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Edward J Stepanski - One of the best experts on this subject based on the ideXlab platform.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:Purpose In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p = 0.0034). Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.
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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, 2009Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract: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 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 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.
Scott R Mckenzie - One of the best experts on this subject based on the ideXlab platform.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:Purpose In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p = 0.0034). Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.
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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, 2009Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract: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 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 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.
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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, 2009Co-Authors: Elizabeth Apgar, Mekre Senbetta, Tanya Burton, Kay Larholt, Chris L Pashos, Lorie Ellis, Scott R MckenzieAbstract: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][1], Hb levels were significantly lower at all time points in the Post-NCD group. | | Hemoglobin Outcomes | |:--------- | ------------------- | ------------------ | | | Pre-NCD | Post-NCD | P Value | | TIMEPOINT | n | Mean Hb, g/dL (SD) | n | Mean Hb, g/dL (SD) | P value | | Baseline | 585 | 10.6 (0.9) | 251 | 9.6 (0.7) | =0.0001 | | Week 4 | 370 | 11.1 (1.3) | 132 | 9.9 (1.2) | <0.0001 | | Week 8 | 259 | 11.2 (1.3) | 89 | 10.2 (1.1) | =0.0001 | | Week 12 | 187 | 11.1 (1.3) | 66 | 10.1 (1.1) | <0.0001 | | Week 16 | 73 | 11.1 (1.0) | 14 | 10.2 (1.5) | 0.0256 | 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. [1]: #T1
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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, 2009Co-Authors: Tanya Burton, Scott R Mckenzie, Mekre Senbetta, Kay Larholt, Chris L Pashos, Luke Boulanger, Janice M S Lopez, Devi Sundaresan, Peggy Preusse, Christopher SeidlerAbstract: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][1] 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). | | Mean Hemoglobin, g/dL (SD) | |:-------- | -------------------------- | ----------- | | | Pre-NCD | Post-NCD | p-value | | Baseline | n=241 | 10.3 (0.07) | n=118 | 10.2 (0.63) | 0.0353 | | Week 4 | n=166 | 10.8 (1.17) | n=73 | 10.8 (1.18) | 0.8191 | | Week 8 | n=151 | 11.3 (1.39) | n=59 | 10.8 (1.39) | 0.039 | | Week 12 | n=128 | 11.6 (1.45) | n=54 | 10.9 (1.22) | 0.0067 | | Week 16 | n=127 | 11.5 (1.35) | n=51 | 11.4 (1.21) | 0.4523 | | Week 20 | n=59 | 11.6 (1.16) | n=25 | 11.5 (1.19) | 0.6279 | 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. [1]: #T1
Catherine Tak Piech - One of the best experts on this subject based on the ideXlab platform.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:Purpose In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p = 0.0034). Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.
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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, 2009Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract: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 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 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.
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impact of limiting erythropoiesis stimulating agent use for chemotherapy induced anemia on the united states blood supply margin
Transfusion, 2009Co-Authors: Francis Vekeman, Scott R Mckenzie, Catherine Tak Piech, Brahim Bookhart, Joshua White, Patrick LefebvreAbstract:BACKGROUND: Recently, the Centers for Medicare and Medicaid Services issued a National Coverage Determination that limited erythropoiesis-stimulating agents (ESAs) utilization in patients with chemotherapy-induced anemia (CIA). This study evaluated the impact of limiting the use of ESAs for CIA on the US blood supply margin. STUDY DESIGN AND METHODS: A modeling simulation was employed to compare the number of red blood cell (RBC) units transfused in CIA patients treated with ESAs to the number of RBC units that would be transfused if ESAs were limited or discontinued. The excess number of RBC units that would be required with limited ESA treatment was contrasted with the available marginal blood supply from 2004 and 2008. Model inputs were obtained from published literature or empirical evidence when published information was unavailable. RESULTS: The model predicted that up to 18 and 15 percent of the respective 2004 and 2008 marginal US blood supply would be required to cover the incremental demand for blood that would arise from a 25 percent decrease in ESA use. For ESA use reductions of 50 and 75 percent, the model predicted 17 to 21 percent (134,667 units) and 26 to 31 percent (202,001 units) of the 2008 and 2004 marginal US blood supply would be required, respectively. CONCLUSION: This study showed that limiting ESA use in CIA patients would impose considerable pressure on the available blood supply margin given the small margin between usable blood and transfusion demand. The public health consequences of such an outcome should be taken into account when revisions to ESA use are being considered.
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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, 2008Co-Authors: Tanya Burton, Catherine Tak Piech, Kay Larholt, Elizabeth Apgar, Chris L Pashos, Brahim Bookhart, Mitra Corral, Scott R MckenzieAbstract: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) Week 4 11.1 (1.3) 9.9 (1.1) 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.
David H. Henry - One of the best experts on this subject based on the ideXlab platform.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:Purpose In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p = 0.0034). Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.
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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, 2009Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract: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 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 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.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:Purpose In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD.
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hematologic outcomes and blood utilization in cancer patients with chemotherapy induced anemia cia pre and post National Coverage Determination ncd results from a multicenter chart review
Supportive Care in Cancer, 2012Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract:In July 2007, the Centers for Medicare and Medicaid Services (CMS) limited Coverage of erythropoiesis-stimulating agents (ESAs) in cancer patients with chemotherapy-induced anemia (CIA) through a National Coverage Determination (NCD). The primary objective of this study was to compare transfusion rates in patients with CIA with lung, breast, or colorectal cancer before and after the NCD. Adult Medicare patients with CIA treated at 49 community oncology clinics were selected from two time periods based on clinics' NCD implementation date. Chart data were abstracted for 12 weeks post-CIA episode start, defined as hemoglobin (Hb) level <11 g/dL while receiving chemotherapy or within 60 days of the last chemotherapy dose. Multivariate analyses were used to calculate the odds of transfusion and to assess the units of blood transfused, controlling for differences in demographics, clinical history, and chemotherapy. Eight hundred pre-NCD and 994 post-NCD patients from 49 sites were selected. Of the patients, 56% used ESAs post-NCD vs. 88% pre-NCD (p < 0.0001). The duration of ESA use decreased in the post-NCD (32.1 days) vs. pre-NCD (48.4 days, p < 0.0001) group. The post-NCD group reported significantly lower Hb levels, higher odds of receiving a transfusion (odds ratio: 1.41, 95% CI 1.05–1.89, p = 0.0238) and increased blood utilization of 53% (units transfused: OR 1.53, 95% CI 1.15–2.04, p = 0.0034). Decreased frequency and duration of ESA administration were reported in the post-NCD vs. pre-NCD period. Findings were accompanied by a modest but statistically significant increase in transfusions and a decrease in Hb values.
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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, 2009Co-Authors: David H. Henry, Scott R Mckenzie, Mekre Senbetta, Catherine Tak Piech, Kathy L Schulman, Corey J Langer, Edward J StepanskiAbstract: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 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 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.
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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, 2009Co-Authors: Elizabeth Apgar, Mekre Senbetta, Tanya Burton, Kay Larholt, Chris L Pashos, Lorie Ellis, Scott R MckenzieAbstract: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][1], Hb levels were significantly lower at all time points in the Post-NCD group. | | Hemoglobin Outcomes | |:--------- | ------------------- | ------------------ | | | Pre-NCD | Post-NCD | P Value | | TIMEPOINT | n | Mean Hb, g/dL (SD) | n | Mean Hb, g/dL (SD) | P value | | Baseline | 585 | 10.6 (0.9) | 251 | 9.6 (0.7) | =0.0001 | | Week 4 | 370 | 11.1 (1.3) | 132 | 9.9 (1.2) | <0.0001 | | Week 8 | 259 | 11.2 (1.3) | 89 | 10.2 (1.1) | =0.0001 | | Week 12 | 187 | 11.1 (1.3) | 66 | 10.1 (1.1) | <0.0001 | | Week 16 | 73 | 11.1 (1.0) | 14 | 10.2 (1.5) | 0.0256 | 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. [1]: #T1
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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, 2009Co-Authors: Tanya Burton, Scott R Mckenzie, Mekre Senbetta, Kay Larholt, Chris L Pashos, Luke Boulanger, Janice M S Lopez, Devi Sundaresan, Peggy Preusse, Christopher SeidlerAbstract: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][1] 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). | | Mean Hemoglobin, g/dL (SD) | |:-------- | -------------------------- | ----------- | | | Pre-NCD | Post-NCD | p-value | | Baseline | n=241 | 10.3 (0.07) | n=118 | 10.2 (0.63) | 0.0353 | | Week 4 | n=166 | 10.8 (1.17) | n=73 | 10.8 (1.18) | 0.8191 | | Week 8 | n=151 | 11.3 (1.39) | n=59 | 10.8 (1.39) | 0.039 | | Week 12 | n=128 | 11.6 (1.45) | n=54 | 10.9 (1.22) | 0.0067 | | Week 16 | n=127 | 11.5 (1.35) | n=51 | 11.4 (1.21) | 0.4523 | | Week 20 | n=59 | 11.6 (1.16) | n=25 | 11.5 (1.19) | 0.6279 | 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. [1]: #T1
