scholarly journals Burden of Disease Progression in Patients with Multiple Myeloma Who Have Received at Least One Line of Therapy in the US

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4754-4754 ◽  
Author(s):  
May Hagiwara ◽  
Thomas Delea ◽  
Sumeet Panjabi ◽  
Emre Yucel ◽  
Rafael Fonseca
Keyword(s):  
Disease Progression ◽  
Economic Burden ◽  
Burden Of Disease ◽  
Research Funding ◽  
Index Date ◽  
Economic Burden Of Disease ◽  
The Us ◽  
Event Date ◽  
Baseline Characteristics ◽  
Line Of Therapy

Abstract Introduction Previous studies have documented substantial economic burden for multiple myeloma (MM) patients (pts). However, data on the economic burden of disease progression in the US are limited. In this study, we estimated effects of disease progression on healthcare resource utilization (HRU) and costs among pts with MM who have received at least one line of therapy (LOT) in the US. Methods Data from the Truven Analytics MedStat MarketScan® Commercial Claims and Encounters and Medicare and Coordination of Benefits databases were used. A retrospective incident user cohort of adult pts with a confirmed diagnosis (Dx), defined as ≥1 inpatient or ≥2 non-diagnostic outpatient claims 30-365 days apart with diagnosis, of MM who initiated a course of MM therapy during the study period (Jan 1, 2006 to Dec 31, 2016) was identified. The first date with Dx for MM was defined as the "Dx date" and LOT was identified based on a published algorithm. Pts were excluded if they had a gap in enrollment during the period beginning 6-month before the Dx date through 30-days after the first LOT (1L) initiation date, received MM therapy or unclassified antineoplastic medications before the Dx date or stem cell transplant (SCT) at any time during the study period, or had missing information required to identify LOT or assess baseline characteristics or study outcomes. The 12 months after initiation of each LOT was designated the "event identification period" for progression. Disease progression was defined as advancement to the next LOT, ICD-9/10 or CPT/HCPCS diagnosis or procedure codes indicative of bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, or acute kidney disease while off MM therapy, or death. The "event date" for progression was defined as date with evidence of progression. For each pt with progression, one pt without progression was randomly selected and assigned an index date to ensure that distribution of time from LOT initiation to event date for pts with progression was the same as that for pts without progression. For each LOT (L1-L4), annual HRU and costs from index date through disenrollment or the end of the study period were compared for pts with vs without progression using inverse probability of treatment weighting (IPTW) to adjust for differences between groups in baseline characteristics including year of index date, age, gender, region, plan type, Medicare status, comorbidities, and pre-index HRU and healthcare costs. All costs were adjusted to 2016 US dollars. In a subgroup analysis, HRU and costs were evaluated for LOTs initiated from 2013 to 2016 to reflect patterns of treatment in current era. Results Of the 28,184 adult MM pts who received one or more MM therapy during the study period, 11,179 qualified for the study, including 4468 and 6598 pts with and without progression during 1L, respectively. The corresponding numbers for 2L, 3L, and 4L were 1563 and 2207, 618 and 714, and 244 and 260, respectively. Mean age at index date was 68 years; 57% were male. After IPTW, all baseline characteristics were well balanced in all LOTs with standardized mean differences <0.1 for all characteristics. The mean number of hospitalizations per year was greater for patents with progression in all LOTs, with differences ranging from 0.46 (95%CI 0.40, 0.52) for 1L to 0.89 (95%CI 0.67, 1.11) for 3L. In all LOTs, annual costs of inpatient and outpatient services were greater for pts with progression while costs of outpatient prescriptions were greater among patient without progression. Total healthcare costs were greater for pts with vs without progression in all LOTs with hospitalizations and outpatient visit costs being key drivers. Total incremental annual costs in those who progressed were higher by $30,381 (1L), $33,064 (2L), $34,495 (3L), and $25,163 (4L). When the analysis was restricted to LOTs initiated between 2013 and 2016, the incremental costs in patients who progressed were greater in the most recent era: $52,739 (1L), $49,012 (2L), $25,329 (3L), and $65,400. Conclusions For MM pts receiving drug therapy, the economic burden of disease progression is substantial across all LOTs and this burden is greater in the most recent era (2013 to 2016). Treatments that prevent or delay progression are likely to yield important reductions in downstream disease management costs. These savings should be considered in frameworks assessing the value of innovative treatments for MM. Disclosures Hagiwara: Jazz Pharmaceuticals: Research Funding; Jazz Pharmaceuticals: Consultancy; Amgen: Research Funding; Amgen: Consultancy; Policy Analysis, Inc: Employment. Delea:Novartis: Consultancy, Research Funding; Amgen: Consultancy, Research Funding; Pfizer: Consultancy, Research Funding; Sanofi: Consultancy, Research Funding; Takeda: Research Funding; Seattle Genetics: Research Funding; Policy Analysis Inc.: Employment. Panjabi:Amgen: Employment, Equity Ownership. Yucel:Amgen: Employment, Equity Ownership. Fonseca:Mayo Clinic: Employment; Amgen: Consultancy.

scholarly journals Economic Burden of Disease Progression Among Transplant Eligible Multiple Myeloma Patients Who Have Received at Least One Line of Therapy in the US

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 2211-2211
Author(s):  
Rafael Fonseca ◽  
May Hagiwara ◽  
Sumeet Panjabi ◽  
Emre Yucel ◽  
Jacqueline Buchanan ◽  
...  
Keyword(s):  
Disease Progression ◽  
Economic Burden ◽  
Burden Of Disease ◽  
Research Funding ◽  
Index Date ◽  
Economic Burden Of Disease ◽  
The Us ◽  
Event Date ◽  
Baseline Characteristics ◽  
Line Of Therapy

Introduction Data on the economic burden of disease progression among multiple myeloma (MM) patients who have had a stem cell transplant (SCT) in the US are limited. This study evaluated the impact of disease progression on healthcare resource utilization (HRU) and costs among these patients in the US. Methods Adult patients (pts) with a confirmed MM diagnosis (Dx), defined as ≥1 inpatient or ≥2 non-diagnostic outpatient claims 30-365 days apart who initiated a course of MM therapy (Rx) during the study period (Jan 1, 2006 to Dec 31, 2016) and received SCT during the first year after the initial diagnosis of MM were identified from the Truven Analytics MedStat MarketScan® Commercial Claims and Encounters and Medicare and Coordination of Benefits databases. The first date with Dx for MM was defined as the "Dx date" and line of therapy (LOT) was identified based on an adaptation of a previously-developed algorithm. Pts were excluded if they had a gap in enrollment during the period beginning 6-month before the Dx date through 30-days after the first LOT (1L) initiation date, received MM Rx, unclassified antineoplastic medications, or SCT before the Dx date, or had missing information required to identify LOT or assess baseline characteristics or study outcomes. The 12 months after initiation of each LOT was designated the "event identification period" for progression. Disease progression was defined as advancement to next LOT, diagnosis or procedure codes indicative of bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, or acute kidney disease while off MM Rx, or death. The "event date" for progression was defined as date with evidence of progression. For each pt with progression, one pt without progression was randomly selected and assigned an event date to ensure that the distribution of time from LOT initiation to event date for pts without progression was the same as the distribution of time from LOT initiation to event date for pts with progression. For each LOT (L1-L3), annual HCRU and costs from index date, defined as 30-day before the event date, through disenrollment or end of the study period were compared for pts with vs without progression using inverse probability of treatment weighting (IPTW) to adjust for differences between groups in baseline characteristics including year of index date, age, gender, region, plan type, Medicare status, comorbidities, and pre-index HRU and healthcare costs. All costs were adjusted to 2016 US $. In a subgroup analysis, HCRU and costs were evaluated for LOTs initiated from 2013 to 2016 to reflect patterns of treatment in current era. Results Of the 28,184 adult MM pts who received ≥1 MM Rx during the study period, 3226 qualified for the study, including 837 pts with progression and 2389 without progression during 1L. The corresponding numbers for 2L, and 3L were 412 and 589, and 226 and 196, respectively. Mean age at index date was 57 years; 57% were male. After IPTW, all baseline characteristics were well balanced in all LOTs with standardized mean differences <0.1 for most baseline characteristics. The mean number of hospitalizations per year was greater for pts with progression in all LOTs, with differences ranging from 1.11 (95%CI 0.85, 1.37) for 2L to 0.34 (95%CI 0.21, 0.47) for 1L. In all LOTs, annual costs of inpatient and outpatient services were greater for pts with progression while costs of outpatient prescriptions were greater among patient without progression. Total healthcare costs were greater for pts with vs without progression in all LOTs with hospitalizations and outpatient visit costs being key drivers. Total incremental annual costs in those who progressed were higher by $13,386 (1L), $105,004 (2L), and $70,206 (3L). When the analysis was restricted to LOTs initiated between 2013 and 2016, the incremental costs in pts who progressed were generally greater in the most recent era: $43,381 (1L), $113,797 (2L), and $115,327 (3L). Conclusions For MM pts receiving drug Rx and SCT the economic burden of disease progression is substantial across all LOTs. Incremental costs of progression are largely attributable to hospitalizations and outpatient visits. Treatments that prevent or delay progression are likely to yield important reductions in downstream disease management costs. These savings should be considered in frameworks assessing the value of innovative treatments for MM. Disclosures Fonseca: AbbVie, Amgen, Bayer, Celgene, Kite, Janssen, Juno, Merck, Pharmacylics, Sanofi, Takeda: Other: Consultant/Advisor; Prognosticatin of MM based on Genetic Categorization by FISH: Patents & Royalties; Adaptive Biotechnologies: Other: Scientific Advisory Board. Hagiwara:Amgen Inc.: Research Funding. Panjabi:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Yucel:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Buchanan:Amgen Inc.: Employment, Other: Owns Amgen stock, Research Funding. Delea:Amgen Inc.: Research Funding.

scholarly journals Economic burden of disease progression among multiple myeloma patients who have received transplant and at least one line of therapy in the US

2021 ◽  
Vol 11 (2) ◽  
Author(s):  
Rafael Fonseca ◽  
May Hagiwara ◽  
Sumeet Panjabi ◽  
Emre Yucel ◽  
Jacqueline Buchanan ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Disease Progression ◽  
Economic Burden ◽  
Burden Of Disease ◽  
Healthcare Resource Utilization ◽  
Cell Transplant ◽  
Economic Burden Of Disease ◽  
Acute Kidney Disease ◽  
Skeletal Related Events ◽  
Line Of Therapy

AbstractEffects of disease progression on healthcare resource utilization (HRU) and costs among multiple myeloma (MM) patients with ≥1 line of therapy (LOT) who received their first stem cell transplant (SCT) within 1 year of initial MM diagnosis were estimated using a large US claims database. Disease progression was defined as advancement to the next LOT, bone metastasis, hypercalcemia, soft tissue plasmacytoma, skeletal related events, acute kidney disease, or death within 12 months of LOT initiation. Annual HRU and costs in the first three LOTs (L1–L3) were compared for patients with versus without disease progression using inverse probability of treatment weighting to adjust for differences between groups in baseline characteristics. In all LOTs, mean annual hospitalizations and healthcare costs were greater for patients with versus without progression. Total incremental annual costs among patients with versus without progression in L1–L3 were $18,359, $87,055, and $71,917, respectively, among LOTs initiated between 2006 and 2018. In LOTs initiated between 2013 and 2018, the figures were $46,024, $100,329, and $101,942 in L1–L3, respectively. The economic burden of disease progression is substantial in this population of MM patients who underwent SCT and received systemic anti-myeloma therapy.

Overall Survival, Adverse Events, and Economic Burden in Medicare-Insured Patients with Mantle Cell Lymphoma Receiving Cancer-Directed Therapy

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 63-63
Author(s):  
Shaum M Kabadi ◽  
Ravi K Goyal ◽  
Saurabh P Nagar ◽  
Keith L Davis ◽  
Hannah Le ◽  
...  
Keyword(s):  
Economic Burden ◽  
Systemic Therapy ◽  
Research Funding ◽  
Index Date ◽  
Treatment Initiation ◽  
Cell Lymphoma ◽  
Baseline Period ◽  
Mantle Cell ◽  
Equity Ownership ◽  
Line Of Therapy

Background: Most data on overall survival (OS) and adverse events (AEs) in patients with mantle cell lymphoma (MCL) are from controlled trials in academic centers; data from real world management and outcomes in patients with MCL are sparse. We therefore conducted a population-based retrospective cohort study of patients with MCL in the Medicare database to assess treatment patterns, OS, AEs, and economic burden. Methods: Patients with MCL who received any systemic cancer-directed treatment from 2013 to 2015 were selected from the nationwide Medicare claims database and followed through 2016. The date of the first observed systemic therapy defined each patient's index date. Patients were included if they (a) were ≥ 18 years of age at the index date; (b) had ≥ 12 months of continuous Medicare enrollment before the index date (baseline period); and (c) had no evidence of prior MCL-directed treatment (systemic therapy and/or SCT) at any time before the index date (i.e., during at least the previous 12 months). An observed line of therapy was defined as all agents received on or within 35 days after the first claim for a systemic therapy drug; the observed therapy line was considered ended upon switch to another regimen or a gap ≥ 90 days after the last treatment. OS was estimated by the Kaplan-Meier method from the index date (start of first observed line of therapy) until the last follow-up or death. We also calculated rates of occurrence for hematologic and nonhematologic AEs often associated with the most commonly observed regimens (irrespective of observed line of therapy). The occurrence of AEs was defined based on the presence of at least one claim containing an AE-specific diagnosis code during the treatment, regardless of any history of the AE before treatment initiation. All-cause health care costs were assessed from Medicare's perspective. Multivariable models were fitted to assess the association between number of AEs and average costs during the first observed therapy. Results: We analyzed 1,465 patients who met the inclusion criteria (median age=74 years; 68% male; 93% white). Across all observed lines of therapy, ibrutinib monotherapy (Ibr) (n=588 [40%]) was the most frequently used regimen, followed by bendamustine/rituximab (BR) (n=527 [36%]). Ibr recipients had a median age of 75 years, median Charlson Comorbidity Index (CCI) score of 4.0, and were followed for a median duration of 15 months; 52% died during the study period. BR recipients had a median age of 75 years, median CCI score of 3.0, and were followed for a median duration of 21 months; 28% died during the study period. In Ibr recipients, median OS was 22 months (95% CI = 16.9-28.6) and 24-month OS was 47% (95% CI = 42.9%-50.5%). In BR recipients, median OS was not reached while OS at 24 months was 73% (95% CI = 69.4%-76.0%). The occurrence of common AEs during Ibr and BR therapies are presented in Tables 1 and 2. The average per patient per month costs, among all patients, were $2,501 (SD = $2,818) during the baseline period and $12,604 (SD = $14,437) during the period after initiation of the first observed MCL-directed systemic therapy. Multivariable analysis showed that the patients with 3 or more AEs had nearly 4 times higher monthly per patient costs (cost ratio = 4.12, 95% CI = 3.53-4.82) compared with those with 0-2 AEs. Conclusions: Two-year survival rates observed in this study are comparable to those reported in clinical trials (47% for Ibr in the relapsed disease setting [Wang, 2015, Blood]) and nearly 75% for BR in patients with relapsed indolent disease and MCL [Rummel, 2016, Lancet]). Rates of AE occurrence in Ibr- and BR-treated patients in this study highlight the substantial burden and susceptibility to AEs among Medicare patients in the real-world setting. These findings also demonstrate a substantial increase in the economic burden from the baseline period to the period after MCL treatment initiation and as the number of AEs increased. Disclosures Kabadi: AstraZeneca: Employment, Equity Ownership. Goyal:RTI Health Solutions: Employment. Nagar:RTI Health Solutions: Employment. Davis:RTI Health Solutions: Employment. Le:AstraZeneca: Employment, Other: Stocks. Wang:Dava Oncology: Honoraria; Guidepoint Global: Consultancy; BioInvent: Consultancy, Research Funding; VelosBio: Research Funding; Loxo Oncology: Research Funding; Celgene: Honoraria, Research Funding; Juno Therapeutics: Research Funding; Aviara: Research Funding; Kite Pharma: Consultancy, Research Funding; Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Pharmacyclics: Honoraria, Research Funding; AstraZeneca: Consultancy, Honoraria, Research Funding, Speakers Bureau; MoreHealth: Consultancy, Equity Ownership; Acerta Pharma: Consultancy, Research Funding. Kaye:RTI Health Solutions: Employment.

scholarly journals Demographic and Comorbidity Characteristics of Newly Diagnosed Multiple Myeloma Patients in the United States: A Real World Data Analysis

Blood ◽  
2014 ◽  
Vol 124 (21) ◽  
pp. 1301-1301 ◽  
Author(s):  
Yaozhu J Chen ◽  
Ajita P De ◽  
Ze Cong ◽  
Sanjay K Aggarwal ◽  
Rolin L Wade
Keyword(s):  
Real World ◽  
Research Funding ◽  
Index Date ◽  
The United States ◽  
Newly Diagnosed ◽  
Real World Evidence ◽  
The Us ◽  
Skeletal Related Events ◽  
Baseline Characteristics ◽  
Baseline Demographic

Abstract Background Multiple myeloma (MM) remains an incurable plasma cell neoplasm with >20,000 new cases diagnosed annually in the United States (US). The presentation of MM is diverse and the management is guided by disease- and patient- related factors. Real world evidence regarding disease presentation is sparse for newly diagnosed MM (NDMM) patients. The goal of this study was to describe the baseline demographic and clinical characteristics of NDMM patients by linking multiple large claims databases in the US. Methods A retrospective cohort study was conducted by linking the records between 01/01/2006-12/31/2013 from three longitudinal IMS databases (Medical Claims, Pharmacy Prescriptions, and Hospital Charge Master), to reflect a complete treatment continuum for patients in all ages and by all payer types across healthcare settings. Included patients met the following criteria: ≥2 claims with a diagnosis of MM (ICD-9-CM 203.0x) at least 30 days apart between 01/01/2007-12/31/2012 (first MM diagnosis date = index date); provider stability for at least 6 months before and 3 months after index date; aged 18+ as of index date. NDMM patients were identified as those with no MM diagnosis in the 6 months pre-index. Patient baseline characteristics were assessed using data at index for age, gender, geographic region and payer type; 6-month pre-index plus index day data for Charlson Comorbidity Index (CCI); 6-month pre-index data for 32 comorbidities (e.g., cardiac arrhythmia, cerebrovascular disease, chronic kidney disease, diabetes, hypertension, among others); and 5 comorbidity categories (cardiovascular, renal, metabolic, skeletal-related events, and other). Autologous stem cell transplant (ASCT) status was also assessed based on the available follow-up data after initial diagnosis. Patient baseline characteristics were compared between the patients with versus without ASCT after MM diagnosis. Chi-square tests for categorical variables and t-tests for continuous variables (alpha=0.05) were conducted. Results The study cohort of 8,239 NDMM patients had a mean (SD) age of 66.2 (11.3) years at diagnosis, with 56.7% aged 65+; 51.8% were female; and the majority were with commercial (43.3%) or Medicare (42.8%) as payer. Patients with post-index ASCT (n=1,429; 17.3%) were distinctly different from those without (n=6,810; 82.7%): they were younger with a mean (SD) age of 58.1 (8.7) vs. 67.9 (11.1) years, fewer aged 65+, 24.1% vs. 63.5%; fewer female, 47.6% vs. 52.6% (all p<0.001); and the majority (67.5%) of patients who later had ASCT were covered by commercial plans, compared to Medicare as the biggest payer (48.2%) for those who did not have post-index ASCT. NDMM patients had an overall mean (SD) CCI score of 3.1 (1.6). Patients who later received ASCT were healthier than those who did not, with mean (SD) CCI scores of 2.7 (1.4) vs. 3.2 (1.6) (p<0.001). Close to half (47.9%) of all NDMM patients had >1 type of comorbidities at baseline. Figure 1 depicts the baseline comorbidity categories among all NDMM patients as well as the two subsets (with versus without post-index ASCT). Comorbidities were prevalent even before MM diagnosis: 43.9% of patients presented with metabolic comorbidities, 21.4% with cardiovascular diseases, 11.5% with renal conditions, 5.9% with skeletal-related events, and 45.0% with other comorbidities. The patient subset with post-index ASCT had lower comorbidity occurrences compared to those without: 10.5% vs. 23.6% in cardiovascular diseases, 5.9% vs. 12.7% in renal conditions, 32.7% vs. 46.3% in metabolic diseases (all p<0.001), consistent with literature showing that ASCT candidates tend to be younger and have less severe comorbidities. Conclusions This study provided baseline demographic and comorbidity profiles of NDMM patients and showed that the NDMM patient population presented with various comorbidities prior to the first MM diagnosis, suggesting the needs for efficacious, tolerable and safe treatment options for a heterogeneous patient population with complex disease profiles. As expected, patients who had ASCT after initial diagnosis were younger and healthier than those who did not have ASCT. The study findings portray a clearer picture of NDMM patients in the US, and provide clinicians with valuable real world evidence to identify appropriate treatment strategies for these patients. Figure 1 Figure 1. Disclosures Chen: Onyx Pharmaceuticals: Research Funding. De:Onyx Pharmaceuticals: Research Funding. Cong:Onyz Pharmaceuticals: Employment. Aggarwal:Onyx Pharmaceuticals: Employment. Wade:Onyx Pharmaceuticals: Research Funding.

scholarly journals Osteoporosis: Economic Burden of Disease in Italy

2020 ◽  
Vol 40 (5) ◽  
pp. 449-458 ◽  
Author(s):  
Andrea Marcellusi ◽  
Maria Assunta Rotundo ◽  
Claudia Nardone ◽  
Paolo Sciattella ◽  
Simone Gazzillo ◽  
...  
Keyword(s):  
Economic Burden ◽  
Burden Of Disease ◽  
Economic Burden Of Disease

Benefits of Early Switching From Imatinib to a Second-Generation Tyrosine Kinase Inhibitor Following 12 Month Complete Cytogenetic Response Failure: A Chart Review Analysis.

Blood ◽  
2012 ◽  
Vol 120 (21) ◽  
pp. 2792-2792
Author(s):  
Daniel J. DeAngelo ◽  
Lei Chen ◽  
Annie Guerin ◽  
Amy Styles ◽  
Clemence Aberki ◽  
...  
Keyword(s):  
Tyrosine Kinase ◽  
Tyrosine Kinase Inhibitor ◽  
Disease Progression ◽  
Research Funding ◽  
Index Date ◽  
Second Generation ◽  
Kinase Inhibitor ◽  
Cytogenetic Response ◽  
Analysis Group

Abstract Abstract 2792 Background: The National Comprehensive Cancer Network (NCCN) guidelines (version 1.2013) recommend that patients with chronic myelogenous leukemia in chronic phase (CML-CP) should be tested for cytogenetic response 12 months following imatinib initiation. Failure to achieve complete cytogenetic response (CCyR) at 12 months should result in either an increased dose of imatinib (up to 800mg) or a change to a second-generation tyrosine kinase inhibitor (TKI). This study observed patients who failed to achieve CCyR at 12 months following the initiation of imatinib and compared treatment response rates and disease progression between patients who switched to a second-generation TKI early versus patients who did not. Methods: An online chart abstraction form was used to survey US oncologists and hematologists. Physicians submitted de-identified information on up to 10 adult patients with CML-CP who initiated imatinib as first line therapy (between 01/01/2007 and 26/07/2010) and failed to achieve CCyR at 12 months (between 10–14 months). Patients either switched to a second-generation TKI within 3 months following CCyR failure (early-switchers), or remained on imatinib for ≥3 months following CCyR failure (non-switchers). Non-switchers may have later switched to a second-generation TKI. The index date was defined as the date of the 12-month CCyR failure. Detailed patient information was collected, including demographics, comorbidities, imatinib dosage, and hematologic and cytogenetic response prior to the index date. Cytogenetic response and disease progression was also collected after the index date. CCyR was defined as 0% Philadelphia chromosome positive (Ph+) cells on cytogenetic testing. The proportion of patients achieving CCyR by 6, 12, and 24 months was reported among patients who had ≥1 cytogenetic test during these periods. Documented CCyR was defined as CCyR achievement analyzed among all patients, if patients were not tested for CCyR following the index date they were considered not to have achieved CCyR. Time to first documented CCyR achievement and time to disease progression were both estimated using multivariate Cox proportional hazard ratios (HR), where exposure was calculated from the index date to the first documented CCyR achievement, or to the date of progression, respectively. Multivariate regression analyses controlled for age, sex, race, index year, Charlson comorbidity index, imatinib dose and hematological response prior to index date, percentage of Ph+ cells and CML disease duration at index date, number of days between CML diagnosis and imatinib initiation, and rise in transcript level and chromosome abnormalities in Ph+ cells reported prior to the index date. Results: The majority of the 108 surveyed physicians were from a private practice (72.2%) and a small/intermediate practice size (61.1%). Physicians provided information on 593 patients who failed to achieve CCyR at 12 months; 306 were early-switchers and 287 were non-switchers. Among the non-switchers, 78 later switched to a second-generation TKI, and 104 increased imatinib dose after the index date. Patient demographics and comorbidities were similar among early-switchers and non-switchers, however, results of the 12-month cytogenetic test revealed that early-switchers had a greater number of Ph+ positive cells (51. 5 ± 16.6) compared to non-switchers (47.2 ± 13.1, p=.002). The median follow-up time was 612.5 days (range = 91–1625) and 591 days (range = 365–1623), respectively. Among patients tested for cytogenetic response during the follow-up period (274 early-switchers and 252 non-switchers), 35% of early-switchers subsequently achieved CCyR, compared to 24 % of non-switchers (p=.006). Within 6 months after the index date, 4.7% of the early-switchers achieved CCyR vs. 0.4% of non-switchers; by 12 months, 20.1% vs. 12.3% achieved CCyR; and by 24 months, 33.6% vs. 21.8% achieved CCyR, respectively (all p<.016). After adjusting for confounding factors, early-switchers had an 80% greater documented CCyR achievement rate compared to that of non-switchers (HR=1.80; p=.002) and a progression rate that was 81% lower (3.8% vs.1.5%, HR=0.19, p=.034). Conclusion: Early switching from imatinib to a second-generation TKI following 12-month CCyR failure was associated with better cytogenetic response and a lower risk of progression. Disclosures: DeAngelo: Novartis: Consultancy. Off Label Use: Everolimus in AML. Chen:Novartis Oncology: Employment, Own stock in Novartis Other. Guerin:Analysis Group, Inc.: Consultancy, Employment, I am an employee of Analysis Group, Inc, which has received consulting fees from Novartis Pharmaceuticals Other, Research Funding. Styles:Analysis Group, Inc.: Consultancy, Employment, Research Funding. Aberki:Analysis Group, Inc.: Consultancy, Employment, Research Funding. Giguere-Duval:Analysis Group, Inc.: Consultancy, Employment, Research Funding. Wu:Analysis Group, Inc.: Consultancy, Employment, I am an employee of Analysis Group, Inc, which has received consulting fees from Novartis Pharmaceuticals Other, Research Funding.

Clinical and Economic Burden Of Peripheral T-Cell Lymphoma In The United States

Blood ◽  
2013 ◽  
Vol 122 (21) ◽  
pp. 2963-2963
Author(s):  
Michele H. Potashman ◽  
Chakkarin Burudpakdee ◽  
Weiying Wang ◽  
Yanyan Zhu ◽  
Kenneth R. Carson
Keyword(s):  
Board Of Directors ◽  
Economic Burden ◽  
Research Funding ◽  
Index Date ◽  
The United States ◽  
Control Group ◽  
Pharmacy Services ◽  
Office Visits ◽  
Peripheral T Cell Lymphoma ◽  
Advisory Committees

Abstract Background Peripheral T-cell lymphoma (PTCL) is an aggressive and heterogeneous subtype of non-Hodgkin lymphoma (NHL). PTCL has a poor prognosis due to advanced stage at presentation, and generally poor response to standard chemotherapy. According to recent SEER estimates, PTCL accounts for about 4% of all NHL cases in the United States each year. To date, few studies have assessed the clinical and economic burden of PTCL. Methods MarketScan data for commercially insured and Medicare supplemental patients were used to retrospectively identify unique PTCL patients. Patients were identified by ICD-9-CM diagnosis codes between October 1, 2007 and June 30, 2011. The time of first PTCL diagnosis code served as the index date, and a second PTCL diagnosis date was used for confirmation. All patients were required to have at least 6 months of continuous enrollment before and 12 months of continuous enrollment after their index date. Patients were excluded if aged <18 years, date of birth or gender were missing, or if they had received a stem cell transplant (SCT) prior to PTCL diagnosis. The control group includes patients that may have any other malignant (excluding PTCL) or non-malignant condition and are considered to represent an average insured patient population from the payer perspective. The control group was matched based on age, sex, region, plan type, payer type, and length of enrollment. Mean cost per month was measured and annualized to provide average yearly costs. Healthcare costs included hospitalizations, pharmacy services, office visits, emergency room visits, hospice stays, SCT, and other patient-related costs (lab procedures, radiology procedures, blood transfusions, and other ancillary procedures). Results Of 2820 patients with ≥1 PTCL diagnosis, 1000 patients were identified that met all inclusion criteria (mean age 56 years, 58% male), and were matched to the control group. On an average annual basis, PTCL patients were hospitalized more often (0.9 vs 0.1 hospitalizations), and experienced a longer length of stay (6.4 vs 4 days) compared with matched controls. In addition, PTCL patients had a higher utilization of office visits (16.2 vs 4.1 visits), pharmacy services (34.2 vs 11.6 prescriptions), emergency room visits (0.8 vs 0.2 visits), and hospice care (0.6 vs 0.1 stays). PTCL patients also experienced higher comorbidities (mean Charlson Comorbidity Index of 1.72 vs 0.39, as determined at index date). Overall, PTCL patients incurred much higher average annual costs compared with matched patients ($75,934.08 vs $4660.64; Table), driven mainly by hospitalizations (32.2% of overall costs) and pharmacy services (19.6% of overall costs). Conclusions PTCL is associated with high resource utilization rates and high overall costs. The development of efficacious treatments for PTCL may offer better disease management and may reduce the clinical and economic burden of PTCL. Disclosures: Potashman: Millennium: The Takeda Oncology Company: Employment. Burudpakdee:Millennium: The Takeda Oncology Company: Consulting researcher Other. Wang:Millennium: The Takeda Oncology Company: Consulting researcher Other, Research Funding. Zhu:Millennium: The Takeda Oncology Company: Employment. Carson:Millennium: The Takeda Oncology Company: Consultancy, Membership on an entity’s Board of Directors or advisory committees, Research Funding; Celgene: Consultancy, Membership on an entity’s Board of Directors or advisory committees; Spectrum, Inc.: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Kyowa Hakko Kirin Pharma, Inc.: Research Funding.

Real-world treatment patterns, health care resource utilization (HRU), and costs among patients with Waldenstrom macroglobulinemia (WM) initiating therapy.

2016 ◽  
Vol 34 (7_suppl) ◽  
pp. 17-17
Author(s):  
Brad Schenkel ◽  
Lorie Ellis ◽  
Stephanie Korrer ◽  
Stacey DaCosta Byfield
Keyword(s):  
Index Date ◽  
B Cell Lymphoma ◽  
Drug Regimen ◽  
Current Therapy ◽  
Anti Cancer ◽  
The Us ◽  
Us Fda ◽  
Line Of Therapy ◽  
Initial Drug

17 Background: WM is a rare, indolent B-cell lymphoma with 1000 to 1500 new cases diagnosed annually in the US. The disease is incurable with current therapy. Prior to January 2015 when ibrutinib was approved by the US FDA for WM, there were no therapies approved in this indication. This study describes initial systemic anti-cancer therapy (SACT) and HRU among WM patients (pts). Methods: A retrospective study using a large, national US claims database from 1/2007-10/2013 was conducted. Adult WM pts ( ≥ 2 claims for WM) with ≥ 1 claim for SACT were identified; the first SACT claim date was the index date. Pts were required to have a WM diagnosis within 3 months (m) prior to the index date and be continuously enrolled (CE) in the health plan for 12m pre- and ≥ 6m post-index date. Pregnant pts and those with SACT in the pre-index period were excluded. The first line of therapy (LOT1) period was examined; the LOT started at index date and the regimen included all drugs received within 60 days. The LOT ended at the earliest of, start of a new drug, ≥ 60-day gap in receipt of initial drug regimen, death or CE end. All-cause HRU and costs during LOT1 were examined. Results: There were 161 WM pts identified. 66% of pts were ≥ 65 yrs (mean age 69), 55% were male, and by insurance type, 49% were Medicare Advantage pts vs. 51% commercially insured. Mean total follow-up time was 23m, and mean duration of LOT1 was 4.7m. The top 4 most common LOT1 regimens accounted for 71% of patients: Rituximab (R) only (39%); bortezomib+ R (14%); bendamustine+ R (9%) and cyclophosphamide+ R (9%). No other regimens identified accounted for more than 4% of pts. Overall, 96% and 81% of pts had ≥ 1 office or hospital outpatient visit with mean per patient per month (PPPM) visits of 3.55 (standard deviation, SD = 2.41) and 2.60 (SD = 3.06), respectively. Approximately 25% and 21% had ≥ 1 ER visit or inpatient stay with mean PPPM visits of 0.11 (SD = 0.24) and 0.06 (SD = 0.16), respectively. Total mean PPPM healthcare costs during LOT1 was $13,589 (SD = $13,404). Conclusions: HRU and costs were high among WM pts initiating SACT. Future studies should examine whether differences in LOT1 regimen choice are associated with differences in cost and outcomes.

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