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Economic aspects of bladder cancer: what are the benefits and costs?

Economic aspects of bladder cancer: what are the benefits and costs? World J Urol (2009) 27:295–300 DOI 10.1007/s00345-009-0395-z TOPI C PAPER Economic aspects of bladder cancer: what are the beneWts and costs? K. D. Sievert · B. Amend · U. Nagele · D. Schilling · J. Bedke · M. Horstmann · J. Hennenlotter · S. Kruck · A. Stenzl Received: 2 February 2009 / Accepted: 5 February 2009 / Published online: 7 March 2009 © The Author(s) 2009. This article is published with open access at Springerlink.com Abstract regimes (intravesical chemotherapy, adjuvant immunother- Objective Bladder cancer (BC) has the highest lifetime apy) have signiWcant potential to improve the diagnosis, treatment costs per patient of all cancers. The high recur- treatment and on-going monitoring of BC patients, with rence rate and ongoing invasive monitoring requirement are potential improvements in clinical outcomes and concur- the key contributors to the economic and human toll of this rent cost-savings. A renewed interest and investment in BC disease. The purpose of this paper was to utilize the recent research are required to ensure future advancements. literature to identify opportunities for improving the bene- Wts and costs of BC care. Keywords Bladder cancer · Diagnosis and treatment · Methods A PubMed search was performed of recent pub- Fluorescence cystoscopy · Imaging technology · Economic lications concerning (BC) cost-eVectiveness. We reviewed and cost considerations · Intravesical chemotherapy · studies, reviews, opinion papers and cost-eVectiveness TURB · PDD · NIMBC · Hexvix analyses, focusing primarily on non-muscle-invasive blad- der cancer (Ta/T1; NMIBC). Results New diagnostic tools such as urine markers may Background and objective assist in more cost-eVectively detecting BC at an earlier stage, however, these markers cannot replace the cystos- Bladder cancer (BC) has the highest lifetime treatment copy, which is the current standard of care. A photody- costs per patient (pp) of all cancers, followed by colorectal, namic diagnostic tool (PDD) using hexylaminolevulinate breast, prostate, and lung cancer [1]; costs have increased (Hexvix ) enhances tumor visibility and improves transure- steadily since 1996 [2]. Worldwide, 336,000 patients were thral resection of bladder cancer (TURB) results, poten- diagnosed with BC in 2000 [2]. The American Cancer tially reducing recurrence rates and lowering treatment Society estimated 50,040 incident cases for 2007 [3], and costs. While the importance of BC research has been treatment costs for non-muscle invasive bladder cancer acknowledged, research investment has been continuously (NMIBC) in the United States (US) are estimated at reduced during the last 5 years. $157.5 M over 5 years [4]. Although most patients present Conclusions The economic burden of BC is well-charac- with NMIBC (70% (78% females; 64% males)), the high terized in the literature. This study suggests that new tech- rate of recurrence and disease progression necessitates nologies (i.e., urine-based tests, PDD) and therapeutic vigilant long-term monitoring for BC patients. The enormous human, psychological and economic bur- den of BC underscores the importance of optimizing diag- nosis and treatment protocols. However, relevant data are K. D. Sievert (&) · B. Amend · U. Nagele · D. Schilling · sparse, making it diYcult to adequately assess cost beneWt J. Bedke · M. Horstmann · J. Hennenlotter · S. Kruck · A. Stenzl for current standards of BC care. The purpose of this paper Department for Urology, University of Tuebingen, was to use the available BC data to identify potential oppor- Hoppe-Seyler-Str. 3, 72076 Tüebingen, Germany tunities for improving the overall cost beneWt proWle of BC e-mail: Karl.Sievert@med.uni-tuebingen.de; kd_sievert@hotmail.com care. 123 296 World J Urol (2009) 27:295–300 Methods identify incident or recurrent tumors earlier [8]; (2) use of outpatient facilities for TURB reducing hospitalizations if A PubMed search was performed on literature published surgical risks can be minimized [8]; (3) improve eYcacy of between 2003 and 2008 using MeSH terms: cost-eVective- intravesical treatments. Finally, but not yet proven, is the ness, screening, tumor markers, photodynamic diagnostic use of photodynamic diagnosis (PDD), instead of conven- (PDD), transurethral resection of the bladder (TURB) and tional white-light cystoscopy, to improve initial TURB BC. The search included prospective and retrospective eYcacy and potentially reduce NIMBC’s residual risk [11]. studies, reviews, opinion papers, and cost eVective analyses as well as European Association of Urology (EAU) and Potential role for non-invasive diagnostic tools American Urology Association (AUA) guidelines for NMIBC and muscle invasive BC (MIBC). With an estimated 4% incidence in a healthy population, BC screening results in a 3.0 life-year gain per 1,000 patients, a 50% reduction in disease progression and a cost Results savings of $101,000 pp [12]. Although urine-based mark- ers, like NMP-22, seem to be cost-eVective for the high-risk Economic burden of bladder cancer population, they will not reduce cystoscopy requirements and must be tested in prospective trials to determine their Depending on the country, BC costs from diagnosis-to-death value in the general population. The estimated cost per range between $89,287 and $202,203 pp [5] and will likely diagnosis (i.e., direct cost divided by observed sensitivity) increase as survival rates increase. In the US, 2006 total can- for NMP-22 is ($39.82), cytology ($54.96), cystoscopy cer costs were estimated at $206.3B with estimated productiv- ($430.14), and CT urogram ($989.06). Cystoscopy was ity losses of $17.9B for cancer-related morbidity and $110.2B more sensitive than the other modalities in diagnosing BC for cancer-related mortality [3]. On average, 12 years of (P < 0.05), although the combination of cystoscopy with income-producing life are lost with each premature death [6]. other tests yielded no statistically signiWcant improvements Among cancers in the US, BC has the highest pp treatment in sensitivity [13]. costs, and the 5th highest overall cost [5], estimated at $3.4B annually with $2.9B in direct treatment-related costs, and Potential to improve clinical outcomes and cost of care indirect costs of $184,762 to $461,907 pp [7]. The United Kingdom (UK) reported a 2001–2002 total After hematuria, positive cytology or positive urine-based NMIBC and MIBC costs of £55.39 M ($82,395 M) or markers, a diagnostic cystoscopy is performed, followed by £8,349 pp ($12,409), of which 60% was spent managing TURB if needed. The average annualized rate of TURB in NMIBC [8]. This cost diVerential likely stems from the US Medicare patients with a BC diagnosis is 51% and is higher incidence, recurrence, and survival rates of NMIBC generally consistent across genders, geographic regions, [8]. NMIBC has an average 60–80% recurrence rate, of and racial and ethnic groups. The annualized TURB rate which 40–60% recurs within 2 years, with 10–30% of the varies by age, ranging from 46% among 65–69-year-olds to patients progressing to MIBC which requires more invasive 60% among 90–94 year old beneWciaries [14]. and costly treatment [9]. Monitoring, which is essential given TURB represents, by far, the largest BC expenditure, the high BC recurrence rates, generates signiWcant on-going accounting for 71% of treatment costs in the UK [8]. costs. About 75% of the post-diagnosis costs relate to Table 1 shows TURB costs in Europe, ranging from D845 pre-operative and intra-operative management including ($1,124) (France) to D2,231 ($2,967) (Germany) [15]. post-surgical complications, tri-annual examinations and Costs are similar in Japan (¥281,600 ($2,428)) but higher in semi-annual diagnostic and laboratory testing [10]. the US $5,305 (D3,453) [16]. Several strategies for reducing BC’s economic burden The quality and result of the initial TURB strongly deter- have been proposed: (1) use of urine-based markers to mines the patient’s prognosis and overall BC treatment costs. Table 1 Average European BC treatment reimbursement (procedure and hospital stay inclusive) UK in £ ($) Germany in D ($) France in D ($) Italy in D ($) Belgium in D ($) Cystoscopy 422 (620) 46 (61) 38 (51) 57 (76) 40 (53) TURB 1,465 (2,154) 2,231 (2,967) 845 (1,124) 2,061 (2,741) 1,655 (2,201) Cystectomy 3,867 (5,684) 15,419 (20,507) 9,697 (12,897) 7,222 (9,605) 10,932 (14,540) The bolded amounts highlight the lowest and highest reimbursement $ The exchange rate was calculated on the basis of 1Euro = 1.33 US$ and 1£ = 1.47US$ 123 World J Urol (2009) 27:295–300 297 Table 2 TURB cost calculation: comparison of conventional TURB versus PDD assisted TURB based on a diagnose related group in a German Hospital Cost parameter Conventional TURB in D ($) PDD assisted TURB in D ($) DiVerence in (§) D ($) Preop.catheter 0,00 (0,00) 23,00 (30,59) +23,00 (+30,59) Hexvix 0,00 (0,00) 412,50 (548,62) +412,50 (+548,62) Equipment/10 years 7,10 (9,44) 10,70 (14,23) +3,60 (+4,78) Bladder TURB 900,00 (1197,00) 900,00 (1197,00) 0,00 (0,00) Histology tumor 40,63 (54,03) 40,63 (54,03) 0,00 (0,00) Histo 4 corner Bx 121,38 (161,44) 0,00 (0,00) ¡121,38 (¡161,44) 20% chance of 2nd TURB 458,00 (609,14) 0,00 (0,00) ¡458,00 (¡609,14) after 3/6 mos. (DRG) Total/TURB 1527,11 (2031,06) 1386,83 (1844,48) ¡140,28 (¡168,57) DRG Diagnosis related group Hardware equipment cost calculated for an individual TURB and PDD based on an estimated 300 TURBs/year over 10 years TURB cost (includes average time of surgeon, anethesiologist, nurse/technician, equipment cost) Pathologist cost for four random biopsies The chance of a re-TURB in relation to the published results of D’Hallewin et al. [40] and Daniltchenko et al. [18] Source University of Tuebingen, Department of Urology $ The exchange rate was calculated on the basis 1Euro = 1.33 US$ Photodynamic diagnosis The statistically signiWcant advantage of decreased BC recurrence after PDD has been reported to persist for at Photodynamic diagnosis (PDD) is an emerging technology least 8 years [21]. Hedelin et al. concluded that if PDD with signiWcant potential for improving the eVectiveness of were used in high-risk patients (15% of all newly diagnosed TURB. PDD was introduced using 5-aminolevulinic acid BC patients estimated at 1720 new cases of BC per year in (5-ALA). Since 2005, hexylaminolevulinate (HAL or Sweden alone), it could save D500 K ($665 K) in the Wrst HEXVIX ) has been approved in 27 European countries year alone. If PDD were used for all TURBs in high and and recommended in EAU NIMBC Guidelines [17–20]. medium risk patients, the Wrst year savings would be Hexylaminolevulinate induces protoporphyrin IX (PpIX) D405,000 ($536,650) and D363,000 ($482,790), respec- production in the bladder where the increased PpIX build- tively [24]. A recent German study also revealed that PDD up better illustrates precancerous and cancerous lesions. signiWcantly reduced costs related to recurring NMIBC When performing a PDD blue light cystoscopy, PpIX Xuo- [19]. rescence is produced by excitation with blue light resulting in a red-to-purple Xuorescence. Intravesical chemotherapy and adjuvant immunotherapy PDD supports a more complete resection [11] and has been reported as improving oncological patient outcome, Depending on tumor stage, the EAU guidelines recommend reducing recurrence rates by approximately 20 and pro- intravesical chemotherapy or adjuvant immunotherapy fol- longing recurrence-free survival [21]. The learning curve lowing TURB. Two primary drugs are currently used: for PDD TURB resulting in a more complete tumor resec- alkylating agents like mitomycin (MMC) and diVerent tion can be shortended by utilizing the virtual TURB train- strains of Bacillus Calmette-Guerin (BCG) [17]. ing system (Karl Storz Tuttlingen, Germany) [22]. MMC is generally considered the Wrst-line agent for The experience of the author’s department (Table 2) low-risk tumors and can be administered immediately after illustrates Daniltchenko et al.’s hypothesis that the initial TURB, however, this practice is considered “unlabelled” in PDD costs can be oVset by fewer TURB follow-ups [18]. In the US and some other countries [5]. In patients with inter- a separate prospective series of 115 patients (void of adju- mediate and high-risk BC tumors, a single administered vant treatment), recurrence rates after 60 months were 59% shot of intravesical chemotherapy should be followed by after PDD and 75% following white-light cystoscopy. The additional instillations or BCG [17]. MMC after TURB has researchers in that study estimated that, in using PDD, they reduced recurrence by as much as 50% compared with have avoided at least 20 additional TURBs over a 5-year transurethral resection alone [25]. follow-up, clearly demonstrating that the beneWts associ- Tolley et al. [26] reported a statistically signiWcant ated with PDD outweigh the costs [23]. decrease in the tumor recurrence in NMIBC patients treated 123 298 World J Urol (2009) 27:295–300 with MMC within a 24-h period following TURB com- related complications contributed $249, $384, and $775 to pared to those who did not receive instillation. If the instil- the monthly patient costs with stage Tis/Ta, T1, and MIBC, lation was performed the following day, the relative risk of respectively. Systemic-related complications (SRCs) added tumor recurrence was estimated to be doubled [27]. Bohle monthly costs averaging $500 in 21% of the patients with et al. [28] conducted a meta-analysis comparing 1328 NMIBC and $700 in 40% of MIBC patients. The mean, NMIBC patients treated with adjuvant-MMC versus 1421 annual post-diagnosis continuing care costs pp were esti- patients treated with BCG. Without a clear separation mated at $4,975, $7,100 and $17,437 for those with Tis/Ta, between intermediate and high-risk patients, the overall T1 and MIBC [33]. The US Medicare annual cost for recurrence rate was 46.4% for MMC and 38.6% for BCG continuing care for the 3634 NMIBC patients and 2083 after a 26-month mean follow-up. MMC demonstrated with MIBC totaled $21 million and nearly $36 million, fewer side eVects. Comparable beneWcial eVects have been respectively. During the preceding 4 months, BC-related demonstrated for MMC, epirubicin, and doxorubicin [25]. care added an estimated $4.7 million to each total [33]. BCG is generally reserved for high-risk tumors and Wrst- Konety et al. reported median total charges of $53,342 line treatment for carcinoma in situ [29]. If the risk of an for patients with radical cystectomies. Medical complica- adverse reaction prevents the use of BCG for carcinoma in tions, which occurred in approximately 28% of patients situ, intravesical MMC may be given instead [30]. Uchida increased costs at least $15,000 [34]. The total annual et al. [16] reported the mean total BCG treatment cost was incremental medicare expenditures for MIBC patients, with ¥224,566 ($1,936)pp. Their 5-year recurrence-free patient and without adjustment for co-morbidity, were more than survival rate with and without BCG instillation therapy was twice those of NMIBC patients (2006 US $99.3 M versus 78 and 28%, respectively. Accordingly, the cost-eVective- $41.8 M, respectively) [33]. ness ratio was ¥449,132 ($3,872) over 5-year recurrence- Avritscher et al. [35] estimated the BC lifetime mean free period (60,906 ¥/year;$525/year) [16]. treatment cost at $99,270 for MIBC patients and $120,684 Kilbridge et al. [31] found that an average 65-year-old for NMIBC patients, with an annual average of 36 hospital- male with high-grade superWcial disease treated with BCG ization days for MIBC patients vs. 1.3 days per year for gains 6 months life expectancy at an incremental cost of NMIBC patients. Admissions and surgical procedures $1,660, or $3,320 per year of life saved. The incremental cost accounted for 50% of the total costs ($32,559) and surveil- eVectiveness of BCG was still better than many other lance for and treatment of tumor recurrences, accounted for accepted medical practices. Both BCG and MMC are consid- 60% ($39,393). In addition, 30% of the total cost ($19,811) ered superior to other intravesical agents (such as interferon- was attributable to treatment of complications: 26% or anthracycline antibiotic-related chemotherapy) for reducing ($16,934) for MIBC and 4% ($2,312) for NMIBC. recurrences; however, it is unclear if any intravesical therapy Progression from NMIBC to MIBC clearly increases ultimately aVects the rate of progression to MIBC [32]. overall treatment costs. Early detection of incident and Bottemann et al. [5] estimated the cost-beneWt ratio in recurrent disease plays a key role in reducing the risk of 100 new NMIBC patients treated with adjuvant intravesical disease progression, as do emerging technologies, such as chemotherapy; 20 would be tumor-free at 3 months and PDD, and adjuvant therapies, such as MCC and BCG. would no longer require further TURBs resulting in savings of £30,000 ($44,100). It could be expected that a lower Economic impact of cancer on patients and families recurrence risk would lead to a less intensive cystoscopic follow-up regime, resulting in further potential savings in There is another side of the enormous Wnancial burden that the Wrst year post-initial TURB of approximately £13,500 cancer exerts on patients and their families. Low-income ($19,845) (HRG estimate of cystoscopy cost £450 ($662) patients undergoing cancer treatment spent approximately resulting in 30 less cystoscopies annually). This example 27% of their annual income on out-of-pocket medical suggests a net savings of £45,500 ($66,882) per 100 new expenses [36]. Twenty-seven percent had to delay or forego NMIBC patients. treatment and 6% Wled for bankruptcy [37]. A study by The combination of PDD TURB and MMC intravesical YabroV et al. [38] showed that the estimated patient’s cost instillation might help to reduce the BC recurrence that for time spent traveling, waiting for appointments and would help to reduce the cost over the long term. receiving services or procedures during the Wrst 12 months after diagnosis was as much as $5605. Cost consequences of disease progression Bladder cancer research investment The MIBC patient treatment costs are nearly three times those for patients with stage Tis/Ta and two times for those Sangar et al. [8] commented that research funding allocation patients with TNM stage T1. On average, the bladder- in the UK for BC is not commensurate with its Wnancial 123 World J Urol (2009) 27:295–300 299 published literature. Pharmacoeconomics 21:1315–1330. burden. They estimate that BC and prostate cancer incur doi:10.2165/00019053-200321180-00003 similar annual healthcare costs pp yet research funding var- 6. 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Economic aspects of bladder cancer: what are the benefits and costs?

World Journal of Urology , Volume 27 (3) – Mar 7, 2009

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Pubmed Central
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© The Author(s) 2009
ISSN
0724-4983
eISSN
1433-8726
DOI
10.1007/s00345-009-0395-z
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World J Urol (2009) 27:295–300 DOI 10.1007/s00345-009-0395-z TOPI C PAPER Economic aspects of bladder cancer: what are the beneWts and costs? K. D. Sievert · B. Amend · U. Nagele · D. Schilling · J. Bedke · M. Horstmann · J. Hennenlotter · S. Kruck · A. Stenzl Received: 2 February 2009 / Accepted: 5 February 2009 / Published online: 7 March 2009 © The Author(s) 2009. This article is published with open access at Springerlink.com Abstract regimes (intravesical chemotherapy, adjuvant immunother- Objective Bladder cancer (BC) has the highest lifetime apy) have signiWcant potential to improve the diagnosis, treatment costs per patient of all cancers. The high recur- treatment and on-going monitoring of BC patients, with rence rate and ongoing invasive monitoring requirement are potential improvements in clinical outcomes and concur- the key contributors to the economic and human toll of this rent cost-savings. A renewed interest and investment in BC disease. The purpose of this paper was to utilize the recent research are required to ensure future advancements. literature to identify opportunities for improving the bene- Wts and costs of BC care. Keywords Bladder cancer · Diagnosis and treatment · Methods A PubMed search was performed of recent pub- Fluorescence cystoscopy · Imaging technology · Economic lications concerning (BC) cost-eVectiveness. We reviewed and cost considerations · Intravesical chemotherapy · studies, reviews, opinion papers and cost-eVectiveness TURB · PDD · NIMBC · Hexvix analyses, focusing primarily on non-muscle-invasive blad- der cancer (Ta/T1; NMIBC). Results New diagnostic tools such as urine markers may Background and objective assist in more cost-eVectively detecting BC at an earlier stage, however, these markers cannot replace the cystos- Bladder cancer (BC) has the highest lifetime treatment copy, which is the current standard of care. A photody- costs per patient (pp) of all cancers, followed by colorectal, namic diagnostic tool (PDD) using hexylaminolevulinate breast, prostate, and lung cancer [1]; costs have increased (Hexvix ) enhances tumor visibility and improves transure- steadily since 1996 [2]. Worldwide, 336,000 patients were thral resection of bladder cancer (TURB) results, poten- diagnosed with BC in 2000 [2]. The American Cancer tially reducing recurrence rates and lowering treatment Society estimated 50,040 incident cases for 2007 [3], and costs. While the importance of BC research has been treatment costs for non-muscle invasive bladder cancer acknowledged, research investment has been continuously (NMIBC) in the United States (US) are estimated at reduced during the last 5 years. $157.5 M over 5 years [4]. Although most patients present Conclusions The economic burden of BC is well-charac- with NMIBC (70% (78% females; 64% males)), the high terized in the literature. This study suggests that new tech- rate of recurrence and disease progression necessitates nologies (i.e., urine-based tests, PDD) and therapeutic vigilant long-term monitoring for BC patients. The enormous human, psychological and economic bur- den of BC underscores the importance of optimizing diag- nosis and treatment protocols. However, relevant data are K. D. Sievert (&) · B. Amend · U. Nagele · D. Schilling · sparse, making it diYcult to adequately assess cost beneWt J. Bedke · M. Horstmann · J. Hennenlotter · S. Kruck · A. Stenzl for current standards of BC care. The purpose of this paper Department for Urology, University of Tuebingen, was to use the available BC data to identify potential oppor- Hoppe-Seyler-Str. 3, 72076 Tüebingen, Germany tunities for improving the overall cost beneWt proWle of BC e-mail: Karl.Sievert@med.uni-tuebingen.de; kd_sievert@hotmail.com care. 123 296 World J Urol (2009) 27:295–300 Methods identify incident or recurrent tumors earlier [8]; (2) use of outpatient facilities for TURB reducing hospitalizations if A PubMed search was performed on literature published surgical risks can be minimized [8]; (3) improve eYcacy of between 2003 and 2008 using MeSH terms: cost-eVective- intravesical treatments. Finally, but not yet proven, is the ness, screening, tumor markers, photodynamic diagnostic use of photodynamic diagnosis (PDD), instead of conven- (PDD), transurethral resection of the bladder (TURB) and tional white-light cystoscopy, to improve initial TURB BC. The search included prospective and retrospective eYcacy and potentially reduce NIMBC’s residual risk [11]. studies, reviews, opinion papers, and cost eVective analyses as well as European Association of Urology (EAU) and Potential role for non-invasive diagnostic tools American Urology Association (AUA) guidelines for NMIBC and muscle invasive BC (MIBC). With an estimated 4% incidence in a healthy population, BC screening results in a 3.0 life-year gain per 1,000 patients, a 50% reduction in disease progression and a cost Results savings of $101,000 pp [12]. Although urine-based mark- ers, like NMP-22, seem to be cost-eVective for the high-risk Economic burden of bladder cancer population, they will not reduce cystoscopy requirements and must be tested in prospective trials to determine their Depending on the country, BC costs from diagnosis-to-death value in the general population. The estimated cost per range between $89,287 and $202,203 pp [5] and will likely diagnosis (i.e., direct cost divided by observed sensitivity) increase as survival rates increase. In the US, 2006 total can- for NMP-22 is ($39.82), cytology ($54.96), cystoscopy cer costs were estimated at $206.3B with estimated productiv- ($430.14), and CT urogram ($989.06). Cystoscopy was ity losses of $17.9B for cancer-related morbidity and $110.2B more sensitive than the other modalities in diagnosing BC for cancer-related mortality [3]. On average, 12 years of (P < 0.05), although the combination of cystoscopy with income-producing life are lost with each premature death [6]. other tests yielded no statistically signiWcant improvements Among cancers in the US, BC has the highest pp treatment in sensitivity [13]. costs, and the 5th highest overall cost [5], estimated at $3.4B annually with $2.9B in direct treatment-related costs, and Potential to improve clinical outcomes and cost of care indirect costs of $184,762 to $461,907 pp [7]. The United Kingdom (UK) reported a 2001–2002 total After hematuria, positive cytology or positive urine-based NMIBC and MIBC costs of £55.39 M ($82,395 M) or markers, a diagnostic cystoscopy is performed, followed by £8,349 pp ($12,409), of which 60% was spent managing TURB if needed. The average annualized rate of TURB in NMIBC [8]. This cost diVerential likely stems from the US Medicare patients with a BC diagnosis is 51% and is higher incidence, recurrence, and survival rates of NMIBC generally consistent across genders, geographic regions, [8]. NMIBC has an average 60–80% recurrence rate, of and racial and ethnic groups. The annualized TURB rate which 40–60% recurs within 2 years, with 10–30% of the varies by age, ranging from 46% among 65–69-year-olds to patients progressing to MIBC which requires more invasive 60% among 90–94 year old beneWciaries [14]. and costly treatment [9]. Monitoring, which is essential given TURB represents, by far, the largest BC expenditure, the high BC recurrence rates, generates signiWcant on-going accounting for 71% of treatment costs in the UK [8]. costs. About 75% of the post-diagnosis costs relate to Table 1 shows TURB costs in Europe, ranging from D845 pre-operative and intra-operative management including ($1,124) (France) to D2,231 ($2,967) (Germany) [15]. post-surgical complications, tri-annual examinations and Costs are similar in Japan (¥281,600 ($2,428)) but higher in semi-annual diagnostic and laboratory testing [10]. the US $5,305 (D3,453) [16]. Several strategies for reducing BC’s economic burden The quality and result of the initial TURB strongly deter- have been proposed: (1) use of urine-based markers to mines the patient’s prognosis and overall BC treatment costs. Table 1 Average European BC treatment reimbursement (procedure and hospital stay inclusive) UK in £ ($) Germany in D ($) France in D ($) Italy in D ($) Belgium in D ($) Cystoscopy 422 (620) 46 (61) 38 (51) 57 (76) 40 (53) TURB 1,465 (2,154) 2,231 (2,967) 845 (1,124) 2,061 (2,741) 1,655 (2,201) Cystectomy 3,867 (5,684) 15,419 (20,507) 9,697 (12,897) 7,222 (9,605) 10,932 (14,540) The bolded amounts highlight the lowest and highest reimbursement $ The exchange rate was calculated on the basis of 1Euro = 1.33 US$ and 1£ = 1.47US$ 123 World J Urol (2009) 27:295–300 297 Table 2 TURB cost calculation: comparison of conventional TURB versus PDD assisted TURB based on a diagnose related group in a German Hospital Cost parameter Conventional TURB in D ($) PDD assisted TURB in D ($) DiVerence in (§) D ($) Preop.catheter 0,00 (0,00) 23,00 (30,59) +23,00 (+30,59) Hexvix 0,00 (0,00) 412,50 (548,62) +412,50 (+548,62) Equipment/10 years 7,10 (9,44) 10,70 (14,23) +3,60 (+4,78) Bladder TURB 900,00 (1197,00) 900,00 (1197,00) 0,00 (0,00) Histology tumor 40,63 (54,03) 40,63 (54,03) 0,00 (0,00) Histo 4 corner Bx 121,38 (161,44) 0,00 (0,00) ¡121,38 (¡161,44) 20% chance of 2nd TURB 458,00 (609,14) 0,00 (0,00) ¡458,00 (¡609,14) after 3/6 mos. (DRG) Total/TURB 1527,11 (2031,06) 1386,83 (1844,48) ¡140,28 (¡168,57) DRG Diagnosis related group Hardware equipment cost calculated for an individual TURB and PDD based on an estimated 300 TURBs/year over 10 years TURB cost (includes average time of surgeon, anethesiologist, nurse/technician, equipment cost) Pathologist cost for four random biopsies The chance of a re-TURB in relation to the published results of D’Hallewin et al. [40] and Daniltchenko et al. [18] Source University of Tuebingen, Department of Urology $ The exchange rate was calculated on the basis 1Euro = 1.33 US$ Photodynamic diagnosis The statistically signiWcant advantage of decreased BC recurrence after PDD has been reported to persist for at Photodynamic diagnosis (PDD) is an emerging technology least 8 years [21]. Hedelin et al. concluded that if PDD with signiWcant potential for improving the eVectiveness of were used in high-risk patients (15% of all newly diagnosed TURB. PDD was introduced using 5-aminolevulinic acid BC patients estimated at 1720 new cases of BC per year in (5-ALA). Since 2005, hexylaminolevulinate (HAL or Sweden alone), it could save D500 K ($665 K) in the Wrst HEXVIX ) has been approved in 27 European countries year alone. If PDD were used for all TURBs in high and and recommended in EAU NIMBC Guidelines [17–20]. medium risk patients, the Wrst year savings would be Hexylaminolevulinate induces protoporphyrin IX (PpIX) D405,000 ($536,650) and D363,000 ($482,790), respec- production in the bladder where the increased PpIX build- tively [24]. A recent German study also revealed that PDD up better illustrates precancerous and cancerous lesions. signiWcantly reduced costs related to recurring NMIBC When performing a PDD blue light cystoscopy, PpIX Xuo- [19]. rescence is produced by excitation with blue light resulting in a red-to-purple Xuorescence. Intravesical chemotherapy and adjuvant immunotherapy PDD supports a more complete resection [11] and has been reported as improving oncological patient outcome, Depending on tumor stage, the EAU guidelines recommend reducing recurrence rates by approximately 20 and pro- intravesical chemotherapy or adjuvant immunotherapy fol- longing recurrence-free survival [21]. The learning curve lowing TURB. Two primary drugs are currently used: for PDD TURB resulting in a more complete tumor resec- alkylating agents like mitomycin (MMC) and diVerent tion can be shortended by utilizing the virtual TURB train- strains of Bacillus Calmette-Guerin (BCG) [17]. ing system (Karl Storz Tuttlingen, Germany) [22]. MMC is generally considered the Wrst-line agent for The experience of the author’s department (Table 2) low-risk tumors and can be administered immediately after illustrates Daniltchenko et al.’s hypothesis that the initial TURB, however, this practice is considered “unlabelled” in PDD costs can be oVset by fewer TURB follow-ups [18]. In the US and some other countries [5]. In patients with inter- a separate prospective series of 115 patients (void of adju- mediate and high-risk BC tumors, a single administered vant treatment), recurrence rates after 60 months were 59% shot of intravesical chemotherapy should be followed by after PDD and 75% following white-light cystoscopy. The additional instillations or BCG [17]. MMC after TURB has researchers in that study estimated that, in using PDD, they reduced recurrence by as much as 50% compared with have avoided at least 20 additional TURBs over a 5-year transurethral resection alone [25]. follow-up, clearly demonstrating that the beneWts associ- Tolley et al. [26] reported a statistically signiWcant ated with PDD outweigh the costs [23]. decrease in the tumor recurrence in NMIBC patients treated 123 298 World J Urol (2009) 27:295–300 with MMC within a 24-h period following TURB com- related complications contributed $249, $384, and $775 to pared to those who did not receive instillation. If the instil- the monthly patient costs with stage Tis/Ta, T1, and MIBC, lation was performed the following day, the relative risk of respectively. Systemic-related complications (SRCs) added tumor recurrence was estimated to be doubled [27]. Bohle monthly costs averaging $500 in 21% of the patients with et al. [28] conducted a meta-analysis comparing 1328 NMIBC and $700 in 40% of MIBC patients. The mean, NMIBC patients treated with adjuvant-MMC versus 1421 annual post-diagnosis continuing care costs pp were esti- patients treated with BCG. Without a clear separation mated at $4,975, $7,100 and $17,437 for those with Tis/Ta, between intermediate and high-risk patients, the overall T1 and MIBC [33]. The US Medicare annual cost for recurrence rate was 46.4% for MMC and 38.6% for BCG continuing care for the 3634 NMIBC patients and 2083 after a 26-month mean follow-up. MMC demonstrated with MIBC totaled $21 million and nearly $36 million, fewer side eVects. Comparable beneWcial eVects have been respectively. During the preceding 4 months, BC-related demonstrated for MMC, epirubicin, and doxorubicin [25]. care added an estimated $4.7 million to each total [33]. BCG is generally reserved for high-risk tumors and Wrst- Konety et al. reported median total charges of $53,342 line treatment for carcinoma in situ [29]. If the risk of an for patients with radical cystectomies. Medical complica- adverse reaction prevents the use of BCG for carcinoma in tions, which occurred in approximately 28% of patients situ, intravesical MMC may be given instead [30]. Uchida increased costs at least $15,000 [34]. The total annual et al. [16] reported the mean total BCG treatment cost was incremental medicare expenditures for MIBC patients, with ¥224,566 ($1,936)pp. Their 5-year recurrence-free patient and without adjustment for co-morbidity, were more than survival rate with and without BCG instillation therapy was twice those of NMIBC patients (2006 US $99.3 M versus 78 and 28%, respectively. Accordingly, the cost-eVective- $41.8 M, respectively) [33]. ness ratio was ¥449,132 ($3,872) over 5-year recurrence- Avritscher et al. [35] estimated the BC lifetime mean free period (60,906 ¥/year;$525/year) [16]. treatment cost at $99,270 for MIBC patients and $120,684 Kilbridge et al. [31] found that an average 65-year-old for NMIBC patients, with an annual average of 36 hospital- male with high-grade superWcial disease treated with BCG ization days for MIBC patients vs. 1.3 days per year for gains 6 months life expectancy at an incremental cost of NMIBC patients. Admissions and surgical procedures $1,660, or $3,320 per year of life saved. The incremental cost accounted for 50% of the total costs ($32,559) and surveil- eVectiveness of BCG was still better than many other lance for and treatment of tumor recurrences, accounted for accepted medical practices. Both BCG and MMC are consid- 60% ($39,393). In addition, 30% of the total cost ($19,811) ered superior to other intravesical agents (such as interferon- was attributable to treatment of complications: 26% or anthracycline antibiotic-related chemotherapy) for reducing ($16,934) for MIBC and 4% ($2,312) for NMIBC. recurrences; however, it is unclear if any intravesical therapy Progression from NMIBC to MIBC clearly increases ultimately aVects the rate of progression to MIBC [32]. overall treatment costs. Early detection of incident and Bottemann et al. [5] estimated the cost-beneWt ratio in recurrent disease plays a key role in reducing the risk of 100 new NMIBC patients treated with adjuvant intravesical disease progression, as do emerging technologies, such as chemotherapy; 20 would be tumor-free at 3 months and PDD, and adjuvant therapies, such as MCC and BCG. would no longer require further TURBs resulting in savings of £30,000 ($44,100). It could be expected that a lower Economic impact of cancer on patients and families recurrence risk would lead to a less intensive cystoscopic follow-up regime, resulting in further potential savings in There is another side of the enormous Wnancial burden that the Wrst year post-initial TURB of approximately £13,500 cancer exerts on patients and their families. Low-income ($19,845) (HRG estimate of cystoscopy cost £450 ($662) patients undergoing cancer treatment spent approximately resulting in 30 less cystoscopies annually). This example 27% of their annual income on out-of-pocket medical suggests a net savings of £45,500 ($66,882) per 100 new expenses [36]. Twenty-seven percent had to delay or forego NMIBC patients. treatment and 6% Wled for bankruptcy [37]. A study by The combination of PDD TURB and MMC intravesical YabroV et al. [38] showed that the estimated patient’s cost instillation might help to reduce the BC recurrence that for time spent traveling, waiting for appointments and would help to reduce the cost over the long term. receiving services or procedures during the Wrst 12 months after diagnosis was as much as $5605. Cost consequences of disease progression Bladder cancer research investment The MIBC patient treatment costs are nearly three times those for patients with stage Tis/Ta and two times for those Sangar et al. [8] commented that research funding allocation patients with TNM stage T1. On average, the bladder- in the UK for BC is not commensurate with its Wnancial 123 World J Urol (2009) 27:295–300 299 published literature. Pharmacoeconomics 21:1315–1330. burden. They estimate that BC and prostate cancer incur doi:10.2165/00019053-200321180-00003 similar annual healthcare costs pp yet research funding var- 6. 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World Journal of UrologyPubmed Central

Published: Mar 7, 2009

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