Dr. Chang is Assistant Professor, Department of Urologic Surgery, Vanderbilt University Medical Center, Nashville, Tenn. He has received a research grant from Amgen and Cytogen, and is on the Speaker's Bureaus of Novartis and Sanofi.

Sam S. Chang, MD

Concerns over high costs, poor outcomes, and poor access to health care in the United States have prompted legislation that emphasizes value and quality of care over quantity. The goal of health care delivery under these legislative changes will be to improve the value and efficiency of care, measuring the outcomes achieved relative to the cost. (Also see, 

“New payment models emphasize outcomes, value")

Quality and cost concerns are particularly relevant in the diagnosis and management of urothelial carcinoma of the bladder (UCB). UCB has the highest lifetime treatment cost of all cancers,

 with estimated expenditures of approximately $187,000 per case and, in 2010, a cost of approximately $4 billion to treat.

 There is significant variation among providers in the clinical management of UCB, with concerns that compliance with treatment guidelines should be optimized to help improve patient outcomes.

In addition, more care does not necessarily mean better care. In an analysis of the Surveillance, Epidemiology and End Results (SEER)–Medicare database, there was no association between survival and the intensity or frequency of the surveillance protocols for bladder cancer.

 Moreover, we have to consider the potential consequences that changes in legislation, billing, and reimbursement can have on our practice patterns. As an example, changes to the reimbursement of in-office cystoscopy provided unintended incentives that increased the utilization of in-office cystoscopy by over 640%, decreasing the overall cost efficiency of cystoscopy with an increase in redundant office-based procedures and decrease in diagnostic yield.

Bladder cancer care delivery represents an opportunity to provide smarter care and improve outcomes while reducing wasteful spending. We will review the evidence and identify potential areas of improvement that can help reduce costs associated with UCB management while improving outcomes.

The goal for bladder cancer screening is to detect tumors at an earlier stage. Studies of screening for bladder cancer have had conflicting results; some have found a survival

 and potential cost-effectiveness benefit

 Current guidelines do not recommend routine screening for bladder cancer in an asymptomatic population because screening would result in increased exposure to unnecessary diagnostic procedures without a relative benefit.

Immediate post-TURBT mitomycin instillation reduces recurrence risk

The management of low-grade, low-risk nonmuscle-invasive bladder cancer (NMIBC) represents an area of possible cost reduction. Expectant management of low-grade NMIBC with active surveillance has been successfully implemented with low risks of progression.

 Because the risk of progression is low, there may be significant overtreatment of low-grade NMIBC that can expose patients to excess harm and increased costs without much benefit.

 Implementation of active surveillance for low-grade, low-risk disease may help decrease the risks of overtreatment and overdiagnosis and in turn decrease the overall costs of bladder cancer care.

In patients with asymptomatic microhematuria, AUA guidelines recommend cystoscopy and upper tract imaging, with a multiphasic computed tomography (CT) scan as the most sensitive and specific test to detect an upper tract urothelial carcinoma.

 However, a recent cost-effectiveness analysis by Halpern et al

 found that the use of ultrasound and cystoscopy could substantially reduce costs, decrease radiation exposure, and not compromise detection of cancer. Halpern et al found that the use of renal ultrasound with cystoscopy had an incremental cost per cancer detected of about $50,000, while the incremental cost per cancer detected was about $6.5 million with a CT scan and cystoscopy, and that replacing the renal ultrasound with a CT scan detected just one more malignancy per 10,000 patients evaluated. These findings suggest that there can be significant reductions in unnecessary costs if ultrasound is used as a first-line diagnostic modality in place of CT scans.

Management of nonmuscle-invasive bladder cancer

The management of NMIBC has been well-established,

 with the central tenets being: a complete initial resection of cancer, close surveillance for progression and recurrence with cystoscopy, and use of intravesical immunotherapy or chemotherapy with a maintenance regimen. However, multiple studies have shown extremely low rates of compliance with level I evidence and national guidelines.

Blue light cystoscopy improves bladder Ca detection

For example, a meta-analysis of seven randomized trials found that instillation of chemotherapy after transurethral resection of a bladder tumor (TURBT) was associated with about a 40% risk reduction in bladder cancer recurrence.

 However, several studies in the SEER–Medicare database have found that instillation of chemotherapy immediately after TURBT occurs extremely rarely.

 In addition, 40% of providers did not perform at least one cystoscopy, cytology, or course of immunotherapy for their patients within 2 years of initial diagnosis. Surgeon compliance with guidelines accounted for almost half of the variation in compliance with post-TURBT intravesical chemotherapy.

 Likewise, despite level I evidence that bacillus Calmette-GuÃ©rin (BCG) instillations with a maintenance protocol can significantly lower the risk of recurrence and progression,

 less than half of patients with NMIBC received a single dose of induction or maintenance BCG.

The completeness of the initial TURBT resection also shows significant variation in its quality. In one study of a high-volume tertiary care center, 74% of patients referred from an outside urologist found residual tumor in the patients who underwent a second TURBT, 30% of whom were upstaged to muscle invasion.

 This can have important implications, as delays beyond 3 months between diagnosis of muscle invasion and definitive treatment can significantly affect survival.

 Improving compliance with level I evidence and national guidelines can improve bladder cancer outcomes while decreasing the costs associated with disease progression or recurrence.

Blue-light, or fluorescence, cystoscopy (BLC) was developed to enhance a complete resection during TURBT and improve cancer detection. Several studies have found significant reduction in recurrence of about 40% with BLC compared to standard white-light cystoscopy.

 The use of BLC can significantly decrease the overall costs of NMIBC treatment,

 primarily powered from a 20%-60% decrease in the number of TURBTs. The total costs of a TURBT at an academic medical center can range from $3,000 to $6,000,

 so the utilization of BLC to improve complete resections has the potential to improve cancer outcomes and decrease costs.

In-office blue light: Solid data, and questions

However, significant up-front expenditures have to be considered in the utilization of photodynamic visualization, including Foley catheters for instillation, increased surveillance for patients that are up-staged with BLC, and any new equipment costs for BLC compatibility. Many of the current studies differ in their cost assumptions and follow-up, so future research will be required to help clarify the true cost-effectiveness.

Muscle-invasive bladder cancer management

The gold-standard treatment for localized muscle-invasive bladder cancer (MIBC) is a radical cystectomy with urinary diversion, with neoadjuvant chemotherapy if the patient is eligible. However, there are multiple areas in the treatment and management of MIBC where patients are not receiving guideline-concordant care. Only about 20% of patients with MIBC undergo radical cystectomy,

 with only about 13% of patients undergoing neoadjuvant chemotherapy.

Test could help detect bladder cancer recurrence

There also appears to be a significant barrier to accessing available providers who would perform a cystectomy, as patients who traveled long distances had lower odds of undergoing a radical cystectomy.

 Patients who underwent a radical cystectomy had improved overall and disease-specific survival compared to those who underwent other alternative treatments.

 Improved compliance with guidelines for the management of MIBC can improve the health-related outcomes associated with bladder cancer.

Minimally invasive approaches to radical cystectomy were developed in the hopes of reducing the morbidity associated with radical cystectomy. Three randomized controlled trials

 have compared the outcomes of the standard open cystectomy to the robot-assisted approach, with the final findings of the multicenter RAZOR study yet to be published. In general, these randomized controlled trials and meta-analyses have found that the robot-assisted cystectomy was associated with decreased blood loss but longer operative times. Associations with length of stay and postoperative complications differed with each study and cohort.

Cost identification analysis was performed comparing the costs of robot-assisted cystectomy with open cystectomy in three separate studies of large-volume centers (about 200-300 cases per year).

 In two of these analyses, robot-assisted cystectomy was associated with a shorter length of stay than open cystectomy, and also conferred a significant decrease in hospitalization costs by 60%-70% and overall costs by 19%-38%.

 The direct equipment costs were higher with robot-assisted cystectomy in these studies of large-volume centers, but overall offset by the improvement in length of stay and complications. However, it is important to remember that these studies are of high-volume centers with expertise in robotic cystectomy, as both studies had operative times that were equivalent or faster than the open cystectomies.

Two population-based analyses confirmed the findings that robot-assisted cystectomies add about $4,000 per case compared to open, primarily because of increased supply costs.

 However, the cost difference with robotic cystectomy would disappear in high-volume centers (>19 cases per year) or when performed by high-volume surgeons (>7 cases per year).

 Robot-assisted cystectomies are consistently associated with higher direct costs than open procedures with more equipment purchases, maintenance, and disposable instruments. However, ownership of a robotic platform can increase utilization for other urologic, surgical, or gynecologic procedures that can then marginalize the additional equipment costs.

In high-volume facilities, there can be potential cost savings associated with the robotic procedure if the length of stay and complication rates can be significantly decreased. Future studies that analyze the cost per quality-adjusted life year will help clarify the potential value for a robot-assisted approach.

Postoperative length of stay is an important factor in the patient’s quality of life and costs of bladder cancer care. Enhanced recovery after surgery (ERAS) protocols aim to standardize perioperative care and reduce variation. Although there is some variation in ERAS protocols between institutions, different randomized trials and meta-analyses have found that overall, ERAS protocols are associated with decreased overall complication rates, length of stay, and a faster return of bowel function.

 A cost-effectiveness analysis at a high-volume tertiary center found that the implementation of an ERAS protocol produced an overall average 30-day cost savings of about $4,500 per procedure.

How will immunotherapy change the future of bladder Ca care?

Postoperative ileus is the most common complication that can affect length of stay. Alvimopan (Entereg) is a mu-opioid receptor antagonist that has been shown to significantly improve time to return of bowel function after cystectomy, decrease the postoperative ileus rate by more than 50%, and decrease the postoperative length of stay.

 The published wholesale price for alvimopan is $62.50, with maximum cost of about $937.50 for 15 doses.

 In one cost-consequence analysis, utilization of alvimopan was associated with a cost reduction of more than $2,300 per patient.

 Most of the cost savings resulted from a shorter length of stay (by almost 3 days), decreased utilization of gastrointestinal medications, and decreased parenteral nutrition use. The routine use of ERAS protocols with alvimopan utilization can significantly decrease postoperative length of stay and complication rates associated with cystectomy and thereby significantly decrease the overall costs of bladder cancer management.

There has been an increasing emphasis on improving the value of health care by improving the quality or outcomes of care while decreasing the costs. The management and treatment of bladder cancer is costly, but certain areas of improvement can have a dramatic impact on outcomes and costs. Cost-saving measures, such as the use of front-line renal ultrasound with cystoscopy instead of a CT scan, can help decrease costs while not compromising outcomes. Quality improvement measures, such as improving compliance with guideline-concordant care in the management of NMIBC and MIBC can decrease recurrence and progression rates, improve outcomes, and prevent unnecessary costs.

Finally, the implementation of newer processes such as blue-light cystoscopy, ERAS protocols, and alvimopan can significantly decrease costs and improve the health outcomes of patients undergoing a cystectomy. Future studies that focus on cost-effectiveness relative to quality of life after cystectomy will be essential to determine other potential areas of improvement.

Riley GF, Potosky AL, Lubitz JD, et al. Medicare payments from diagnosis to death for elderly cancer patients by stage at diagnosis. 

Mariotto AB, Yabroff KR, Shao Y, Feet al. Projections of the cost of cancer care in the United States: 2010-2020. 

Skolarus TA, Ye Z, Montgomery JS, et al. Use of restaging bladder tumor resection for bladder cancer among Medicare beneficiaries. 

Hollenbeck BK, Ye Z, Dunn RL, et al. Provider treatment intensity and outcomes for patients with early-stage bladder cancer. 

Karl A, Adejoro O, Saigal C, et al. General adherence to guideline recommendations on initial diagnosis of bladder cancer in the United States and influencing factors. 

O'Neil B, Graves AJ, Barocas DA, et al. Doing More for More: Unintended Consequences of Financial Incentives for Oncology Specialty Care. 

Messing EM, Madeb R, Young T, et al. Long-term outcome of hematuria home screening for bladder cancer in men. 

Messing EM, Young TB, Hunt VB, et al. Hematuria home screening: repeat testing results. 

Ellwein LB, Farrow GM, Friedell GH, et al. An assessment of the impact of urine cytology screening using a computer-based model of bladder cancer. 

Svatek RS, Sagalowsky AI, Lotan Y. Economic impact of screening for bladder cancer using bladder tumor markers: a decision analysis. 

Lotan Y, Svatek RS, Sagalowsky AI. Should we screen for bladder cancer in a high-risk population?: A cost per life-year saved analysis. 

ThÃ©riault GP, Tremblay CG, Armstrong BG. Bladder cancer screening among primary aluminum production workers in Quebec.

Friedman GD, Hiatt RA, Quesenberry CP. Problems in assessing screening experience in observational studies of screening efficacy: example of urinalysis screening for bladder cancer. 

Lotan Y, Elias K, Svatek RS, et al. Bladder cancer screening in a high risk asymptomatic population using a point of care urine based protein tumor marker. 

Chou R, Dana T. Screening adults for bladder cancer: a review of the evidence for the U.S. Preventive Services Task Force. 

Chang SS, Boorjian SA, Chou R, et al. Diagnosis and Treatment of Non-Muscle Invasive Bladder Cancer: AUA/SUO Guideline. 

Pruthi RS, Baldwin N, Bhalani V, et al. Conservative management of low risk superficial bladder tumors. 

Tiu A, Jenkins LC, Soloway MS. Active surveillance for low-risk bladder cancer. 

Soloway MS, Bruck DS, Kim SS. Expectant management of small, recurrent, noninvasive papillary bladder tumors.

Davis R, Jones JS, Barocas DA, et al. Diagnosis, evaluation and follow-up of asymptomatic microhematuria (AMH) in adults: AUA guideline. 

Halpern JA, Chughtai B, Ghomrawi H. Cost-effectiveness of Common Diagnostic Approaches for Evaluation of Asymptomatic Microscopic Hematuria. 

Sylvester RJ, Oosterlinck W, van der Meijden AP. A single immediate postoperative instillation of chemotherapy decreases the risk of recurrence in patients with stage Ta T1 bladder cancer: a meta-analysis of published results of randomized clinical trials. 

Chamie K, Saigal CS, Lai J, et al. Quality of care in patients with bladder cancer: a case report? 

Chamie K, Saigal CS, Lai J, et al. Compliance with guidelines for patients with bladder cancer: variation in the delivery of care. 

Lamm DL, Blumenstein BA, Crissman JD, et al. Maintenance bacillus Calmette-Guerin immunotherapy for recurrent TA, T1 and carcinoma in situ transitional cell carcinoma of the bladder: a randomized Southwest Oncology Group Study. 

Huang GJ, Hamilton AS, Lo M, et al. Predictors of intravesical therapy for nonmuscle invasive bladder cancer: results from the Surveillance, Epidemiology and End Results program 2003 patterns of care project. 

Herr HW. Role of re-resection in non-muscle-invasive bladder cancer. 

Gore JL, Lai J, Setodji CM, et al. Mortality increases when radical cystectomy is delayed more than 12 weeks: results from a Surveillance, Epidemiology, and End Results-Medicare analysis. 

Burger M, Grossman HB, Droller M, et al. Photodynamic diagnosis of non-muscle-invasive bladder cancer with hexaminolevulinate cystoscopy: a meta-analysis of detection and recurrence based on raw data. 

Burger M, Zaak D, Stief CG, et al. Photodynamic diagnostics and noninvasive bladder cancer: is it cost-effective in long-term application? A Germany-based cost analysis. 

Otto W, Burger M, Fritsche HM, et al. Photodynamic diagnosis for superficial bladder cancer: do all risk-groups profit equally from oncological and economic long-term results? 

Garfield SS, Gavaghan MB, Armstrong SO, et al. The cost-effectiveness of blue light cystoscopy in bladder cancer detection: United States projections based on clinical data showing 4.5 years of follow up after a single hexaminolevulinate hydrochloride instillation. 

MalmstrÃ¶m PU, Hedelin H, Thomas YK, et al. Fluorescence-guided transurethral resection of bladder cancer using hexaminolevulinate: analysis of health economic impact in Sweden. 

Svatek RS, Hollenbeck BK, HolmÃ¤ng S, et al. The economics of bladder cancer: costs and considerations of caring for this disease. 

Schrag D, Mitra N, Xu F, et al. Cystectomy for muscle-invasive bladder cancer: patterns and outcomes of care in the Medicare population. 

Gray PJ, Fedewa SA, Shipley WU, et al. Use of potentially curative therapies for muscle-invasive bladder cancer in the United States: results from the National Cancer Data Base. 

Gore JL, Litwin MS, Lai J, et al. Use of radical cystectomy for patients with invasive bladder cancer.

Fedeli U, Fedewa SA, Ward EM. Treatment of muscle invasive bladder cancer: evidence from the National Cancer Database, 2003 to 2007. 

Nix J, Smith A, Kurpad R, et al. Prospective randomized controlled trial of robotic versus open radical cystectomy for bladder cancer: perioperative and pathologic results. 

Bochner BH, Sjoberg DD, Laudone VP, Group MSKCCBCST. A randomized trial of robot-assisted laparoscopic radical cystectomy. 

Parekh DJ, Messer J, Fitzgerald J, et al. Perioperative outcomes and oncologic efficacy from a pilot prospective randomized clinical trial of open versus robotic assisted radical cystectomy. 

Li K, Lin T, Fan X, et al. Systematic review and meta-analysis of comparative studies reporting early outcomes after robot-assisted radical cystectomy versus open radical cystectomy. 

Tang K, Xia D, Li H, et al. Robotic vs. open radical cystectomy in bladder cancer: A systematic review and meta-analysis. 

Ishii H, Rai BP, Stolzenburg JU, et al. Robotic or open radical cystectomy, which is safer? A systematic review and meta-analysis of comparative studies. 

Smith A, Kurpad R, Lal A, et al. Cost analysis of robotic versus open radical cystectomy for bladder cancer. 

Martin AD, Nunez RN, Castle EP. Robot-assisted radical cystectomy versus open radical cystectomy: a complete cost analysis. 

Lee R, Chughtai B, Herman M, et al. Cost-analysis comparison of robot-assisted laparoscopic radical cystectomy (RC) vs open RC. 

Yu HY, Hevelone ND, Lipsitz SR, et al. Comparative analysis of outcomes and costs following open radical cystectomy versus robot-assisted laparoscopic radical cystectomy: results from the US Nationwide Inpatient Sample. 

Leow JJ, Reese SW, Jiang W, et al. Propensity-matched comparison of morbidity and costs of open and robot-assisted radical cystectomies: a contemporary population-based analysis in the United States. 

Tyson MD, Chang SS. Enhanced Recovery Pathways Versus Standard Care After Cystectomy: A Meta-analysis of the Effect on Perioperative Outcomes. 

Nabhani J, Ahmadi H, Schuckman AK, et al. Cost Analysis of the Enhanced Recovery After Surgery Protocol in Patients Undergoing Radical Cystectomy for Bladder Cancer.

Lee CT, Chang SS, Kamat AM, et al. Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled trial. 

Kraft M, Maclaren R, Du W, et al. Alvimopan (entereg) for the management of postoperative ileus in patients undergoing bowel resection.

Kauf TL, Svatek RS, Amiel G, et al. Alvimopan, a peripherally acting Î¼-opioid receptor antagonist, is associated with reduced costs after radical cystectomy: economic analysis of a phase 4 randomized, controlled trial. 

Next: New payment models emphasize outcomes, value

New payment models emphasize outcomes, value

The United States has the highest per capita health care expenditures in the world, accounting for approximately 17% of the national gross domestic product in 2015.

 In fact, from 1980 to 2010, the cumulative difference in health care spending between the United States and Switzerland, the country with the second-highest per capita health care expenditures, amounts to approximately $15.5 trillion.

 Over the last two decades, health care costs have continued to increase dramatically, and at current rates, have been estimated to increase about 40% over the next 25 years.

Despite the high costs, health care outcomes are often much worse than those of other countries; the United States currently ranks 42

 There is also significant geographic variation in the quality of health care, as some states have life expectancies and infant mortality rates that are worse than countries ranked in the 100s.

Given the poor health outcomes, significant barriers to access care, and rising health care costs, legislation and payment models have shifted dramatically in an attempt to transition from a fee-for-service model that incentivizes high-output health care to one that emphasizes value and quality of care. Passage of the Patient Protection and Affordable Care Act (ACA) and the Medicare Access and CHIP Reauthorization Act (MACRA) represents a long-standing adjustment to value-based compensation that incorporates quality outcomes, cost savings, patient satisfaction, and preventive care. In fact, the Centers for Medicare & Medicaid Services has a goal of tying 50% of traditional payments to quality metrics by 2018.

By linking payments to outcomes, these alternative payment models provide incentives to coordinate care, ensure quality care provision, and prevent overtreatment or improper care. It has been estimated that up to $425 billion of the health care expenditures in 2011 were from failures in care delivery, care coordination, and improper overtreatment.

 With these legislative changes, the goal of health care delivery will be focused on improving the value and efficiency of care, measuring the outcomes achieved relative to the cost.

Articles

"We will review the evidence and identify potential areas of improvement that can help reduce costs associated with UCB management while improving outcomes," write Daniel J. Lee, MD, and Sam S. Chang, MD.

Sam S. Chang, MD

Articles

Cost considerations in the management of bladder cancer