Contemporary cost-effectiveness analysis comparing sequential bacillus Calmette-Guerin and electromotive mitomycin versus bacillus Calmette-Guerin alone for patients with high-risk non-muscle-invasive bladder cancer.

BACKGROUND: Sequential bacillus Calmette-Guerin (BCG) and electromotive mitomycin (sequential therapy) have been shown in a randomized prospective trial to be superior to therapy with BCG alone in patients with high-risk non-muscle-invasive bladder cancer. The objective of the current study was to compare the costs and benefits of these 2 treatment strategies by performing a 5-year and 10-year cost-effectiveness study. METHODS: A Markov model was developed to estimate the incremental cost-effectiveness ratio over a 5-year and 10-year period. Estimates of disease progression, death, and treatment efficacy were obtained from what to the authors' knowledge is the only randomized trial comparing the 2 therapies. Costs included: 1) medical costs (physician fees); 2) drug costs (preparation and instillation); and 3) hospital costs (procedure fees, admission fees, and tests and procedures done during surveillance). Patients were allowed a second course of induction therapy. RESULTS: Sequential therapy was found to be associated with a higher initial material cost for induction and maintenance. The average effectiveness for the patients treated with therapy with BCG alone was 4.39 years with a mean cost of $9236 (95% confidence interval, $9118-$9345) per patient. The sequential group resulted in an average effectiveness of 4.65 years, with a mean cost of $16,468 (95% confidence interval, $16,371-$16,527). The 5-year incremental cost-effectiveness ratio of sequential versus BCG-alone therapy was $27,815 per life-year gained. The corresponding figure over a 10-year period was $8618 per life-year gained. CONCLUSIONS: The results of the current study suggest that sequential therapy is a cost-effective treatment for patients with high-risk non-muscle-invasive bladder cancer.

The cost effectiveness of bevacizumab when added to capecitabine, with or without mitomycin-C, in first line treatment of metastatic colorectal cancer: results from the Australasian phase III MAX study.

BACKGROUND: Based on the clinical data, bevacizumab has been approved in Australia and globally for the treatment of advanced colorectal cancer. However, limited evidence exists for its cost-effectiveness. The purpose of this study was to evaluate the cost effectiveness of adding bevacizumab to capecitabine monotherapy in patients with metastatic colorectal cancer, using data from the prospective economic evaluation conducted alongside the MAX trial. METHODS: Individual patient level data on resource use and progression free survival were prospectively collected in the phase III MAX trial. Resource use data were collected for the period between randomisation and disease progression, and unit costs were assigned from the perspective of the Australian health care funder. Effectiveness was measured in quality adjusted progression free survival years, with utility scores obtained from both the community valued EQ-5D questionnaire and the patient valued UBQ-C questionnaire. Progression free survival was used as a secondary effectiveness measure. RESULTS: The addition of bevacizumab to capecitabine monotherapy cost approximately $192,156 (95% confidence interval [CI], $135,619 to $326,894) per quality adjusted progression free survival year gained when using publicly listed pharmaceutical prices and utility values from the EQ-5D questionnaire. This decreased to $149,455 (95% CI, $100,356 to $245,910) when values from the UBQ-C questionnaire were applied. The incremental cost per progression free survival year was $145,059 (95% CI, $106,703 to $233,225). CONCLUSIONS: Bevacizumab was not found to be cost effective at its listed price, based on results from the MAX trial.

Economic and humanistic consequences of preventable bladder tumor recurrences in nonmuscle invasive bladder cancer cases.

PURPOSE: Perioperative intravesical chemotherapy following transurethral resection of bladder tumor has been underused despite level 1 evidence supporting its performance. The primary objective of this study was to estimate the economic and humanistic consequences associated with preventable recurrences in patients initially diagnosed with nonmuscle invasive bladder cancer. MATERIALS AND METHODS: Using population based estimates of nonmuscle invasive bladder cancer incidence, a 2-year model was developed to estimate the number of preventable recurrences in eligible patients untreated with perioperative intravesical chemotherapy. Therapy utilization rates were obtained from a retrospective database analysis and a chart review study of 1,010 patients with nonmuscle invasive bladder cancer. Recurrence rates of nonmuscle invasive bladder cancer were obtained from a randomized clinical trial comparing transurethral resection of bladder tumor with or without perioperative mitomycin C. Costs were estimated using prevailing Medicare reimbursement rates. Quality adjusted life-year estimates and disutilities for complications were obtained from the literature. RESULTS: The model estimated that 7,827 bladder recurrences could be avoided if all patients received immediate intravesical chemotherapy. It estimated an economic savings of $3,847 per avoidable recurrence, resulting in an aggregate savings of $30.1 million. The model also estimated that 1,025 quality adjusted life-years are lost every 2 years due to preventable recurrences, resulting in 0.13 quality adjusted life-years (48 quality adjusted days) lost per avoidable recurrence. This translates into 0.02 quality adjusted life-years (8.1 quality adjusted days) lost per patient not receiving immediate intravesical chemotherapy. CONCLUSIONS: Greater use of immediate intravesical chemotherapy in the United States has the potential to substantially decrease the economic and humanistic burdens of nonmuscle invasive bladder cancer.

Contemporary cost analysis of single instillation of mitomycin after transurethral resection of bladder tumor in a universal health care system.

OBJECTIVE: Although recommended management strategy for nonmuscle-invasive bladder cancer (NMIBC) involves a single postoperative intravesical therapy with mitomycin C (MMC), it is uncommonly used among urologists, in part because of potential increased costs. Our objective was to perform a 5-year cost analysis of this strategy within a single-provider health care environment. METHODS: A decision-analytic model was used. Input estimates for 5-year recurrence rates (50%) and MMC efficacy (absolute risk reduction of 17% and 12%) were identified via a systematic literature search and data from 2 meta-analyses. Direct costs included physician fees, MMC drug and preparation costs, transurethral bladder tumor resection (TURBT), and cystoscopy, as well as institutional hospital fees. Indirect societal costs such as work absences and productivity loss were not considered. The model was limited to a 5-year follow-up period with the following assumptions: similar rates of progression, constant recurrence rates, and no cross-over between groups. RESULTS: Overall 5-year analysis reveals that TURBT plus MMC strategy is not associated with increased costs; it saves the Medicare system $148/patient compared with TURBT alone. Calculated differences took into account avoidance of cystoscopic surveillance, urinary cytology, and reoperative and follow-up costs associated with multiple recurrences. Analysis revealed dominance of MMC usage over TURBT alone as early as 4 years from surgery. CONCLUSIONS: Routine usage of MMC after TURBT is not associated with increased costs to the health care system. In fact, there is a significant cost savings. Nonquantified patient quality of life benefits and secondary societal advantages of gained wages and productivity owing to decreases in recurrence and surgery would further increase the cost savings.

Mitomycin-c application in airway stenosis surgery: analysis of safety and costs.

OBJECTIVE: This study describes a large series of patients receiving topical mitomycin-c (MMC) during airway surgery, including complications, and carries out a cost analysis for its use in laryngotracheal stenosis. STUDY DESIGN AND SETTING: Retrospective review, tertiary center. Airway patients receiving MMC are reviewed for demographics, stenosis characteristics, and MMC usage. A basic cost analysis is carried out. RESULTS: Fifty patients underwent 93 MMC applications (mean = 50.8 years, 25 male, 25 female). In 89 of 93 applications (96%), the concentration of MMC was 0.4 mg/ml. One major complication occurred (1.1%). The expense for MMC is $455; the mean cost for airway surgery is $7,840. It is estimated that if 1 of 17 MMC treated patients requires one less operation, the cost ratio is favorable. CONCLUSIONS: This large series contributes to literature that MMC is a safe adjunct to laryngotracheal surgery. The marginal cost for MMC application is favorable based on our basic cost analysis and existing efficacy data. SIGNIFICANCE: Mitomycin-c seems to be safe and cost-effective in endoscopic airway surgery. EBM RATING: C-4.

5-fluorouracil and mitomycin-C: effective, low-cost chemotherapy for colorectal cancer.

OBJECTIVE: To evaluate the regimen of 5-fluorouracil (5-FU) and mitomycin-C (MMC) in terms ofresponse rate and overall survival in advanced colorectal cancer. MATERIAL AND METHOD: Between January 1993 and December 2000, 121 from 559 patients with advanced colorectal cancer were treated with chemotherapy. Bolus MMC (10 mg/m2) on first day, 5-FU (600 mg/m2/day) was given as a continuous infusion for 5 days, repeated every 4 weeks for 6 cycles. Toxicity and response were analyzed according to WHO criteria, and survival was analyzed according to Kaplan-Meier methodology. RESULTS: In the chemotherapy group (121 patients), 70 were males and 51 were females, the mean age was 52 years. The ratio of colon and rectal cancer was 0.57. Nearly all patients (88.89%) had tumors with moderate differentiation. Forty patients with liver metastasis showed an overall response rate of 45% (95% CI 35.4-54.6) with a CR in 3 (7.5%) and PR in 15 (37.5%). The median survival was 13.1 months. The regimen was well tolerated with 11.64% of patients experiencing WHO grade 3-4 toxicity. CONCLUSION: The present study has indicated a highly active, acceptable toxic, inexpensive regimen of old drugs to be used as an alternative to the more expensive combination including CPT-11 or oxaliplatin.

Patterns, costs and cost-effectiveness of care in a trial of chemotherapy for advanced non-small cell lung cancer.

In a recently published randomised trial of chemotherapy versus palliative care in advanced non-small cell lung cancer (the MIC2 trial), chemotherapy was shown to prolong survival without compromising quality of life. The study presented here examines patterns of care and their associated costs within a representative subgroup of patients from the MIC2 trial. The study consisted of 116 patients from the South Birmingham Health Authority area. The total health service cost for each patient from entry to trial to death or last follow-up was calculated by combining the resources used with their associated unit costs. The mean cost for patients with complete data on the chemotherapy arm was 6999 pounds sterling (standard deviation (S.D.) 4194 pounds sterling) compared to 4076 pounds sterling (S.D. 3078 pounds sterling) for those with complete data on the palliative care arm. Non-parametric bootstrapping gave a difference between treatment arms in mean cost of 2924 pounds sterling(95% CI 1234 pounds sterling - 4323 pounds sterling). With a difference in mean survival of 2.4 months, this translates to an incremental cost-effectiveness ratio of 14,620 pounds sterling per life year gained. Chemotherapy was found to be more costly than standard palliative care, mainly due to the increased number of hospital in-patient days.

[A comparative study of thio-tepa and mitomycin C in the treatment of pterygium. Preliminary results]. / Etude comparative du Thio-tepa et de la Mitomycine C dans le traitement du ptérygion. Résultats préliminaires.

AIMS: To compare the efficacy of Thio-tepa and Mitomycine C to obviate recurrence; to compare cost-efficacy ratios; to evaluate their facility of use and their complications. METHODS: In a prospective blinded study, 36 patients undergoing surgery for 46 primary and recurrent pterygium were assigned randomly to three groups: group 1 received 0.02 mg/ml of Mitomycine C three times daily for 5 days; group 2 received Thio-tepa four times daily for 6 weeks, group 3 served as a control receiving distilled water three times daily for five days. RESULTS: Recurrence rates were 38%, in group 1; 28% in group 2; 82% in group 3 respectively. Follow-up ranged from 15 to 44 weeks (mean 27.93 +/- 8.9 weeks). Mean delay recurrence time was 6.3 weeks. Topical Mitomycin caused: iritis, conjunctival irritation, excessive lacrymation, photophobia, ocular pain; Thio-tepa caused: photophobia, foreign body sensation, headache. CONCLUSIONS: Mitomycine C appears to be an effective and safe adjunctive treatment for this cost-efficacy and this facility of use comparison.

The cost-effectiveness of four cisplatin-containing chemotherapy regimens in the treatment of stages III B and IV non-small cell lung cancer: an Italian perspective.

The cost-effectiveness of four cisplatin-containing chemotherapy regimens used in the treatment of non-small cell lung cancer (NSCLC) stages III B and IV was retrospectively assessed specifically with respect to the situation in Italy and from the third party payer perspective. The chemotherapy regimens compared were gemcitabine+cisplatin (G + C), mitomycin+ifosfamide+cisplatin (MIP), etoposide+cisplatin (E + C), and vinorelbine+cisplatin (V + C). Efficacy and safety data for the regimens were calculated from studies selected from the international literature using formal inclusion and exclusion criteria. In total, one study with one G + C treatment arm (48 patients), one study with one MIP treatment arm (133 patients), three studies with one E + C treatment arm (total 325 patients), and two studies with one V + C treatment arm (total 327 patients) were included. Where efficacy and toxicity results for the same regimen were reported in more than one study, the values were combined using a random effects meta-analysis method. The mean tumour response rates were: 54% (95% confidence intervals (CI) 40-69%); 40% (95% CI 32-49%); 26% (95% CI 20-30%); and 35% (95% CI 24-48) for G + C, MIP, E + C and V + C, respectively. Costs were evaluated for World Health Organization (WHO) grade 3 and 4 toxicities with high impact on medical costs using computer modelling techniques. The official prices of drugs and official reimbursement rates were used to calculate direct medical costs. Average cost-effectiveness analysis demonstrated no significant difference between the treatments. Marginal cost-effectiveness analysis showed that the use of MIP, E + C or V + C instead of G + C would result in additional costs of 7.7, 55.2 (p < 0.05), and 46.2 million lira, respectively, for every patient with a tumour response.

Chemotherapy in gastric cancer: an economic evaluation of the FAM (5-fluorouracil, adriamycin, mitomycin C) versus ELF (etoposide, leucovorin, 5-fluorouracil) regimens.

The prognosis in gastric cancer has been almost unchanged for the last 20 years. At the time of diagnosis the majority of patients have disseminated disease. The 5-year survival is only about 15%. Several efforts with numerous antineoplastic regimens have been studied. The most widely used regimen has been the FAM (5-fluorouracil, adriamycin, mitomycin C) regimen. Because of the cardiotoxicity and dose intensity of the FAM regimen, a low toxicity regimen, the ELF (etoposide, leucovorin, 5-fluorouracil) regimen, has been introduced. We present the data from the treatment of 26 patients (17 FAM, 9 ELF) with advanced gastric cancer at the University Hospital of Tromsø. The monthly costs of FAM and ELF treatment were calculated to a price of 553 pounds and 2976 pounds (British pounds). The median survival of 5 months (FAM) and 6 months (ELF) is in accordance with other studies. Assuming that the median survival in our study is correct, the cost of one year saved was 123,834 pounds, while the cost of one QALY (quality adjusted life year) employing the ELF compared to the FAM regimen was 104,334 pounds. We conclude that the standard ELF regimen too expensive in the treatment of gastric cancer.