Blood and Resource Utilization in Cancer Patients with Chemotherapy-Induced Anemia (CIA) in the Pre- and Post-National Coverage Determination (NCD) Timeframes: Results From An Electronic Medical Record Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2472-2472
Author(s):  
Tanya Burton ◽  
Luke Boulanger ◽  
Kay Larholt ◽  
Chris L. Pashos ◽  
R. Scott McKenzie ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Resource Utilization ◽  
Research Funding ◽  
Treatment Patterns ◽  
Lower Proportion ◽  
Administrative Claims ◽  
Tumor Type ◽  
Ortho Biotech ◽  
Blood Utilization ◽  
The Impact

Abstract Abstract 2472 Poster Board II-449 Background: The Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA in July 2007 restricting ESA administration to those with hemoglobin (Hb) less than 10 g/dL and contingent on specific achieved Hb levels. Data assessing CIA patients regardless of ESA treatment pre- and post-NCD are scarce. This study evaluated Pre- and Post-NCD data in patients with CIA from a single oncology clinic in the northeastern United States to understand anemia treatment patterns, hematologic outcomes, and resource utilization. The oncology clinic, which is a part of a multi-specialty capitated integrated medical group, implemented the ESA NCD policy in September 2007. Methods: Medical, laboratory, and administrative claims data between 1/2005 and 4/2008 were retrospectively analyzed. Assessed patients had a diagnosis of malignant cancer (ICD-9-CM 140.XX-208.xx), received chemotherapy, and were anemic (Hb < 11 g/dL) during the chemotherapy treatment period. Patients diagnosed with myelodysplasia, acute leukemia, or chronic kidney disease who received dialysis, and those enrolled in ESA clinical trials were excluded. Data were categorized and analyzed in two time frames (Pre-NCD: 07/06-05/07, Post-NCD: 09/07-04/08). Baseline characteristics, ESA treatment patterns, hematologic outcomes (transfusion and available Hb levels), and resource utilization were assessed during the 20 week observation period following the index date of Hb < 11 g/dL. Results: 359 patients were identified (241 Pre-NCD; 118 Post-NCD). Baseline age, gender, race, weight, height, and distribution of tumor type were similar between groups. In the Post-NCD group, a significantly higher proportion of patients had comorbidities of congestive heart failure, coronary artery disease, and chronic obstructive pulmonary disease. The Post-NCD group had a significantly lower proportion of patients treated with ESAs (Pre-NCD 64%, Post-NCD 47%, p=0.0023). Among patients on ESA therapy (≥ 2 ESA injections), there was a trend toward shorter duration of ESA treatment in the Post-NCD arm [mean (SD): Pre-NCD 57.9 days (39.1), Post-NCD 47.3 days (38.1), p=0.08]. As noted in the table below, transfusion-independent Hb levels were lower in the Post-NCD group at baseline, Week 8, and Week 12. The proportion of patients transfused and blood utilization were similar in the Pre- and Post-NCD groups. The average number of oncology/hematology visits per patient was lower in the Post-NCD group [mean (SD): Pre-NCD 8.8 (5.9), Post-NCD 7.4 (6.5), p=0.01], however, a significantly higher proportion of patients in the Post-NCD period had a hospital admission (Pre-NCD 37.8%, Post-NCD 50.8%, p=0.02) or an emergency room (ER) visit (Pre-NCD 44.8%, Post-NCD 55.9%, p=0.048). Conclusion: Data from this single center observational study reported a lower proportion of patients initiated on ESAs, similar blood utilization, and an increased proportion of patients with hospitalization and ER visits in CIA patients with Hb < 11 g/dL in the Post-NCD as compared to the Pre-NCD time period. Further study assessing the impact of CIA NCD policy on healthcare resource utilization in multiple clinical centers is warranted. Disclosures: Burton: Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Boulanger:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. McKenzie:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Lopez:Centocor Ortho Biotech Services, LLC: Employment. Sundaresan:Centocor Ortho Biotech Services, LLC: Consultancy. Preusse:Centocor Ortho Biotech Services, LLC: Consultancy. Seidler:Centocor Ortho Biotech Services, LLC: Consultancy.

Pre- and Post-National Coverage Determination (NCD) Hematologic Outcomes and Blood Utilization in Cancer Patients with Chemotherapy-Induced Anemia (CIA): Results From a Multicenter Chart Review.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2491-2491
Author(s):  
David H. Henry ◽  
Corey J. Langer ◽  
R. Scott McKenzie ◽  
Catherine Tak Piech ◽  
Mekré Senbetta ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Research Funding ◽  
Chart Review ◽  
Negative Binomial ◽  
Performance Status ◽  
Cancer Type ◽  
Tumor Type ◽  
Ecog Performance Status ◽  
Ortho Biotech ◽  
Blood Utilization

Abstract Abstract 2491 Poster Board II-468 Introduction: In July 2007, the Centers for Medicare & Medicaid Services issued erythropoiesis-stimulating agent (ESA) coverage limitations for cancer patients with CIA through an NCD, which limits ESA utilization in patients with CIA to hemoglobin (Hb) levels of less than 10 g/dL at ESA initiation and after the initial 4 weeks of treatment. The primary objective of this study was to compare transfusion rates in patients with breast, colorectal or lung cancer who developed CIA before and after the NCD, regardless of treatment with ESAs. Patients and Methods: Chart data from adult cancer patients with Medicare as their primary payer and treated at community oncology clinics were abstracted for 12 weeks following the beginning of a CIA episode, provided that the entire episode occurred either before or after the change in policy. CIA was defined as Hb level < 11 g/dL, while receiving chemotherapy or within 8 weeks (60 days) of the last dose of chemotherapy. Logistic regression was used to calculate the odds of transfusion following the Hb < 11 g/dL index date. A negative binomial model was used to assess the change in units of blood transfused per patient. Multivariate models controlled for differences in age, gender, cancer type, line of therapy, ECOG performance status, history of antecedent transfusion and exposure to platinum, anthracyclines, antimetabolites and plant alkaloids. Results: 1794 patients were identified (800 Pre-NCD and 994 Post-NCD) from 49 sites. Patient groups were similar with respect to age, gender, race, weight, tumor type, line of treatment and recent exposure to radiation or surgery. As shown in the table below, there were significant differences in the chemotherapy class exposure in the Post- vs. Pre-NCD period. In addition, Hb levels were lower in the Post-NCD period, with a decrease in the proportion of ESA-treated patients and ESA treatment duration. The odds of receiving a transfusion were significantly higher Post-NCD (OR 1.41, 95% CI; 1.05 - 1.89; p=0.02) with an overall increase in adjusted units transfused of 53% (OR 1.53, 95% CI; 1.15 - 2.04; p=0.003). The table below summarizes patient characteristics and unadjusted Hb and transfusion outcomes. Conclusion: This large multicenter chart review reported decreased frequency and duration of ESA administration in CIA patients with Hb < 11 g/dL in the Post-NCD period compared to the Pre-NCD period. This was accompanied by a modest but statistically significant increase in blood utilization and decrease in Hb values. Further studies are warranted to assess other outcomes. Disclosures: McKenzie: Centocor Ortho Biotech Services, LLC: Employment. Piech:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. Schulman:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Stepanski:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding.

Hematologic and Hospitalization Outcomes in Patients with Chemotherapy-Induced Anemia (CIA) Treated with Erythropoiesis-Stimulating Agents (ESAs) in the Pre- Vs Post-National Coverage Determination (NCD) Time Periods.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 2482-2482
Author(s):  
Elizabeth Apgar ◽  
Tanya M. Burton ◽  
Kay Larholt ◽  
Chris L. Pashos ◽  
Lorie Ellis ◽  
...  
Keyword(s):  
Blood Transfusion ◽  
Cancer Patients ◽  
Research Funding ◽  
Study Patient ◽  
Patient Specific ◽  
Tumor Type ◽  
Ortho Biotech ◽  
Blood Utilization ◽  
Time Periods ◽  
Hospital Days

Abstract Abstract 2482 Poster Board II-459 Background: National coverage limitations for ESA treatment in cancer patients with CIA were established by the Centers for Medicare & Medicaid Services in July 2007. Clinical outcomes based on ESA dosing described in the NCD have not been reported in prospective observational or clinical trial data. To understand hematologic and hospitalization outcomes in CIA patients treated in Pre- and Post-NCD time periods, an analysis of data from the D.O.S.E. (Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies) registry, an ongoing prospective observational study, was conducted. Methods: ESA-treated cancer patients with CIA were selected if they initiated ESA treatment 12/01/2005-04/01/2007 (Pre-NCD) or 10/01/2007-02/01/2009 (Post-NCD), had ≥ 2 ESA administrations, and had both a baseline and ≥ 1 transfusion-independent post-ESA initiation hemoglobin (Hb) assessment. Assessed outcomes included proportion of patients receiving blood transfusion, number of units/study patient, Hb levels (at baseline and at weeks 4, 8, 12, 16) and hospitalization rates (admissions, number of hospital days) adjusted for ESA therapeutic duration (defined as time (days) from first to last ESA administration + patient-specific ESA treatment interval). Results: This analysis included 836 patients (Pre-NCD 585; Post-NCD 251) from 54 sites. Patients in the Pre-NCD and Post-NCD cohorts were similar in gender distribution and weight. The Post-NCD cohort was significantly older (64.7 yrs vs. 61.9 yrs; p<0.01). The groups also differed significantly in overall tumor type distribution (p<0.0001). The Post-NCD group had a lower proportion of patients with breast cancer and higher proportion of patients with lung cancer and gynecologic malignancies. ESA treatment duration was significantly shorter in the Post-NCD group (mean days ± SD: Post-NCD 55.5 ± 32.7, Pre-NCD 65.8 ± 33.8, p<0.0001). The proportion of patients receiving blood transfusion was significantly greater in the Post-NCD group (Post-NCD 26.7%, Pre-NCD 15.6%, p=0.0002) as was blood utilization (Units/study patient: Post-NCD 0.9, Pre-NCD 0.4, p=0.0001). As shown in the table, Hb levels were significantly lower at all time points in the Post-NCD group. The rate of hospital admissions was significantly greater in the Post-NCD group [Admissions/100-patient ESA therapeutic days (95% CI): Post-NCD 0.42 (0.34, 0.53), Pre-NCD 0.28 (0.24, 0.33)] as was the number of hospital days [Hospital days/100-patient ESA therapeutic days (95% CI): Post-NCD 2.3 (2.1, 2.5), Pre-NCD 1.3 (1.2, 1.4)]. Conclusions: Significantly greater blood utilization and lower Hb levels were observed in ESA-treated CIA patients in the Post-NCD period compared to the Pre-NCD period. Rates of hospitalizations and hospital length of stay were also significantly greater in the Post-NCD group. Study of comparative hematologic and resource utilization outcomes before and after the NCD is warranted in additional clinical centers. Disclosures: Apgar: Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Burton:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Larholt:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Pashos:Centocor Ortho Biotech Services, LLC: Consultancy, Research Funding. Ellis:Centocor Ortho Biotech Services, LLC: Employment. Senbetta:Centocor Ortho Biotech Services, LLC: Employment. McKenzie:Centocor Ortho Biotech Services, LLC: Employment.

Pre- vs. Post-National Coverage Determination (NCD) Blood Utilization and Hemoglobin Values among Medicare Patients Treated with Erythropoietic-Stimulating Agents (ESAs) for Chemotherapy-Induced Anemia (CIA)

Blood ◽  
2008 ◽  
Vol 112 (11) ◽  
pp. 1301-1301 ◽  
Author(s):  
Tanya Burton ◽  
Kay Larholt ◽  
Elizabeth Apgar ◽  
Chris Pashos ◽  
Brahim Bookhart ◽  
...  
Keyword(s):  
Cancer Patients ◽  
Clinical Trial Data ◽  
Study Patient ◽  
P Value ◽  
Tumor Type ◽  
Time Period ◽  
Hospital Systems ◽  
Utilization Patterns ◽  
Blood Utilization ◽  
The Impact

Abstract Background: In July 2007, the Centers for Medicare and Medicaid Services issued ESA coverage limitations for cancer patients with CIA through a national coverage determination (NCD). Clinical outcomes based on ESA dosing described in the NCD have not been reported in prospective observational or clinical trial data. To understand hematologic outcomes in the Medicare population treated in pre- and post-NCD time period, an analysis of hematologic outcomes from the DOSE (Dosing and Outcomes Study of Erythropoiesis-Stimulating Therapies) registry, an ongoing prospective observational study, was conducted. Methods: ESA-treated cancer patients with CIA were selected based on Medicare primary coverage, available baseline hemoglobin (Hb) value, and receipt of at least two ESA administrations. Data were categorized into two timeframes based on date of initial ESA administration: pre-NCD (4/06-4/07) and post-NCD (10/07-5/08). Baseline demographics, Hb values during ESA treatment, and blood utilization patterns were analyzed. Results: 288 patients were identified (Pre-NCD – 230; Post-NCD – 58) from 41 sites. Patient groups were similar with respect to age, gender, weight, and tumor type. ESA treatment duration was significantly greater in the pre-NCD group (70 days vs. 54 days, p = 0.0011). As shown in the table, differences with regard to blood utilization and Hb values were observed between the Pre-NCD and Post-NCD populations. A significantly greater proportion of patients required a blood transfusion and the number of units administered per study patient was significantly higher in the Post-NCD group. Hb levels were significantly lower at all time points of observation in the Post-NCD group. Pre-NCD Post-NCD p-value Transfusion Outcomes Proportion of Patients Transfused 18.3% 32.8% p = 0.0157 Mean No. of Units per Study Patient 0.5 1.1 p = 0.0089 Hematologic Outcomes: Mean Hb (SD) Baseline 10.6 (0.8) 9.6 (0.5) &lt; 0.0001 Week 4 11.1 (1.3) 9.9 (1.1) &lt; 0.0001 Week 8 11.2 (1.3) 10.4 (1.3) 0.013 Week 12 11.1 (1.3) 9.8 (1.2) 0.0002 Week 16 11.0 (1.1) 9.7 (0.2) 0.018 Conclusion: Greater blood utilization and lower Hb values were observed in Medicare CIA patients treated with ESAs during the Post-NCD time period compared to the Pre- NCD time period. The impact of the NCD on patient outcomes is important to providers and hospital systems and warrants further research.

Associations of pre-existing cardiovascular disease (CVD) with treatment patterns and survival outcomes in patients with metastatic prostate cancer: A real-world, population-based study.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e17056-e17056
Author(s):  
Atul Batra ◽  
Shiying Kong ◽  
Winson Y. Cheung
Keyword(s):  
Prostate Cancer ◽  
Metastatic Prostate Cancer ◽  
Population Based ◽  
Treatment Patterns ◽  
Survival Outcomes ◽  
Administrative Claims ◽  
World Population ◽  
Cancer Treatments ◽  
Lower Likelihood ◽  
The Impact

e17056 Background: Prior cardio-oncology research has focused on examining the future risk of CVD as a result of cancer treatments. The impact of pre-existing CVD on cancer treatments is less clear. This study aimed to identify the associations of baseline CVD on treatment patterns and survival outcomes in metastatic prostate cancer where older age and exposure to androgen deprivation therapy can potentiate cardiac risks. Methods: We identified all patients diagnosed with metastatic prostate cancer in a large Canadian province from 2004 to 2017 using the population-based cancer registry. Administrative claims were linked to ascertain any diagnoses of pre-existing CVD, defined as any of arrythmias [AR], cerebrovascular accidents [CVAs], myocardial infarctions [MIs], or congestive heart failure [CHF] that preceded the diagnosis of metastatic prostate cancer. Logistic and Cox regression models were constructed to determine the associations of baseline CVD with receipt of cancer treatments (such as radiation, or systemic therapy) and overall survival (OS). Results: A total of 3,257 patients were included. The median age was 66 years (interquartile range, 46-95 years). At diagnosis of advanced prostate cancer, 993 (30.5%) had pre-existing CVD: 10.0% AR, 4.3% CVAs, 3.0% MIs, 2.8% CHF and 10.4% multiple CVDs. The Charlson comorbidity index (CCI) was 0, 1 and >1 in 53.4%, 27.3% and 19.3%, respectively. Overall, 2078 (63.8%) patients received chemotherapy, while 747 (22.9%) received radiotherapy. After adjusting for age and CCI, pre-existing CVD was associated with a lower likelihood of chemotherapy (odds ratio [OR], 0.67; 95% confidence interval [CI], 0.61-0.75; P=0.001) and radiotherapy (OR, 0.87; 95% CI, 0.85-0.91; P<0.001). Likewise, CVD was associated with worse OS, after adjusting for measured confounding variables (see table). Conclusions: One-third of patients with metastatic prostate cancer had pre-existing CVD, which was associated with a lower likelihood of chemotherapy and worse OS. In the context of an aging general population, early cardio-oncology consultations to optimize CVD management may lead to safer and broader uptake of appropriate prostate cancer treatments.[Table: see text]

In Vitro Anti-Myeloma Activity of the Multitargeted Kinase Inhibitor Midostaurin in the Context of Heterotypic Cocultures of Myeloma Cells with Nonmalignant Microenvironmental Accessory Cells

Blood ◽  
2011 ◽  
Vol 118 (21) ◽  
pp. 2923-2923
Author(s):  
Panisinee Lawasut ◽  
Hannah M. Jacobs ◽  
Jake E Delmore ◽  
Joseph Negri ◽  
Douglas W. McMillin ◽  
...  
Keyword(s):  
Drug Resistance ◽  
Research Funding ◽  
Kinase Inhibitor ◽  
Conditioned Media ◽  
Myelogenous Leukemia ◽  
Tumor Type ◽  
Accessory Cells ◽  
The Impact ◽  
Positive Controls

Abstract Abstract 2923 Midostaurin (PKC412; Novartis Pharmaceuticals) is a multi-targeted kinase inhibitor currently being evaluated in clinical trials in acute myelogenous leukemia (AML), because of its potent activity in cells expressing mutant FLT3. Prior preclinical studies from our groups have shown that PKC412 has FLT3-independent anti-MM activity, and the effects on AML cells is suppressed by the presence of conditioned media from bone marrow stromal cells (BMSCs), such as the immortalized BMSC line HS-5 (Weisberg et al. Mol Cancer Ther 2007). In this study, we evaluated whether the microenvironment-dependent drug resistance to PKC412 applies to not only AML cells, but also to cells from MM and other FLT3-negative malignant cells. We tested a panel of cells from MM (n=8), FLT-ITDneg AML (n=1), CML (n=2) and breast cancer (n=2) for their response to PKC412 in the presence or absence of BMSCs and other non-malignant accessory cells using tumor cell compartment-specific bioluminescence imaging (CS-BLI), as in our antecedent studies (McMillin et al. Nat Medicine 2010). We also compared the PKC412 response of the aforementioned neoplastic cells when cultured in vitro in the presence or absence of conditioned media (CM) from different types of BMSCs known to confer PKC412 resistance in FLT3-mutant AML cells. Consistent with our previous studies of PKC412 treatment in conventional cultures of MM cells in isolation, we observed that PKC412 exhibits an anti-proliferative effect within the first 24 hrs of treatment, with major reduction of the numbers of viable cells at 48 and 72 hrs. At sub-micromolar doses that did not significantly affect the viability of non-malignant accessory cells tested, PKC412 had similar (or for some MM cell lines had more pronounced) activity against the MM cells, both in the presence and absence of the non-malignant accessory cells tested (HS-5, HS-27a, NIH-3T3 cells with or without transfection with human CD40L, etc.). In contrast, under the same experimental conditions, coculture with either BMSCs or exposure to their conditional media, decreased the response of MM cells to dexamethasone. These results suggested in contrast to the impact on FLT3mut AML, that the anti-MM activity of PKC412 is preserved (and in some cases slightly enhanced) when the MM cells interact with microenvironmental accessory cells and/or their secreted growth/survival factors. To obtain insight on possible mechanistic foundations of these observations, we examined the pattern of kinases inhibited by PKC412 at sub-μM concentrations (using FLT3 and FGFR3, known targets of PKC412 as positive controls). The results of in vitro kinase activity assays showed that PKC412 potently suppresses the aforementioned positive controls, but also exerts >50% inhibitory effect on the in vitro activity of additional kinases such as Akt2, Pim1, GSK3a, PDK1, p70S6K, SRC and Aurora A. Many of these kinases are known to participate in proliferative/anti-apoptotic signaling cascades downstream of cytokine/growth factor receptors or cell adhesion-mediated events triggered during MM–stromal interactions. We therefore conclude that the influence of the tumor microenvironment on the anti-neoplastic effects of PKC412 may be tumor-type dependent. The anti-MM activity of PKC412 is not subject to drug resistance triggered by non-malignant accessory cells, and conversely is occasionally moderately enhanced by these MM-stromal interactions. Mechanistically, this observation may be attributed in part to the multi-targeted nature of this inhibitor and, in particular, its aggregate impact on several kinases known to mediate stroma-induced proliferative and antipoptotic signaling in MM. Disclosures: Griffin: Novartis Pharmaceuticals: Consultancy, Research Funding. Richardson:Millennium: ; Celgene: ; Johnson & Johnson: ; Novartis: ; Bristol Myers Squibb:. Anderson:Celgene: Consultancy, Honoraria; Millennium Pharmaceuticals, Inc.: Consultancy, Honoraria; Novartis: Consultancy, Honoraria. Mitsiades:EMD Serono: Research Funding; AVEO Pharma: Research Funding; Amgen: Research Funding; OSI Pharmaceuticals: Research Funding; PharmaMar: licensing royalties; Amnis Therapeutics: Consultancy, Honoraria; Centocor: Consultancy, Honoraria; Pharmion: Consultancy, Honoraria; Kosan: Consultancy, Honoraria; Merck: Consultancy, Honoraria; Bristol-Myers Squibb: Consultancy, Honoraria; Novartis Pharmaceuticals: Consultancy, Honoraria; Celgene: Consultancy, Honoraria; Millennium Pharmaceuticals: Consultancy, Honoraria; Sunesis: Research Funding; Gloucester Pharmaceuticals: Research Funding; Genzyme: Research Funding; Johnson & Johnson: Research Funding.

scholarly journals Real-World Analysis of Ruxolitinib Treatment Patterns and Outcomes Among Patients with Myelofibrosis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 4750-4750 ◽  
Author(s):  
Tanya Burton ◽  
Kejal Parikh ◽  
Manish Patel ◽  
Kevin Sundquist ◽  
Lincy S. Lal ◽  
...  
Keyword(s):  
Health Plan ◽  
Research Funding ◽  
Index Date ◽  
Myeloproliferative Neoplasm ◽  
Treatment Patterns ◽  
Systemic Steroid ◽  
Administrative Claims ◽  
Employment Equity ◽  
Oncology Research ◽  
Equity Ownership

Background: Myelofibrosis (MF) is a myeloproliferative neoplasm characterized by bone marrow fibrosis, splenomegaly, cytopenias, and poor survival. Ruxolitinib (RUX) is the only approved treatment for Intermediate or High-risk MF. In a previous study, we have shown almost 1 in 3 patients initiating RUX had dose modifications during the first 3 months of treatment (Burton T et al. HemaSphere 2019). The objective of this study was to assess RUX treatment patterns among patients with MF. Methods: This retrospective analysis used administrative claims data from a large US health plan to identify adults (aged ≥ 18 years) with ≥ 1 claim for RUX and ≥ 2 non-diagnostic medical claims for primary (International Classification of Diseases [ICD] 9th or 10th Revision [9/10]: 238.76, D47.4) or secondary MF (ICD-9/10: 289.83, D75.81) from January 1, 2012 to June 30, 2018. The first RUX claim on or after the first MF claim defined the index date. Included patients were continuously enrolled in a commercial or Medicare Advantage health plan for 3 months before the index date (pre-index period) and 6 months on or after the index date (post-index period). Clinical characteristics, MF-related treatments, health care resource utilization (HCRU), and costs were assessed during the pre- and post-index periods. Costs were adjusted to 2018 US dollars using the medical component of the Consumer Price Index. Cohorts were created based on the maximum (max) RUX daily dose observed during the 6-month post-index period: suboptimal max < 30 mg/day (SUB); and optimal max ≥ 30 mg/day (OPT). All variables were analyzed descriptively. Results: Among 495 eligible patients, mean (SD) age was 69.4 (10.3) years; 54.1% were male; and 25% had a primary MF diagnosis code. Median initial RUX dose was 30 mg/day and patients continued with this dose for a mean (SD) of 70.0 (45.8) days. RUX dose was modified for 19.4% of patients during the 6-month post-index period, and the distribution of max RUX daily doses was: < 15 mg (13.7%), 15-29 mg (24.9%), 30-40 mg (55.8%), and > 40 mg (5.7%). Two groups based on max RUX dosing were further analyzed: 191 (38.6%) in the SUB cohort (< 30 mg), and 304 (61.4%) in the OPT cohort (≥ 30 mg). Patients in the SUB cohort were older than patients in the OPT cohort (SUB: mean 70.8 [SD 10.1] years; OPT: mean 68.5 [SD 10.3] years; P = 0.013), but the mean Charlson Comorbidity Index scores did not differ (SUB: mean 1.6 [SD 1.8]; OPT: mean 1.5 [SD 1.8]; P = 0.601). Rates of anemia were higher at baseline for the SUB cohort than the OPT cohort (SUB: 64.9%; OPT: 53%; P = 0.009). During the 6-month post-index period, compared with patients in the OPT cohort, patients in the SUB cohort had a higher proportion of thrombocytopenia (SUB: 31.4%; OPT: 22.7%; P = 0.03). Nearly half (45.5%) the sample used a supportive agent such as an androgen, systemic steroid, or erythropoiesis-stimulating agent during the post-index period (SUB: 48.2%; OPT: 43.8%; P = 0.34). With respect to HCRU and costs, the SUB cohort had a higher proportion of emergency department (ED) visits than the OPT cohort during baseline (SUB: 31.4%; OPT: 23.4%; P = 0.048); and baseline total mean (SD) all-cause costs were USD 18,079 (21,876) overall, USD 18,908 (24,411) for the SUB cohort, and USD 17,559 (20,145) for the OPT cohort (P = 0.523). During the 6-month follow-up period, 31.1% of patients had ≥ 1 ED visit (SUB: 35.1%; OPT: 28.6%; P = 0.131), 22.8% had ≥ 1 inpatient (IP) hospitalization (SUB: 24.6%; OPT: 21.7%; P = 0.455), and total mean (SD) all-cause costs were USD 94,498 (97,391) overall (SUB: USD 93,289 [115,418]; OPT: USD 95,258 [84,315]; P = 0.839). Conclusion: In this study, patients with MF treated with RUX experienced significant disease burden and high costs, regardless of dose. Both anemia and thrombocytopenia were observed along with nearly half of patients using a supportive agent. Given the large proportion of patients with a dose adjustment, suboptimal dosing, and an IP hospitalization, there continues to be a need for additional therapeutic options for patients with MF. Disclosures Parikh: Celgene Corporation: Employment, Equity Ownership. Patel:Celgene Corporation: Employment, Equity Ownership. Sundquist:Optum: Employment, Equity Ownership. Lal:Optum: Employment. Copher:Celgene Corporation: Employment. Gerds:Roche: Research Funding; Incyte: Consultancy, Research Funding; Sierra Oncology: Research Funding; CTI Biopharma: Consultancy, Research Funding; Imago Biosciences: Research Funding; Celgene Corporation: Consultancy, Research Funding; Pfizer: Consultancy.

Characterising the Burden of Chronic Lymphocytic Leukemia in Fludarabine-Ineligible Patients in Spain, Italy, and the United Kingdom (UK): A Retrospective Observational Study

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 2646-2646 ◽  
Author(s):  
Julio Delgado ◽  
Davide Rossi ◽  
Francesco Forconi ◽  
Edith Schodl ◽  
Karissa M Johnston ◽  
...  
Keyword(s):  
Resource Utilization ◽  
Annual Cost ◽  
Research Funding ◽  
Standard Dose ◽  
Treatment Patterns ◽  
Lymphocytic Leukemia ◽  
First Line ◽  
Advisory Committees ◽  
Reduced Dose ◽  
The Uk

Abstract Chronic lymphocytic leukemia (CLL) is the most common leukemia in the western world, accounting for approximately 30% of adult leukemias. The majority of CLL patients are elderly and have co-existing medical conditions. This limits therapeutic options and precludes many from receiving the recognized standard of care regimen, fludarabine, cyclophosphamide and rituximab (FCR). A number of recent studies have evaluated alternative chemoimmunotherapies for these patients. The objective of this study was to describe patient characteristics, treatment patterns, and resource utilization for patients who are unfit for a standard fludarabine-based regimen as first-line treatment for CLL in Spain, Italy, and the UK. A retrospective chart review was undertaken at 18 sites in Spain, 16 in Italy, and 17 in the UK, to identify CLL patients who initiated treatment between January 2011 and December 2012, with a target sample size of 150 per country. Eligible patients were defined as those who initiated first-line CLL treatment that did not include fludarabine (UK and Spain) or standard-dose fludarabine (Italy) which ensured that elderly patients with comorbidities were included. The variability in definitions was due to increased use of reduced-dose fludarabine regimens in Italy for patients not otherwise suitable for a standard dose of fludarabine. Data on demographic and disease-related characteristics, treatment patterns, and health resource utilization were abstracted from diagnosis until December 2013. Among eligible patients (Spain, n=127, Italy, n=121, UK, n=94), the mean age at treatment initiation was 75.9, 73.8, and 76.8 years, respectively. In the UK, 89.4% had 2 or more comorbidities compared to 74.8% in Spain and 65.3% in Italy. In all countries, chlorambucil monotherapy was the single most common regimen, prescribed to 59.6% of patients in the UK, 38.6% in Spain, and 30.6% in Italy. Bendamustine plus rituximab was the next most common regimen in the UK (17.0%) and Italy (23.1%). In Spain, the second-most common regimen was chlorambucil plus rituximab (18.9%). In Italy, 9.9% of patients received the reduced-dose fludarabine regimen, FCR-Lite. In both Spain and the UK, 40% of patients were hospitalized during the follow-up period, compared to 27% in Italy. Emergency room use ranged from 2% in the UK to 40% in Spain. A large majority of patients in all countries utilized outpatient services and laboratory monitoring, with more frequent of visits in Spain and Italy relative to the UK. Hospitalization costs were the largest cost driver (€3284 in Spain, €1312 in Italy, €10291 in the UK). Observed differences in hospital costs across countries were due to variation in: the proportion of individuals being hospitalized, with hospitalizations less common in Italy; length of hospital stay, with a minority of long and costly hospital stays in the UK; and hospital per diem costs. In Spain, outpatient visits comprised the second largest category of costs, while in Italy the second largest category was laboratory tests. In the UK, the second largest category was hospice care, although this was heavily influenced by a small number of individuals with very lengthy hospice stays. For the majority of UK patients, outpatient care was the second-highest category of costs. In conclusion, CLL patients who initiated first-line therapy during 2011 and 2012, with a regimen that did not include fludarabine (UK and Spain) or did not contain standard-dose fludarabine (Italy), were elderly, with 2 or more comorbidities. The most frequently administered treatment was chlorambucil monotherapy. Resource utilization patterns varied across countries; while some differences may have resulted from differences in patient and disease characteristics, they likely also reflect variation in management strategies between these countries. These results provide valuable baseline data to understand the potential impact of future treatments for this patient population. Abstract 2646. Table 1.SpainItalyUK% with utilizationMean annual cost per patient (€)% with utilizationMean annual cost per patient (€)% with utilizationMean annual cost per patient (€)Hospitalization40.5328426.9131240.410291Hospice008.42055.36380Emergency room40.311515.01072.24Laboratory95.052899.052687.178Outpatient95.0116794.021968.8874Transfusions25.25117.04330.1226 Disclosures Delgado: Roche: Consultancy, Honoraria, Research Funding; Gilead: Consultancy, Research Funding, Speakers Bureau; GSK: Consultancy, Honoraria, Research Funding; Mundipharma: Consultancy, Honoraria; Celgene: Honoraria; Novartis: Consultancy, Honoraria. Rossi:Amgen: Membership on an entity's Board of Directors or advisory committees, Research Funding; Janssen: Membership on an entity's Board of Directors or advisory committees, Research Funding. Raine:GSK: Employment. Haiderali:GSK: Employment.

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