Healthcare costs related to adverse events in hepatocellular carcinoma treatment: A retrospective observational claims study.

BACKGROUND: Hepatocellular carcinoma (HCC) is an aggressive form of liver cancer with increasing incidence and mortality worldwide. For metastatic disease, systemic treatment is recommended. In addition to tumor characteristics, adverse events (AEs) may influence regimen choice. AIM: To analyze healthcare burden among patients with advanced HCC, by treatment type and AEs observed. METHODS: Included were adult commercial and Medicare Advantage enrollees with ≥2 non-diagnostic claims coded for HCC (the first setting the index date); ≥1 claim for systemic treatment of advanced/metastatic HCC; and continuous enrollment for a 6-month pre-index baseline period to ≥1 month post-index (follow-up). Patients were excluded by lack of systemic treatment; incomplete demographic information; pregnancy, liver transplant, other cancers during baseline or clinical trial participation. We describe patient characteristics, common AEs, overall survival, and healthcare burden in 2017 USD up to 12 months after initiation of tyrosine kinase inhibitor (TKI) monotherapy; immune checkpoint inhibitor (ICI) monotherapy; or FOLFOX combination therapy. RESULTS: The analytic sample consisted of 322 patients (median age 65.8 years, 76% male) who had 12 months' (unless death occurred prior) available follow-up, with median follow-up of 9 months. Among these, 241 (75%) had TKI monotherapy, 23 (7%) had ICI monotherapy, and 58 had FOLFOX (18%) first-line treatment. Overall, patients had a high burden of AEs (mean 3.2), with the most prevalent being pain (75%), infection (39%), ascites (34%), and bleeding (29%). After adjusting for covariates, infection ($50 374), fever ($47 443), and diarrhea ($29 912) imposed the highest incremental annual costs versus patients without the AE. Up to 90% of costs were attributable to inpatient admissions, with 56% to 60% involving intensive care. Median 1-year survival was 32%. CONCLUSIONS: This real-world study demonstrated AE burden in alignment with previous clinical studies. Regardless of regimen used, AEs are associated with substantial healthcare costs due to inpatient care.

Clinical and economic outcomes by first-line treatment among women with HR+/HER2- metastatic breast cancer in a large US health plan database.

BACKGROUND: Guidelines recommend that women with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) metastatic breast cancer (mBC) initiate hormonal therapy before chemotherapy. This study compared outcomes of women with mBC who received chemotherapy first vs hormonal therapy. METHODS: A retrospective cohort study of women with mBC was conducted using a large US commercial health plan database between January 1, 2008-April 30, 2013. Subjects had evidence of a HR+/HER2- tumor sub-type in a cancer registry and use of chemotherapy or hormonal therapy in claims. Subjects were continuously enrolled for ≥6 months after metastasis and assigned to cohorts for receiving chemotherapy only or hormonal therapy only during first-line (CT-1L vs HT-1L). Adjusted incidence rates of clinically significant events were compared using a negative binomial model, and adjusted healthcare costs were compared using a generalized linear model. RESULTS: Three hundred and twenty-four women with HR+/HER2- mBC met the selection criteria; 179 (55%) received CT-1L and 145 (45%) received HT-1L. Mortality rates did not differ between cohorts (unadjusted incidence rate ratio (IRR) = 1.67, 95% CI = 0.82-3.46; adjusted IRR = 0.64, 95% CI = 0.32-1.27). Adjusted average total all-cause healthcare costs were $11 090 for women with CT-1L and $6743 for women with HT-1L (cost ratio =1.64, 95% CI =1.36-1.99). CONCLUSIONS: Observed use of first-line chemotherapy (>50%) was higher than expected given the HR + molecular profile of the tumors. Chemotherapy use during first-line did not appear to be associated with a survival benefit, but was associated with significantly higher costs compared with the use of hormonal therapy during first-line; however, this comparison is limited by demographic and baseline characteristic differences between the two cohorts. This study contributes to understanding real-world treatment patterns and the associated clinical and economic outcomes of using chemotherapy vs hormonal therapy as a first-line treatment option for the HR+/HER2- mBC population.

An Evaluation of Algorithms for Identifying Metastatic Breast, Lung, or Colorectal Cancer in Administrative Claims Data.

BACKGROUND: Administrative health care claims data are used for epidemiologic, health services, and outcomes cancer research and thus play a significant role in policy. Cancer stage, which is often a major driver of cost and clinical outcomes, is not typically included in claims data. OBJECTIVES: Evaluate algorithms used in a dataset of cancer patients to identify patients with metastatic breast (BC), lung (LC), or colorectal (CRC) cancer using claims data. METHODS: Clinical data on BC, LC, or CRC patients (between January 1, 2007 and March 31, 2010) were linked to a health care claims database. Inclusion required health plan enrollment ≥3 months before initial cancer diagnosis date. Algorithms were used in the claims database to identify patients' disease status, which was compared with physician-reported metastases. Generic and tumor-specific algorithms were evaluated using ICD-9 codes, varying diagnosis time frames, and including/excluding other tumors. Positive and negative predictive values, sensitivity, and specificity were assessed. RESULTS: The linked databases included 14,480 patients; of whom, 32%, 17%, and 14.2% had metastatic BC, LC, and CRC, respectively, at diagnosis and met inclusion criteria. Nontumor-specific algorithms had lower specificity than tumor-specific algorithms. Tumor-specific algorithms' sensitivity and specificity were 53% and 99% for BC, 55% and 85% for LC, and 59% and 98% for CRC, respectively. CONCLUSIONS: Algorithms to distinguish metastatic BC, LC, and CRC from locally advanced disease should use tumor-specific primary cancer codes with 2 claims for the specific primary cancer >30-42 days apart to reduce misclassification. These performed best overall in specificity, positive predictive values, and overall accuracy to identify metastatic cancer in a health care claims database.

Diagnostic testing managed by hematopathology specialty and other laboratories: costs and patient diagnostic outcomes.

BACKGROUND: Successful management of patients with hematologic malignancies depends upon accurate and timely diagnosis, which frequently requires integration and interpretation of multiple tests. Our retrospective analysis compared diagnostic uncertainty, resource utilization, and costs for patients with diagnostic bone marrow (BM) tests managed by commercial laboratories. METHODS: Patients with BM biopsies and suspected hematologic cancer/condition were identified from claims (2005-2011) within a large US health plan (coverage ≥6 pre- and ≥3-months post-biopsy). Cohorts defined by laboratories performing BM morphologic assessment/directing testing sequence: Genoptix (GX, specialty hematology-testing laboratory), large commercial laboratories (LL), other laboratories (OL). One-year post-biopsy changes in diagnosis or treatments, tests performed, and diagnostic/treatment medical costs (measured as per-patient-per-month [PPPM]) were examined. RESULTS: The study population included 1,387 GX, 4,162 LL, and 19,115 OL patients with suspected hematologic malignancy/disease and BM morphology assessment. GX had lower diagnostic uncertainty measured between 2 time periods by diagnostic stability (no conditions the same; 6.16% GX, 8.04% LL, 9.73% OL; p < 0.001) and changes (≥1 condition different; 7.88% GX, 11.19% LL, and 14.08% OL; p < 0.001), fewer repeat BM biopsies, and fewer chemotherapy changes (30-days and 60-days post-initiation). One-year PPPM costs adjusted for patient characteristics differences were $8,202 GX, $7,711 LL, and $10,302 OL (p < 0.05); adjusted PPPM costs (excluding testing period) were $6,019 GX, $6,649 LL, and $7,801 OL (p < 0.05). CONCLUSIONS: Our data suggests that a hematopathology specialty laboratory may result in earlier final diagnosis, fewer subsequent diagnosis changes, reduced need for follow-on testing requiring repeat biopsy procedures, and may result in lower downstream healthcare costs. Further evaluations using medical chart abstractions or registries will be valuable.

Health care utilization and costs by site of service for nonmetastatic breast cancer patients treated with trastuzumab.

BACKGROUND: Adjuvant trastuzumab treatment is administered to early stage breast cancer patients in physician office (POV) or hospital outpatient (HOP) settings. OBJECTIVE: To identify treatment patterns, utilization, and costs by site of care (POV vs. HOP) of patients with adjuvant treatment of breast cancer with trastuzumab. METHODS: This retrospective analysis identified adult, female breast cancer patients who initiated trastuzumab treatment (index date) from a large U.S. claims database. Inclusion criteria also required ≥ 2 claims for both trastuzumab (from July 1, 2006, to July 31, 2012) and breast cancer (during 6-month pre-index baseline period), no evidence of metastatic breast cancer or other cancers in the baseline period, and continuous enrollment with commercial or Medicare Advantage coverage 6 months pre- and post-index, except that patients who died during follow-up were retained. Patients with evidence of trastuzumab receipt during the baseline period or more than 1 site of care during follow-up were excluded. Patients were stratified by site of care and were followed from index date to 30 days after the last trastuzumab infusion prior to a gap ≥ 90 days, death, disenrollment, or end-of-study period. Differences in treatment patterns between the POV and HOP cohorts were assessed by t-test and chi-square test. The relationship between site of care and health care costs was modeled with a generalized linear model with gamma distribution and log link, and the number of trastuzumab infusions was modeled with negative binomial regression controlling for log follow-up time. All models were adjusted for age, baseline comorbidity score, and insurance type. RESULTS: Of the 3,439 breast cancer patients identified, 77.6% (2,669) received adjuvant trastuzumab in the POV setting. Mean age (53.7 years) and baseline comorbidity score (3.91) were similar among cohorts; a higher percentage of POV versus HOP patients had commercial insurance (91.1% vs. 86.4%, P < 0.001). Compared with the POV cohort, HOP patients had a shorter mean duration of trastuzumab treatment (324.8 vs. 343.0 days, P < 0.001); more treatment gaps (30-59 day gap: 67.4% vs. 24.1%, P < 0.001); and fewer trastuzumab infusions per month (1.37 vs. 1.98, P < 0.001) during follow-up. In multivariate analysis, the monthly count of trastuzumab infusions in the HOP cohort was lower than the POV cohort (incidence rate ratio = 0.693; 95% CI = 0.672-0.715). Adjusted per patient per month total health care costs were 53.6 % higher in the HOP setting (cost ratio = 1.536, 95% CI = 1.472-1.604). CONCLUSIONS: Breast cancer patients treated with adjuvant trastuzumab in the HOP setting had a shorter duration of trastuzumab treatment and fewer trastuzumab infusions but incurred higher monthly total costs than patients treated in the POV setting.

Healthcare costs, treatment patterns, and resource utilization among pancreatic cancer patients in a managed care population.

BACKGROUND: Pancreatic adenocarcinoma has few effective treatment options and poor survival. The objective of this study was to characterize treatment patterns and estimate the costs and resource use associated with its treatment in a commercially-insured US population. METHODS: In this retrospective claims-based analysis, individuals ≥18 years old with evidence of pancreatic adenocarcinoma between January 1, 2001 and December 31, 2010 were selected from a managed care database. Treatment phase (either initial non-metastatic or metastatic) was determined using a claims-based algorithm. Patients in the pancreatic cancer population were matched 1:3 to a control population. Resource use (events/person-years), treatment patterns, and healthcare costs (per-patient per-month, PPPM) were determined during a variable length follow-up period (from first pancreatic cancer diagnosis to earliest of death, disenrollment, or study end). RESULTS: In this study, 5262 pancreatic cancer patients were matched to 15,786 controls. Rates of office visits, inpatient visits, ER visits, and inpatient stays, and mean total all-cause healthcare costs PPPM ($15,480 vs $1001) were significantly higher among cancer patients than controls (all p < 0.001). Mean inpatient costs were the single largest cost driver ($9917 PPPM). Also, mean total all-cause healthcare costs were significantly higher during the metastatic treatment phase vs the initial treatment phase of non-metastatic disease ($21,637 vs $10,358, p < 0.001). CONCLUSIONS: These results indicate that pancreatic cancer imposes a substantial burden on the US healthcare system, and that treatment of more advanced disease is significantly more costly than initial treatment of non-metastatic disease. LIMITATIONS: Additional research is needed to validate the accuracy of the claims-based algorithms used to identify the treatment phase.

Retrospective claims analysis of best supportive care costs and survival in a US metastatic renal cell population.

INTRODUCTION: Survival and best supportive care (BSC) costs for patients with metastatic renal cell carcinoma (mRCC), after stopping therapy, are poorly characterized yet an important aspect of patient care. This study examined survival and costs associated with BSC after one or two lines of therapy (LOTs) for mRCC. METHODS: A retrospective cohort analysis used claims data from commercially insured or Medicare Advantage Prescription Drug (MAPD) plan enrollees of a large United States health plan with an index RCC diagnosis (ICD-9-CM 189.0) between January 1, 2007 and June 30, 2010; initiating any of the following therapies 30 days pre-index date through disenrollment from plan: sunitinib, temsirolimus, sorafenib, bevacizumab, everolimus, pazopanib, cytokines. LOT was identified using prescription fill and administration dates. Health care costs represent health plan- plus patient-paid amounts. RESULTS: The cohort (n = 274) was 73% male, with a mean age of 63.3 years (SD 11.1), with 80% commercially insured (20% MAPD), and 68% starting BSC following one LOT. Mean BSC duration was longer following one than two LOTs (223 [SD 260], 176 [SD 163] days). Median survival from the start of BSC was similar following one and two LOTs (126 and 118 days). Total BSC costs following one and two LOTs averaged US$50,188 (SD $96,984) and $37,295 (SD $51,102). Monthly costs for BSC following one and two LOTs ($10,151 and $10,566) were not substantially lower than costs while on treatment ($14,621 and $16,957). Inpatient hospital costs represented 47% and 49% following one and two LOTs, with ambulatory costs of approximately 36% following each LOT. CONCLUSION: Our study found similar survival and monthly costs for BSC following either one or two LOTs, with almost half of the cost reflecting inpatient care. Compared to costs on treatment ($14,621 to $16,957), BSC costs can be considerable ($10,151 to $10,566).

Corroboration of claims algorithm for second-line costs of metastatic colorectal cancer treatment with targeted agents.

OBJECTIVE: To refine a claims algorithm for identifying second-line systemic regimens for metastatic colorectal cancer (mCRC) based on clinical evidence and to compare costs during second-line treatment by targeted therapy administered. METHODS: This retrospective analysis of a large US managed care database identified patients diagnosed with mCRC during 1 July 2007-30 June 2011. A claims-based algorithm was developed to identify patients with at least two lines of therapy (LOT) and the second LOT contained one targeted agent: bevacizumab or any anti-epidermal growth factor receptor (EGFR). Medical chart data from 92 patients were used to corroborate and refine the LOT algorithm. The positive predictive value (PPV) of the initial algorithm and refined algorithm for identification of second LOT are presented. The final algorithm was applied to claims data and two mutually exclusive second-line cohorts were examined: patients with bevacizumab- or cetuximab-containing regimens. Second-line healthcare costs were analyzed with generalized linear models adjusted for demographic and clinical characteristics. RESULTS: The PPV increased from 50.0% (95% CI = 39.4-60.6) for the initial algorithm to 72.1% (95% CI = 59.2-82.9) for the final algorithm. Mean age in the cohorts (n = 569) was 61 years; 58% were men. Days of therapy were similar for the bevacizumab (n = 450) vs cetuximab (n = 119) cohorts, respectively: 131 vs 148 in first LOT and 123 (both cohorts) in second LOT (p ≥ 0.27). Total costs during second-line treatment in the bevacizumab cohort were lower by $12,318 (p = 0.02) and medical costs were lower by $13,809 (p = 0.01). Monthly total and medical costs were lower by $2728 (p = 0.03) and $3133 (p = 0.01), respectively. Results are based on commercially or Medicare-insured patients and may not be generalizable to Medicaid or uninsured patients. CONCLUSIONS: Corroboration of claim-based algorithms with medical chart data improved algorithm performance. Second-line total and medical costs were lower for mCRC patients treated with bevacizumab compared with cetuximab.

Comparative analysis of survival, treatment, cost and resource use among patients newly diagnosed with brain metastasis by initial primary cancer.

Brain metastases are a frequent complication of many systemic cancers and portend a poor prognosis. This retrospective analysis of health claims data compared survival, treatment and health care utilization and costs in patients with brain metastasis by primary tumor site. Adult commercial and Medicare Advantage enrollees newly diagnosed with brain metastasis in 01 Jan 2004 through 30 Apr 2010 were identified. Inclusion required at least 2 claims that identified the same primary cancer site prior to diagnosis of brain metastasis and no evidence of primary brain tumors. Health care utilization rates and costs were calculated at the patient level for each month of follow-up. Differences among primary cancer site cohorts were assessed by ANOVA (continuous variables), Chi square test (proportions) and the Poisson distribution (utilization rates). The primary cancer cohorts comprised 1,031 lung cancer, 93 melanoma and 395 female breast cancer patients. During the 6 months prior to brain metastasis diagnosis, 59 % of lung cancer patients had no evidence of lymph node involvement or other metastatic disease compared to 55 and 42 % of melanoma and breast cancer patients (P < 0.001). Survival after brain metastasis diagnosis was less than 3 months for 52, 43 and 39 % for lung cancer, breast cancer and melanoma, respectively (P < 0.001). Melanoma patients had the highest rate of inpatient stays and outpatient visits (P ≤ 0.003). Total monthly all-cause costs were: melanoma, $23,426; breast cancer $19,708; lung cancer, $17,007 (P = 0.003). Health care utilization and costs after brain metastasis diagnosis were substantial and differed by primary tumor site.

The burden of metastatic melanoma: treatment patterns, healthcare use (utilization), and costs.

Using a large national claims database, this study investigates the differences in survival and healthcare costs of metastatic melanoma patients by the number of metastatic sites. An analysis was carried out using data obtained from January 2007 to March 2010. Patients included had at least two claims for metastatic disease at least 30 days apart, at least two claims for melanoma at least 30 days apart, or at least one claim for cancer-related treatment with a diagnosis of melanoma and evidence of anticancer systemic therapy. The index date was the first metastatic diagnosis date. Patients were characterized as having evidence of lymph node (LN) involvement only, 1-3 distant metastatic sites, or 4+ distant metastatic sites. Average per-patient per-month (PPPM) costs and mortality were examined. There were 431 metastatic melanoma patients: most were male (65%) with mean baseline Charlson's comorbidity index of 3.52. The mean (SD) total unadjusted costs PPPM in the follow-up period were lower for patients with metastases to LN only ($6773 [$5521]) than for those who had 1-3 ($10 999 [$11 319]) or 4+ ($15 762 [$12 377]) distant metastases (P<0.001). When compared with patients with LN metastases only, patients having 1-3 [cost ratio (CR): 1.739, P<0.001] or 4+ (CR: 2.375, P<0.001) distant metastatic sites had higher all-cause healthcare costs. Among the entire study cohort, 42% died with a median survival time of 270 days. Mortality varied by cohort: 3% in LN only; 37% in 1-3 non-LN, and 64% in >3 non-LN (P<0.001). In conclusion, patients with metastatic melanoma with a greater number of metastatic sites have increased healthcare costs and significantly worse survival times.

Health care costs and resource utilization, including patient burden, associated with novel-agent-based treatment versus other therapies for multiple myeloma: findings using real-world claims data.

BACKGROUND: . Treatment of multiple myeloma has dramatically improved with the introduction of bortezomib (BOR), thalidomide (THAL), and lenalidomide (LEN). Studies assessing health care costs, particularly economic burden on patients, are limited. We conducted a claims-based, retrospective analysis of total health care costs as well as patient burden (patient out-of-pocket costs and number of ambulatory/hospital visits) associated with BOR/THAL/LEN treatment versus other therapies (OTHER). METHODS. Treatment episodes starting between January 1, 2005 and September 30, 2010 were identified from the claims database of a large U.S. health plan. Health care costs and utilization were measured during 1 year after initiation and analyzed per treatment episode. Multivariate analyses were used to adjust for patient characteristics, comorbidities, and line of treatment. RESULTS: A total of 4,836 treatment episodes were identified. Mean adjusted total costs were similar between BOR ($112,889) and OTHER ($111,820), but higher with THAL ($129,412) and LEN ($158,428). Mean adjusted patient out-of-pocket costs were also similar for BOR ($3,846) and OTHER ($3,900) but remained higher with THAL ($4,666) and LEN ($4,483). Mean adjusted rates of ambulatory visits were similar across therapies (BOR: 69.67; THAL: 66.31; LEN: 65.60; OTHER: 69.42). CONCLUSIONS: Adjusted analyses of real-world claims data show that total health care costs, as well as patient out-of-pocket costs, are higher with THAL/LEN treatment episodes than with BOR/OTHER therapies. Additionally, similar rates of ambulatory visits suggest that any perceived advantage in patient convenience of the orally administered drugs THAL/LEN is not supported by these data.

Evaluation of the clinical benefit of long-term (beyond 2 years) treatment of skeletal-related events in advanced cancers with zoledronic acid.

BACKGROUND: Skeletal complications of malignant bone disease are common among patients with both solid tumors and multiple myeloma (MM). Zoledronic acid (ZOL; Zometa*) is an intravenous bisphosphonate with proven efficacy in reducing the incidence of skeletal complications and delaying the time to a first skeletal complication. This study was designed to assess the continued benefit of ZOL treatment over a prolonged period. METHODS: This was a retrospective claims analysis study using information gathered from two national US managed-care plan databases. Patients ≥18 years of age with a single type of solid tumor or MM who were diagnosed with bone lesions and experienced at least one skeletal complication (before or after receiving ZOL) were included. RESULTS: Of the 28,385 patients, those with lung and breast cancer composed the largest group. Greater percentages of MM and breast cancer patients were treated with ZOL. On average, those with renal cell carcinoma and lung cancer had a longer time between bone metastasis diagnosis and start of therapy with ZOL. Compared with an untreated cohort, patients treated with ZOL had a 24% reduction in incidence of fracture, a 45% reduction in incidence of spinal cord compression, and a 56% reduction in risk of mortality. Patients with persistence with ZOL over 180 days had a reduced incidence of fracture before controlling for other factors. CONCLUSIONS: Patients treated with ZOL had reduced risks of fracture, spinal cord compression, and mortality compared with patients in the no-treatment cohort. Longer persistence with ZOL was associated with better outcomes. Greatest benefits were observed for patients treated on a regular basis with ZOL for a period beyond 18 months.

Persistency with zoledronic acid is associated with clinical benefit in patients with multiple myeloma.

Zoledronic acid (ZOL), an intravenous bisphosphonate, has been shown to reduce and delay the incidence of skeletal-related events (SREs) in multiple myeloma (MM) patients with bone disease. A retrospective claims-based analysis was conducted that used two distinct US managed care databases to examine the relationship between persistency with ZOL and clinical benefit. Patients >18 years, diagnosed with MM, and with at least one claim for ZOL (or a claim for malignant bone disease and ZOL initiation within 30 days) between 1/1/2001 and 12/31/2006 were included. Patients were evaluated for incidence of SREs and for mortality. Treatment persistency was defined as the absence of a >45 day gap between ZOL administrations. Of 1,655 patients in this analysis, 1,060 received ZOL and 595 received no intravenous bisphosphonate therapy. Compared with patients not receiving bisphosphonate therapy, ZOL-treated patients had lower incidences of SREs (P < 0.0001) and death (P = 0.0001). Longer persistency with ZOL was associated with lower risks of SREs (P = 0.001), fracture (P = 0.003), and death (P = 0.002) versus shorter persistency. Patients who were persistent with ZOL for ≥1.5 years had an incidence of 15.0 SREs and 6.2 fractures per 100 person-years. Patients who were persistent for 31-90 days had an incidence of 24.6 SREs and 14.0 fractures per 100 person-years, and patients not receiving intravenous bisphosphonates had an incidence of 32.2 SREs and 16.9 fractures per 100 person-years. These data from a real-world setting indicate that among MM patients, longer persistency with ZOL was associated with a lower risk of SREs and fracture.

Patient survival and healthcare utilization costs after diagnosis of triple-negative breast cancer in a United States managed care cancer registry.

BACKGROUND: Triple-negative breast cancer (TNBC) makes up 10-17% of all breast cancers and, due to lack of receptor expression, is unresponsive to therapies that target hormonal receptors or HER2. Unique in its tumor aggression and high rates of recurrence, TNBC is less likely to be detected by mammogram and has a poorer prognosis than other breast cancer subtypes (non-TNBC). OBJECTIVES: To examine the survival, healthcare utilization, and healthcare cost for women with TNBC compared with non-TNBC breast cancer. METHODS: The study population was derived from a US managed care cancer registry linked to health insurance claims and social security mortality data. Based on initial type and stage at diagnosis, patients were divided into two cohorts: patients with TNBC and those with non-TNBC. Records were analyzed from initial diagnosis until death, disenrollment, or end of observation period. Survival and annual healthcare utilization and costs were estimated and compared between cohorts after adjusting for baseline demographic characteristics, comorbidities, and prior resource use. Subgroup analyses were performed in patients diagnosed with stage I-III and IV breast cancer. RESULTS: The study included women diagnosed with TNBC (n = 450) and non-TNBC (n = 1807). Median follow-up time for all patients was 716 days (688.5 and 733 days for TNBC and non-TNBC patients, respectively). After initial diagnosis, overall mortality risk for the TNBC cohort was twice as high as the non-TNBC cohort (HR = 2.02, p < 0.0001). Patients with TNBC had more annual hospitalizations, hospitalized days, and number of emergency room visits relative to non-TNBC. Despite similar annual total healthcare costs, adjusted inpatient costs for patients with non-TNBC averaged 77% higher ($8395 vs. $4745, p < 0.0001). Furthermore, payer reimbursements were higher for TNBC than non-TNBC patients ($8213 vs. $4486, p < 0.0001). CONCLUSIONS: While it does not control for race or socioeconomic status, this study found that in a US managed care setting, patients with TNBC compared with non-TNBC have significantly shorter survival, accompanied by higher inpatient utilization and healthcare costs.

Health care costs for patients with cancer at the end of life.

PURPOSE: With rising health care costs in the United States, clearly defined end-of-life (EOL) cancer costs are needed to help health administrators proactively manage this important care. Our objective was to examine EOL health care resource costs among oncology patients in a US commercial insurance population. METHODS: A retrospective claims database affiliated with OptumInsight was analyzed. Included patients had: a medical claim with cancer diagnosis between July 1, 2002, and December 31, 2009; death on or before December 31, 2009; continuous enrollment with medical/pharmacy benefits from diagnosis until death; ≥ 180 follow-up days; and active cancer in the last 6 months before death (MBD). Death was captured from facility discharge codes or Social Security Administration death files. Costs were determined by summing paid amounts on all services utilized within the last 6 MBD: cancer-related inpatient (IP) stays, cancer- related hospice care, and cancer-related outpatient (OP) services (ie, chemotherapy, erythropoiesis-stimulating agents, granulocyte colony-stimulating factors, radiation, cancer-related office or emergency room visits, cancer-related hospital OP procedures, and other services with cancer diagnosis). RESULTS: A total of 28,530 patients met inclusion criteria. Mean total cancer-related costs in the last 6 MBD were $74,212 (standard deviation, $112,740), comprising IP costs of $40,702 (55%), OP costs of $30,254 (41%), and hospice costs of $3,256 (4%). OP costs decreased from $6,021 in the sixth MBD to $2,238 in the last MBD, whereas IP care costs increased from $1,785 to $20,559. Hospice utilization increased from 0.7% in the sixth MBD to 35.6% in the last MBD. CONCLUSION: Oncology costs increase in the last 6 MBD largely because of increased IP costs, whereas OP costs decrease.

Retrospective evaluation of the clinical benefit of long-term continuous use of zoledronic acid in patients with lung cancer and bone metastases.

BACKGROUND: For patients with bone metastases, skeletal-related events including fracture are common, can cause considerable morbidity, and may reduce overall survival (OS). This retrospective analysis assessed the effect of Zometa (zoledronic acid, ZOL), an intravenous bisphosphonate (IV-BP), on fracture risk and OS in patients with bone metastases from lung cancer (LC). (Zometa is a registered trademark of Novartis Pharmaceuticals Corporation, USA.) METHODS: A claims-based analysis using commercial and Medicare Advantage data from >45 US managed-care plans was used to evaluate the association between fracture risk and treatment persistency (31-90, 91-180, 181-365, and ≥366 days) and follow-up duration in LC patients diagnosed with bone metastases between 01/01/2001 and 12/31/2006 and treated with ZOL or without (no IV-BP). Persistency was defined as the absence of a >45-day gap between ZOL treatments. Analysis of variance tests were used to compare follow-up duration, a proxy for OS, between ZOL persistency groups. The effect of time to treatment with ZOL was also assessed. RESULTS: In 9874 LC patients with bone metastases (n = 1090 ZOL; n = 8784 no IV-BP) the unadjusted relative fracture risk was reduced by 40% with ZOL vs no IV-BP; fracture risk decreased consistently with increasing duration of ZOL treatment. Even short-term (31-90 days) ZOL significantly reduced fracture risk (47%) vs no IV-BP (p = 0.005) with adjustment for differences in demographic and clinical characteristics. Delaying ZOL until after bone metastases were diagnosed significantly increased fracture risk (p = 0.0017). For a sub-set of patients included in a survival analysis (n = 550 ZOL; n = 4512 no IV-BP), mortality was significantly lower (mean, 38.6 vs 46.8 deaths/100 person-years; p = 0.038) in those treated with ZOL vs no IV-BP. LIMITATIONS: Interpretation of this claims-based analysis must be tempered by the inherent limitations of observational data, such as limited clinical information and the ability to control for prognostic factors. CONCLUSIONS: This retrospective analysis demonstrates that LC patients with bone metastases receiving ZOL had significantly reduced risk of fracture (p = 0.005) and death (p < 0.038) vs patients receiving no IV-BP. Longer ZOL persistency consistently yielded better outcomes, with ≥12 months' treatment producing the greatest benefit.

Economic burden of resected squamous cell carcinoma of the head and neck in a US managed-care population.

BACKGROUND: Squamous cell carcinoma of the head and neck (SCCHN) places a high burden on society and poses complex challenges to healthcare providers. METHODS: Retrospective claims-based analysis of commercially insured patients identified between 01-31-04 and 12-31-07 with diagnostic evidence of cancer of the lip, tongue, oral cavity, pharynx, or larynx who underwent surgical resection during identification period. Outcomes included treatment patterns, healthcare utilization, and costs. All study variables were analyzed descriptively. RESULTS: Among the 1104 patients in the final study sample, 71.9% were male, with mean age 56.6 years. On average, patients were followed for 830 days (range of mean days: 805 for lip or tongue cancer to 847 for pharyngeal cancer). About half received radiation therapy during follow-up, whereas only 16.2% received chemotherapy. Patients with pharyngeal cancer were most likely to undergo chemotherapy. After their index surgery, 57.9% of patients had ≥1 inpatient stay, 44.9% had ≥1 ER visit, and all had ≥1 ambulatory visit. The percentage with ≥1 inpatient stay post-index was highest among patients with pharyngeal cancer (73.0%) and lowest in the laryngeal cancer cohort (49.5%). Mean number of hospitalized days, ER visits, and ambulatory visits was 0.45, 0.69, and 27.4, respectively, per-patient per-year. Overall, patients incurred ~$94 million in cost following index surgery ($85,000 per-person, on average). Mean total healthcare cost was $34,450 per-patient per-year, the bulk of which comprised medical expenses ($32,401). The highest mean healthcare cost was incurred by the pharyngeal cancer cohort ($40,214). CONCLUSIONS: Patients with resected SCCHN incur substantial healthcare costs and have high utilization rates. Results of this analysis are primarily applicable to resected SCCHN in a managed-care setting, and therefore may not be generalizable to the entire US population. Furthermore, disease stage is an important factor impacting outcomes, but these analyses did not stratify patients according to disease stage.

Impact on daily functioning and indirect/direct costs associated with chemotherapy-induced nausea and vomiting (CINV) in a U.S. population.

PURPOSE: Chemotherapy-induced nausea and vomiting (CINV) is a debilitating side effect of chemotherapy, but it may be prevented or mitigated with medications. Uncontrolled CINV can lead to reduced quality of life and can result in increased costs (due to health care utilization and missed work). We prospectively assessed the prevalence and burden of CINV in a US population. METHODS: Final analysis was performed on 178 patients, beginning chemotherapy during 2007-2008 at oncology specialty settings. Patients kept a diary recording use of antiemetic medications just before the start of chemotherapy and use of antiemetic medications, health care resources, and episodes of nausea and vomiting during the 5 days following. In addition, they completed a Functional Living Index-Emesis (FLIE) questionnaire and a Work Productivity and Assessment Inventory-Nausea and Vomiting assessment, to determine the impact of CINV on daily functioning and on work productivity, respectively. Physicians independently recorded prescribed medications and health care utilization. RESULTS: Of the patients, 61.2% reported experiencing CINV (34.3% with acute CINV and 58.4% with delayed CINV). Based on the FLIE assessment, 37.2% of all patients reported reduced daily functioning, and of those with poorly managed CINV, about 90% reported a significant impact on daily functioning. Total costs due to CINV were on average $778.58 per patient from the day of administration through the 5 days following the first cycle of chemotherapy; patients with more severe CINV typically had higher costs. CONCLUSIONS: CINV remains a significant problem among US patients, suggesting a need for more effective prophylaxis use in clinical practice.