scholarly journals A Retrospective Database Analysis of Treatment Pathways in US Medicare Patients with Multiple Myeloma and Prior Exposure to Daratumumab, an Immunomodulatory Agent, and a Proteasome Inhibitor

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4019-4019
Author(s):  
Natalie Boytsov ◽  
Anissa Cyhaniuk ◽  
Gary Leung ◽  
Feng Wang ◽  
Cosmina Hogea ◽  
...  
Keyword(s):  
Index Date ◽  
Treatment Patterns ◽  
Publicly Traded ◽  
Immunomodulatory Agent ◽  
Medicare Patients ◽  
Treatment Sequencing ◽  
The Mean ◽  
Retrospective Database Analysis ◽  
Retrospective Database

Abstract Introduction: Recentreal-world data for multiple myeloma (MM) treatment patterns and outcomes are limited, particularly for patients with refractory or relapsed MM. As the MM treatment landscape evolves, it is important to understand how new treatments are integrated into patient treatment patterns. The aim of this study was to examine patient demographics, clinical characteristics, treatment patterns, and survival among Medicare patients with MM following exposure to daratumumab (DAR), an immunomodulatory agent, and a proteasome inhibitor (PI). Methods: This was a retrospective database analysis utilizing the Centers for Medicare and Medicaid Services claims data during the study period of January 1, 2016, through December 31, 2018. The start of the study period was chosen to align with DAR market entry in the United States (FDA approval November 2015). Medicare patients, diagnosed with MM, and with existing claims for DAR, an immunomodulatory agent, and a PI (tri-exposure) were eligible for inclusion. Index tri-exposure was achieved once a patient had been exposed to all 3 MM treatments, regardless of their sequence. The index date was the first observed claim for any MM regimen (index line of therapy [LOT]) following tri-exposure. Patients were required to have ≥6 months of continuous enrollment prior to the index date (baseline period). Therapies given after the index LOT were defined as post-index therapy. Patient data were assessed until health plan disenrollment, death, or end of study period, whichever occurred first. Results: There were 1336 Medicare patients with MM who met the inclusion criteria. Of these patients, the mean age (standard deviation [SD]) at the index date was 71 (8.5) years and 705 (52.8%) were male. The Southern United States showed the largest representation of patients in this population (n=471, 35.3%). The top baseline comorbidities included respiratory infections (98.3%), osteoarthritis (86.8%), anemia (86.9%), hypertension (78.1%), dyslipidemia (66.5%), chronic pain/fibromyalgia (51.9%), acute or chronic kidney disease (44.5%), cardiac arrhythmia (45.81%), and neutropenia (47.98%). The mean (SD) number of days from the index date until the end of index LOT was 48.7 days (12.0). Among 949 patients (71.0%) who had post-index therapy, the mean (SD) time from the last observed claim for index LOT to the beginning of the post-index therapy and duration of post-index therapy was 51.8 (44.2) days and 57.8 (16.0) days, respectively. The median (range) duration of follow-up time from the index date was 223 (3─886) days. During the study follow-up period, 571 patients (42.7%) died, and the median (range) number of days from the index date until death was 173 (3─873) days. While there was variation in treatment sequencing leading to tri-exposure, the most frequent tri-exposure sequence was an immunomodulatory agent < PI < DAR (33.2% [See Table for overview of treatment sequencing]). Among patients who received index LOT following tri-exposure, 49.4% had triplet therapy and 29.8% had doublet therapy. The most common index LOT regimens were triplet: DAR/pomalidomide/dexamethasone (DEX; 7.6%), elotuzumab/lenalidomide/DEX (5.2%), and DAR/bortezomib/DEX (4.9%). The most common post-index LOT regimens were triplet (39.9%): DAR/pomalidomide (6.1%), carfilzomib/cyclophosphamide/DEX (3.7%), DAR/bortezomib/DEX (3.5%), and DAR/lenalidomide/DEX (3.5%). During follow-up, 52.8% of patients were retreated with DAR, 79% with PI, and 77.3% with immunomodulatory drugs. Conclusions: This study suggests wide variation in treatment sequencing and regimens after tri-exposure to DAR, an immunomodulatory agent, and a PI. Triplet regimens were predominant treatment after the tri-exposure and following the index LOT. Retreatment with the same agents was common. Among those who died, survival was often less than 1 year following tri-exposure. These results highlight the need for new treatment options in triple-class refractory MM settings. Funding: GSK (Study 213462) Figure 1 Figure 1. Disclosures Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Cyhaniuk: STATinMED Research: Current Employment. Leung: STATinMED Research: Current Employment. Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Hogea: GlaxoSmithKline, paid employee: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Mudumby: STATinMED Research: Current Employment.

scholarly journals A Retrospective Database Analysis of Treatment Pathways in US Medicare Patients with Multiple Myeloma Following Sequential Treatment with Lenalidomide and a Proteasome Inhibitor

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4963-4963
Author(s):  
Natalie Boytsov ◽  
Anissa Cyhaniuk ◽  
Gary Leung ◽  
Feng Wang ◽  
Cosmina Hogea ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Baseline Period ◽  
Publicly Traded ◽  
Database Analysis ◽  
Treatment Pathways ◽  
The Past ◽  
Medicare Patients ◽  
Retrospective Database Analysis ◽  
Retrospective Database

Abstract Introduction: Although multiple myeloma (MM) is currently incurable, the survival rate has improved over the past decade. Despite advances in treatment, most patients will become refractory to treatment. Lenalidomide and proteasome inhibitors (PI) are frequently used in early MM treatment regimens; however, there is a need to further understand how follow-up treatments affect patient outcomes. The aim of this retrospective database analysis was to examine the demographics, clinical characteristics, treatment sequencing, and overall survival in US Medicare patients with MM who initiated any MM treatment after observed treatment with lenalidomide and a PI. Methods: Claims data from the Centers for Medicare and Medicaid Services (CMS) were assessed during the study period of January 1, 2016, through December 31, 2018. Medicare patients who were diagnosed with MM and had any MM therapy at least 28 days following treatment with lenalidomide and PI were eligible. The index date (ID) was the date of the first observed claim for any MM therapy as a next line of therapy (LOT) following treatment with lenalidomide and a PI. Patients were required to have ≥6 months of continuous enrollment prior to ID (baseline period). Patient data were assessed until health plan disenrollment, death, or end of study period (whichever occurred first). Results: This study identified a cohort of 6590 eligible Medicare patients with MM exposed to lenalidomide and a PI. The mean age (standard deviation) was 72 (8.0) years, and 53.0% of patients were male. The Southern United States showed the largest representation of patients in this population (37.0%). The top baseline comorbidities included osteoarthritis (83.0%), hypertension (76.9%), anemia (76.7%), and respiratory infections (75.7%). PIs used in the lenalidomide/PI combination in the baseline period included bortezomib (67%), carfilzomib (30%), and ixazomib (29%). A patient could have received one or more of these PIs. Of the 6590 patients who received index therapy, 51% had triplet therapy, 35% had doublet therapy, 10% had monotherapy, 3% had quad therapy, and <1% had another combination. Among the 78% patients with a post-index LOT, 37% had triplet therapy, 37% had doublet therapy, 22% had monotherapy, 4% had quad therapy, and <1% had another combination. The most common therapies during the follow-up were dexamethasone (88%), lenalidomide (73%), bortezomib (45%), pomalidomide (31%), and daratumumab (31%). Patients could have received one or more of these therapies in the follow-up period. Overall, 4,788 (73%) patients were retreated with lenalidomide and 5,613 (85%) patients were retreated with a PI during the follow-up period. Between the ID and the end of study period, 24.4% of patients died. The median (range) time to death was 211 (1─890) days from ID. Conclusions: This study showed there was wide variation in subsequent treatment strategies following lenalidomide/PI exposure. After exposure, patients were most often treated with triplet therapies, and there was frequent re-treatment with previously used agents and/or classes. These results highlight the need for novel treatments/classes of therapy and sequencing strategies that may improve outcomes in patients with MM. Funding: GSK (Study 213462) Disclosures Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Cyhaniuk: STATinMED Research: Current Employment. Leung: STATinMED Research: Current Employment. Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Hogea: GlaxoSmithKline, paid employee: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Mudumby: STATinMED Research: Current Employment.

scholarly journals Real-World Treatment Patterns, Healthcare Resource Utilization and Associated Costs Among Patients with Chronic Myeloid Leukemia in Later Lines of Therapy

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 8-9
Author(s):  
Ehab L. Atallah ◽  
Rodrigo Maegawa ◽  
Dominick Latremouille-Viau ◽  
Carmine Rossi ◽  
Annie Guerin ◽  
...  
Keyword(s):  
Medical Costs ◽  
Healthcare Resource Utilization ◽  
Treatment Patterns ◽  
Publicly Traded ◽  
Pharmaceutical Corporation ◽  
Analysis Group ◽  
Ed Visits ◽  
The Mean ◽  
Line Of Therapy

Introduction: Despite advances in tyrosine kinase inhibitor (TKI) therapy for chronic myeloid leukemia (CML), there remains a sizeable proportion of patients (pts) with CML in chronic phase who are refractory or intolerant to these agents. A good understanding of the most recent real-world patterns of care in these pts is necessary in order to provide context for assessing the potential benefits of new treatments undergoing clinical development. The aim of this study was to evaluate treatment patterns in CML pts cycling through TKI therapies achieving later lines of therapy, and to estimate their healthcare resource utilization (HRU) and costs. Methods: Adult pts with CML in the United States who received at least 3 lines of TKI therapy were identified in the IBM MarketScan Commercial and Medicare Supplement databases (Q1/2001-Q2/2019). Treatment patterns were observed from CML diagnosis. Pt characteristics were measured during the 6 months prior to third line (3L) initiation (baseline period). All-cause HRU (inpatient [IP] admissions and days, days with outpatient [OP] services, and emergency department [ED] visits) and costs (medical and pharmacy) were measured 1) during the course of 3L therapy (from 3L initiation to termination) and 2) between 3L initiation and end of follow-up (stem cell transplant [SCT], or end of data availability/health plan coverage). HRU was reported using monthly incidence rates per 100 pts (IR/100pts); costs (2019 USD) were evaluated per-pt-per-month (PPPM) from a payer's perspective. Results: Of the 48,168 pts identified with CML, a total of 296 CML pts initiated 3L therapy; median age was 58.5 years (30% were aged ≥65 years) and 50% were female. The mean follow-up period from CML diagnosis was 57.8 months and from 3L initiation was 24.5 months. Most pts had their first CML diagnosis in or after 2010 (71%) and achieved 3L in or after 2014 (50%). At baseline, the mean modified Charlson Comorbidity Index score (excluding CML) was 1.6 with 24% of pts with a score ≥3, 64% of pts had a moderate or severe Darkow Disease Complexity Index, and the most prevalent comorbidities were hypertension (45%) and diabetes (25%); 21% of pts (i.e., ≥1 indicator of congestive heart failure, cirrhosis, or end-stage renal disease, or ≥75 years old). The most common sequences of TKIs from first line (1L) to 3L were imatinib → dasatinib → nilotinib (28%), imatinib → nilotinib → dasatinib (16%), imatinib → dasatinib → imatinib (9%), and dasatinib → imatinib → nilotinib (5%). The mean duration of 1L, second line (2L), and 3L therapy was 14.9, 10.4, and 15.6 months, respectively; 62% of pts were still in 3L at the end of follow-up. Only one patient received SCT after 3L. The most common TKIs received at each line were imatinib in 1L (65%), dasatinib in 2L (49%), and nilotinib in 3L (36%). The mean treatment-free period (time between line of therapy termination and next line initiation) between 1L and 2L was 1.3 months, 2.6 months between 2L and 3L, and 1.5 months between 3L and 4L. During 3L therapy, pts had a monthly IR/100pts of 3.4 IP admissions, 21.2 IP days, 248.8 OP days, and 10.2 ED visits (Figure 1A). Pharmacy costs accounted for 69% of the mean total costs of $15,192 PPPM, with medical costs accounting for the remainder (Figure 1B). In 3L therapy and later, pts had a monthly IR/100pts of 3.5 IP admissions, 28.7 IP days, 252.2 OP days, and 10.0 ED visits (Figure 1A). Pharmacy costs accounted for 49% of the mean total costs of $18,767 PPPM, with medical costs mainly driven by IP costs (Figure 1B). Conclusions: This study characterized CML pts receiving later lines of therapy, a clinical population which has not been previously well studied with important unmet treatment needs as they repetitively fail TKI therapy. Although the majority of pts were likely fit for SCT, SCT was rare. In addition, pts quickly switched to the subsequent line of therapy, both facts suggesting that an important proportion of pts were intolerant to previous TKIs. While pharmacy costs accounted for nearly half of the total cost burden during 3L, the proportion of medical costs PPPM took more importance following 3L therapy, with IP costs being the primary cost drivers for this increase. These findings support the need for better treatment options in pts with CML undergoing later lines of therapy. Disclosures Atallah: Novartis Pharmaceutical Corporation: Consultancy; Jazz: Consultancy; Pfizer: Consultancy; Takeda: Consultancy, Research Funding; Abbvie: Consultancy; Genentech: Consultancy. Maegawa:Novartis Pharmaceutical Corporation: Current Employment, Current equity holder in publicly-traded company. Latremouille-Viau:Novartis Pharmaceutical Corporation: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.; Sanofi Genzyme: Consultancy, Other: Dominique Latremouille-Viau is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.. Rossi:Novartis Pharmaceutical Corporation: Consultancy, Other: Carmine Rossi is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Guerin:Abbvie: Consultancy, Other; Sanofi Genzyme: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Sanofi Genzyme.; Novartis Pharmaceuticals Corporation: Consultancy, Other: Annie Guerin is an employee of Analysis Group, Inc. which received consultancy fees from Novartis.. Patwardhan:Novartis Pharmaceutical Corporation: Current Employment, Current equity holder in publicly-traded company.

scholarly journals Characteristics, Treatment Patterns, Healthcare Resource Use, and Costs among Pediatric Patients Diagnosed with Neurofibromatosis Type 1 and Plexiform Neurofibromas: A Retrospective Database Analysis of a Medicaid Population

2020 ◽  
Author(s):  
Xiaoqin Yang ◽  
Kaushal Desai ◽  
Neha Agrawal ◽  
Kirti Mirchandani ◽  
Sagnik Chatterjee ◽  
...  
Keyword(s):  
Resource Use ◽  
Neurofibromatosis Type 1 ◽  
Pediatric Patients ◽  
Healthcare Resource ◽  
Neurofibromatosis Type ◽  
Treatment Patterns ◽  
Healthcare Resource Use ◽  
The Mean

Abstract Background: Neurofibromatosis type 1 (NF1)-related plexiform neurofibromas (PN) can cause substantial morbidity by disfigurement and compression of vital structures. Real-world data on the burden and cost of disease among pediatric patients with NF1 and PN is limited. The objectives of this study were to describe the characteristics, treatment patterns, healthcare resource use (HCRU), and costs of these patients.Results: A total of 383 patients were included in the retrospective analysis of patients aged ≤18 with at least 1 ICD-10-CM diagnosis code for both NF1 and PN enrolled in the MarketScan® Multistate Medicaid database from October 1, 2014 to December 31, 2017. The mean follow-up was 448 days. The mean age was 11.4 years and 52.0% of patients were male. Most patients were diagnosed by a specialist (63.5%). During the follow-up period, pain medications were used by 58.5% of patients, 25.1% were treated with chemotherapy, 7.1% received surgery for PN, 1.6% received MEK inhibitors, and 0.8% received radiation. Mean per patient per year inpatient, outpatient, emergency room, pharmacy, and other visits were 1.4, 17.3, 1.6, 13.6, and 25.8, respectively. Mean ±SD (median) total per patient per year healthcare costs (2018 USD) were $17,275 ±$61,903 ($2,889), with total medical costs of $14,628 ±$56,203 ($2,334) and pharmacy costs of $2,646 ±$13,303 ($26). Inpatient costs were the largest drivers of medical cost, with a mean per patient per year cost of $6,739.Conclusions: This study showed that many pediatric patients diagnosed with NF1 and PN were treated with supportive care only, highlighting a substantial unmet medical need. This study also highlights the considerable economic burden among patients with NF1 and PN.

scholarly journals Treatment Patterns and Outcomes of Patients with Double-Class Refractory or Triple-Class Refractory Multiple Myeloma: A Retrospective US Electronic Health Record Database Study

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 2705-2705
Author(s):  
Feng Wang ◽  
Boris Gorsh ◽  
Maral DerSarkissian ◽  
Prani Paka ◽  
Rachel Bhak ◽  
...  
Keyword(s):  
Research Funding ◽  
Performance Status ◽  
Treatment Patterns ◽  
Multiple Drug ◽  
Publicly Traded ◽  
Analysis Group ◽  
Refractory Status ◽  
Drug Classes ◽  
Immunomodulatory Drug

Abstract Introduction: Patients with relapsed/refractory multiple myeloma (RRMM) resistant to multiple drug classes remain a high unmet need population, despite advances in MM patient care. The objective of this study was to assess real-world treatment patterns and outcomes in patients with RRMM who had failed multiple prior lines of therapy (LOT) and were refractory to multiple drug classes to identify gaps in their treatment pathways. Methods: This longitudinal retrospective cohort study utilized the COTA de-identified real-world database derived from US electronic health records of partnered healthcare providers from Q3 1988 through Q1 2020. Adults with active RRMM previously exposed to a proteasome inhibitor (PI) and an immunomodulatory drug and who received ≥3 prior LOTs were identified. Patients were further categorized as refractory to a PI and an immunomodulatory drug (double-class refractory [DCR]) or additionally to an anti-CD38 monoclonal antibody (i.e. daratumumab; triple-class refractory [TCR]). Determining refractory status was based on International Myeloma Working Group criteria. Index LOT was a new LOT after evidence of DCR or TCR status following ≥3 (DCR) or ≥4 (TCR) prior LOTs. Patient characteristics described included Eastern Cooperative Oncology Group (ECOG) performance status, International Staging System (ISS) stage, cytogenetic risk, age, index date, sex, and follow up time. Treatment pattern assessments included treatments received before/during/after index LOT, reasons for discontinuation, refractory status, and retreatment characteristics. Patient outcomes (overall survival [OS], duration of treatment [DOT], and time to next therapy [TTNT]) were analyzed using Kaplan-Meier survival analysis methods. Results: After excluding patients who were aged <18 years at start of index LOT with no evidence of clinical activity and who participated in a clinical trial during index LOT, 381 (DCR) and 173 (TCR) patients were available for analysis. Median follow-up from index LOT initiation through end of data availability/death was 14 (DCR) and 8 (TCR) months. Demographic characteristics were consistent between DCR and TCR patients. Approximately half were aged ≥65 years (49% DCR; 53% TCR), majority had high-risk cytogenetics (56% DCR; 66% TCR) or prior autologous stem cell transplantation (>62%), and 14-16% had ISS stage III. Patients had a median of 3 (DCR) and 6 (TCR) prior LOTs. Prior to index LOT, bortezomib and lenalidomide were the most commonly received PI and immunomodulatory drug (received by >98% of DCR or TCR patients) and the most common PI and immunomodulatory drugs to which patients were refractory (71% and 84% DCR; 76% and 83% TCR, respectively). At index LOT, PI/immunomodulatory drug-based and daratumumab-based therapies remained the most common therapies. Bortezomib and lenalidomide had the longest time to refractory status and highest retreatment rates among DCR or TCR patients. Approximately 40% of TCR patients were retreated with daratumumab-based therapies after becoming refractory (Table). After index LOT, 70% of DCR and 58% of TCR patients continued to a subsequent LOT. Patients most frequently discontinued index LOT due to disease progression (59% DCR; 60% TCR), toxicity (23% DCR; 25% TCR), or doctor preference (14% DCR; 10% TCR). Median duration of gaps between LOTs generally were shorter than 1 month (Table). Median OS was 22.3 (DCR) and 11.6 (TCR) months. Median DOT was 3.3 (DCR) and 2.8 (TCR) months, and median TTNT was 4.1 (DCR) and 3.2 (TCR) months. In multivariate statistical analyses, inferior baseline ECOG performance scores, and high-risk cytogenetic abnormalities were associated with worse prognosis (higher risk of death, shorter DOT, and shorter TTNT) in DCR and TCR patients. Age was not a significant factor after adjusting for other baseline factors. Conclusions: Treatment options are limited for US patients with DCR and TCR RRMM. DCR and TCR patients were frequently retreated with a PI, an immunomodulatory drug, or daratumumab, despite refractoriness to these agents. Many DCR and TCR MM patients stopped active MM treatment after discontinuing index treatment. Patients with DCR and TCR MM have poor prognosis, especially among high cytogenetic risk and poor performance status patients. This study provides the benchmark for new therapies, like BCMA-targeted agents, to be tested in this population. Funding: GSK (Study 217353). Figure 1 Figure 1. Disclosures Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Gorsh: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. DerSarkissian: Analysis Group, Inc.: Current Employment. Paka: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Bhak: Analysis Group, Inc.: Current Employment; GlaxoSmithKline: Research Funding. Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Zichlin: GlaxoSmithKline: Research Funding; Analysis Group, Inc.: Consultancy, Current Employment. Sansbury: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Yee: Analysis Group, Inc.: Current Employment; GlaxoSmithKline: Research Funding. Ferrante: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Khanal: GlaxoSmithKline: Research Funding; Analysis Group, Inc.: Current Employment. Noman: Analysis Group, Inc.: Current Employment; GlaxoSmithKline: Research Funding. Duh: Novartis: Other: I am an employee of Analysis Group, a consulting company that received funding from Novartis for this research study..

scholarly journals P393 Treatment patterns of patients with perianal fistulizing Crohn’s disease from a US administrative claims database

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S403-S403
Author(s):  
S Cazzetta ◽  
G Chen ◽  
V Pedarla ◽  
K Null ◽  
Q Rana Khan ◽  
...  
Keyword(s):  
Crohn’S Disease ◽  
Crohn's Disease ◽  
Health Plan ◽  
Index Date ◽  
Treatment Patterns ◽  
Administrative Claims ◽  
Opioid Treatment ◽  
State Management ◽  
Cumulative Prevalence

Abstract Background Perianal fistula (PAF), a complication of Crohn’s disease (CD), is indicative of high disease severity and poor prognosis. We estimated the cumulative prevalence and treatment patterns of PAF CD in the USA. Methods In this retrospective study of IBM® MarketScan® Commercial and Medicare databases (conducted 1 October 2015 to 30 September 2018), patients (pts) were 18 to 89 years of age with at least two diagnoses of CD at least 30 days apart, and had continuous health plan enrolment for at least 12 months pre- and post-index date (first PAF diagnosis or procedure [PAF pts]). Non-PAF CD pts were assigned the same index date as matched PAF pts based on birth year, sex, presence/lack of CD diagnosis before index date, CD disease location and follow-up duration. Descriptive analysis was used for all variables. Treatment patterns and costs related to opioid use were compared among PAF pts. We also assessed four PAF pt cohorts with PAF-related surgery treated with one (cohort 1) or more than one (cohort 2) opioid within 7 days of index date or one (cohort 3) or more than one (cohort 4) opioid more than 7 days after index date. Results Cumulative prevalence of PAF CD (n = 81 862) was 7.7% (0.01% of the US population) over 3 years. The economic impact and treatment patterns were assessed in PAF (n = 1218; mean age 42 years; 52.4% men; 56.5% preferred provider organization [PPO] health plan) and matched non-PAF CD pts (n = 4095; mean age 43 years; 50.9% men; 57.6% PPO health plan). During follow-up, 65.8% of PAF and 42.3% of non-PAF pts were treated with at least one biologic agent. In the 30 days post-index, 31.9% of PAF pts were treated with biologics, with this percentage increasing over time; steroid use also remained high (Figure 1). Opioid treatment was associated with higher mean per patient per year (PPPY) total gastrointestinal (GI)-related costs for PAF pts (p < 0.0001). Mean PPPY total GI-related costs for pts with PAF-related surgery and opioid treatment were $50 605, $53 984, $82 973 and $92 375 for cohorts 1, 2, 3 and 4, respectively (Figure 2). Generalized linear model-adjusted mean PPPY PAF-related surgeries were 7.2 versus 0 for PAF pts and non-PAF pts (p < 0.0001), respectively. In the 30 days post-index date, 22.5% of PAF pts had minor surgeries and 20.0% had definitive surgeries. Conclusion Based on treatment guidelines as well as the study population’s use of inflammatory bowel disease medications and opioids, and higher rates of PAF-related surgeries, a need for better disease state management of patients with PAF CD is warranted. Sponsor: Takeda Pharmaceuticals USA, Inc.

scholarly journals Real-World Treatment Patterns Among a Contemporary Cohort of Commercially Insured Mantle Cell Lymphoma Patients in the United States

Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 4845-4845
Author(s):  
Lindsey E. Roeker ◽  
Shaum Kabadi ◽  
Chakkarin Burudpakdee ◽  
Aimee Near ◽  
Keiko Wada ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Real World ◽  
Research Funding ◽  
Index Date ◽  
Treatment Patterns ◽  
Treatment Regimens ◽  
Oral Medications ◽  
Mantle Cell ◽  
Insured Patients

Abstract Introduction Mantle cell lymphoma (MCL) is a rare, aggressive non-Hodgkin lymphoma associated with a poor prognosis. The approval of ibrutinib in November 2013 has changed the treatment paradigm for patients with relapsed or refractory MCL. There remains a lack of information on the current treatment patterns used in clinical practice in a contemporary cohort of commercially insured patients. We aimed to identify the treatment patterns for MCL overall and by line of therapy (LOT) and to describe patient demographics and clinical characteristics in a large cohort of commercially insured MCL patients. Methods A retrospective cohort study was conducted with the IQVIA Real-World Data Adjudicated Claims-US database. Adult patients (≥18 years old) with ≥1 claim for a NCCN-recommended MCL treatment between November 1, 2013 and December 31, 2017 were identified. Index date was the first treatment claim. Patients were also required to have ≥1 diagnosis of MCL during the study period (November 1, 2012 to January 31, 2018), ≥12 months of continuous enrollment prior to index date (pre-index period) and ≥30 days after index date (follow-up period). Patients were excluded if they were ≥65 years at index and not enrolled in Medicare Risk or Medicare Cost, enrolled in a clinical trial during the study period, had evidence of MCL treatment in the pre-index period (except for patients indexed on ibrutinib as it is indicated for MCL patients with ≥1 prior treatment), or had evidence of stem cell transplant (SCT) before index date. The most commonly observed MCL treatment regimens were identified, and demographic and clinical characteristics of patients and treatment durations by regimen were described. Treatment regimen was defined as the combination of all agents observed in the 35-day period after the first MCL treatment claim; treatment duration was defined as the start of treatment until a gap of ≥90 days between end date and next date of treatment or treatment modification. Treatment end date occurred 90 days after the end of the supply for oral medications or 30 days after the last administration for non-oral medications. Results There were 1,785 patients treated with the most commonly observed MCL treatment regimens. The most common regimens, irrespective of LOT, were rituximab monotherapy (including maintenance therapy; n=773, 43.3%), R-CHOP (n=723, 40.5%), B-R (n=436, 24.4%), and ibrutinib monotherapy (n=199, 11.1%). Overall, patients had a median (IQR) age of 57 (52-62) years, and 59.4% were male. Most patients were commercially or self- insured (57.5% and 33.6%, respectively). Patients had a median Charlson Comorbidity Index (CCI) of 0 (IQR 0-1; mean [SD] 0.9 [1.4]), with the most common CCI components being diabetes (15.7%), chronic pulmonary disease (12.8%), and congestive heart failure (9.5%). During the follow-up period (median [IQR] 22.5 [10.5-35.3] months), in addition to the MCL regimen(s), patients received radiation therapy (17.4%), SCT (10.0%), and/or immunotherapy (0.2%). The use of targeted therapies (i.e. lenalidomide, bortezomib) other than ibrutinib was infrequent. When considering treatment lines, R-CHOP was the most commonly observed first regimen, followed by rituximab, B-R, and ibrutinib; for the second and third observed regimens, rituximab was the most common, followed by ibrutinib (Figure 1). The median (IQR) duration for the first observed regimen was 8.1 (3.9-18.0) months for ibrutinib, 5.0 (3.3-5.6) months for B-R, 4.0 (2.5-4.4) months for R-CHOP, and 1.9 (1.7-4.4) months for rituximab; ibrutinib also had the longest duration in the second and third line (median [IQR] 5.5 [2.4-13.5] months and 8.3 [3.9-12.4] months, respectively). Conclusion This is the largest study of MCL patients describing treatment patterns in current clinical practice among commercially insured patients. MCL patients were most commonly treated with chemoimmunotherapy for all treatment lines while ibrutinib was the second most common LOT2 and LOT3 regimen. As the treatment landscape and clinical practice continues to change with the use of novel agents, future studies are warranted to further study toxicities and outcomes in the real-world setting. Disclosures Kabadi: AstraZeneca: Employment. Burudpakdee:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Near:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Wada:IQVIA received funds from AstraZeneca to conduct the analysis, interpret data, and coauthor the publication.: Consultancy. Mato:TG Therapeutics: Research Funding; Sunesis: Honoraria, Research Funding; Acerta: Research Funding; Janssen: Consultancy, Honoraria; AstraZeneca: Consultancy; Pharmacyclics: Consultancy, Honoraria, Research Funding; Regeneron: Research Funding; Celgene: Consultancy; Prime Oncology: Speakers Bureau; Abbvie: Consultancy.

scholarly journals Thrombosis and Risk of Mortality in Newly Diagnosed High-Risk Polycythemia Vera: An Analysis of the Medicare Claims Database in the United States

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 9-10
Author(s):  
Naveen Pemmaraju ◽  
Aaron T. Gerds ◽  
Shreekant Parasuraman ◽  
Jingbo Yu ◽  
Anne Shah ◽  
...  
Keyword(s):  
High Risk ◽  
Median Time ◽  
Research Funding ◽  
Index Date ◽  
Newly Diagnosed ◽  
Publicly Traded ◽  
Risk Of Mortality ◽  
Increased Risk ◽  
History Of

Background Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN) associated with an increased risk of thrombotic events (TEs), a major cause of morbidity and mortality. Patients aged ≥60 years and/or with a history of thrombosis are considered to have high-risk PV. There is limited contemporary, real-world evidence exploring the effect of TEs on mortality in patients with PV. The aim of this analysis was to compare the risk of mortality in patients newly diagnosed with high-risk PV who experienced a TE vs those who did not experience a TE. Study Design and Methods All data from the Medicare Fee-for-Service (FFS) claims database (Parts A/B/D) from January 2010-December 2017 were used to identify patients with a PV diagnosis (all high risk based on cohort being ≥65 years of age) with ≥1 inpatient or ≥2 outpatient claims. The index date was the date of the first qualifying PV claim. Patients with a PV diagnosis or use of cytoreductive therapy within 12 months before the index date (pre-index period) were excluded; ≥12-months continuous medical and pharmacy enrollment pre-index dates was required. The study sample was categorized into TE and non-TE groups based on the occurrence of any of the following events during follow-up: deep vein thrombosis, pulmonary embolism, ischemic stroke, acute myocardial infarction, transient ischemic attack, peripheral arterial thrombosis, or superficial thrombophlebitis. TEs were evaluated from the index date to the end of follow-up. Cox regression analyses with time-varying effects were used to assess mortality risk among patients with PV, with post-index TE as a time-dependent variable, stratified by pre-index TE, and adjusting for patient demographic characteristics and comorbid conditions. Results A total of 56,176 Medicare FFS beneficiaries with PV diagnoses met inclusion criteria. The median age was 73 years, 51.9% were men, and 90.7% were white; 10,110 patients (18.0%) had a history of TE before diagnosis (ie, pre-index). In the follow-up period, 20,105 patients (35.8%) had a TE and 36,071 patients (64.2%) did not have a TE. In the comparison between the TE vs non-TE groups, the median (range) age (75.0 [65-104] vs 73.0 [65-106] years, respectively), mean (SD) Charlson comorbidity index score (3.1 [2.6] vs 2.2 [2.3]), and percentage of patients with a history of cardiovascular events (34.1% vs 23.8%), bleeding (13.3% vs 10.4%), or anemia (28.6% vs 23.4%) were higher (Table 1). Among all patients with PV, the median time from diagnosis to first post-index TE was 7.5 months. Among those with pre-index TE (n=10,093), median time from index to first post-index TE was 0.6 months, whereas patients without pre-index TE (n=46,083) had a median time to first post-index TE of 14.2 months. Among all patients with TE during follow-up, the most common TEs were ischemic stroke (47.5%), transient ischemic attack (30.9%), and acute myocardial infarction (30.5%). The risk of mortality was increased for patients who experienced a TE compared with those who did not (hazard ratio [HR; 95% CI], 9.3 [8.4-10.2]; P<0.0001). For patients who experienced a pre-index TE, the risk of mortality was increased for patients who experienced a subsequent TE during follow-up compared with patients who did not (HR [95% CI], 6.7 [5.8-7.8]; P<0.0001). Likewise, for patients who did not experience a pre-index TE, the risk of mortality was increased for patients who experienced a TE during follow-up compared with patients who did not (HR [95% CI], 13.1 [11.4-15.0]; P<0.0001). Conclusions In this real-world study, approximately one-third of patients with newly diagnosed high-risk PV experienced a TE during follow-up and had a 9-fold increased risk of mortality vs those who did not experience a TE. TE risk mitigation remains an important management goal in patients with PV, particularly in those with prior TE. Disclosures Pemmaraju: Samus Therapeutics: Research Funding; Celgene: Honoraria; SagerStrong Foundation: Other: Grant Support; Affymetrix: Other: Grant Support, Research Funding; MustangBio: Honoraria; Blueprint Medicines: Honoraria; LFB Biotechnologies: Honoraria; Plexxikon: Research Funding; Novartis: Honoraria, Research Funding; AbbVie: Honoraria, Research Funding; Stemline Therapeutics: Honoraria, Research Funding; Pacylex Pharmaceuticals: Consultancy; Daiichi Sankyo: Research Funding; Incyte Corporation: Honoraria; Roche Diagnostics: Honoraria; Cellectis: Research Funding; DAVA Oncology: Honoraria. Gerds:Sierra Oncology: Research Funding; Celgene: Consultancy, Research Funding; Gilead Sciences: Research Funding; Imago Biosciences: Research Funding; Pfizer: Research Funding; CTI Biopharma: Consultancy, Research Funding; Roche/Genentech: Research Funding; Apexx Oncology: Consultancy; AstraZeneca/MedImmune: Consultancy; Incyte Corporation: Consultancy, Research Funding. Parasuraman:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Yu:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Shah:Avalere Health: Current Employment. Xi:Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation; Avalere Health: Current Employment. Kumar:Avalere Health: Current Employment; Incyte Corporation: Other: Avalere Health is a paid consultant of Incyte Corporation. Scherber:Incyte Corporation: Current Employment, Current equity holder in publicly-traded company. Verstovsek:Gilead: Research Funding; Incyte Corporation: Consultancy, Research Funding; Novartis: Consultancy, Research Funding; CTI Biopharma Corp: Research Funding; Promedior: Research Funding; Roche: Research Funding; AstraZeneca: Research Funding; Blueprint Medicines Corp: Research Funding; Genentech: Research Funding; Sierra Oncology: Consultancy, Research Funding; Protagonist Therapeutics: Research Funding; ItalPharma: Research Funding; PharmaEssentia: Research Funding; NS Pharma: Research Funding; Celgene: Consultancy, Research Funding.

scholarly journals The First Retrospective Commercial Claims-Based Analysis of CAR T Treated Patients with Relapsed or Refractory Large B-Cell Lymphoma (R/R LBCL)

Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 31-31
Author(s):  
Anna Purdum ◽  
Jonathan Johnson ◽  
Anthony Bonagura ◽  
Liliosa Nyamutswa ◽  
Caitlin Elliott ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Characteristics ◽  
B Cell Lymphoma ◽  
P Value ◽  
Publicly Traded ◽  
Index Event ◽  
Car T ◽  
Ed Visits ◽  
The Mean

Introduction: Approximately 74,000 Americans are diagnosed with Non-Hodgkin Lymphoma (NHL) each year, of whom 30% are identified as having LBCL. In recent years, two autologous anti-CD19 chimeric antigen receptor T-Cell (CAR T) therapies were approved for the treatment of patients with R/R LBCL with ≥ 2 prior systemic therapies. Objectives: To describe the demographic and clinical characteristics of the CAR T patients and to compare healthcare resource utilization (HCRU) and costs pre- and post-CAR T therapy. Methods: This pre/post-index comparison evaluated in the Optum Research Database included adult (age ≥ 18 years) commercial and Medicare Advantage (MA) enrollees, with medical benefits and evidence of medical/procedure codes indicative of CAR T therapy between 01/01/2017 and 03/31/2019. Patients must have been continuously enrolled in their commercial healthcare plan for at least 3 months prior to and 6 months after the infusion (index) unless death occurred. Patients with evidence of pre-index leukemia were excluded. Baseline demographic and clinical characteristics included age, gender, insurance type, geographic region, and comorbidities. Measures of pre/post HCRU and standardized cost (scaled as per patient per month (PPPM) values to account for variable follow-up durations) included ambulatory visits, emergency department (ED) visits, and inpatient admissions (both Intensive Care Unit (ICU) and non-ICU visits). Information on the CAR T administration index visit and length of stay (LOS) for inpatient admissions were also captured. Data analysis (descriptive statistics) was conducted using Statistical Analysis System (SAS) Version 9.4. Results: 109 patients met all inclusion criteria. The patient mean age was 59.31 (SD = 12.60), 59% were male, 70% were commercially insured, 30% MA, and the mean Quan-Charlson Comorbidity score was 3.60.Thirty patients received CAR T administration through clinical trials. Seventeen percent received CAR T therapy in a Prospective Payment System (PPS) Exempt Cancer Hospital and 83% received treatment in Inpatient PPS hospitals. The CAR T therapy index event was administered inpatient for 82% of patients and twenty patients (18%) received CAR T in the outpatient setting. The median LOS during CAR T administration was 16 days which included 52% ICU admissions. During the pre-index period, all patients experienced an ambulatory visit with an average of 15.09 visits PPPM, whereas 41% had an ED encounter for an average rate of 0.39 visits PPPM, and 44% had an inpatient stay with 0.28 PPPM. The total medical and pharmacy costs were $128K PPPM. With a median follow-up of 8.4 months, patients experienced 46% fewer ambulatory visits (average 8.14 PPPM, p-value < 0.001), 49% fewer ED visits (average 0.20 PPPM, p-value < 0.037), and 18% fewer inpatient visit rates (average 0.23 PPPM, p-value = 0.415) in the post index period (excluding the index event) than pre-index period. The mean total medical and pharmacy costs were also 49% lower at $66K PPPM (p-value < 0.008). Conclusions:Post-CAR T care was associated with lower health care utilization including fewer ambulatory visits, and ED visits and lower overall total health care costs compared to pre-CAR T care. Disclosures Purdum: Kite: Current Employment, Current equity holder in publicly-traded company. Johnson:Optum: Current Employment, Current equity holder in publicly-traded company. Bonagura:Optum: Current Employment, Current equity holder in publicly-traded company. Nyamutswa:Kite: Current Employment, Current equity holder in publicly-traded company. Elliott:Optum: Current Employment. Lal:Optum: Current Employment.

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