Carcinoma of the gallbladder: CT findings in 50 cases

Fifty patients with histologically proven carcinoma of the gallbladder were examined by computed tomography (CT). The gallbladder masses were categorized into two broad groups: group 1 (74%) included patients in whom the gallbladder was identified along with a mass lesion; and group 2 (26%), where a large mass was present in the gallbladder fossa with no identifiable gallbladder. Group 1 was further divided into three types according to the nature of the tumor: Type 1, mass almost filling the entire gallbladder lumen; Type 2, a polypoidal mass projecting into the lumen; type 3, an infiltrating tumor seen as focal or diffuse wall thickening. Liver involvement, in the form of localized invasion in the vicinity of the primary gallbladder malignancy, was the most common associated finding (80%). Other ancillary features included presence of calculi, lymphadenopathy, and biliary obstruction. CT was found useful for characterizing and defining the extent of carcinoma of the gallbladder. However, it may not consistently demonstrate involvement of the gastrointestinal tract, omentum, and abdominal wall. CT can also be used for aspiration/biopsy guidance of the gallbladder mass in selected cases.     

Cost-effectiveness of denosumab vs zoledronic acid for prevention of skeletal-related events in patients with solid tumors and bone metastases in the United States

Abstract

Objective:

With increasing healthcare resource constraints, it has become important to understand the incremental cost-effectiveness of new medicines. Subcutaneous denosumab is superior to intravenous zoledronic acid (ZA) for the prevention of skeletal-related events (SREs) in patients with advanced solid tumors and bone metastases. This study sought to determine the lifetime cost-effectiveness of denosumab vs ZA in this setting, from a US managed-care perspective.

Methods:

A lifetime Markov model was developed, with relative rate reductions in SREs for denosumab vs ZA derived from three pivotal Phase 3 trials involving patients with castration-resistant prostate cancer (CRPC), breast cancer, and non-small-cell lung cancer (NSCLC), and bone metastases. The real-world SRE rates in ZA-treated patients were derived from a large commercial database. SRE and treatment administration quality-adjusted life year (QALY) decrements were estimated with time-trade-off studies. SRE costs were estimated from a nationally representative commercial claims database. Drug, drug administration, and renal monitoring costs were included. Costs and QALYs were discounted at 3% annually. One-way and probabilistic sensitivity analyses were conducted.

Results:

Across tumor types, denosumab was associated with a reduced number of SREs, increased QALYs, and increased lifetime total costs vs ZA. The costs per QALY gained for denosumab vs ZA in CRPC, breast cancer, and NSCLC were $49,405, $78,915, and $67,931, respectively, commonly considered good value in the US. Costs per SRE avoided were $8567, $13,557, and $10,513, respectively. Results were sensitive to drug costs and SRE rates.

Limitations:

Differences in pain severity and analgesic use favoring denosumab over ZA were not captured. Mortality was extrapolated from fitted generalized gamma function beyond the trial duration.

Conclusion:

Denosumab is a cost-effective treatment option for the prevention of SREs in patients with advanced solid tumors and bone metastases compared to ZA. The overall value of denosumab is based on superior efficacy, favorable safety, and more efficient administration.     

Healthcare utilization and costs with fixed-source versus variable-source tacrolimus in patients receiving a kidney transplant

Abstract

Aims: Switching drug manufacturers in transplant patients may require an increased intensity of therapeutic monitoring, leading to additional healthcare visits, associated laboratory tests, and perhaps hospitalizations. As real-world studies examining the interchangeability of tacrolimus from different manufacturers are limited, the purpose of this study was to examine the healthcare resource utilization (HRU) and economic impact of tacrolimus-switching in kidney transplantation.

Materials and methods: This cross-sectional, retrospective study examined HRU and healthcare costs (HCCs) among patients with a kidney transplant who were prescribed tacrolimus from fixed-source (FS) vs variable-source (VS) manufacturers using claims data from the large US health plan Humana from October 1, 2012, to December 31, 2013.

Results: Overall, 1,024 patients were identified (FS: n?=?674, 66%; VS: n?=?350, 34%). The number of therapeutic drug monitoring (TDM) events for the VS group was 13% greater than for the FS group after controlling for demographics, comorbidity score, and number of medications (incidence rate ratio?=?1.13, p?=?.033). Adjusted total HCCs were 9% lower for VS (US$28,054 vs US$30,823, p?=?.045). In the unadjusted analysis, VS had greater emergency department (ED) utilization (45% vs 35%, p?<?.002). In the VS group, the mean (standard deviation [SD]) number of days from manufacturer switch to first outpatient visit was 23.8 (33.6), and the number of days (SD) to first TDM event was 43.6 (56.2).

Limitations: Study limitations include the lack of availability of many transplant-specific variables within the Humana database, potential errors/omissions in claims coding, and restriction of cross-sectional data examination to a 1-year period.

Conclusions: VS patients had greater TDM and lower total HCCs. Further research is warranted to understand the drivers of ED use among the VS group, and to determine factors associated with delayed TDM after regimen modification. Opportunities may exist to improve the quality of care for patients receiving immunosuppressant treatment with tacrolimus.     

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

Abstract

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.     

MRI of Budd-Chiari syndrome

A retrospective study was undertaken to reassess the various magnetic resonance imaging (MRI) features of Budd-Chiari syndrome (BCS). MRI examinations of 22 patients with pathologically confirmed BCS were studied. Spin-echo (SE) T1- (TR = 300–450 ms/TE = 12–15 ms), and SE T2-weighted (TR = 1600–2000 ms/TE = 30–60/90–120 ms) MRI images were obtained in all patients. Gradient-recalled-echo (GRE) images (TR = 7–60 ms/TE = 3–19 ms, flip angle = 10–40°) were obtained in 14 patients. MRI showed thrombosis of three or two hepatic veins in 19 (86%) and 3 (14%) patients, respectively. Spontaneous intrahepatic anastomoses was depicted in five (23%) patients. Ascites appeared in 15 patients (68%). Thrombosis or external compression of the inferior vena cava (IVC) by an enlarged caudate lobe was depicted in six (27%) and five (23%) patients, respectively. Prominent azygos and hemiazygos veins were demonstrated in seven (32%) patients (six of whom had thrombosis of the IVC). MRI showed hepatomegaly in all patients and enlarged caudate lobe in 18 (82%) patients. SE T1- and SE T2-weighted MRI images revealed inhomogeneous signal intensity of hepatic parenchyma in 14 (64%) patients. SE T1- and SE T2-weighted MRI images showed homogeneous signal intensity of hepatic parenchyma in eight (36%) patients. Our results demonstrate that BCS displays various features on MRI images, and such information is important for diagnosis.     

Brain metastases in patients with ALK+ non-small cell lung cancer: clinical symptoms,treatment patterns and economic burden

Abstract

Objective:

Brain metastases (BM) are highly prevalent among anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) patients; yet little is known about their real-world treatment patterns and clinical and economic burdens. This study aimed to describe these patients’ treatment patterns, symptoms, and costs.

Research design and methods:

Retrospective study pooling data from three large administrative databases in the US (08/2011–06/2013). ALK+ NSCLC patients with BM and continuous enrollment for ≥ 60 days before and ≥30 days after the first observed BM diagnosis were identified by pharmacy records for crizotinib among patients with lung cancer and BM diagnostic codes.

Main outcome measures:

Treatment patterns, symptoms, healthcare resource utilization, and costs, before and after BM diagnosis.

Results:

Of the 213 crizotinib patients with BM diagnoses meeting the selection criteria, 23.0% had BM prior to NSCLC diagnosis; 47.4% had BM prior to crizotinib initiation; 19.2% during crizotinib treatment; and 10.3% post-crizotinib treatment. For those diagnosed with BM after NSCLC diagnosis, the median time between the NSCLC and BM diagnoses was 88 days. Following the first observed BM diagnosis, 88.7% used chemotherapy, 63.4% had radiotherapy, and 31.9% had stereotactic radiosurgery. The prevalence of BM-related symptoms substantially increased post-BM-diagnosis: fatigue (from 15% to 39%), headaches (from 5% to 24%), and depression (from 5% to 15%). Monthly costs per patient averaged $5983 before the BM diagnosis and $22,645 after diagnosis. Patients’ resource utilization increased significantly post-BM-diagnosis, with a 3-fold increase in OP visits and a 6-fold increase in IP stays. Post-BM-diagnosis costs were driven by pharmacy (42.0%), inpatient (29.6%), and outpatient costs (26.0%).

Limitations:

The study sample was limited to crizotinib-treated patients.

Conclusions:

Post-BM-diagnosis, patients experience high symptom burden. Post-BM-diagnosis, treatment is highly variable and costly: average monthly costs per patient almost quadrupled post-BM-diagnosis.     

The economic contribution of the “C” in ICT: Evidence from OECD countries

Numerous studies have documented the contribution of ICT to growth. Less has been done on the contribution of communications technology, the “C” in ICT. We construct an international dataset of fourteen OECD countries and present contributions to growth for each ICT asset (IT hardware, CT equipment and software) using alternative ICT deflators. Using each country’s deflator we find that the contribution of CT capital deepening to productivity growth is lower in the EU than the US. Thus we ask: is that lower contribution due to a lower rate of CT investment or differing sources and methods for measurement of price change? We find that: (a) there are still considerable disparities in measures of ICT price change across countries; (b) in terms of growth-accounting, price harmonisation has a greater impact on the measured contributions of IT hardware and software in the EU relative to the US, than that of CT equipment; over 1996–2013, harmonising investment prices explains just 15% of the gap in the EU CT contribution relative to the US, compared to 25% for IT hardware; (c) over 1996–2013, CT capital deepening accounted for 0.11% pa (6% as a share) of labour productivity growth (LPG) in the US, compared to 0.03% pa (2.5% of LPG) in the EU-13 when using national accounts deflators; and (d) using OECD harmonised deflators, the figure for the EU-13 is raised to 0.04% pa (4% of LPG).     

Treatment patterns,healthcare resource utilization,and costs in patients with acute myeloid leukemia in commercially insured and Medicare populations

Objective: To describe the setting, duration, and costs of induction and consolidation chemotherapy for adults with newly-diagnosed acute myeloid leukemia (AML), who are candidates for standard induction chemotherapy, in the US.

Methods: Adults newly-diagnosed with AML who received standard induction chemotherapy in an inpatient setting were identified from the Truven Health Analytics MarketScan (2006–2015) and SEER-Medicare (2007–2011) databases. Patients were observed from induction therapy start to the first of hematopoietic stem cell transplant, 180 days after induction discharge, health plan enrollment/data availability end, or death. Induction and consolidation chemotherapy were identified using Diagnosis-Related Group codes (chemotherapy with acute leukemia) or procedure codes for AML chemotherapy administration. AML treatment episode setting (inpatient or outpatient), duration, and costs (2015 USD, payers’ perspective) were described for commercially insured patients and Medicare beneficiaries.

Results: In total, 459 commercially insured patients and 563 Medicare beneficiaries (mean age?=?54 and 66 years; 53% and 54% male; respectively) were identified. For induction therapy, mean costs were $145,189 for commercially insured patients and $85,734 for Medicare beneficiaries, and median inpatient duration was 31 days (both). Following induction, 64% of commercially insured patients and 53% of Medicare beneficiaries had ≥1 consolidation cycle; 75% and 65% of consolidation cycles were in an inpatient setting, respectively. For consolidation cycles, in the inpatient setting, mean costs were $28,137 for commercially insured patients and $28,843 for Medicare beneficiaries, median cycle duration was 6 days (both); in the outpatient setting, mean costs were $11,271 for commercially insured patients and $5,803 Medicare beneficiaries, median duration was 5 days (both).

Limitations: Granular information on chemotherapy type administered was unavailable.

Conclusions: This is the first exploratory study providing a complete picture of recent AML treatment patterns and management costs among commercially insured patients and Medicare beneficiaries. There is substantial heterogeneity in the management and costs of AML.     

Peritoneal fluid in children with intussusception: Its sonographic detection and relationship to successful reduction

A retrospective review of the abdominal/pelvic ultrasound (US) examinations in 21 consecutive children with intussusception proven on barium enema was performed to determine what is the incidence of US detected peritoneal fluid in this population and to see if the rate of reduction was different in this subset. Twelve of the 21 children (57%) had free fluid demonstrated with US. Eight of these 12 (67%) had successful reduction. Six of the nine children (67%) without free fluid were also successfully reduced.     

Carcinoma of the ampulla of Vater: Sonographic and CT diagnosis

Twenty patients with carcinoma of the ampulla of Vater were studied with sonography (N = 9) or both sonography and CT (N = 11). The tumor was shown by sonography in 16 patients (80%) as a small, round or oval, fairly well delineated mass in between the dilated distal common bile duct and duodenum which was delineated owing to luminal fluid or gas (N = 13); or as a polypoid mass within the dilated distal common bile duct resulting in abrupt obstruction (N = 3). In the remaining four patients, the mass was not delineated. Bile ducts were dilated down to the level of mass or ampullary region in all cases (100%), while the pancreatic duct was dilated in five cases (45%). We believe that sonography is the technique of initial choice in the diagnosis of carcinoma of the ampulla of Vater by identifying the mass at the distal end of the dilated common bile duct and/or pancreatic duct.     

Brain metastases in non-small cell lung cancer patients on epidermal growth factor receptor tyrosine kinase inhibitors: symptom and economic burden

Objective: This study describes the symptom and economic burden associated with brain metastases (BM) in patients with non-small cell lung cancer (NSCLC) receiving epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (EGFR-TKIs).

Methods: This retrospective study included adults with ≥2 medical claims, within 90 days, for lung cancer and ≥1 administration of EGFR-TKIs. Based on ICD-9 codes, patients were stratified into cohorts by type of metastases (BM, other metastases [OM], or no metastases [NM]), and by when the metastasis diagnosis occurred (synchronous or asynchronous).

Results: The population (synchronous BM [SBM]?=?24, synchronous OM [SOM]?=?23, asynchronous BM [ASBM]?=?15, asynchronous OM [ASOM]?=?49, NM?=?85) was mostly female (57%), average age 69 years (SD?=?11). SBM patients experienced more fatigue and nausea/vomiting compared with SOM and NM patients and more headaches and loss of appetite than NM patients. ASBM was associated with more fatigue, nausea/vomiting, headaches, pain/numbness, altered mental status, and seizures than NM, and more headaches and pain/numbness than ASOM. SBM patients experienced a greater increase in per-member-per-month all-cause total healthcare costs after diagnosis ($20,301) vs SOM ($9,131, p?=?.001) and NM ($2,493, p?=?.001). ASBM’s cost increase between baseline and follow-up ($7,867) did not differ from ASOM’s ($4,947, p?=?.195); both were larger than NM ($2,493, p?=?.001 and p?=?.009, respectively).

Limitations: EGFR mutation status was inferred based on EGFR-TKI treatment, not by molecular testing. Patients were from US commercial insurance plans; results may not be generalizable to other populations.

Conclusions: Among patients with EGFR-TKI-treated NSCLC, patients with BM experienced more symptoms and, when diagnosed synchronously, had significant increases in total medical costs vs patients with OM and NM. Therapeutic options with central nervous system activity may offer advantages in symptomatology and costs in EGFR-mutated patients with BM.     

Dynamic conditional score models of degrees of freedom: filtering with score-driven heavy tails

This article extends the quasi-autoregressive (QAR) plus Beta-t-EGARCH (exponential generalized autoregressive conditional heteroscedasticity) dynamic conditional score (DCS) model. For the new DCS model, the degrees of freedom parameter is time varying and tail thickness of the error term is updated by the conditional score. We compare the performance of QAR plus Beta-t-EGARCH with constant degrees of freedom (benchmark model) and QAR plus Beta-t-EGARCH with time-varying degrees of freedom (extended model). We use data from the Standard and Poor’s 500 (S&P 500) index, and a random sample of its 150 components that are from different industries of the United States (US) economy. For the S&P 500, all likelihood-based model selection criteria support the extended model, which identifies extreme events with significant impact on the US stock market. We find that for 59% of the 150 firms, the extended model has a superior statistical performance. The results suggest that the extended model is superior for those industries, which produce products that people usually are unwilling to cut out of their budgets, regardless of their financial situation. We perform an application to compare the density forecast performance of both DCS models. We perform an application to Monte Carlo value-at-risk for both DCS models.     

Palonosetron versus other 5-HT3 receptor antagonists for prevention of chemotherapy-induced nausea and vomiting in patients with hematologic malignancies treated with emetogenic chemotherapy in a hospital outpatient setting in the United States

Abstract

Objective:

This study evaluated the rate of uncontrolled chemotherapy-induced nausea and vomiting (CINV) after initiating antiemetic prophylaxis with palonosetron versus other 5-HT₃ receptor antagonists (RAs) in patients diagnosed with hematologic malignancies (lymphoma and leukemia) and receiving highly emetogenic chemotherapy (HEC) or moderately emetogenic chemotherapy (MEC) in a hospital outpatient setting.

Methods:

Patients aged?≥?18 years and diagnosed with hematologic malignancies initiating HEC or MEC and antiemetic prophylaxis with palonosetron (Group 1) and other 5-HT₃ RAs (Group 2) for the first time in a hospital outpatient setting between 4/1/2007 and 3/31/2009 were identified from the Premier Perspective Database. Within each cycle, CINV events were identified (in the hospital outpatient, inpatient, and emergency room settings) through ICD-9 codes for nausea, vomiting, and/or volume depletion (from each CT administration day 1 until the end of the CT cycle), or use of rescue medications (day 2 until the end of the CT cycle). Negative binomial distribution generalized linear multivariate regression model estimating the CINV event rate on CT, specific CT cycles, and cancer diagnosis (leukemia/lymphoma)-matched groups in the follow-up period (first of 8 cycles or 6 months) was developed.

Results:

Of 971 identified patients, 211 initiated palonosetron (Group 1). Group 1 patients comprised of more females [50.2 vs. 41.4%; p?=?0.0226], Whites [74.4 vs. 70.4%, and Hispanics [7.6 vs. 6.3%; all races p?=?0.0105], received more HEC treatments [89.6 vs. 84.2%; all CT types p?=?0.0129], and had more lymphoma diagnosed patients [89.6 vs. 76.3%; all cancer types p?=?0.0033] at baseline. After controlling for differences in several demographic and clinical variables, the regression model predicted a 20.4% decrease in CINV event rate per CT cycle for Group 1 versus Group 2 patients. Study limitations include potential lack of generalizability, absence of data on certain confounders including alcohol consumption and prior history of motion sickness, potential underestimation of incidence of uncontrolled CINV, and inability to draw conclusions pertaining to cause and effect relationship.

Conclusion:

In this retrospective hospital study, patients with hematologic malignancies treated with HEC or MEC and initiated on antiemetic prophylaxis with palonosetron in the hospital outpatient setting were more likely to experience significantly lower CINV event rates (in the hospital outpatient, inpatient, and emergency room settings) versus patients initiated on other 5-HT₃ RAs.     

Cost-effectiveness of currently recommended direct-acting antiviral treatments in patients infected with genotypes 1 or 4 hepatitis C virus in the US

Objective: This study compared the cost-effectiveness of direct-acting antiviral therapies currently recommended for treating genotypes (GT) 1 and 4 chronic hepatitis C (CHC) patients in the US.

Methods: A cost-effectiveness analysis of treatments for CHC from a US payer’s perspective over a lifelong time horizon was performed. A Markov model based on the natural history of CHC was used for a population that included treatment-naïve and -experienced patients. Treatment alternatives considered for GT1 included ombitasvir/paritaprevir/ritonavir?+?dasabuvir?±?ribavirin (3D?±?R), sofosbuvir?+?ledipasvir (SOF/LDV), sofosbuvir?+?simeprevir (SOF?+?SMV), simeprevir?+?pegylated interferon/ribavirin (SMV?+?PR) and no treatment (NT). For GT4 treatments, ombitasvir/paritaprevir/ritonavir?+?ribavirin (2D?+?R), SOF/LDV and NT were compared. Transition probabilities, utilities and costs were obtained from published literature. Outcomes included rates of compensated cirrhosis (CC), decompensated cirrhosis (DCC), hepatocellular carcinoma (HCC) and liver-related death (LrD), total costs, life-years and quality-adjusted life-years (QALYs). Costs and QALYs were used to calculate incremental cost-effectiveness ratios.

Results: In GT1 patients, 3D?±?R and SOF-containing regimens have similar long-term outcomes; 3D?±?R had the lowest lifetime risks of all liver disease outcomes: CC =?30.2%, DCC = 5.0?%, HCC = 6.8%, LT =?1.9% and LrD =?9.2%. In GT1 patients, 3D?±?R had the lowest cost and the highest QALYs. As a result, 3D?±?R dominated these treatment options. In GT4 patients, 2D?+?R had lower rates of liver morbidity and mortality, lower cost and more QALYs than SOF/LDV and NT.

Limitations: While the results are based on input values, which were obtained from a variety of heterogeneous sources—including clinical trials, the findings were robust across a plausible range of input values, as demonstrated in probabilistic sensitivity analyses.

Conclusions: Among currently recommended treatments for GT1 and GT4 in the US, 3D?±?R (for GT1) and 2D?+?R (for GT4) have a favorable cost-effectiveness profile.     

Healthcare costs in patients with advanced non-small cell lung cancer and disease progression during targeted therapy: a real-world observational study

Aims: To assess healthcare costs during treatment with epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs) and following disease progression in patients with advanced non-small cell lung cancer (NSCLC).

Methods: A retrospective analysis of medical records of US community oncology practices was conducted. Eligible patients had advanced NSCLC (stage IIIB/IV) diagnosed between January 1, 2008 and January 1, 2015, initiated treatment with erlotinib or afatinib (first-line or second-line), and had disease progression. Monthly Medicare-paid costs were evaluated during the TKI therapy period and following progression.

Results: The study included 364 patients. The total mean monthly cost during TKI therapy was $20,106 (95% confidence interval [CI]?=?$16,836–$23,376), of which 47.0% and 42.4% represented hospitalization costs and anti-cancer therapy costs, respectively. Following progression on TKI therapy (data available for 316 patients), total mean monthly cost was $19,274 (95% CI?=?$15,329–$23,218), and was higher in the 76.3% of patients who received anti-cancer therapy following progression than in the 23.7% of those who did not ($20,490 vs $15,364; p?<?.001). Among patients who received it, anti-cancer therapy ($11,198; 95% CI?=?$7,102–$15,295) represented 54.7% of total mean monthly cost. Among patients who did not receive anti-cancer therapy, hospitalization ($13,829; 95% CI?=?$4,922–$22,736) represented 90.0% of total mean monthly cost. Impaired performance status and brain metastases were significant predictors of increased cost during TKI therapy.

Limitations: The study design may limit the generalizability of findings.

Conclusions: Healthcare costs during TKI treatment and following progression appeared to be similar and were largely attributed to hospitalization and anti-cancer therapy. Notably, almost one-quarter of patients did not receive anti-cancer therapy following progression, potentially indicating an unmet need; hospitalization was the largest cost contributor for these patients. Additional effective targeted therapies are needed that could prolong progression-free survival, leading to fewer hospitalizations for EGFR mutation-positive patients.     

Healthcare costs associated with skeletal-related events in breast cancer patients with bone metastases

Background:

Patients with bone metastases secondary to breast cancer are pre-disposed to skeletal-related events (SREs), including spinal cord compression (SCC), pathologic fracture (PF), surgery to bone (SB), and radiotherapy to bone (RT).

Objective:

To document current patterns of healthcare utilization and costs of SREs in patients with breast cancer and bone metastases.

Methods:

This was a retrospective, observational study using the Thomson MedStat MarketScan Commercial Claims and Encounters database from 9/2002 to 6/2011. Study subjects included all persons with claims for breast cancer and for bone metastases, and ≥1 claims for an SRE. Unique SRE episodes were identified based on a gap of at least 90 days without an SRE claim, and classified by treatment setting (inpatient or outpatient) and SRE type (SCC, PF, SB, or RT).

Results:

Of 17,266 patients with breast cancer and bone metastases, 9142 (53%) had one or more SRE episodes. Among 5809 patients who met all other criteria, there were 7617 SRE episodes over mean (SD) follow-up of 17.2 (15.2) months. The percentage of episodes that required inpatient treatment ranged from 11% (RT) to 76% (SB). On average, inpatient SCC episodes (n?=?83 episodes) were most costly; while outpatient PF episodes (n?=?552 episodes) were least costly. Of the total SRE costs (mean [SE] $21,072 [$36,462]/episode), 36% were attributable to outpatient RT (n?=?5265 episodes) and 31% to inpatient PF (n?=?838 episodes).

Limitations:

The administrative claims data used in this study may lack sensitivity and specificity for identification of clinical events and may not be generalizable to other populations. Also, for some SRE episode categories, the number of events was small and cost estimates may lack precision.

Conclusion:

In patients with breast cancer and bone metastases, SREs are associated with high costs and hospitalizations.     

Tumor necrosis factor blocker dose escalation among biologic naïve rheumatoid arthritis patients in commercial managed-care plans in the 2 years following therapy initiation

Abstract

Objective:

This study uses real-world US managed-care claims data to estimate dose escalation rates over the first and second years of therapy among biologic naïve rheumatoid arthritis (RA) patients initiating tumor necrosis factor (TNF) blocker therapy with etanercept, adalimumab, or infliximab.

Methods:

Non-elderly adult (age 18–65 years) RA patients initiating etanercept, adalimumab, or infliximab from July 1, 2005 to April 30, 2009, were identified using the MarketScan Commercial Database. National and regional dose-escalation patterns were evaluated 12 and 24 months after initiation. In the single-instance method, dose escalation was defined as having one average weekly dose 115%, 130%, or 150% greater than the initial average weekly dose. By the two-instances method, dose escalation was defined as having two consecutive claims with an average weekly dose 115% or 130% greater than the initial average weekly dose.

Results:

A total of 2747 patients met the inclusion criteria (mean age 50 years [SD?=?10]; 74% female). More patients initiated etanercept (44%) than adalimumab (37%) or infliximab (20%). Using the single-instance method, dose escalation at 12 months ranges were 0.8–1.5% for etanercept, 10.8–12.5% for adalimumab, and 16.4–42.5% for infliximab; ranges at 24 months were 0.8–2.1% for etanercept, 14.3–17.5% for adalimumab, and 26.4–57.6% for infliximab. The two-instances method showed a similar relationship among the treatment cohorts at both 12 and 24 months, with lower dose-escalation rates for etanercept (0.8%, 0.8%) than adalimumab (8.7%, 13.3%) or infliximab (22.9%, 37.6%) at the 130% threshold (p?<?0.001). Dose-escalation rates for etanercept, adalimumab, and infliximab were consistent across US geographic regions.

Conclusion:

Patients initiating etanercept had lower rates of dose escalation than patients initiating adalimumab or infliximab in the first and second year following therapy initiation, as well as across US geographic regions. These results may not be generalizable to the entire US RA population.