Differences in Patients with Progressive Versus Non-Progressive AML, CLL, or NHL: Implications for Proposed Bundled Payment Strategies

Abstract Background: Increasingly, payers are redefining how payments for cancer care are structured. Demonstration programs and policy proposals by insurers and oncology organizations have bundled payments for various services, including chemotherapy. The impact of such payment policies may vary for patients (pts) with hematologic malignancies given their widely varying disease severity. Progression of disease (PD), and costs associated with it, may stress bundled payment programs, particularly if such programs do not accurately assess risk of progression across the insured cohort. To inform this ongoing development of new payment strategies for pts with hematologic malignancy, this study compared patterns of care in pts with AML, CLL or other forms of NHL who do, or do not, experience PD. Methods: This retrospective studyused medical and pharmacy claims from a large national US health plan to identify commercially insured and Medicare Advantage (MA) pts age ≥18 years from 1/2007 - 8/2014 with ≥2 medical claims for AML (ICD-9-CM code 205.0x), CLL ( ICD-9-CM code 204.1x), or other NHL (ICD-9-CM codes 200.xx, 202.0x-202.2x, 202.4x, 202.7x-202.9x, 203.8x, 204.8x-204.9x, 273.3x). Pts required ≥1 claim for systemic anti-cancer therapy (SACT); the first observed claim was the index date. Continuous enrollment (CE) in the health plan for 6 months (mths) prior to (baseline period) and ≥6 mths after index date (variable follow-up period) was required; pts with <6 mths of follow-up due to death were included. Pts with baseline SACT or additional primary malignancies were excluded. Line of therapy (LOT) periods were defined. The 1st LOT (LOT1) started on index date; regimens included all drugs received in the first 45 days. LOT1 ended at the earliest of: start of a new drug, ≥60-day gap in initial regimen, death or end of CE or study period. LOT2 started with a SACT after LOT1 end. PD was defined as: start of LOT2, receipt of hospice care (based on procedure or revenue codes) or death (based on Social Security Administration death data). Results: Among 667 AML, 1354 CLL and 9399 NHL pts who met study criteria, 70%, 45%, and 46% respectively had PD during the study period. Mean (median) time in mths to PD was 6.6 (4.2) for AML, 12.8 (9.2) for CLL and 10.0 (7.1) for NHL. Descriptive results are shown in the Table. Compared to pts without PD during the study period, pts who progressed were MA pts, older and had shorter initial LOTs. The most common initial therapy varied across PD cohorts. Among pts with PD, the AML cohort had the highest percentage of death and evidence of hospice care. Conclusion: Characteristics and treatment patterns varied for pts with PD versus non-PD AML, CLL and NHL. Understanding the variability across patient groups will aid in the development of new bundled payment policies and help providers determine whether and in which payment systems to participate. Table 1. AML CLL NHL PD N=464 No PD N=203 PD N=604 No PD N=750 PD N=4291 No PD N=5108 Age, yrs mean (SD), median^# 60 (17), 62 58 (17), 59 71 (11), 72 67 (11), 67 64 (14), 65 60 (16), 62 Baseline Quan-Charlson comorbidity score mean (SD), median# 3.1 (1.6), 2 3.1 (1.6), 2 2.8 (1.3), 2 2.7 (1.2), 2 3.4 (2.0), 3 3.3 (1.9), 2 Male, N (%)# 271 (58) 115 (57) 366 (61) 490 (65) 2480 (58) 2832 (55) Insurance, N (%)*^# Commercial 300 (65) 148 (73) 284 (47) 428 (57) 2,723 (63) 3489 (68) MA 164 (35) 55 (27) 320 (53) 322 (43) 1568 (37) 1619 (32) Stem Cell Transplant, N (%) 105 (23) 61 (30) 11 (2) 5 (1) 443 (10) 169 (3) Length of follow-up, mths, mean (SD), median ^# 17.6 (17.1), 12.1 19.9 (15.5), 14.4 28.6 (21.4), 23.7 22.4 (15.9), 17.2 28.2 (21.5), 22.3 27.2 (19.9), 20.9 Length of LOT1, mths, mean (SD), median *^# 3.8 (4.3), 2.5 5.4 (6.5), 3.5 3.6 (4.0), 2.8 4.8 (4.0), 4.3 4.1 (3.6), 3.6 5.2 (5.1), 4.5 Monotherapy in LOT1*^# 322 (69) 158 (78) 371 (61) 272 (36) 1623 (38) 1254 (25) Biologic in LOT*^# 136 (29) 38 (19) 384 (64) 603 (80) 3523 (82) 4066 (80) Most common LOT1 regimens (%)┼ 1st aza (19) cyt (17) R (24) FCR (23) R (26) RCHOP (39) 2nd dec (15) dec (17) chl (19) BR (21) RCHOP (25) R (14) 3rd cyt (9) aza (17) FCR (12) R (16) RCVP (9) BR (7) Hospice, N (%) 124 (27) - 74 (12) - 664 (15) - Died, N (%) 204 (44) - 177 (29) - 1040 (24) - *^# p<0.05 for AML, CLL and NHL progression cohorts respectively ┼no testing Aza-azacitadine, B-bendamustine, C-cyclophosphamide, chl-chlorambucil, cyt-cytarabine, dec-decitabine, F-fludarabine, R-rituximab, V-vincristine RCHOP=R,C,V,doxorubicin±prednisone RCVP=R,C,V±prednisone Disclosures Dacosta Byfield: Optum: Employment. Engel-Nitz:United Health Group: Equity Ownership; Optum: Employment. Bancroft:Optum: Employment; United Health Group: Equity Ownership. Anderson:Optum: Employment; United Helath Group: Equity Ownership. Reyes:Genentech: Employment; Roche: Equity Ownership. Ravelo:Roche: Equity Ownership; Genentech, Inc.: Employment. Ogale:Roche: Equity Ownership; Genentech, Inc.: Employment.

Download Full-text

What Is the Cost of Disease Progression Among Patients with Indolent or Aggressive Non-Hodgkin Lymphoma (NHL)?

Blood ◽

10.1182/blood.v128.22.5957.5957 ◽

2016 ◽

Vol 128 (22) ◽

pp. 5957-5957

Author(s):

Nicole Engel-Nitz ◽

Stacey Dacosta Byfield ◽

Timothy Bancroft ◽

Anderson J. Amy ◽

Carolina Reyes ◽

...

Keyword(s):

Health Care ◽

Index Date ◽

Progressive Disease ◽

Hospice Care ◽

Diagnosis Codes ◽

Equity Ownership ◽

The Cost ◽

The Impact ◽

Care Costs

Abstract Background: The natural histories of aggressive and indolent NHL vary in terms of the timing and pattern of disease progression. However, little is known about the impact of progression of disease (PD) on costs, and in particular how this differs between aggressive and indolent subtypes of NHL. This study examined patterns of care and outcomes for patients with aggressive and indolent NHL, and the impact of PD on health care costs. Methods: To identify cases of NHL, this retrospective studyused medical and pharmacy claims from a large national US health plan to identify commercially insured and Medicare Advantage (MA) patients age ≥18 years from 1/2007 - 8/2014 with ≥2 medical claims for NHL based on ICD-9-CM diagnosis codes. Patients were divided into cohorts of aggressive (AGG) NHL and indolent (IND) and based on diagnosis codes. Patients were required to have ≥1 claim for systemic anti-cancer therapy, with the index date being defined as the first observed claim for such therapy. Continuous enrollment in the health plan for 6 months prior to (baseline period), and ≥6 months after, the index date (variable follow-up period) was required; patients with <6 months of follow-up due to death were included. An algorithm to identify line of therapy (LOT) periods was implemented. PD was defined as: start of a second LOT, receipt of hospice care (based on procedure or revenue codes) or death (based on Social Security Administration death data). Health care costs were calculated over 6-month periods of follow-up (6, 12, 18, 24 months), with costs calculated for pharmacy, inpatient hospital, ambulatory, and other sites of service. Results: A total of 1,197 AGG and 2,454 IND patients met study criteria. Progression was experienced by 40.6% of AGG and 49.4% of IND patients respectively during the entire study period; 6-month progression was 18.9% (AGG) and 18.5% (IND). Compared to patients without PD during the study period, patients who progressed had higher average costs over each time period: in the first 6-months, costs were $138,957 PD vs. $108,607 for non-PD among AGG, and $114,644 PD vs. $80,873 for non-PD among IND (Figure, Table). Similarly, total costs for PD were higher than non-PD over 12, 18, and 24 months (Figure). Costs by site of service were higher for PD patients compared to non-PD patients among both the AGG and IND groups, particularly for inpatients costs; the table shows costs by site of service for the first 6 months, and results were similar over 12, 18, and 24 months. A higher proportion of AGG patients died compared with IND patients. Approximately one third of patients who died used hospice services among AGG and IND, and of these, 90.1% of AGG and 91.3% of IND used 3 or more days of hospice care. Conclusion: Among both aggressive and indolent NHL populations, costs were higher for patients with progressive versus without progressive disease, and increased over longer follow-up time. Patients with aggressive NHL had higher costs compared with patients with indolent NHL for both progressive and non-progressive disease. This study is the first to quantify systematically the cost of progression in NHL, both indolent and aggressive, and can inform efforts to improve value-based care, taking into account costs not just of therapy, but of subsequent progression. Disclosures Engel-Nitz: Optum: Employment, Other: UnitedHealth Group stock. Dacosta Byfield:UnitedHealth Group: Equity Ownership; Optum: Employment. Bancroft:Optum: Employment, Other: UnitedHealth Group stock. Amy:Optum: Employment, Other: UnitedHealth Group stock. Reyes:Genentech: Employment; Roche: Equity Ownership.

Download Full-text

Health Care Utilization and Associated Costs in Elderly Persons with Non-CML Myeloproliferative Neoplasms: Real-World Evidence From a United States Medicare Population

Blood ◽

10.1182/blood.v120.21.4273.4273 ◽

2012 ◽

Vol 120 (21) ◽

pp. 4273-4273 ◽

Cited By ~ 1

Author(s):

Sudeep Karve ◽

Gregory L Price ◽

Keith L Davis ◽

Gerhardt M Pohl ◽

Richard A Walgren

Keyword(s):

Health Care ◽

Health Care Utilization ◽

Index Date ◽

Myeloproliferative Neoplasms ◽

Care Utilization ◽

Cell Transplant ◽

Elderly Persons ◽

Employment Equity ◽

Equity Ownership

Abstract Abstract 4273 Background: Non-CML myeloproliferative neoplasms (MPNs), which include essential thrombocythemia (ET), polycythemia vera (PV), myelofibrosis (MF) and MPN not otherwise specified (MPN-NOS), are characterized by activation of JAK2 signaling and abnormal blood cell production. Median survival ranges from months to years for MF and up to a decade or more for PV and ET. Some symptomatic treatment options exist, but with the exception of hematopoietic stem cell transplant, none are curative. Although MPN incidence is highest in persons aged ≥65 years, little is known about overall health care utilization and costs in elderly persons with these diseases. MPNs are more prevalent in the elderly and therefore Medicare enrollees are a highly relevant source for US-based resource utilization and cost data for these diseases. Objective: To compare all-cause health care utilization and costs from four subtypes of elderly MPN patients (ET, PV, MF and MPN-NOS) with matched non-MPN/non-cancer controls. Methods: Retrospective data were taken from the Survey, Epidemiology, and End Results (SEER)-Medicare linked database in the US, which combines clinical information from the SEER cancer registry (MPN reporting has been required since 2001) with medical and pharmacy claims for Medicare enrollees. Patients with a new MPN diagnosis between Jan 1, 2001 and Dec 31, 2007 were selected and evaluated for all-cause health care utilization and costs from Jan 1, 2008 (index date) through Dec 31, 2008 (follow-up end date). Patients were classified by MPN subtype based on the most recent diagnosis information (ICD-O-3 from the SEER registry or ICD-9-CM from Medicare claims) before the index date. Patients who died before follow-up end, had HMO or discontinuous Medicare enrollment during the follow-up year, had enrollment based on end stage renal disease, or a diagnosis of a non-MPN malignancy before follow-up end were excluded from the study. Separate non-MPN/non-cancer control groups were selected for each MPN subtype and matched (5:1) on birth year, gender, ethnicity, geography, and reason for Medicare eligibility. Per patient health care utilization and costs during the follow-up year were aggregated and stratified by care setting. Costs were adjusted to 2010 US$ and represent amounts reimbursed by Medicare to providers. Costs were compared between MPN cases and controls using univariate t-tests. Results: A total of 1,355 MPN patients (n = 445 ET, 684 PV, 81 MF, 145 MPN-NOS) were identified for study inclusion and assigned matching controls. For ET, PV, MF and MPN-NOS cases, respectively, mean [SD] age at index was 75.5 [9.7], 70.8 [11.3], 70.8 [10.4] and 74.1 [8.9] years and % female was 69.0, 43.9, 54.3, and 55.2. Mean [SD] years between first MPN diagnosis and study index date was 3.1 [2.0], 3.4[1.9], 2.7 [2.0], and 3.1 [2.1] for ET, PV, MF and MPN-NOS cases, respectively. A significantly (p<0.05) higher proportion of MPN cases, regardless of subtype, had ≥1 hospitalization during follow-up vs. controls (ET vs. control: 22% vs. 16%, PV vs. control: 27% vs. 15%, MF vs. control: 31% vs. 12%, MPN-NOS vs. control: 36% vs. 17%). Mean [SD] total days of hospital care were similarly higher in MPN cases (ET vs. control: 2.7 [12.8] vs. 1.6 [6.6], PV vs. control: 2.6 [7.0] vs. 1.7 [9.5], MF vs. control: 2.5 [6.2] vs. 1.2 [5.9], MPN-NOS vs. control: 4.0 [10.0] vs. 2.1 [13.7]), although the PV vs. control difference was not statistically significant. The ER visit rate during follow-up was also significantly (p<0.05) higher in MPN cases (ET vs. control: 34% vs. 24%, PV vs. control: 38% vs. 25%, MF vs. control: 46% vs. 21%, MPN-NOS vs. control: 44% vs. 29%). All-cause costs for MPN cases vs. matched controls are presented in the figure. Mean total costs per patient, driven equally by inpatient and outpatient services, were significantly (p<0.001) higher in MPN cases (ET vs. control: $11,259 vs. $8,897, PV vs. control: $13,337 vs. $8,530, MF vs. control: $20,917 vs. $7,367, MPN-NOS vs. control: $20,174 vs. $9,800). Conclusions: Total health care costs during a given year for elderly patients with MPNs are 1.3 to 3 times higher (depending on subtype) than those of matched controls. These findings may help inform future cost effectiveness evaluations of novel MPN treatments, as well as decision making in the provision of optimal MPN care within a Medicare system in which resources are finite and must be allocated ethically and efficiently. Disclosures: Karve: RTI Health Solutions: Consultancy, Research Funding. Price:Eli Lilly and Company: Employment, Equity Ownership. Davis:Eli Lilly, Merck, GlaxoSmithKline, Bristol-Myers Squibb, Pfizer, Eisai, Sanof-Aventis, Gilead Sciences, MedImmune: Consultancy, Honoraria, Membership on an entity's Board of Directors or advisory committees. Pohl:Eli Lilly and Company: Employment, Equity Ownership. Walgren:Eli Lilly and Company: Employment, Equity Ownership.

Download Full-text

Burden of CRAB Events By Relapse in Patients with Newly Diagnosed Multiple Myeloma Not Eligible for Stem Cell Transplant

Blood ◽

10.1182/blood-2018-99-111236 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 4770-4770

Author(s):

Shivani Pandya ◽

Zoe Clancy ◽

Sulena Shrestha ◽

Li Wang ◽

Onur Baser

Keyword(s):

Economic Burden ◽

Index Date ◽

Stem Cell Transplant ◽

Event Rate ◽

Cell Transplant ◽

Employment Equity ◽

Equity Ownership ◽

Line Of Therapy ◽

Event Rates

Abstract Background: For decades, CRAB criteria (hypercalcemia, renal impairment, anemia, and bone disease) have been used to diagnose multiple myeloma (MM), but little is known about the economic burden of CRAB in patients with MM who have relapsed. The only category 1 doublet regimens recommended by NCCN Guidelines for non-transplant candidates are lenalidomide-based (NCCN Myeloma v4.2018). This study aims to evaluate CRAB event rates and the associated economic burden among newly diagnosed MM (NDMM) patients on doublet therapy who were not eligible for stem cell transplant (SCT) and were followed to next line of therapy. Methods: This retrospective study identified patients with ≥ 2 claims of MM (ICD-9-CM code: 203.0x; ICD-10-CM code: C90.0x) ≥ 30 days apart and ≥ 1 treatment (first claim date was used as index date) between January 1, 2011 and December 31, 2015 from the Medicare database. Eligible patients were required to have continuous enrollment from 6 months pre-index or first MM diagnosis date until ≥ 12 months post-index date unless patients died < 12 months post-index date (the follow-up period); ≥ 1 full cycle of therapy; no evidence of prior MM diagnosis or treatment (including autologous SCT [ASCT]); and no evidence of ASCT in the follow-up period. First line of therapy (LOT1) included all treatments prescribed within 60 days of the index date, and patients were included in the doublet therapy cohort based on the index treatment regimen. Progression to a subsequent LOT (LOT2) was defined by the earliest occurrence of an addition or switch to new non-maintenance treatment > 60 days post-index date, restart of any non-maintenance MM treatment after a > 180-day gap, or a dose increase from maintenance to relapse therapy. CRAB event rate per 1,000 person-years (PYs), CRAB event-related healthcare resource utilization (HRU) per patient per month (PPPM), and costs PPPM were evaluated during the LOT1 (the time from index date to end of LOT1) and LOT2 (the time from initiation of LOT2 to end of LOT2) among patients on doublet therapy with LOT1 and those who progressed to LOT2, respectively. Mean was calculated for the continuous variables, while categorical variables were presented as percentage values. Since the LOT2 population was a subset of the LOT1 population and they were not mutually exclusive cohorts, no statistical comparisons were made. Results: The study included 4,970 patients with MM not eligible for ASCT, of which 3,065 (61.7%) patients were prescribed doublet therapy in LOT1. Among these patients on doublet therapy, 1,122 (36.6%) initiated LOT2. The mean age was approximately 77 years, and most patients were white (LOT1, 77.0%; LOT2, 79.7%). The majority of the patients had hypertension (LOT1, 88.3%; LOT2, 86.1%), followed by anemia (LOT1, 79.0%; LOT2, 75.6%) and osteoarthritis (LOT1, 75.7%; LOT2, 76.7%), as comorbidities during the 6 months prior to the index date. CRAB event rates declined from LOT1 to LOT2, with the highest event rate per 1,000 PYs observed for anemia (LOT1, 1,965.1; LOT2, 1,808.2), followed by bone disease (LOT1, 258.1; LOT2, 244.1), renal impairment (LOT1, 167.9; LOT2, 159.9), and hypercalcemia (LOT1, 106.9; LOT2, 99.6); a decline in event rate was observed from LOT1 to LOT2 (Figure 1). CRAB event-related HRU PPPM increased from LOT1 to LOT2, including number of inpatient visits (LOT1, 0.1; LOT2, 0.2), length of inpatient stay (LOT1, 0.8 days; LOT2, 1.0 days), and number of outpatient hospital visits (LOT1, 2.0; LOT2, 2.2). However, the number of outpatient office visits PPPM decreased from LOT1 to LOT2 (LOT1, 0.9; LOT2, 0.8). Similarly, there was a trend toward increased CRAB event-related healthcare costs PPPM from LOT1 to LOT2 (Figure 2) including inpatient (LOT1, USD 1,548; LOT2, USD 2,031), outpatient hospital (LOT1, USD 214; LOT2, USD 301), outpatient office (LOT1, USD 77; LOT2, USD 89), and total medical costs (LOT1, USD 2,120; LOT2, USD 2,593). Conclusions: This study shows that CRAB events were more expensive to treat as patients relapse. Delaying disease progression may be associated with lower HRU and potential cost savings, thereby reducing the burden of MM. A potential limitation of this study is that claims data do not include clinical parameters. Future studies should be considered to evaluate the impact of age and comorbidities on the economic burden associated with CRAB events. This study also highlights the value of delaying progression and the time to next treatment. Disclosures Pandya: Celgene Corporation: Consultancy; STATinMED Research: Employment. Clancy:Celgene Corporation: Employment, Equity Ownership, Research Funding. Shrestha:STATinMED Research: Employment, Equity Ownership. Wang:STATinMED Research: Employment, Equity Ownership.

Download Full-text

Real world treatment patterns in chronic myeloid leukemia patients newly initiated on tyrosine kinase inhibitors in an U.S. integrated healthcare system

Journal of Oncology Pharmacy Practice ◽

10.1177/1078155217697484 ◽

2017 ◽

Vol 24 (4) ◽

pp. 253-263

Author(s):

Nazia Rashid ◽

Han A Koh ◽

Kathy J Lin ◽

Brian Stwalley ◽

Eugene Felber

Keyword(s):

Chronic Myelogenous Leukemia ◽

Index Date ◽

Stem Cell Transplant ◽

Study Time ◽

Myelogenous Leukemia ◽

Prior History ◽

Cell Transplant ◽

Time Period ◽

History Of

Purpose To evaluate treatment patterns in patients diagnosed with incident chronic myelogenous leukemia (CML) newly initiating therapy with imatinib, dasatinib, or nilotinib. Patients were followed to determine switching and discontinuation rates. Factors associated with switching or discontinuation from index TKI therapy, reasons for discontinuation based on electronic chart notes, and frequency of laboratory monitoring were assessed during the follow-up period. Methods A retrospective cohort study was conducted in chronic myelogenous leukemia patients aged ≥ 18 years who were identified from the Kaiser Permanente Southern California (KPSC) Cancer Registry database during the study time period of 1 January 2007 to 12 December 2013. The index date was defined as the date of the first TKI prescription (imatinib, dasatinib, or nilotinib) identified during the study time period with no prior history of TKI use within 12 months. Patients had to have continuous membership with drug benefit eligibility and no prior history of stem cell transplant (SCT) or other cancers during the 12 months prior to the index date. Baseline characteristics were identified during 12 months prior to the index date and outcomes were identified during the follow-up period after the index date. All patients were followed from index TKI therapy until end of study time period (12 December 2014), death, stem cell transplant, or disenrollment from the health plan unless one of the following occurred first: a patient switched their index therapy, or a patient discontinued their index therapy. Forward stepwise selection multivariable logistic regression models were used to evaluate factors associated with patients who continued therapy compared to those who switched or discontinued therapy with the index TKI. Chart notes were reviewed 30 days prior and 30 days post index TKI discontinuation to evaluate reasons for discontinuation. Molecular and cytogenetic testing frequency was also assessed during the follow-up period among the different patient groups. Results Two hundred sixteen patients were identified with incident chronic myelogenous leukemia and use of TKI therapy: 189 (87.5%) received imatinib, 19 (8.8%) received dasatinib, and 8 (3.7%) received nilotinib. The mean age on index date was 53 years and 63% were male; 103 patients (48%) continued on their index therapy, while 62 patients (28%) switched, and 51 patients (24%) discontinued.

Download Full-text

1325. Inpatient Initiation of ART Improves Short-Term Mortality in People Living with HIV

Open Forum Infectious Diseases ◽

10.1093/ofid/ofz360.1188 ◽

2019 ◽

Vol 6 (Supplement_2) ◽

pp. S479-S479

Author(s):

Jamie Campbell ◽

Christopher Polk ◽

Danya Roshdy ◽

Michael Leonard

Keyword(s):

Hospice Care ◽

Intervention Group ◽

People Living With Hiv ◽

Virologic Suppression ◽

Short Term ◽

Patient Admissions ◽

Short Term Mortality ◽

Living With Hiv ◽

The Impact

Abstract Background Treatment of HIV is recommended as soon as possible and early initiation of combined antiretroviral therapy (cART) is associated with improved engagement in care; however, treatment with cART is often deferred in hospitalized patients despite being correlated with improved outcomes. We implemented an institutional intervention to ensure all people living with HIV (PLwH) were on cART during hospitalization to improve patient outcomes. Methods We prospectively identified all PLwH hospitalized at our institution and had ID physicians and pharmacists ensure they were on appropriate cART and linked to outpatient care. We retrospectively collected clinical and lab data to assess the impact of our intervention on inpatient mortality, 30-day mortality, 30-day readmission rate, and frequency of outpatient follow-up. Patients were excluded from analysis if they were admitted for hospice care. Results We identified 389 patient admissions in 275 unique patients, of which 304 admissions were already on cART at admission. After ID physician assessment, 37 of the 85 not on cART at admission were initiated on therapy. We assessed the impact of this intervention on short-term outcomes as listed in Table 1. Despite the intervention group having similar immunologic and virologic baseline characteristics to those not initiated on cART, their inpatient and 30-day mortality was similar to those already on cART. Readmission rates also decreased in the intervention group. Thirteen of 24 patients in the intervention group who could be tracked for long-term follow-up within our system achieved virologic suppression by 90 days after hospital discharge. Conclusion Inpatient treatment with cART during hospitalization improves short-term mortality outcomes. This study also demonstrates the value of inpatient cART treatment as most patients achieved virologic suppression at subsequent outpatient follow-up. Disclosures All authors: No reported disclosures.

Download Full-text

Improved Outcomes Using Tacrolimus/Sirolimus for graft Versus Host Disease prophylaxis with a Reduced Intensity Conditioning Regimen for Allogeneic Hematopoietic Cell Transplant for Myelofibrosis

Blood ◽

10.1182/blood.v112.11.4410.4410 ◽

2008 ◽

Vol 112 (11) ◽

pp. 4410-4410

Author(s):

David S. Snyder ◽

Joycelynne Palmer ◽

Karl Gaal ◽

Anthony Selwyn Stein ◽

Vinod Pullarkat ◽

...

Keyword(s):

Acute Gvhd ◽

Hematopoietic Cell ◽

Cell Transplant ◽

Reduced Intensity Conditioning ◽

Host Disease ◽

Gvhd Prophylaxis ◽

The Impact ◽

Kinase Mutation ◽

Reduced Intensity

Abstract Allogeneic hematopoietic cell transplantation (HCT) using reduced intensity conditioning (RIC) regimens is a potentially curative treatment for patients (pts) with myelofibrosis (MF), as we (BBMT12:1161,2006) and others have reported. Treatment related mortality (TRM) from Graft vs. Host Disease (GVHD) and other complications has limited the success of this approach. We have recently utilized a combination of tacrolimus(tacro)/sirolimus (siro) +/− methotrexate (MTX) for GVHD prophylaxis in a cohort of 14 consecutive pts with MF treated with RIC HCT at City of Hope in an effort to reduce TRM from GVHD and related complications. In this report, we present results for 23 pts including extended follow up for the previously reported 9 pts who received cyclosporine (CSA)/mycophenolate (MMF) +/− MTX, and the current cohort of 14 pts who received tacro/siro +/− MTX, and evaluate the impact of the GVHD prophylaxis regimen on the outcomes. MTX was included for all recipients of matched unrelated donor (MUD) products. The cohort median age was 58 yrs (range 39–69) with 12 females, 11 males. Two of nine CSA/MMF pts developed MF secondary to a prior myeloproliferative disorder and 3/14 tacro/siro pts had secondary MF. The Lille risk score was high for 10 pts, intermediate for 12, and low for 1. The RIC regimen consisted of Fludarabine/melphalan for 23 pts, including all 14 of the tacro/siro pts, and fludarabine/total body irradiation for the first pt in the CSA/MMF cohort. Eight pts received stem cell products from HLA matched siblings (2/9 CSA/MMF pts; 6/14 tacro/siro pts) and 15 from MUDs (7/9 CSA/MMF pts; 8/14 tacro/siro pts). The source of stem cells was GCSF primed peripheral blood for 21 pts, and unprimed bone marrow for 2 pts. The median cell dose was 7.8 × 10^6 CD34 cells/kg. Median follow up for alive patients was 26.7 mos (3.4–97.6). All evaluable pts engrafted with neutrophils (median 16.5 days) and platelets (median 18.0 days). Chimerism studies demonstrated donor engraftment in 94–100% of cells using STR or FISH analysis. JAK 2 kinase mutation analysis was available pre-HCT for 4/14 pts in the tacro/siro cohort. Two of these four pts were positive, and both became JAK2 kinase mutation negative post-HCT. No pt in either cohort relapsed, and none developed veno-occlusive disease or thrombotic microangiopathy. Five pts died- 4 from GVHD +/− infections or multi-organ failure and one from graft failure with sepsis. The estimated 2 yr overall survival (OS) for the CSA/MMF cohort was 66.7 %(confidence intervals 20.4,80.5), and for the tacro/siro cohort it was 92.3% (56.6,98.9) (p=0.0472). The probability of grade III or IV acute GVHD was 60% for the CSA/MMF pts, and 10% for the tacro/siro group (p=0.0102). The 100-day TRM was 33.3% for the CSA/MMF pts and 0 for the tacro/siro group (p=0.0215). Five of the six evaluable pts in the CSA/MMF cohort developed chronic GVHD (4/5 extensive) compared to 9/14 pts (6/9 extensive) in the tacro/siro group. We conclude that the combination of tacro/siro +/− MTX for GVHD prophylaxis in the setting of RIC HCT for MF appears to lead to improved OS compared to CSA/MMF +/− MTX, and that this benefit may be due to a significant decrease in the incidence of severe acute GVHD with the use of tacro/siro +/− MTX.

Download Full-text

Acute myeloid leukemia: Comparison of epidemiology and treatment outcomes between insured and uninsured patients.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.15_suppl.e17012 ◽

2012 ◽

Vol 30 (15_suppl) ◽

pp. e17012-e17012

Author(s):

Samer Ali Srour ◽

Michael Machiorlatti ◽

Usman Bhutta ◽

Namali Pierson ◽

Mohamad Ali Cherry ◽

...

Keyword(s):

Acute Myeloid Leukemia ◽

Treatment Outcomes ◽

Myeloid Leukemia ◽

Private Insurance ◽

Cell Transplant ◽

Public Insurance ◽

Insurance Type ◽

The Impact ◽

Acute Myeloid

e17012 Background: The overall prognosis for most acute myeloid leukemia (AML) patients remains poor. The majority of adult patients (pts) with AML will ultimately need allogeneic stem cell transplant (allo-SCT). Limited data is available comparing epidemiology and treatment outcomes between uninsured and insured pts with AML. We describe a retrospective analysis of adult pts with AML treated at our institution. Methods: From January 2000 to June 2011 we identified 239 pts with AML, of which 185 met inclusion criteria. Patients were classified as having private insurance, public insurance (Medicaid and Medicare), or no insurance. Primary outcomes were overall survival at follow up (OS), complete remission (CR), and percent of pts receiving allo-SCT. Kaplan-Meier analysis was used to estimate survival rates. Results: Of the 185 pts studied, 146 (81%) were white, 16 (9%) African-American and 11 (6%) were Native American. The median age at diagnosis was 49 years. 75 pts had private insurance at the time of diagnosis, 70 had public insurance, and 33 were uninsured. Of those receiving allo-SCT (n=60; 38 male) 48% had private insurance, 30% public, and 22% were uninsured. Whether a patient underwent allo-SCT did not differ according to insurance source (p=0.2189) nor to status at follow-up (p= 0.6480). The proportion of patients achieving CR was higher among those undergoing allo-SCT (p=0.0002). Median OS was 920 days for those who underwent allo-SCT and 192 days for those who did not (p< 0.0001). Median OS did not differ by insurance type (p = 0.1454). The proportion of patients achieving CR did not differ by insurance type (p=0.2665) (66.7% of those with private, 62.7% of those with public, and 78.8% of those with no insurance). Conclusions: For the population referred to our institution, a tertiary referral center for the state, there were no differences in treatment outcomes or in the percent of pts receiving allo-SCT when pts were stratified according to insurance source. Further analysis of this dataset will identify the impact of pretreatment variables stratified by type of insurance.

Download Full-text

Treatment patterns among patients with higher-risk myelodysplastic syndromes in a real-world setting: Electronic medical record (EMR)-based data.

Journal of Clinical Oncology ◽

10.1200/jco.2017.35.8_suppl.247 ◽

2017 ◽

Vol 35 (8_suppl) ◽

pp. 247-247

Author(s):

Bruce Jeffrey Dezube ◽

Jill Bell ◽

Aaron Galaznik ◽

Eileen Farrelly ◽

Marlo Blazer ◽

...

Keyword(s):

Real World ◽

Index Date ◽

Treatment Guidelines ◽

Specific Treatment ◽

Cell Transplant ◽

Newly Diagnosed ◽

Limited Information ◽

Nccn Guidelines ◽

Real World Setting

247 Background: Treatment decisions in MDS are based on a prognostic scoring system that divides pts into five distinct risk categories (NCCN 2016). Treatment guidelines for HR MDS pts include hypomethylating agents (HMAs) alone (azacitidine & decitabine), high-intensity induction chemotherapy (IC), & stem cell transplant (SCT) alone or after HMAs. Limited information is available on how these recommendations are applied in practice. This study evaluated the real-world treatment of HR MDS pts. Methods: Newly diagnosed HR MDS pts who were ≥18 years old & initiated first-line therapy (1LT) were retrospectively identified from a large United States EMR database between 1/1/2008 & 7/31/2015. As complete cytogenetics were not available in the database, HR was based on: ICD coding: ≥1 inpatient claim with an HR MDS ICD-9/10 code (ICD-9 code: 238.73; ICD-10 codes: D46.20, D46.21, D46.22), or ≥2 outpatient claims with an MDS ICD-9/10 code, or an adapted HR MDS algorithm (NCCN Guidelines in Oncology for MDS v.1.2016; Greenberg, et al. Blood. 2012;120:2454-65; Schanz et al. J Clin Oncol. 2012;30:820-9). The first MDS claim served as the index date. 1LT was defined as an MDS-specific treatment initiated on or after the index date. Pts were followed until death, progression to acute myeloid leukemia (AML), loss to follow-up, or end of study (9/30/2015). Results: 720 newly diagnosed HR MDS pts were identified; of these, 229 (32%) pts received MDS-specific treatment. Median time to treatment was 22 days (interquartile range [IQR]: 10, 74). HMAs were the most common agents in the 1LT with 60% (n= 138) & 24% (n=54) receiving azacitidine & decitabine, respectively. Lenalidomide was used in 7.4% of pts (n=17), 4.8% received SCT alone (n=11), & 3.9% (n=9) received IC. At median follow-up of 9.4 months (IQR: 4.3, 18.4), 38% (n=86) died & 28% (n=63) progressed to AML. Conclusions: Despite guidelines, most HR MDS pts in a real-world setting were not treated with MDS-specific treatment. Among treated pts, 1LT with HMAs & azacitidine predominated. Subsequent research is needed to understand reasons for lack of treatment.

Download Full-text

Could Patients with Multiple Myeloma (MM) Derive Additional Benefit from Their Treatments? Real-World Evidence for Carfilzomib Dosing Intensity on Survival and Treatment Progression

Blood ◽

10.1182/blood-2018-99-113414 ◽

2018 ◽

Vol 132 (Supplement 1) ◽

pp. 836-836 ◽

Cited By ~ 1

Author(s):

Rohan Medhekar ◽

Dionne Hines ◽

Sumeet Panjabi ◽

Tim Welliver ◽

Xin Wang ◽

...

Keyword(s):

Multiple Myeloma ◽

Real World ◽

Lower Risk ◽

Index Date ◽

Cox Model ◽

Weekly Dose ◽

Employment Equity ◽

K Index ◽

Equity Ownership ◽

The Impact

Abstract Introduction: Carfilzomib (K) was first approved in 2012 for the treatment of relapsed/refractory multiple myeloma (RRMM) at a dose of 27 mg/m2 twice weekly (27 BIW). The K dose has since been optimized; carfilzomib plus dexamethasone (Kd) is approved for patients with RRMM at a recommended K dose of 56 mg/m2 twice weekly (56 BIW) since 2016. Recently, the A.R.R.O.W trial showed that Kd 70mg/m2 once weekly (70 QW) significantly improved progression free survival compared to Kd 27 BIW. Considering the study time-period, however, patients are still treated with 27 BIW in the real-world leaving them possibly under-treated. The Kd 27 BIW, corresponds to a cumulative weekly dose (CWD) of K <120mg, while both Kd 56 BIW and Kd 70 QW (optimized dose-56 BIW/70 QW) correspond to a CWD of K >120mg. Therefore, in order to understand the relationship between dose and outcomes we examined the impact of K-dosing (CWD >120mg [optimized dose-56 BIW/70 QW] vs. CWD ≤120 mg [27 BIW]) on time to next treatment (TTNT) and overall survival (OS) among patients treated with Kd regimen. Methods: IQVIA's Oncology Electronic Medical Records database was used to identify patients ≥18 years of age, with a diagnosis of MM between 1/1/2010 and 10/31/2017, receiving Kd regimen in any line of therapy, with ≥ 3 doses of K on or after their K-index date (first administration of K in the Kd regimen, between 1/1/2013 and 10/31/2017). Patients were required to have ≥ 3 doses of K in order to establish continuity and for calculating CWD. CWD was calculated as the cumulative sum of weekly dose of K received by the patient divided by the number of weeks with Kd administration. The first two K doses were excluded from the calculation of CWD as these represent the loading dose. OS and TTNT were compared between patients receiving optimized dose-56 BIW/70 QW vs. 27 BIW. OS was evaluated among the subset of patients with a recorded deceased or alive status and measured from the K-index date until death due to any cause or the end of the study period, where they were censored. TTNT was defined as the time from initiation of the Kd regimen until the start of a subsequent regimen that did not contain Kd (treatment progression). Additionally, a landmark analysis at 12 months from initiation of Kd regimen was conducted to measure the proportion of patients alive and the proportion of patients with treatment progression. Kaplan-Meier analysis was used to estimate OS and TTNT and the log-rank test was used to compare the groups. Adjusted hazard ratios for OS and TTNT were evaluated using Cox models. Results : A total of 1,469 eligible MM patients with ≥3 Kd administrations were identified, of which 129 (8.8%; mean age: 63.5, SD: 9.8) received optimized dose-56 BIW/70 QW and 1,340 (91.2%; mean age: 67.0, SD: 10.4) received 27 BIW. The median follow-up time was slightly over a year for patients in both cohorts. The median K dose was 147.0 mg among patients in optimized dose-56 BIW/70 QW group and 88.1 mg among patients in 27 BIW group. Median OS was not estimable (NE), however, OS for the optimized dose-56 BIW/70 QW group (n=78) was significantly longer than that of the 27 BIW group (n=771; p=0.002) (Fig. 1). The proportion of patients in optimized dose-56 BIW/70 QW group alive at 12 months was 90.3% compared to 79.7% for patients in 27 BIW group respectively. Covariate-adjusted cox model showed that patients in optimized dose-56 BIW/70 QW group had a 64% lower risk of death than patients in 27 BIW group (adjusted HR: 0.364; 95% CI: 0.178-0.745; p = 0.0057, Table 1). TTNT was significantly longer for patients in optimized dose-56 BIW/70 QW group compared to patients in 27 BIW group (p=0.023; median TTNT: 17.5 [95% CI: 14.8-NE] and 13.2, [95% CI: 12.4-14.4], respectively) (Fig. 2). Covariate-adjusted cox model showed that patients in optimized dose-56 BIW/70 QW group had a 33% lower risk of treatment progression than patients in 27 BIW group (adjusted HR: 0.669; 95% CI: 0.483-0.927; p=0.0155, Table 1). Conclusion: Among patients treated with Kd regimen, a smaller proportion were prescribed K at optimized dose-56 BIW/70 QW. Patients receiving the optimized dose-56 BIW/70 QW had significantly improved OS and TTNT compared to those receiving 27 BIW. Our findings suggest that these patient-relevant outcomes may be improved in a vast majority of RRMM patients currently under-treated with carfilzomib by optimizing the dose, taking into consideration patients' comorbidities and ability to tolerate therapy. Disclosures Medhekar: Amgen: Employment, Equity Ownership. Hines:Amgen: Consultancy. Panjabi:Amgen: Employment, Equity Ownership. Welliver:Amgen: Employment, Equity Ownership. Wang:Amgen: Consultancy. Wade:Amgen: Consultancy.

Download Full-text

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

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjab076.517 ◽

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.

Download Full-text