Lung Cancer Survivorship: Physical, Social, Emotional, and Medical Needs of NSCLC Survivors.

BACKGROUND: Newer therapies prolong survival for patients with lung cancer. Beyond extending survival, the needs of lung cancer (LC) survivors are poorly described. METHODS: We conducted a single-institution needs assessment survey of LC survivors alive ≥1 year from diagnosis. Needs were rated on a 5-point Likert scale for 4 domains (physical, social, emotional, and medical). Multiple regression models identified demographic or treatment characteristics associated with more needs in each category. A subset analysis of survivors with metastatic LC was performed. RESULTS: Of 360 patients approached, 235 surveys were completed. Among completed survey respondents, the median age was 69 years; most were female (62%), married (71%), and White (74%); and 41% had stage IV cancer. Finding support resources (34%) was the most common medical need. Fatigue (70%), sleep disturbance (60%), memory and concentration (57.5%), weakness (54%), and trouble breathing (51%) were physical needs affecting more than half of respondents. The most common social need was managing daily activities (42%). Emotional needs were highly prevalent, with 79% of respondents reporting a fear of recurrence and 74.5% reporting living with uncertainty. Multiple regression analysis identified that receipt of multiple lines of systemic therapy and lower household income were associated with higher physical and social needs. Younger age was associated with having a greater number of social and emotional needs. Similar results were found in the subset of survivors with metastatic disease at diagnosis. CONCLUSIONS: The needs of LC survivors are diverse across multiple domains. Several clinical and demographic factors are independently associated with higher numbers of patient-reported needs. Our study identifies critical gaps in survivorship care for LC survivors with all stages of disease and highlights areas of future intervention.

Real-world outcomes among patients with EGFR-mutated non-small cell lung cancer treated with EGFR tyrosine kinase inhibitors versus immunotherapy or chemotherapy in the first-line setting.

BACKGROUND: Despite national guideline recommendations, epidermal growth factor receptor mutated (EGFRm) metastatic non-small cell lung cancer (mNSCLC) patients may still receive suboptimal treatment in the first line (1L). This study evaluated 1L therapy initiation in relation to biomarker testing results and time to next-treatment or death (TTNTD) in patients receiving EGFR tyrosine kinase inhibitors (TKIs) versus immunotherapy (IO) or chemotherapy. METHODS: Stage IV EGFRm mNSCLC adults that initiated 1L EGFR TKI (first, second, or third generation), IO ± chemotherapy (IO users), or chemotherapy alone from 5/2017-12/2019 were identified from the Flatiron database. Logistic regression estimated the likelihood of initiating treatment before receiving testing results for each therapy. Median TTNTD was evaluated via Kaplan-Meier analysis. Adjusted hazards ratios (HRs) and 95% CI examining the association of 1L therapy with TTNTD were reported from multivariable Cox proportional-hazards models. RESULTS: Among 758 EGFRm mNSCLC patients, EGFR TKI was used as 1L therapy for 87.3% of patients (n = 662), IO in 8.3% (n = 63), and chemotherapy only in 4.4% (n = 33). The majority of IO (61.9%) and chemotherapy only patients (60.6%) initiated therapy before test results were available, compared to 9.7% of EGFR TKIs. The odds of initiating therapy before receiving test results were higher for IO (OR: 19.6, p < 0.001) and chemotherapy alone (OR: 14.1, p < 0.001) in comparison to EGFR TKIs. Compared to IO and chemotherapy, EGFR TKIs had longer median TTNTD (EGFR TKI: 14.8 months, 95% CI: 13.5-16.3; IO: 3.7 months, 95% CI 2.8-6.2; chemotherapy: 4.4 months, 95% CI 3.1-6.8, p < 0.001). EGFR TKI patients had significantly lower risk of initiating second-line therapy or death compared to patients on 1L IO (HR: 0.33, p < 0.001) or 1L chemotherapy (HR: 0.34, p < 0.001). CONCLUSIONS: A portion of biomarker testing results were not used to guide 1L therapy. Patients initiating EGFR TKI as 1L therapy had longer TTNTD than IO or chemotherapy.

Real-world treatment patterns of metastatic non-small cell lung cancer patients receiving epidermal growth factor receptor tyrosine kinase inhibitors.

BACKGROUND: Several epidermal growth factor receptor tyrosine kinase inhibitors (EGFR TKI) have been approved for first-line (1L) treatment of EGFR-mutated metastatic non-small cell lung cancer (mNSCLC) in the United States (US). Real-world analyses of 1L treatment patterns with EGFR TKIs, including the third-generation EGFR TKI osimertinib which was most recently approved in 2018, are still sparse. METHODS: This retrospective observational study used data from IQVIA's prescription claims (LRx) and medical claims (Dx) databases. mNSCLC patients newly treated with any EGFR TKI in the 1L setting were identified from January 1, 2015 to April 30, 2020; the first date of EGFR TKI (third-generation osimertinib, first-generation [erlotinib, gefitinib], or second-generation [afatinib, dacomitinib]) was the index date. Treatment patterns were reported in the cohorts stratified by 1L EGFR TKI. RESULTS: A total of 2505 patients were included in the study (982 osimertinib, 1060 first-generation, and 463 second-generation EGFR TKI). Beginning in 2018, osimertinib became the most common 1L EGFR TKI (66.7%) and in early 2020, it accounted for 90.6% of 1L EGFR TKIs. Nearly all patients (>97%) were treated with 1L EGFR TKI monotherapy. Patients with 1L osimertinib had longer treatment duration compared to patients with 1L first- or second-generation EGFR TKI (median months: 17.8 vs. 8.7 vs. 10.5, respectively; log-rank test for comparisons with osimertinib p < 0.0001) over median follow-up times of 9.8, 20.5, and 19.3 months. 32.5% and 36.3% of the first- and second-generation EGFR TKI cohorts, respectively, had evidence of 2L treatment. Osimertinib monotherapy accounted for the majority of 2L treatments (58.3%/60.7%) and 11.3%/8.9% had 2L chemotherapy or immuno-oncology therapy following 1L first- or second-generation EGFR TKI. CONCLUSION: In this real-world study of a US claims database, 1L treatment duration was longer with osimertinib compared with other EGFR TKIs. Future studies with longer follow-up are recommended to understand treatment patterns after progression on EGFR TKIs.

EGFR mutation testing and TKI treatment patterns among veterans with stage III and IV non-small cell lung cancer.

BACKGROUND: Epidermal growth factor receptor (EGFR) mutation testing is recommended in metastatic non-small cell lung cancer (NSCLC). The objective of this study was to assess changes in EGFR mutation testing patterns and tyrosine kinase inhibitor (TKI) use in US veterans with stage III-IV NSCLC between 2013 and 2017. PATIENTS AND METHODS: Retrospective study using linked data from Department of Veterans Affairs (VA) Cancer Registry System, Corporate Data Warehouse, commercial laboratories, and clinical notes. Generalized linear mixed models accounting for clustering by VA facility were used to determine factors associated with EGFR mutation testing. RESULTS: From 2013 to 2017, EGFR mutation testing increased from 29.5% to 38.4% among veterans with stage III-IV NSCLC and from 47.0% to 57.4% among veterans with stage IV non-squamous disease. Factors associated with increased odds of testing included being married, Medicare enrollment, and adenocarcinoma histology. Factors associated with decreased odds of testing included Medicaid eligibility, stage III disease, increasing age, being a current or former smoker, increasing Charlson-Deyo comorbidity score, and receiving cancer care in the South. Appropriate use of a TKI rose from 2013 to 2017 (17.2% to 74.1%). CONCLUSION: EGFR mutation testing rates increased to almost 60% in the stage IV non-squamous NSCLC population in 2017, with residual opportunity for further increase. Several sociodemographic characteristics, comorbidities, and geographic regions were associated with EGFR mutation testing suggestive of inequitable testing decisions. Appropriate use of TKI improved drastically from 2013 to 2017 demonstrating rapidly changing practice patterns through the adoption phase of new treatment options.

Real-world impact of brain metastases on healthcare utilization and costs in patients with non-small cell lung cancer treated with EGFR-TKIs in the US.

BACKGROUND: Non-small cell lung cancer (NSCLC) with brain metastases (BM) is difficult to treat and associated with poor survival. This study assessed the impact of BM on healthcare-related utilization and costs (HRUC) among patients receiving epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs). PATIENTS AND METHODS: Adults newly-diagnosed with metastatic NSCLC, initiating first-/second-generation EGFR-TKI treatment, with BM or no BM (NBM), were identified retrospectively from IBM MarketScan healthcare claims databases (2013-2017). HRUC were measured during the variable-length follow-up period. Generalized linear models assessed the impact of BM on total healthcare costs, standardized to 2017 US$. RESULTS: Overall, 222 BM and 280 NBM patients were included, with a mean duration of follow-up of 14 months. Adjusted NSCLC-related and all-cause costs over average follow-up were 1.2 times higher among BM patients (Δ$5,640 and Δ$6,366, respectively; p <0.05); differences were driven primarily by radiation treatment and radiology. More than two times more BM than NBM patients received NSCLC-related radiation treatment, in both inpatient (15.3% vs 6.8%; p <0.05) and outpatient settings (87.8% vs 37.5%; p <0.05). Per-patient per-month (PPPM) radiation costs were also higher among BM patients, both inpatient ($796 vs $464, p =0.172) and outpatient ($2,443 vs $747, p <0.05). All-cause PPPM radiology visits (2.0 vs 1.3) and associated costs ($3,824 vs $1,621) were higher among BM patients (both p <0.05). CONCLUSION: NSCLC-related HRUC, especially those attributable to radiation treatment, were higher among patients with BM. Future research should compare the potential for CNS-active EGFR-TKIs vs first-/second-generation EGFR-TKIs combined with radiotherapy to reduce HRUC.

Real-world systemic therapy utilization in Medicare patients with locally advanced or metastatic urothelial carcinoma diagnosed between 2008 and 2012.

PURPOSE: Treatment of advanced urothelial carcinoma (UC) remains a challenging clinical entity occurring predominantly in older patients with limited treatment options. However, real-world treatment patterns, differential cancer center access, and association with outcomes is lacking in nationally representative clinical practice and will provide context for emerging therapies. MATERIALS AND METHODS: We used SEER-Medicare data to identify patients with locally advanced or metastatic UC of the bladder or upper urinary tract diagnosed between 2008 and 2012. We characterized utilization systemic therapy, including first- and second-line chemotherapy. Patients receiving neoadjuvant chemotherapy were excluded; results were stratified by academic versus non-academic setting. RESULTS: 3569 patients met study criteria; 48% received some form of chemotherapy within 2 years of diagnosis. Of these, one-third subsequently received second-line chemotherapy. The majority received a regimen including ≥2 agents. Gemcitabine alone or in combination with platinum was the most common first- and second-line treatment. Similar patterns of first- and second-line chemotherapy were observed between patients treated in academic and non-academic centers. Sensitivity analyses of trial-similar patients demonstrated increased utilization (69%). Receipt of platinum doublet as 1st line therapy was less likely in older patients and those with renal disease, and more likely for grade IV disease. CONCLUSIONS: Roughly half of all Medicare patients with locally advanced/metastatic UC receive systemic therapy regardless of access to academic cancer centers and despite poor oncologic outcomes. Cytotoxic, gemcitabine-based doublet chemotherapy remains the most common treatment. A substantial population of older patients exists for whom alternative, non-cytotoxic, treatment options may be of benefit.

Medical oncology referral and systemic therapy of patients with advanced stage urothelial carcinoma.

Aim: To understand physician visit patterns among patients with stage IV (including nonmetastatic [M0] and metastatic [M1] disease) urothelial carcinoma (UC) and understand factors associated with a timely referral to a medical oncologist and systemic treatment. Patients & methods: Retrospective analysis of Surveillance, Epidemiology and End Results-Medicare data. Results: First physician encounter was with a urologist (M0: 69%; M1: 53%) or primary care physician ([PCP]; M0: 19%, M1: 25%) for the majority of patients around UC diagnosis. After the index urologist encounter, most patients had a subsequent medical oncologist visit at a median of 52 days (M0: 69.5 days, M1: 33 days). In an adjusted model, older age, index PCP visit, higher comorbidities and M0 disease were negatively associated with a medical oncologist referral. Among those referred to a medical oncologist, older age, Hispanic or non-Hispanic Black race and not being married were negatively associated with subsequent chemotherapy receipt (p < 0.05). Conclusion: Many patients with advanced UC encounter multiple specialists during their disease course. Older patients or those with a first UC-related encounter with a PCP are less likely to be referred to medical oncology. Once referred to medical oncology, social determinants, including race and marital status, are relevant predictors of receiving chemotherapy.

The Real-World Lifetime Economic Burden of Urothelial Carcinoma by Stage at Diagnosis.

BACKGROUND: Urothelial carcinoma (UC) is generally diagnosed early and may incur significant lifetime costs. This study estimated, from the payer's perspective, the lifetime costs among patients diagnosed with UC according to stage at diagnosis. METHODS: This retrospective analysis of the linked Surveillance, Epidemiology, and End Results (SEER)-Medicare database identified patients ≥66 years with newly diagnosed UC from 2004-2013. Patients were followed from UC diagnosis to death or last follow-up to estimate lifetime costs. Costs were allocated to 3 phases: diagnosis (≤3 months after diagnosis), terminal (≤3 months before death), and continuation (months between diagnosis and terminal phases). Survival-adjusted lifetime costs (total and major UC-related) were estimated for patients with UC based on stage at diagnosis (stages 0 through IV) and in a subgroup of patients receiving ≥1 systemic line of chemotherapy (LOC). RESULTS: The sample included 15,588 patients: 3,446 stage 0 (8% ≥1 LOC; median [IQR] follow-up in months: 44 [23-71]); 3,902 stage I (12% ≥1 LOC; 33 [15-62]); 4,301 stage II (26% ≥1 LOC; 17 [7-39]); 1,612 stage III (25% ≥1 LOC; 17 [7-42]); and 2,327 stage IV (33% ≥1 LOC; 8 [3-18]). Median age was 78 years and 72% were male. Mean lifetime costs were lowest for stage IV patients (stage 0, $151,626; stage 1, $150,123; stage II, $149,728; stage III, $190,996; stage IV, $117,503). Hospitalizations not involving a cystectomy contributed about half of lifetime costs across all stages. Cystectomy contributed 2-13% of the total lifetime UC costs ($3,356 stage 0; $7,011 stage I; $11,855 stage II; $25,509 stage III; $11,693 stage IV). UC-related office visits contributed 8-15% of lifetime costs ($11,717 stage 0; $14,611 stage I; $19,882 stage II; $21,480 stage III; $17,820 stage IV). CONCLUSION: UC continues to be a costly cancer with stage III patients having highest lifetime costs. Hospitalizations drive most of the lifetime costs across all stages; most of these hospitalizations did not involve costs related to cystectomy. Treatment plans requiring shorter and fewer hospitalizations may lessen the economic burden of UC.

Adherence to National Comprehensive Cancer Network Guidelines for BRCA testing among high risk breast Cancer patients: a retrospective chart review study.

BACKGROUND: Testing for BRCA variants can impact treatment decisions for breast cancer patients and affect surveillance and prevention strategies for both patients and their relatives. National Comprehensive Cancer Network (NCCN) guidelines recommend testing for patients at heightened risk of BRCA pathogenic variant. We examined the BRCA testing rate among high risk breast cancer patients treated in community oncology practices. METHODS: We conducted a retrospective medical chart review among community-based US oncologists using a physician panel approach. High risk breast cancer patients with a known family history of cancer and diagnosis with breast cancer at age ≥ 18 years between January 2013-October 2017 were included. We assessed the proportions of patients tested for BRCA variants in accordance with NCCN guidelines. RESULTS: Charts from 63 physicians, averaging 16 years of practice, were included; 97% were medical oncologists and 66.7% had a genetic counselor in their practice. We analyzed data for 410 randomly-selected patients with mean age of 52 years; 95% were female, 74% were White, and 19% had Ashkenazi Jewish ancestry. Among all patients, 94% were tested for BRCA variants. The testing rate ranged from 78 to 100% in various high risk groups; lower rates were observed among Black patients (91%), men (92%), and patients meeting NCCN criteria based on family history of male breast cancer (78%) and prostate cancer (87%). We observed a higher testing rate in patients treated by physicians with a genetic counselor in their practice (95% versus 91%). CONCLUSIONS: Adherence to NCCN BRCA testing guidelines is high in this group of predominantly medical oncologists with extensive experience, with a high proportion having a genetic counselor in practice. Testing rates can be improved in patients with risk factors related to male relatives. High level of compliance to guidelines in a community setting is possible with a delivery model for genetic counseling and testing.

Real-world treatment patterns for patients with metastatic head and neck squamous cell carcinoma treated with immuno-oncology therapy.

BACKGROUND: Real-world use of immuno-oncology (IO) therapies (nivolumab and pembrolizumab) in metastatic head and neck squamous cell carcinoma (mHNSCC) has not been well studied. METHODS: mHNSCC patients treated with an IO therapy were identified from a large US claims database from 2016 to 2017. Treatment patterns before and after initiation of IO therapy (index date) were described. RESULTS: Among 416 mHNSCC patients, 85% had ≥1 regimen prior to IO therapy. Ninety-seven percent of patients initiated IO as monotherapy and 3% initiated IO combined with another systemic treatment. One hundred seventeen (28%) patients had a subsequent regimen, usually chemotherapy (n = 58, 50%) or IO monotherapy (n = 27, 23%), of which 22 patients restarted the same IO therapy and 5 switched to another IO monotherapy. CONCLUSION: The majority of mHNSCC patients initiated IO as a monotherapy. Approximately half of patients with a subsequent regimen received chemotherapy and one-fourth received IO monotherapy.

Healthcare resource utilization and costs of adverse events among patients with metastatic urothelial cancer in USA.

Aim: To estimate incremental costs and healthcare resource utilization (HRU) associated with select severe adverse events (AEs) and AEs of any severity in patients with metastatic urothelial carcinoma receiving first-line (1L) therapy. Materials & methods: Adults treated with 1L systemic therapy between January 2012 and September 2017 with ≥1 urothelial cancer diagnosis were identified using claims data. Per-patient-per-month cost differences and HRU rate ratios comparing patients with and without select AEs were estimated. Results: Patients with any severe select AEs had higher costs than those without (cost difference = $6130 per-patient-per-month; p < 0.001). Healthcare costs and HRU for patients with select AEs were significantly higher versus those without. Conclusion: Select AEs during 1L therapy for metastatic urothelial carcinoma can result in significant burden to patients and healthcare systems.

Treatment patterns, clinical outcomes, health resource utilization, and cost in patients with BRCA-mutated metastatic breast cancer treated in community oncology settings.

PURPOSE: This retrospective study of community oncology patients with breast cancer gene (BRCA)-mutated metastatic breast cancer (MBC) examined treatment outcomes and health resource utilization (HRU) and costs for a sample of patients with human epidermal growth factor receptor 2 (HER2)-negative disease who were either hormone receptor positive (HR+) or triple negative breast cancer (TNBC). METHODS: Evidence from the Vector Oncology Data Warehouse, a repository of electronic medical records/billing data and provider notes, was analyzed. Treatment outcomes were progression-free survival (PFS) and overall survival (OS) from start of first-line therapy in the metastatic setting. HRU and cost measures were collected from the time of MBC diagnosis to end of the record. HRU included hospitalizations, emergency room visits, infused/parenteral supportive care drugs, and outpatient visits. Costs were computed both as total and monthly costs. RESULTS: 57 HR+ and 57 TNBC patients (2013-2015) met inclusion criteria. Eight TNBC patients did not get treatment. HR+ patients had median first line PFS of 12.1 months and TNBC patients had 6.1 months. HR+ patients had median OS from start of first line of 38.4 months, and TNBC patients had 23.4 months. Rate of use of infused/parenteral supportive care drugs was 25.5% overall and 36.7% among TNBC patients with 15.8% among HR+ patients. CONCLUSION: There is an unmet need in BRCA-mutated patients with MBC, including those with HR+ and TNBC disease. The unmet need among TNBC patients was most evident in that 12% were not treated and TNBC patients appeared to have poor treatment outcomes. MICRO ABSTRACT: Reviewed medical records for outcomes, resource utilization, and costs in 114 community patients with BRCA mutated metastatic breast cancer. 57 hormone positive (HP); 57 triple negative (TN). RESULTS: median PFS: 12.1 months HP; 6.1 TN. HP OS was 38.4; TN 23.4. Rate of infused supportive care drugs: 25.5% HP; 36.7% TN. Patients with TN disease need better therapeutic options.

Incidence of secondary myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) in patients with ovarian or breast cancer in a real-world setting in the United States.

OBJECTIVE: Real-world data on patients with cancer developing secondary malignancies such as myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML) are lacking. This study assessed the incidence and impact of select DNA-damaging therapy exposure on risk of secondary MDS and AML in patients with ovarian cancer (OC) or breast cancer (BC). METHODS: Adults with a first observed OC or BC diagnosis (index date) between 1/1/2000 and 6/30/2014 were identified from MarketScan® Commercial and Medicare databases. Patients had ≥12 months of pre-index and ≥1 month of post-index continuous health plan enrollment. Incidence of MDS/AML was evaluated over a variable-length period following the index date for each cancer cohort. Risk factors for secondary MDS/AML, including duration of DNA-damaging therapy exposure, were assessed using Poisson regression. RESULTS: Study selection criteria identified 23,862 patients with OC and 281,473 patients with BC (mean [SD] follow-up: 35.8 [31.4] and 46.0 [37.2] months, respectively). Incidence of MDS/AML was 2.77 and 1.44 per 1000 person-years among patients with OC and BC, respectively. Within both cohorts, incidence of MDS and AML was higher among patients exposed than those not exposed to select DNA-damaging therapy (alkylating agents, antimetabolites, platinum-based antineoplastic agents, and topoisomerase inhibitors). Duration of exposure to DNA-damaging therapy was a significant risk factor for developing MDS/AML during follow-up. CONCLUSIONS: Data suggest that there is likely a background risk of secondary MDS/AML associated with use of DNA-damaging therapies in earlier lines of chemotherapy and it is elevated in subcohorts exposed to select DNA-damaging therapies.

Treatment Patterns and Outcomes in Stage IV Bladder Cancer in a Community Oncology Setting: 2008-2015.

INTRODUCTION: Current real-world data regarding treatment patterns in advanced bladder cancer in the community setting are limited. This study describes patient characteristics, treatment patterns, and effectiveness outcomes for stage IV bladder cancer in the community setting. METHODS: Medical records data of adults diagnosed with stage IV bladder cancer between January 1, 2008 and June 1, 2015 were retrospectively collected from a network of United States community oncology practices. Patient characteristics, treatment patterns, and efficacy outcomes were assessed. Across-group comparisons were conducted using bivariate analyses. Kaplan-Meier and Cox regression analyses of progression-free survival and overall survival (OS) were conducted. RESULTS: Of 508 patients (mean age, 70 ± 11 years), 75.2% were male, 79.1% white, 15.4% black, and 71.5% were ≥ 65 years. The most prevalent comorbidities were diabetes (23.4%) and renal disease (16.5%). Overall, 56% of patients received first-line platinum-based chemotherapy; the most common regimen was gemcitabine/carboplatin (23.6%), followed by gemcitabine/cisplatin (17%). The median OS was 9.4 months from stage IV bladder cancer diagnosis and 8.4 months from start of first-line therapy. Cox regression analysis of OS from diagnosis showed a higher risk of death for patients with no treatment (hazard ratio [HR], 2.06; P < .0001) or other treatment (HR, 1.83; P = .002) versus cisplatin and for patients with impaired performance (HR, 2.05; P < .0001). CONCLUSION: Platinum-based chemotherapy was the most prescribed treatment for stage IV bladder cancer in the community setting. Several patients were not treated with any chemotherapy, although we did not observe the reason for no treatment. This study highlights an unmet need in this population, particularly in a relapsed/refractory setting, and the need for improvement in outcomes.

A Retrospective Cohort Study of the Incidence, Health Care Resource Utilization and Costs of International Classification of Diseases, Clinical Modification, 9th Revision Diagnosed Influenza and Related Complications in US Children.

BACKGROUND: There is a paucity of data on the clinical and economic impact of seasonal influenza in children. This study estimated the incidence of diagnosed influenza and related complications and associated health care resource utilization and costs in US children. METHODS: Children ≥6 months and <18 years old diagnosed with influenza using International Classification of Diseases, Clinical Modification, 9th revision codes and enrolled in a health plan during at least one influenza season between 2010 and 2014 were matched to similar patients without diagnosed influenza (GSK study identifier: HO-15-15728). Outcomes included incidence of influenza and complications, health care resource utilization frequency and health care costs during 21 days of follow-up. Adjusted costs were estimated using generalized linear models. RESULTS: Incidence (per 1000) of influenza was 20.3 (commercially insured) and 32.6 (Medicaid), with the highest incidence among 6-35 months old (Commercial: 26.8; Medicaid: 47.9). Approximately 12%-17% of influenza patients experienced complications, with the 6-35 months group having the highest percentage (25%-30%). The 6-35-month-old influenza patients with complications had the highest proportion with hospitalizations (5%-6%) and emergency room visits (Commercial: 19%; Medicaid: 36%). Influenza patients with (vs. without) complications had greater adjusted mean influenza-specific costs (Commercial: $1161 vs. $337; Medicaid: $1199 vs. $354; P<0.05), and influenza cases (vs. controls) had greater adjusted mean all-cause costs (Commercial: $688 vs. $470; Medicaid: $818 vs. $453; P < 0.05). CONCLUSIONS: Pediatric patients with influenza incurred higher health care costs compared with matched controls, and influenza-specific costs were greater among those with complications.

Economic burden of hepatitis B infection among patients with diabetes.

Despite ACIP recommendation and cost-effectiveness established in those 19-59 y old diabetes patients the uptake of Hepatitis B vaccine in diabetes patients is low. There is need to highlight the impact of Hepatitis B virus (HBV) infection in diabetes patients in terms of healthcare utilization and costs to recognize the burden of HBV in this population. This retrospective claims analysis included patients with diabetes and HBV (cases; n=1,236) and those with diabetes without HBV (controls; n=4,944), identified by ICD-9-CM diagnosis codes. Cases were matched with 4 controls using propensity score matching. Healthcare utilization and cost were compared; incremental effect of HBV infection was assessed using multivariate analysis. In the adjusted analyses, the mean number of hospitalizations (0.6 vs 0.4), outpatient service visits (34.2 vs. 20.4), and office visits (10.9 vs. 9.8) were 41%, 68%, and 11% higher, respectively, in cases vs. controls (all p<0.05). Gastroenterologist visits (0.8 vs. 0.2) and infectious disease visits (0.1 vs. 0.0) were 80% and 18% higher in subset of case and controls with these events. Cases ($39,435) incurred $16,397 incremental total costs compared with controls ($23,038). Medical ($30,968 vs. $17,765) and pharmacy costs ($8,029 vs. $5,114) were both significantly higher for cases (p < 0.0001). Healthcare utilization and costs were higher among patients with diabetes and HBV than in those with diabetes alone. These results provide evidence supporting the need for HBV vaccination among unvaccinated diabetes patients.

Patient cost sharing and receipt of erythropoiesis-stimulating agents through medicare part D.

PURPOSE: Medicare Part D prescription benefits cover injected medications, normally covered under Part B, when administered outside of physician offices. Erythropoiesis-stimulating agents (ESAs) used for chronic anemia management in patients with myelodysplastic syndromes (MDS) are commonly injected in a physician office but can be administered safely at home. In this study, we explored out-of-pocket (OOP) costs and receipt of Part D-covered ESAs in Medicare beneficiaries with MDS. MATERIALS AND METHODS: Patients with MDS enrolled in Medicare Parts A, B, and D were identified using diagnosis codes from 100% claims from 2006 to 2008. OOP costs for the mean erythropoietin alfa claim were compared for Parts B and D. Multivariable models examined the effect of low-income subsidy (LIS) and other Part D cost sharing on receipt of any ESA and any Part D-covered ESA. RESULTS: A total of 13,117 (62.9%) of 20,848 patients received ESAs, but only 1,436 (6.9%) had any Part D claim. OOP payment was $348 under Part D versus $161 under Part B. Among patients with ESA use, those with LIS were 4× more likely to receive Part D ESAs (P < .01). CONCLUSION: Few patients with MDS received ESAs through Part D. OOP payments required under Part D were substantially higher than under Part B. Cost sharing, as reflected by LIS receipt, likely affected decisions to prescribe ESAs outside of the physician office. Improved coordination between Part B and D benefits regarding issues of home injection of medications may create incentives that improve patient access and convenience and reduce costs associated with administration.

How Medicare Part D benefit phases affect adherence with evidence-based medications following acute myocardial infarction.

OBJECTIVE: Assess impact of Medicare Part D benefit phases on adherence with evidence-based medications after hospitalization for an acute myocardial infarction. DATA SOURCE: Random 5 percent sample of Medicare beneficiaries. STUDY DESIGN: Difference-in-difference analysis of drug adherence by AMI patients stratified by low-income subsidy (LIS) status and benefit phase. DATA COLLECTION/EXTRACTION METHODS: Subjects were identified with an AMI diagnosis in Medicare Part A files between April 2006 and December 2007 and followed until December 2008 or death (N = 8,900). Adherence was measured as percent of days covered (PDC) per month with four drug classes used in AMI treatment: angiotensin-converting enzyme (ACE) inhibitors/angiotensin II receptor blockers (ARBs), beta-blockers, statins, and clopidogrel. Monthly exposure to Part D benefit phases was calculated from flags on each Part D claim. PRINCIPAL FINDINGS: For non-LIS enrollees, transitioning from the initial coverage phase into the Part D coverage gap was associated with statistically significant reductions in mean PDC for all four drug classes: statins (-7.8 percent), clopidogrel (-7.0 percent), beta-blockers (-5.9 percent), and ACE inhibitor/ARBs (-5.1 percent). There were no significant changes in adherence associated with transitioning from the gap to the catastrophic coverage phase. CONCLUSIONS: As the Part D doughnut hole is gradually filled in by 2020, Medicare Part D enrollees with critical diseases such as AMI who rely heavily on brand name drugs are likely to exhibit modest increases in adherence. Those reliant on generic drugs are less likely to be affected.

How does drug treatment for diabetes compare between Medicare Advantage prescription drug plans (MAPDs) and stand-alone prescription drug plans (PDPs)?

OBJECTIVE: To compare the use of guideline-recommended prescription medications for diabetes among Medicare beneficiaries enrolled in stand-alone prescription drug plans (PDPs) with Medicare Advantage prescription drug plans (MAPDs) in the presence of potential selection bias. DATA SOURCES/STUDY SETTING: Centers for Medicare and Medicaid Services' Chronic Condition Data Warehouse (2006, 2007). STUDY DESIGN: Retrospective cross-sectional comparison of drug use and proportion of days covered (PDC) for oral-antidiabetics, ACE-inhibitors/ARBs, and antihyperlipidemics among PDP and MAPD enrollees with diabetes. We estimated "naïve" regression models assuming exogenous plan choice and two-stage residual inclusion (2SRI) models to study endogeneity in choice of Part D plan type. DATA COLLECTION/EXTRACTION METHODS: We identified 111,290 diabetics based on ICD-9 codes in Medicare claims from a random 5 percent sample of Medicare beneficiaries in 2005 excluding dual eligibles. PRINCIPAL FINDINGS: The naïve regression models indicated lower probability of drug use for oral-antidiabetics (-4 percent; p < .001) and ACE-inhibitors/ARBS (-2 percent; p = .004) among PDP enrollees, but their PDC was higher (3-5 percent) for all drug classes (p < .001). 2SRI models produced no significant differences in any-use equations, but significantly higher PDC values for PDP enrollees for oral-antidiabetics and ACE-inhibitors/ARBs. CONCLUSIONS: We found similar overall use of recommended drugs in diabetes treatment and no consistent evidence of favorable or adverse selection into PDPs and MAPDs.

Use and spending on antineoplastic therapy for Medicare beneficiaries with cancer.

BACKGROUND: Oral antineoplastic drugs, not generally covered by Medicare Part B, have assumed an increasingly important role in cancer treatment. OBJECTIVE: We examined use and spending on infused/injected (Part B covered) and non-Part B antineoplastic agents in a Medicare beneficiary population with cancer, and the effect of supplemental insurance. RESEARCH DESIGN: This retrospective, observational study used pooled 1997-2007 data from the Medicare Current Beneficiary Survey, linked to Medicare claims. Logistic regression models identified factors associated with antineoplastic use. Generalized linear models were used to estimate spending among antineoplastic users. POPULATION STUDIED: A total of 1836 Medicare beneficiaries with newly diagnosed cancer were selected based on the presence of claims-based diagnoses after a 12-month washout period. RESULTS: Five hundred fifty-nine (31.0%) Medicare beneficiaries received antineoplastic therapy; 395 (21.3%) used Part B, 253 (14.6%) used non-Part B antineoplastics. Spending per user was $7841 (any), $10,364 (Part B), and $1535 for non-Part B antineoplastics. Supplemental insurance was associated with antineoplastic use. Primary cancer site and age were key predictors of spending among users. Spending on non-Part B antineoplastics increased during 2006-2007 relative to 2004-2005 but time trends were not significant in multivariate analysis. CONCLUSIONS: Antineoplastic therapy use by Medicare beneficiaries is sensitive to the presence but not type of supplemental insurance. Non-Part B therapy was used by a relatively large proportion of beneficiaries with cancer receiving therapy, although spending was less than for Part B therapy. Monitoring the role of supplemental insurance, and particularly the role of Medicare Part D is a critical area for ongoing research.