Cost-Effectiveness and Net Monetary Benefit of Olaparib Maintenance Therapy Versus No Maintenance Therapy After First-line Platinum-based Chemotherapy in Newly Diagnosed Advanced BRCA1/2-mutated Ovarian Cancer in the Italian National Health Service.

PURPOSE: The aim of this study was to evaluate the cost-effectiveness and net monetary benefit of olaparib maintenance therapy compared with no maintenance therapy after first-line platinum-based chemotherapy in newly diagnosed advanced BRCA1/2-mutated ovarian cancer from the Italian National Health Service (NHS) perspective. METHODS: We developed a lifetime Markov model in which a cohort of patients with newly diagnosed advanced BRCA1/2-mutated ovarian cancer was assigned to receive either olaparib maintenance therapy or active surveillance (Italian standard of care) after first-line platinum-based chemotherapy to compare cost-effectiveness and net monetary benefit of the 2 strategies. Data on clinical outcomes were obtained from related clinical trial literature and extrapolated using parametric survival analyses. Data on costs were derived from Italian official sources and relevant real-world studies. The incremental cost-effectiveness ratio (ICER), incremental cost-utility ratio (ICUR), and incremental net monetary benefit (INMB) were computed and compared against an incremental cost per quality-adjusted life-year (QALY) gained of €16,372 willingness-to-pay (WTP) threshold. We used deterministic sensitivity analysis (DSA) and probabilistic sensitivity analysis (PSA) to assess how uncertainty affects results; we also performed scenario analyses to compare results under different pricing settings. FINDINGS: In the base-case scenario, during a 50-year time horizon, the total costs for patients treated with olaparib therapy and active surveillance were €124,359 and €97,043, respectively, and QALYs gained were 7.29 and 4.88, respectively, with an ICER of €9,515 per life-year gained, an ICUR of €11,345 per QALY gained, and an INMB of €12,104. In scenario analyses, considering maximum selling prices for all other drugs, ICUR decreased to €11,311 per QALY and €7,498 per QALY when a 10% and 20% discount, respectively, was applied to the olaparib official price, and the INMB increased to €12,186 and €21,366, respectively. DSA found that the model results were most sensitive to the proportion of patients with relapsing disease in response to platinum-based chemotherapy, time receiving olaparib first-line maintenance treatment, and subsequent treatments price. According to PSAresults, olaparib was associated with a probability of being cost-effective at a €16,372 per QALY WTP threshold ranging from 70% to 100% in the scenarios examined. IMPLICATIONS: Our analysis indicates that olaparib maintenance therapy may deliver a significant health benefit with a contained upfront cost during a 50-year time horizon, from the Italian NHS perspective, providing value in a setting with curative intent.

Disparities in care among patients with low-grade serous ovarian carcinoma.

OBJECTIVE: Low-grade serous carcinoma (LGSC) is a rare histotype of ovarian cancer with a unique disease course. Little data exist regarding the influence of sociodemographic factors on diagnosis and outcomes in this disease. Our objective was to evaluate the associations between these factors and the clinical characteristics, treatment approaches, and survival in LGSC. METHODS: The National Cancer Database (NCDB) was queried for data between 2004 and 2015 on patients with LGSC. LGSC was inclusive of invasive, grade 1, serous carcinoma of the ovary, fallopian tube, or peritoneum. Patient demographics, insurance status, disease characteristics, treatment approach, and survival were evaluated. ANOVA, Chi Square, Kaplan-Meier, and Cox regression were used in the analysis. RESULTS: 3221 patients with LGSC were evaluated (89.5% White, 6.2% Black; 7.2% Hispanic, 92.8% non-Hispanic). Compared to Whites, Blacks were diagnosed younger (50.4 vs. 55.9 years, p < 0.01), received less chemotherapy (61.8% vs 67.0%, p = 0.04), and had less CA-125 elevation (OR 4.14 [1.26-13.57], p = 0.02). Compared to non-Hispanics, Hispanics were younger (49.5 vs. 55.8 years, p < 0.01) and received less chemotherapy (55% vs 67%, p < 0.001). In contrast to private insurance, government insurance was associated with a higher 30-day mortality (1.5% vs 0.01%, p < 0.001). Race/ethnicity were not predictive of OS, while older age (HR 1.013 [1.002-1.024], p = 0.03), advanced stage (HR 3.09 [2.15-4.43], p < 0.001), and government insurance (HR 2.33 [1.65-3.30], p < 0.001) were all independently associated with worse OS. CONCLUSIONS: Significant differences exist in the clinical characteristics, treatments, and outcomes of LGSC by sociodemographics, with Blacks and Hispanics being diagnosed younger and receiving less chemotherapy. Age, stage, and insurance status were predictive of overall survival.

Identifying disparities in germline and somatic testing for ovarian cancer.

OBJECTIVE: Germline mutations occur in approximately 25% of patients with epithelial ovarian cancers while somatic BRCA mutations are estimated at 5-7%. The objectives of this study were to determine the rate of germline and somatic testing in women with ovarian cancer and to identify disparities in testing at a comprehensive cancer center (CCC) and a safety net hospital (SNH). METHODS: Patients treated for ovarian cancer from 2011 to 2016 were included. Clinicopathologic data were abstracted from the electronic medical records. Logistic regression modeling were performed to calculate odds ratios (OR) and corresponding 95% confidence intervals (95%CI). RESULTS: Out of 367 women, 55.3% completed germline testing; 27.0% received somatic testing. Women at the CCC were more likely to be tested for germline (60.4% vs 38.1%, p ≤ 0.001) and somatic (34.3% vs 2.4%, p ≤ 0.001) mutations than those at the SNH. Patients with Medicare (aOR = 0.51, 95%CI 0.28-0.94, p = 0.032) or Medicaid (aOR = 0.42, 95%CI 0.18-0.99, p = 0.048) were less likely to receive germline testing than those privately insured. Patients with Medicaid were less likely to receive somatic testing (aOR = 0.15, 95%CI 0.04-0.62, p = 0.009) than those privately insured. Women with disease recurrence had a higher likelihood of being tested for germline (OR = 3.64, 95%CI 1.94-6.83, P < 0.001) and somatic (OR = 7.89, 95%CI 3.41-18.23, p < 0.001) mutations. There was no difference in germline or somatic testing by race/ethnicity. CONCLUSIONS: Disparities in both germline and somatic testing exist. Understanding and overcoming barriers to testing may improve cancer-related mortality by allowing for more tailored treatments as well as for improved cascade testing.

[Efficacy and costs of ovarian cancer therapy in Poland--regional approach]. / Skutecznosc i koszty leczenia raka jajnika w PoIsce--ujecie regionalne.

UNLABELLED: Ovarian cancer (OC) affects over 3 000 women in Poland annually The efficacy of the therapy remains relatively low due to challenges of systematic improvement in the early detection OC rates. International comparisons indicate a positive correlation between health expenditures and 5-year survival rates of cancer patients. To the best of our knowledge, our study has been the first to present a correlation between the 5-year survival rates (SRs) and the cost of ovarian cancer therapy in particular regions of Poland. MATERIAL AND METHODS: The study was based on the National Health Fund (NHF) data, available in the Disease Treatment Registry The analysis included approximately 13,000 OC patients who started their treatment between 2005 and 2008 to allow for the evaluation of long-term therapy results. The 5-year survival rates were analyzed in relation to average NHF expenditures in various regions of Poland, distinguishing the population of patients aged 45-64 years. RESULTS: The 5-year survival rate in the cohorts diagnosed in 2005 and 2008 changed marginally from 42% to 43%, maintaining relatively large differences between the regions (from 35% to 53% in patients diagnosed in 2008). The NHF expenditures in particular regions differed significantly: mean cost for the entire treatment cycle ranged from 31.600 PLN do 58.000 PLNperperson among patients diagnosed in 2008. No significant correlation between the survival and the cost was found. CONCLUSIONS: SRs of OC patients in particular regions of Poland are not correlated with average treatment cost. Thus, the differences in SRs between various regions of Poland have their source in other factors, e.g., clinical stage at diagnosis, or prevailing treatment patterns in the given region. Further studies may decrease regional discrepancies in patient care and SRs in OC subjects.

Improving NCCN guideline-adherent care for ovarian cancer: Value of an intervention.

OBJECTIVE: To estimate the potential cost-effectiveness of an intervention to improve adherence to National Comprehensive Cancer Network (NCCN) guideline-based care for ovarian cancer. METHODS: A modified Markov model with a 5-year time horizon estimated the potential cost-effectiveness of an intervention (AD-INT) to improve NCCN-guideline adherence compared to status quo (SQ) levels of adherence. Data were obtained from a population-based analysis of National Cancer Data Base records for ovarian cancer diagnosed from 1998 to 2002 (N=47,160). Cohorts were defined by race and adherence to NCCN guideline-based care. Costs were estimated using 2014 Medicare reimbursements. Incremental cost-effectiveness ratios (ICERs) were calculated in 2014 US dollars per year of life saved (YLS) using the standard threshold of $50,000/YLS. We simulated an AD-INT that reduced non-adherence by 25% and cost at least $100 per patient. One-way sensitivity analyses were performed. RESULTS: Although the individual components of guideline-adherent care are more costly than non-adherent care, a reasonably effective AD-INT is also highly likely to be cost-effective. An AD-INT costing $100 per patient and reducing non-adherence by 25% is cost-effective with an ICER of $22/YLS compared with SQ, while interventions costing over $1000 remain cost-effective, up to a per-patient intervention cost of up to $8000 (targeting only blacks) or $4000 (targeting all patients). CONCLUSIONS: An ovarian cancer intervention that moderately decreases racial disparities in NCCN guideline adherent care or improves adherence for all is potentially cost-effective. Further research may determine which modifiable factors may be targeted to help reduce adherence disparities.

Socioeconomic status as a predictor of adherence to treatment guidelines for early-stage ovarian cancer.

OBJECTIVE: Investigate the impact of socioeconomic status and other demographic variables on adherence to the National Comprehensive Cancer Network ovarian cancer treatment guidelines among patients with stage I/II disease. METHODS: Patients diagnosed with stage I/II epithelial ovarian cancer between 1/1/96-12/31/06 were identified from the California Cancer Registry. Univariate analysis and multivariate logistic regression models were used to evaluate differences in surgical procedures, chemotherapy regimens, and overall adherence to the NCCN guidelines according to increasing SES quintiles (SES-1 to SES-5). RESULTS: A total of 5445 stage I and II patients were identified. The median age at diagnosis was 54.0years (range=18-99years); 72.5% of patients had stage I disease, while 27.5% had stage II disease. With a median follow-up time of 5years, the 5-year ovarian cancer-specific survival for all patients was 82.7% (SE=0.6%). Overall, 23.7% of patients received care that was adherent to the NCCN guidelines. Compared to patients in the highest SES quintile (SES-5), patients in the lowest SES quintile (SES-1) were significantly less likely to receive proper surgery (27.3% vs 47.9%, p<0.001) or chemotherapy (42.4% vs 53.6%, p<0.001). There were statistically significant trends between increasing SES and the likelihood of overall treatment plan adherence to the NCCN guidelines: SES-1=16.4%, SES-2=19.0%, SES-3=22.4%, SES-4=24.2% and SES-5=31.6% (p<0.001). Multivariate logistic regression analysis revealed that compared to SES-5, decreasing SES was independently predictive of a higher risk of non-standard overall care. CONCLUSIONS: For patients with early-stage ovarian cancer, low SES is a significant and independent predictor of deviation from the NCCN guidelines for surgery, chemotherapy, and overall treatment.

Topotecan, pegylated liposomal doxorubicin hydrochloride, paclitaxel, trabectedin and gemcitabine for advanced recurrent or refractory ovarian cancer: a systematic review and economic evaluation.

BACKGROUND: Ovarian cancer is the fifth most common cancer in the UK, and the fourth most common cause of cancer death. Of those people successfully treated with first-line chemotherapy, 55-75% will relapse within 2 years. At this time, it is uncertain which chemotherapy regimen is more clinically effective and cost-effective for the treatment of recurrent, advanced ovarian cancer. OBJECTIVES: To determine the comparative clinical effectiveness and cost-effectiveness of topotecan (Hycamtin(®), GlaxoSmithKline), pegylated liposomal doxorubicin hydrochloride (PLDH; Caelyx(®), Schering-Plough), paclitaxel (Taxol(®), Bristol-Myers Squibb), trabectedin (Yondelis(®), PharmaMar) and gemcitabine (Gemzar(®), Eli Lilly and Company) for the treatment of advanced, recurrent ovarian cancer. DATA SOURCES: Electronic databases (MEDLINE(®), EMBASE, Cochrane Central Register of Controlled Trials, Health Technology Assessment database, NHS Economic Evaluations Database) and trial registries were searched, and company submissions were reviewed. Databases were searched from inception to May 2013. METHODS: A systematic review of the clinical and economic literature was carried out following standard methodological principles. Double-blind, randomised, placebo-controlled trials, evaluating topotecan, PLDH, paclitaxel, trabectedin and gemcitabine, and economic evaluations were included. A network meta-analysis (NMA) was carried out. A de novo economic model was developed. RESULTS: For most outcomes measuring clinical response, two networks were constructed: one evaluating platinum-based regimens and one evaluating non-platinum-based regimens. In people with platinum-sensitive disease, NMA found statistically significant benefits for PLDH plus platinum, and paclitaxel plus platinum for overall survival (OS) compared with platinum monotherapy. PLDH plus platinum significantly prolonged progression-free survival (PFS) compared with paclitaxel plus platinum. Of the non-platinum-based treatments, PLDH monotherapy and trabectedin plus PLDH were found to significantly increase OS, but not PFS, compared with topotecan monotherapy. In people with platinum-resistant/-refractory (PRR) disease, NMA found no statistically significant differences for any treatment compared with alternative regimens in OS and PFS. Economic modelling indicated that, for people with platinum-sensitive disease and receiving platinum-based therapy, the estimated probabilistic incremental cost-effectiveness ratio [ICER; incremental cost per additional quality-adjusted life-year (QALY)] for paclitaxel plus platinum compared with platinum was £24,539. Gemcitabine plus carboplatin was extendedly dominated, and PLDH plus platinum was strictly dominated. For people with platinum-sensitive disease and receiving non-platinum-based therapy, the probabilistic ICERs associated with PLDH compared with paclitaxel, and trabectedin plus PLDH compared with PLDH, were estimated to be £25,931 and £81,353, respectively. Topotecan was strictly dominated. For people with PRR disease, the probabilistic ICER associated with topotecan compared with PLDH was estimated to be £324,188. Paclitaxel was strictly dominated. LIMITATIONS: As platinum- and non-platinum-based treatments were evaluated separately, the comparative clinical effectiveness and cost-effectiveness of these regimens is uncertain in patients with platinum-sensitive disease. CONCLUSIONS: For platinum-sensitive disease, it was not possible to compare the clinical effectiveness and cost-effectiveness of platinum-based therapies with non-platinum-based therapies. For people with platinum-sensitive disease and treated with platinum-based therapies, paclitaxel plus platinum could be considered cost-effective compared with platinum at a threshold of £30,000 per additional QALY. For people with platinum-sensitive disease and treated with non-platinum-based therapies, it is unclear whether PLDH would be considered cost-effective compared with paclitaxel at a threshold of £30,000 per additional QALY; trabectedin plus PLDH is unlikely to be considered cost-effective compared with PLDH. For patients with PRR disease, it is unlikely that topotecan would be considered cost-effective compared with PLDH. Randomised controlled trials comparing platinum with non-platinum-based treatments might help to verify the comparative effectiveness of these regimens. STUDY REGISTRATION: This study is registered as PROSPERO CRD42013003555. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

Peritonectomy and hyperthermic intraperitoneal chemotherapy: cost analysis and sustainability.

BACKGROUND: Malignancies of the peritoneum remain a challenge in any hospital that accepts to manage them, due not only to difficulties associated with the complexity of the procedures involved but also the costs, which - in Italy and other countries that use a diagnosis-related group (DRG) system - are not adequately reimbursed. MATERIAL AND METHODS: We analyzed data relative to 24 patients operated on between September 2010 and May 2013 with special regard to operating room expenditure, ICU stay, duration of hospitalization, and DRG reimbursement. The total costs per patient included clinical, operating room, procedure, pathology, imaging, ward care, allied healthcare, pharmaceutical, and ICU costs. RESULTS: Postoperative hospital stay, drugs and materials, and operating room occupancy were the main factors affecting the expenditure for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy. We had a median hospitalization of 14 days, median ICU stay of 2.4 days, and median operating room occupancy of 585 min. The median expenditure for each case was € 21,744; the median reimbursement by the national health system € 8,375. CONCLUSIONS: In a DRG reimbursement system, the economic effort in the management of patients undergoing peritonectomy procedures may not be counterbalanced by adequate reimbursement. Joint efforts between medical and administration parties are mandatory to develop appropriate treatment protocols and keep down the costs.

Can we maximize both value and quality in gynecologic cancer care? A work in progress.

Value is defined as desirable health outcomes achieved per monetary unit spent. Comparative effectiveness research and cost-effectiveness research are methods that have been developed to quantify effectiveness and value to inform management decisions. In this article we review the comparative and cost-effectiveness literature in the field of ovarian cancer treatment. Studies have shown that improved ovarian cancer survival is associated with complete primary surgical cytoreduction, with treatment at high volume facilities by subspecialist providers (gynecologic oncologists) and with National Comprehensive Cancer Network (NCCN) guideline-adherent care in both surgical staging and chemotherapy regimens. Intraperitoneal/intravenous chemotherapy (compared with intravenous alone) has been associated with improved survival and cost-effectiveness. Bevacizumab for primary and maintenance therapy has been found to not be cost-effective (even in selective subsets) despite a small progression-free survival (PFS) advantage. For platinum-sensitive recurrent ovarian cancer, secondary cytoreduction and platinum-based combinations are associated with improved overall survival (OS); several platinum-based combinations have also been found cost-effective. For platinum-resistant recurrence, single agent therapy and supportive care are cost-effective compared with combination therapies. Although little prospective clinical research has been done around end-of-life care, one study reported that for platinum-resistant ovarian cancer, palliative intervention would potentially reduce costs and increase quality adjusted life years compared with usual care (based on improvement in quality of life [QOL]). Overall, cost comparisons of individual chemotherapy regimens are highly dependent on market prices of novel therapeutic agents.

Spatial analysis of adherence to treatment guidelines for advanced-stage ovarian cancer and the impact of race and socioeconomic status.

OBJECTIVE: To determine the impact of geographic location on advanced-stage ovarian cancer care adherence to the National Comprehensive Cancer Network (NCCN) guidelines in relation to race and socioeconomic status (SES). METHODS: Patients diagnosed with stage IIIC/IV epithelial ovarian cancer (1/1/96-12/31/06) were identified from the California Cancer Registry. Generalized additive models were created to assess the effect of spatial distributions of geographic location, proximity to a high-volume hospital (≥20 cases/year), distance traveled to receive care, race, and SES on adherence to NCCN guidelines, with simultaneous smoothing of geographic location and adjustment for confounding variables. Disparities in geographic predictors of treatment adherence were analyzed with the x(2) test for equality of proportions. RESULTS: Of the 11,770 patients identified, 45.4% were treated according to NCCN guidelines. Black race (OR=1.49, 95%CI=1.21-1.83), low-SES (OR=1.46, 95%CI=1.24-1.72), and geographic location ≥80 km/50 mi from a high-volume hospital (OR=1.88, 95%CI=1.61-2.19) were independently associated with an increased risk of non-adherent care, while high-volume hospital treatment (OR=0.59, 95%CI=0.53-0.66) and travel distance to receive care ≥32 km/20 mi (OR=0.80, 95%CI=0.69-0.92) were independently protective. SES was inversely associated with location ≥80 km/50 mi from a high-volume hospital, ranging from 6.3% (high-SES) to 33.0% (low-SES) (p<0.0001). White patients were significantly more likely to travel ≥32 km/20 mi to receive care (21.8%) compared to Blacks (14.4%), Hispanics (15.9%), and Asian/Pacific Islanders (15.5%) (p<0.0001). CONCLUSION: Geographic proximity to a high-volume hospital and travel distance to receive treatment are independently associated with NCCN guideline adherent care for advanced-stage ovarian cancer. Geographic barriers to standard ovarian cancer treatment disproportionately affect racial minorities and women of low-SES.

Evaluation of the cost of CA-125 measurement, physical exam, and imaging in the diagnosis of recurrent ovarian cancer.

OBJECTIVE: Ovarian cancer accounts for 50% of deaths from gynecologic malignancies. We sought to determine the cost of common methods of surveillance of women with ovarian cancer in first clinical remission. The current standard for post treatment surveillance is the National Comprehensive Cancer Network (NCCN) guidelines. METHODS: We retrospectively determined how recurrence was initially detected at our institution and a cost model was created and applied to the United States population to calculate surveillance costs using the Surveillance Epidemiology & End Results (SEER) database. RESULTS: 57% (n=60) of first recurrences were identified by increasing CA 125 level. Routine office visit identified 27% (n=29) of recurrences, and 15% (n=16) were diagnosed initially with CT scan. In 5% (5/105), CT abnormality was the only finding. 95% (100/105) of patients had either elevated CA 125 or office visit findings at time of recurrence. Of the 22,000 women diagnosed with ovarian cancer yearly, 60% (n=13,266) will have advanced disease and are likely to recur. The surveillance cost for this population for 2 years using our model is $32,500,000 using NCCN guidelines and $58,000,000 if one CT scan is obtained. CONCLUSIONS: Our data suggests that following NCCN guidelines will detect 95% of recurrences. An additional $26 million will be needed to identify the 5% of women with recurrence seen on CT only. Post treatment surveillance of ovarian cancer patients contributes significantly to health care costs. Use of CT scan to follow these patients largely increases cost with only a small increase in recurrence detection.

Disparities in ovarian cancer care quality and survival according to race and socioeconomic status.

BACKGROUND: The relationship between racial and socioeconomic status (SES) disparities and the quality of epithelial ovarian cancer care and survival outcome are unclear. METHODS: A population-based analysis of National Cancer Data Base (NCDB) records for invasive primary epithelial ovarian cancer diagnosed in the period from 1998 to 2002 was done using data from patients classified as white or black. Adherence to National Comprehensive Cancer Network (NCCN) guideline care was defined by stage-appropriate surgical procedures and recommended chemotherapy. The main outcome measures were differences in adherence to NCCN guidelines and overall survival according to race and SES and were analyzed using binomial logistic regression and multilevel survival analysis. RESULTS: A total of 47 160 patients (white = 43 995; black = 3165) were identified. Non-NCCN-guideline-adherent care was an independent predictor of inferior overall survival (hazard ratio [HR] = 1.43, 95% confidence interval [CI] = 1.38 to 1.47). Demographic characteristics independently associated with a higher likelihood of not receiving NCCN guideline-adherent care were black race (odds ratio [OR] = 1.36, 95% CI = 1.25 to 1.48), Medicare payer status (OR = 1.20, 95% CI = 1.12 to 1.28), and not insured payer status (OR = 1.33, 95% CI = 1.19 to 1.49). After controlling for disease and treatment-related variables, independent racial and SES predictors of survival were black race (HR = 1.29, 95% CI = 1.22 to 1.36), Medicaid payer status (HR = 1.29, 95% CI = 1.20 to 1.38), not insured payer status (HR = 1.32, 95% CI = 1.20 to 1.44), and median household income less than $35 000 (HR = 1.06, 95% CI = 1.02 to 1.11). CONCLUSIONS: These data highlight statistically and clinically significant disparities in the quality of ovarian cancer care and overall survival, independent of NCCN guidelines, along racial and SES parameters. Increased efforts are needed to more precisely define the patient, provider, health-care system, and societal factors leading to these observed disparities and guide targeted interventions.

Prophylactic salpingectomy and delayed oophorectomy as an alternative for BRCA mutation carriers.

OBJECTIVE: Prophylactic bilateral salpingo-oophorectomy is advised for women with BRCA mutations, but there are adverse consequences of premature menopause. The majority of BRCA-associated ovarian cancers appear to arise in the fallopian tube; therefore, salpingectomy may be an alternative to bilateral salpingo-oophorectomy. We compared the costs and benefits of salpingectomy with bilateral salpingo-oophorectomy among BRCA mutation carriers. METHODS: We developed a Markov Monte Carlo simulation model to compare three strategies for risk reduction in women with BRCA mutations: 1) bilateral salpingo-oophorectomy; 2) bilateral salpingectomy; and 3) bilateral salpingectomy with delayed oophorectomy. Net health benefits were measured in years-of-life expectancy and quality-adjusted life-year expectancy, and the primary outcome was the incremental cost-effectiveness ratio. The model estimated the number of future breast and ovarian cancers and cardiovascular deaths attributed to premature menopause with each strategy. RESULTS: Bilateral salpingo-oophorectomy was associated with the lowest cost and highest life expectancy compared with the other two strategies. When quality-of-life measures were included, salpingectomy followed by delayed oophorectomy yielded the highest quality-adjusted life expectancy with incremental cost-effectiveness ratios of $37,805 and $89,680 per quality-adjusted life-year for BRCA1 and BRCA2, respectively, relative to salpingectomy alone. Bilateral salpingo-oophorectomy yielded the lowest number of future breast and ovarian cancers compared with the other two strategies. CONCLUSION: Bilateral salpingo-oophorectomy offers the greatest risk reduction for breast and ovarian cancer among BRCA mutation carriers. However, when considering quality-adjusted life expectancy, bilateral salpingectomy with delayed oophorectomy is a cost-effective strategy and may be an acceptable alternative for those unwilling to undergo bilateral salpingo-oophorectomy.

[Hyperthermic intraperitoneal chemotherapy in the German DRG system. Analysis of case cost calculations of a maximum care university]. / Hypertherme intraperitoneale Chemotherapie im G-DRG-System. Analyse der Fallkostenkalkulationen eines universitären Maximalversorgers.

BACKGROUND: Cytoreductive surgery with hyperthermic intraperitoneal chemotherapy (HIPEC) offers patients with peritoneal cancer of various origins the chance of a relevant increase in life expectancy. These cases are very complex from a medical viewpoint and very expensive from an economical aspect. An analysis of case cost calculations was performed to find out whether this procedure can on average be carried out cost-effectively by a maximum care university. MATERIALS AND METHODS: All cases from 2008 in which HIPEC was carried out were analyzed. The types of main diagnosis, secondary diagnoses, procedures, times from incision to suture and hospital stay were analyzed. On the basis of the case costs the proceeds and marginal returns were calculated from the diagnosis-related groups (DRGs) and additional remuneration when applicable. The causes of positive and negative marginal returns were explained using the InEK cost matrix. RESULTS: In 18 patients there were 9 different main diagnoses and 7 different "main procedures" (from a surgical perspective the most resource intensive procedures) and a total of 10 different DRGs were identified in the grouping algorithm. With an average of 2 operations (range 1-7) per patient the summed incision-to-suture time was 423 min (170-962 min). The patients stayed on average 6.4 days (1.3-17.6 days) in intensive care. The average case cost was 21,072€ (range 8,657-55,904€) and the proceeds 20,474€ (6,333-37,497€). Each case had on average a debit balance of 598€ (range from 11,843€ profit balance to 18,407€ debit balance) with an assumed base rate of 2,786€. The causes for positive or negative marginal profits were mostly operating times, incision-to-suture times and duration of intensive care. CONCLUSIONS: The proceeds showed on average a deficit of only 3% compared to the costs. The operating times must be decreased by optimization particularly of the preoperative approach. Interventions should be carried out in one stage only and the intraoperative connecting and waiting times should be reduced in order to reduce the incision-to-suture times.

Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy in the management of peritoneal carcinomatosis. Preliminary results and cost from two centers in Greece.

PURPOSE: To report our preliminary experience in the combined treatment of peritoneal carcinomatosis (PC) using cytoreductive surgery plus hyperthermic intraperitoneal chemotherapy (HIPEC). PATIENTS AND METHODS: This prospective study included patients with PC from gynaecological, gastric and colon cancer, treated in two centers. Cytoreductive surgery included the peritonectomy procedures described by Jacquet and Sugarbaker as well as multivisceral resections in order to achieve a complete macroscopical cancer eradication. The HIPEC that followed was performed via the open abdomen technique. RESULTS: Twenty-four patients (3 men and 21 women, mean age 60 years) were treated. Twelve patients had PC from ovarian cancer, 7 from colon, 3 from gastric and 2 from uterine cancer. The mean duration of the procedure was 7.83 h (range 5 -12.30). Macroscopically, complete cytoreduction (CC) was achieved in 18 (75%) patients. Two (8.3%) patients died in the first 30 days. The overall morbidity was 42% and 2 patients were reoperated. The mean follow up was 22 months (range 3-36). The overall 1-year survival was 59.1%; concerning the gynaecological cancers it was 53.8% (mean survival 11.7 months) and for gastrointestinal cancers it was 44.4% (mean survival 9.5 months). CONCLUSION: Our preliminary data suggest that the combined treatment of cytoreduction plus HIPEC for PC is associated with acceptable mortality and morbidity and offers an improved survival in these patients. An optimal patient selection and establishment of experienced centres are of paramount importance.

Analysis of the cost-effectiveness of paclitaxel as alternative combination therapy for advanced ovarian cancer.

PURPOSE: A phase III trial by the Gynecologic Oncology Group (GOG) provides strong evidence that a new alternative therapy--paclitaxel (Taxol; Bristol-Myers Squibb Co, Princeton, NJ) in combination with cisplatin (Platinol; Bristol-Myers Squibb Co)--is clinically more effective than the standard therapy using cyclophosphamide (Cytoxan; Bristol-Myers Squibb Co) in combination with cisplatin in the treatment of advanced ovarian cancer. We conducted a pharmacoeconomic analysis to determine whether the alternative paclitaxel-cisplatin (TP) therapy is cost-effective (CE) in comparison to standard cyclophosphamide-cisplatin (CP) therapy. METHODS: Using an economic model, we applied cost data figures to resource utilization data derived from the two arms of the GOG trial. We examined paclitaxel benefits in terms of increased mean survival time, as well as median survival time. Estimates of the cumulative proportion surviving in the trial were based on Kaplan-Meier procedures. RESULTS: Per year of life gained (YLG), TP therapy costs more ($19,820 more for inpatient treatment; $21,222 outpatient) than CP treatment. CONCLUSION: The TP regimen's increased mean survival cost per YLG (inpatient and outpatient settings) adds a substantial benefit at an acceptable cost compared with CP therapy.