiologischen Krebsregister in Deutschland. Krebs in Deutschland 2005/2006. Häufigkeiten und Trends. Berlin: Robert Koch-Institut (RKI) und Gesellschaft der epidemiologischen Krebsregister in Deutschland e. V; 2010
• 2 Statistik Austria. Krebsinzidenz und Krebsmortalität in Österreich. Wien: Bundesanstalt Statistik Österreich; 2010
• 3 Statistisches Bundesamt Deutschland. Statistisches Jahrbuch 2010. Wiesbaden: Statistisches Bundesamt Deutschland; 2010
• 4 Statistisches Bundesamt Deutschland. Gesundheit: Todesursachen in Deutschland. Wiesbaden: Statistisches Bundesamt Deutschland; 2010
• 5 Deutsche Gesellschaft für Urologie. Interdisziplinäre Leitlinie der Qualität S3 zur Früherkennung, Diagnose und Therapie der verschiedenen Stadien des Prostatakarzinoms. Düsseldorf: Deutsche Gesellschaft für Urologie (e. V.); 2009
• 6 Briganti A, Chun FK, Salonia A et al. Validation of a nomogram predicting the probability of lymph node invasion based on the extent of pelvic lymphadenectomy in patients with clinically localized prostate cancer. BJU Int 2006; 98: 788-793
• 7 Humphrey PA. Gleason grading and prognostic factors in carcinoma of the prostate. Mod Pathol 2004; 17: 292-306
• 8 Cookson MS, Fleshner NE, Soloway SM et al. Correlation between Gleason score of needle biopsy and radical prostatectomy specimen: accuracy and clinical implications. J Urol 1997; 157: 559-562
• 9 Shen BY, Tsui KH, Chang PL et al. Correlation between the Gleason scores of needle biopsies and radical prostatectomy specimens. Chang Gung Med J 2003; 26: 919-924
• 10 Chun FK, Karakiewicz PI, Huland H et al. Role of nomograms for prostate cancer in 2007. World J Urol 2007; 25: 131-142
• 11 King CR, Long JP. Prostate biopsy grading errors: a sampling problem?. Int J Cancer 2000; 90: 326-330
• 12 Steinberg DM, Sauvageot J, Piantadosi S et al. Correlation of prostate needle biopsy and radical prostatectomy Gleason grade in academic and community settings. Am J Surg Pathol 1997; 21: 566-576
• 13 Ahmed HU, Kirkham A, Arya M et al. Is it time to consider a role for MRI before prostate biopsy?. Nat Rev Clin Oncol 2009; 6: 197-206
• 14 Wang L, Hricak H, Kattan MW et al. Prediction of organ-confined prostate cancer: incremental value of MR imaging and MR spectroscopic imaging to staging nomograms. Radiology 2006; 238: 597-603
• 15 Wang L, Hricak H, Kattan MW et al. Prediction of seminal vesicle invasion in prostate cancer: incremental value of adding endorectal MR imaging to the Kattan nomogram. Radiology 2007; 242: 182-188
• 16 Siebert U. Entscheidungsanalytische Modelle zur Sicherung der Übertragbarkeit internationaler Evidenz von HTA auf den Kontext des deutschen Gesundheitssystems. Berlin: Deutsche Argentur für Health Technology Assessment des Deutschen Instituts für Medizinische Dokumentation und Information; 2005
• 17 Menn P, Holle R. Comparing three software tools for implementing markov models for health economic evaluations. Pharmacoeconomics 2009; 27: 745-753
• 18 Philips Z, Ginnelly L, Sculpher M et al. Review of guidelines for good practice in decision-analytic modelling in health technology assessment. Health Technol Assess 2004; 8: 1-158
• 19 Heidenreich A, Aus G, Bolla M et al. EAU guidelines on prostate cancer. Eur Urol 2008; 53: 68-80
• 20 Foley CL, Feneley MR. The clinical significance and therapeutic implications of extraprostatic invasion. Surg Oncol 2009; 18: 203-212
• 21 Prezioso D, Galasso R, Di Martino M et al. Role of surgery in treatment of locally advanced prostate cancer. Anticancer Res 2006; 26: 3151-3158
• 22 Reitsma JB, Glas AS, Rutjes AW et al. Bivariate analysis of sensitivity and specificity produces informative summary measures in diagnostic reviews. J Clin Epidemiol 2005; 58: 982-990
• 23 Beemsterboer PM, de Koning HJ, Birnie E et al. Advanced prostate cancer: course, care, and cost implications. Prostate 1999; 40: 97-104
• 24 Burkhardt JH, Litwin MS, Rose CM et al. Comparing the costs of radiation therapy and radical prostatectomy for the initial treatment of early-stage prostate cancer. J Clin Oncol 2002; 20: 2869-2875
• 25 Heuzenroeder L, Donnelly M, Haby MM et al. Cost-effectiveness of psychological and pharmacological interventions for generalized anxiety disorder and panic disorder. Aust N Z J Psychiatry 2004; 38: 602-612
• 26 Langa KM, Fultz NH, Saint S et al. Informal caregiving time and costs for urinary incontinence in older individuals in the United States. J Am Geriatr Soc 2002; 50: 733-737
• 27 Neumann PB, Grimmer KA, Grant RE et al. The costs and benefits of physiotherapy as first-line treatment for female stress urinary incontinence. Aust N Z J Public Health 2005; 29: 416-421
• 28 Glick HA, Briggs AH, Polsky D. Quantifying stochastic uncertainty and presenting results of cost-effectiveness analyses. Expert Rev Pharmacoecon Outcomes Res 2001; 1: 25-36
• 29 Laska EM, Meisner M, Siegel C et al. Statistical determination of cost-effectiveness frontier based on net health benefits. Health Econ 2002; 11: 249-264
• 30 Stinnett AA, Mullahy J. Net health benefits: a new framework for the analysis of uncertainty in cost-effectiveness analysis. Med Decis Making 1998; 18: 68-80
• 31 Akin O, Sala E, Moskowitz CS et al. Transition zone prostate cancers: features, detection, localization, and staging at endorectal MR imaging. Radiology 2006; 239: 784-792
• 32 Beyersdorff D, Darsow U, Stephan C et al. MRI of prostate cancer using three different coil systems: image quality, tumor detection, and staging. Fortschr Röntgenstr 2003; 175: 799-805
• 33 Beyersdorff D, Taymoorian K, Knosel T et al. MRI of prostate cancer at 1.5 and 3.0 T: comparison of image quality in tumor detection and staging. Am J Roentgenol 2005; 185: 1214-1220
• 34 Bloch BN, Furman-Haran E, Helbich TH et al. Prostate cancer: accurate determination of extracapsular extension with high-spatial-resolution dynamic contrast-enhanced and T2-weighted MR imaging – initial results. Radiology 2007; 245: 176-185
• 35 Cornud F, Flam T, Chauveinc L et al. Extraprostatic spread of clinically localized prostate cancer: factors predictive of pT3 tumor and of positive endorectal MR imaging examination results. Radiology 2002; 224: 203-210
• 36 Futterer JJ, Engelbrecht MR, Jager GJ et al. Prostate cancer: comparison of local staging accuracy of pelvic phased-array coil alone versus integrated endorectal-pelvic phased-array coils. Local staging accuracy of prostate cancer using endorectal coil MR imaging. Eur Radiol 2007; 17: 1055-1065
• 37 Futterer JJ, Engelbrecht MR, Huisman HJ et al. Staging prostate cancer with dynamic contrast-enhanced endorectal MR imaging prior to radical prostatectomy: experienced versus less experienced readers. Radiology 2005; 237: 541-549
• 38 Graser A, Heuck A, Sommer B et al. Per-sextant localization and staging of prostate cancer: correlation of imaging findings with whole-mount step section histopathology. Am J Roentgenol 2007; 188: 84-90
• 39 Heijmink SW, Futterer JJ, Hambrock T et al. Prostate cancer: body-array versus endorectal coil MR imaging at 3 T – comparison of image quality, localization, and staging performance. Radiology 2007; 244: 184-195
• 40 Yoshizako T, Wada A, Hayashi T et al. Usefulness of diffusion-weighted imaging and dynamic contrast-enhanced magnetic resonance imaging in the diagnosis of prostate transition-zone cancer. Acta Radiol 2008; 49: 1207-1213
• 41 Wetter A, Engl TA, Nadjmabadi D et al. Combined MRI and MR spectroscopy of the prostate before radical prostatectomy. Am J Roentgenol 2006; 187: 724-730
• 42 Futterer JJ, Scheenen TW, Heijmink SW et al. Standardized threshold approach using three-dimensional proton magnetic resonance spectroscopic imaging in prostate cancer localization of the entire prostate. Invest Radiol 2007; 42: 116-122
• 43 Ogura K, Maekawa S, Okubo K et al. Dynamic endorectal magnetic resonance imaging for local staging and detection of neurovascular bundle involvement of prostate cancer: correlation with histopathologic results. Urology 2001; 57: 721-726
• 44 Pegios W, Bentas W, Wittmann L et al. Kernspintomographisches Staging des Prostatakarzinoms mittels kombinierter Endorektal-Body-Phased-Array-Spule und histopathologische Korrelation. Fortschr Röntgenstr 2003; 175: 1660-1666
• 45 Turkbey B, Pinto PA, Mani H et al. Prostate cancer: value of multiparametric MR imaging at 3 T for detection – histopathologic correlation. Radiology 2010; 255: 89-99
• 46 Wang L, Mullerad M, Chen HN et al. Prostate cancer: incremental value of endorectal MR imaging findings for prediction of extracapsular extension. Radiology 2004; 232: 133-139
• 47 Divrik RT, Eroglu A, Sahin A et al. Increasing the number of biopsies increases the concordance of Gleason scores of needle biopsies and prostatectomy specimens. Urol Oncol 2007; 25: 376-382
• 48 Loughlin KR, Prasad MM. Post-prostatectomy urinary incontinence: a confluence of 3 factors. J Urol 2010; 183: 871-877
• 49 Magheli A, Burnett AL. Erectile dysfunction following prostatectomy: prevention and treatment. Nat Rev Urol 2009; 6: 415-427
• 50 Pow-Sang JM, Velasquez J, Myers MD et al. Pure laparoscopic and robotic-assisted laparoscopic radical prostatectomy in the management of prostate cancer. Cancer Control 2007; 14: 250-257
• 51 Wilt TJ, MacDonald R, Rutks I et al. Systematic review: comparative effectiveness and harms of treatments for clinically localized prostate cancer. Ann Intern Med 2008; 148: 435-448
• 52 Hollenbeck BK, Dunn RL, Wei JT et al. Determinants of long-term sexual health outcome after radical prostatectomy measured by a validated instrument. J Urol 2003; 169: 1453-1457
• 53 Hu JC, Gu X, Lipsitz SR et al. Comparative effectiveness of minimally invasive vs open radical prostatectomy. Jama 2009; 302: 1557-1564
• 54 Kundu SD, Roehl KA, Eggener SE et al. Potency, continence and complications in 3,477 consecutive radical retropubic prostatectomies. J Urol 2004; 172: 2227-2231
• 55 Penson DF, McLerran D, Feng Z et al. 5-year urinary and sexual outcomes after radical prostatectomy: results from the Prostate Cancer Outcomes Study. J Urol 2008; 179: 40-S44
• 56 Touijer K, Eastham JA, Secin FP et al. Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005. J Urol 2008; 179: 1811-1817
• 57 Dillioglugil O, Leibman BD, Leibman NS et al. Risk factors for complications and morbidity after radical retropubic prostatectomy. J Urol 1997; 157: 1760-1767
• 58 Hargreave TB, Heynes CF, Kendrick SW et al. Mortality after transurethral and open prostatectomy in Scotland. Br J Urol 1996; 77: 547-553
• 59 Thorpe AC, Cleary R, Coles J et al. Deaths and complications following prostatectomy in 1400 men in the northern region of England. Northern Regional Prostate Audit Group. Br J Urol 1994; 74: 559-565
• 60 Wolf AM, Wender RC, Etzioni RB et al. American Cancer Society guideline for the early detection of prostate cancer: update 2010. CA Cancer J Clin 2010; 60: 70-98
• 61 Grills IS, Martinez AA, Hollander M et al. High dose rate brachytherapy as prostate cancer monotherapy reduces toxicity compared to low dose rate palladium seeds. J Urol 2004; 171: 1098-1104
• 62 Talcott JA, Manola J, Clark JA et al. Time course and predictors of symptoms after primary prostate cancer therapy. J Clin Oncol 2003; 21: 3979-3986
• 63 Vargas C, Ghilezan M, Hollander M et al. A new model using number of needles and androgen deprivation to predict chronic urinary toxicity for high or low dose rate prostate brachytherapy. J Urol 2005; 174: 882-887
• 64 Statistisches Bundesamt Deutschland. Lebenserwartung in Deutschland: Durchschnittliche und fernere Lebenserwartung nach ausgewählten Altersstufen. Wiesbaden: Statistisches Bundesamt Deutschland; 2008
• 65 Cowen ME, Halasyamani LK, Kattan MW. Predicting life expectancy in men with clinically localized prostate cancer. J Urol 2006; 175: 99-103
• 66 Tewari A, Johnson CC, Divine G et al. Long-term survival probability in men with clinically localized prostate cancer: a case-control, propensity modeling study stratified by race, age, treatment and comorbidities. J Urol 2004; 171: 1513-1519
• 67 Walz J, Gallina A, Saad F et al. A nomogram predicting 10-year life expectancy in candidates for radical prostatectomy or radiotherapy for prostate cancer. J Clin Oncol 2007; 25: 3576-3581
• 68 Kim HL, Puymon MR, Qin M et al. A method for using life tables to estimate lifetime risk for prostate cancer death. J Natl Compr Canc Netw 2010; 8: 148-154
• 69 Dale W, Basu A, Elstein A et al. Predicting utility ratings for joint health States from single health States in prostate cancer: empirical testing of 3 alternative theories. Med Decis Making 2008; 28: 102-112
• 70 Stewart ST, Lenert L, Bhatnagar V et al. Utilities for prostate cancer health states in men aged 60 and older. Med Care 2005; 43: 347-355
• 71 Smith DS, Krygiel J, Nease Jr RF et al. Patient preferences for outcomes associated with surgical management of prostate cancer. J Urol 2002; 167: 2117-2122
• 72 Wetter A, Ajdukovic AN, Fliessbach K et al. Staging des Prostatakarzinoms:Wertigkeit der kombinierten Information aus endorektaler MRT, bioptischem Gleason Score und präoperativem PSA-Wert. Fortschr Röntgenstr 2006; 178: 385-390
• 73 Engelbrecht MR, Jager GJ, Laheij RJ et al. Local staging of prostate cancer using magnetic resonance imaging: a meta-analysis. Eur Radiol 2002; 12: 2294-2302
• 74 Engelbrecht MR, Jager GJ, Severens JL. Patient selection for magnetic resonance imaging of prostate cancer. Eur Urol 2001; 40: 300-307
• 75 Jager GJ, Severens JL, Thornbury JR et al. Prostate cancer staging: should MR imaging be used? A decision analytic approach. Radiology 2000; 215: 445-451
• 76 Villers A, Lemaitre L, Haffner J et al. Current status of MRI for the diagnosis, staging and prognosis of prostate cancer: implications for focal therapy and active surveillance. Curr Opin Urol 2009; 19: 274-282
• 77 Huppertz A, Schmidt M, Wagner M et al. Whole-body MR imaging versus sequential multimodal diagnostic algorithm for staging patients with rectal cancer: cost analysis. Fortschr Röntgenstr 2010; 182: 793-802