Baseline Charlson Comorbidity Index Research Articles

The Clinical and Economic Burden of Newly Diagnosed Hereditary Transthyretin (ATTRv) Amyloidosis: A Retrospective Analysis of Claims Data.

IntroductionLittle is known about the burden of hereditary transthyretin (ATTRv) amyloidosis, a genetic, progressive, and fatal disease caused by extracellular deposition of transthyretin amyloid fibrils. The study’s aim was to estimate costs and disease burden associated with ATTRv amyloidosis in a real-world setting.MethodsUsing IBM® MarketScan® Commercial and Medicare Supplemental data, we identified patients at least 18 years of age with newly diagnosed ATTRv amyloidosis. Diagnosis required at least one medical claim with relevant diagnosis code (International Classification of Diseases, 9th Revision, Clinical Modification [ICD-9-CM] 277.30–.31, 277.39; ICD-10-CM E85.0–.4, E85.89, E85.9) between January 1, 2014 and December 31, 2016, and at least one additional criterion occurring during study period (2013–2017): at least 15 days diflunisal use without more than a 30-day gap; liver transplant; or claim with codes E85.1 or E85.2. First diagnosis date was study index. Continuous enrollment 1-year pre-index (baseline) and post-index (follow-up) was required. Patients with baseline amyloidosis diagnosis were excluded. Outcomes of interest were comorbidities and 1-year follow-up healthcare utilization and costs (also reported quarterly).ResultsAmong 185 qualifying patients, mean age was 59.2 years (standard deviation 15.2), 54.1% were female, and baseline Charlson comorbidity index was 2.2 (2.5). Neuropathy (30.3%), diabetes (27.0%), and cardiovascular-related comorbidities, including dyspnea (25.9%) and congestive heart failure (21.6%), were common during follow-up. Nearly a quarter of patients (24.9%) were hospitalized during follow-up. Most hospitalizations and emergency department visits occurred in the first quarter post-diagnosis (18.9%, 17.8%, respectively) and dropped in subsequent quarters. The annual mean total cost was $64,066, with inpatient services contributing the majority of the expenses ($34,461), followed by outpatient ($23,853), and then pharmacy ($5752). As with utilization, costs were highest in the first quarter post-diagnosis and dropped in subsequent quarters.ConclusionPatients newly diagnosed with ATTRv amyloidosis have substantial healthcare utilization and costs in the first year, primarily the initial months, post-diagnosis. Further research should examine later costs associated with disease progression and end-of-life care.

A Retrospective Cohort Study of the Effect of Gout on Mortality Among Patients with a History of Kidney Transplantation.

BackgroundKidney transplantation is associated with increased prevalence of gout. However, evidence of the effect of gout on long-term kidney transplantation outcomes is mixed. This study examined mortality risk among patients with a history of kidney transplantation with vs. without gout.Material/MethodsA retrospective study was conducted using Medicare Fee-for-Service administrative claims of patients with a history of kidney transplantation. Cox proportional hazards models determined the effect of gout on all-cause mortality, controlling for confounders, including comorbid mortality risk, via the Charlson Comorbidity Index. Because the relationships between gout and components of the Charlson Comorbidity Index are also debated, 3 different model assumptions were used: 1) gout shares a common cause with these comorbidities, 2) gout is upstream of these comorbidities, 3) the effect of gout on mortality is modified by these comorbidities.ResultsGout increased the risk of all-cause mortality in the unadjusted model (hazard ratio: 1.44, 95% CI 1.27–1.63) and after adjustment for demographics and transplant vintage (hazard ratio: 1.16, 95% CI 1.02–1.32). Gout was not a significant risk after adjustment for baseline Charlson Comorbidity Index (hazard ratio: 1.03, 95% CI 0.90–1.17). Gout was associated with greater mortality among patients without baseline comorbidities (Charlson Comorbidity Index=0; hazard ratio: 3.48, 95% CI 1.27–9.57) in the stratified model.ConclusionsAmong patients with a history of kidney transplantation, gout did not have an independent effect on all-cause mortality. However, gout was a predictor of mortality among patients with no comorbidities, suggesting that gout is an early warning sign of poor health in kidney transplantation patients.

Real-world incidence and burden of adverse events among non-metastatic prostate cancer patients treated with secondary hormonal therapies following androgen deprivation therapy

Aims: To describe the incidence and identify prognostic factors of central nervous system (CNS) adverse events (AEs) and any AEs (CNS, skin rash, or fracture) and evaluate the healthcare resource utilization (HCRU), direct medical costs, and therapy discontinuation associated with these AEs among non-metastatic prostate cancer (nmPC) patients who received secondary hormone therapies.Methods and results: nmPC patients who had initiated secondary hormonal therapy with enzalutamide, bicalutamide, or abiraterone ≥1 year after androgen deprivation therapy (ADT) were identified in the MarketScan database. Survival analyses were used to describe the incidence of CNS or any AEs. Annual HCRU and costs were compared across patient groups (CNS AE vs no CNS AE; any AE vs no AE) using propensity score weighted generalized linear models. Multivariate Cox proportional hazards models were used to identify AE predictors and compare risks of discontinuation.Results: The analysis included 532 patients who initiated secondary hormonal therapies, among whom 201 (38%) and 244 (46%) experienced a CNS AE and any AE, respectively. Median times to CNS AE and any AE from therapy initiation were 17.90 and 11.00 months, respectively. Predictors of any AE were any AE in the baseline period (≤6 months before starting therapy), Charlson Comorbidity Index (CCI) score (1 vs 0), surgical castration, and older age. Predictors of CNS AEs were CNS AE in the baseline period and CCI score (1 vs 0). CNS and any AEs were associated with significantly higher HCRU. CNS AEs were associated with significantly higher incremental total medical costs ($18,522). CNS AEs and any AEs significantly increased therapy discontinuation risk by 48% and 38%, respectively.Conclusions: AEs increase the economic burden and therapy discontinuation among nmPC patients receiving secondary hormonal therapies subsequent to ADTs. These patients should be carefully evaluated for AEs to reduce therapy discontinuation, HCRU, and direct medical costs.

Clinical trajectories, healthcare resource use, and costs of long-term hematopoietic stem cell transplantation survivors: a latent class analysis.

To identify patterns of healthcare utilization in allogeneic and autologous hematopoietic stem cell transplantation (HSCT) recipients and evaluate factors associated with high-need and high-cost post-transplantation care. Latent class analysis of a retrospective cohort of long-term allogeneic (n = 436) and autologous (n = 888) HSCT survivors within the Truven MarketScan database (2009-2014). We assessed factors associated with the latent classes by comparing post-transplantation healthcare utilization including inpatient admissions and length of stay, emergency room visits, specialist visits, and primary care provider visits. Four utilization classes were identified in allogeneic and autologous HSCT recipients: (i) outpatient specialist care dominant (51.8% and 57.3%), (ii) outpatient primary care dominant (10.3% and 25.7%), (iii) outpatient/inpatient balanced (20.6% and 13.5%), and (iv) inpatient dominant (17.2% and 3.5%). Mean monthly healthcare expenditures in the inpatient dominant utilization class were $41,097 and $25,556 for allogeneic and autologous survivors, respectively, which were two to five times higher compared with other classes during the 2-year post-transplantation period. Factors associated with the high utilization class were transfusion (OR = 1.87, 95% CI 1.06-3.30) and 100-day post-transplant graft-versus-host-disease (OR = 1.76, 95% CI 1.05-2.94) in allogeneic HSCT; higher baseline Charlson comorbidity index (OR = 1.45, 95% CI 1.19-1.76) in autologous HSCT. Based on distinct patterns of healthcare utilization following HSCT, we identified factors associated with higher resource utilization and greater healthcare related expenditures. Earlier identification of high-cost and high-need HSCT long-term survivors could pave the way for clinicians to offer more continuous engagement in survivorship care delivery.

Prostatic Artery Embolization Using 100-300-μm Trisacryl Gelatin Microspheres to Treat Lower Urinary Tract Symptoms Attributable to Benign Prostatic Hyperplasia: A Single-Center Outcomes Analysis with Medium-Term Follow-up.

To report medium-term outcomes of prostatic artery embolization (PAE) using 100-300-μm trisacryl gelatin microspheres to treat lower urinary tract symptoms (LUTS) from benign prostatic hyperplasia (BPH) and to evaluate how cone-beam computed tomography-measured prostate gland volume (PGV), median lobe enlargement (MLE), age, and Charlson Comorbidity Index (CCI) affect these results. Seventy-four consecutive patients who underwent PAE from April 2014 through August 2018 were retrospectively reviewed. Patients had International Prostate Symptom Score (IPSS) >12, Quality of Life (QoL) score >2, prostate gland volume (PGV) >40 mL, age older than 45 years, and medical therapy failure. Twelve patients were excluded for bladder pathology or prostate cancer. Patients (n= 62, age= 71.8 ± 9.3 years, CCI= 3.5 ± 1.7, PGV= 174 ± 110 mL) had pre-procedure IPSS= 22.4 ± 5.6, QoL score= 4.4±0.9, and post-void residual (PVR)= 172 ± 144 mL. Post-procedure values were compared to baseline at 1, 3, 6, 12, and 24 months. Associations between outcomes and PGV, MLE, age, and CCI were evaluated. Adverse event recording used Clavien-Dindo classification. One month after PAE (n= 37), IPSS improved to 7.6 ± 5.2 (P < .0001) and QoL score improved to 1.7 ± 1.4 (P < .0001). At 3 months (n= 32), improvements continued, with IPSS= 6.4 ± 5.1 (P < .0001), QoL score= 1.2 ± 1.2 (P < .0001), PVR= 53 ± 41 mL (P < .001), and PGV= 73 ± 38 mL (P < .0001). Results were sustained at 6 months (n= 35): IPSS= 6.4 ± 4.1 (P < .0001), QoL score= 1.2 ± 1.2 (P < .0001), PVR= 68 ± 80 mL (P < .0001), PGV= 60 ± 19 mL (P < .001). At 12 months, patients (n= 26) had IPSS= 7.3 ± 5.5 (P < .0001), QoL score= 1.2 ± 0.8 (P <.0001), PVR= 89 ± 117 mL (P < .0001), PGV= 60 ± 48 mL (P < .01). At 24 months, patients (n= 8) had IPSS= 8.0 ± 5.4 (P < .0001), QoL score= 0.7 ± 0.5 (P < .0001), PVR= 91 ± 99mL (P= 0.17), and PGV= 30 ± 5mL (P= .11). Improvements were independent of PGV, MLE, age, and CCI. Two grade II urinary infections occurred. PAE with 100-300-μm microspheres produced sustained substantial improvements in LUTS, PGV, and PVR, which were independent of baseline PGV, MLE, age, or CCI.

Immune thrombocytopenic purpura increased risk of subsequent pancreatitis: A Nationwide population cohort study

Immune thrombocytopenic purpura (ITP) is characterized by thrombocytopenia and bleeding diathesis. Pancreatitis is a very rare complication but may be fatal. We analyzed data of newly diagnosed ITP patients, excluding those with a history of splenectomy, unknown sex or date of birth, or preexisting pancreatitis at the time of ITP diagnosis, and compared these with selected age-, gender-, and index-year-matched controls, using the Taiwan National Health Insurance Research Database from 1996 to 2013. The study enrolled 100,177 ITP patients and 100,177 controls. We found that pancreatitis risk was higher in secondary ITP patients, regardless of age group, gender, baseline Charlson comorbidity index (CCI) score, history of biliary stone, hyperlipidemia, or alcoholism, than in the control population. Primary ITP patients with CCI score 1 and without biliary tract stone history also showed a higher pancreatitis risk than the controls. The incidence rate and cumulative incidence of pancreatitis were increased in primary, secondary, and unspecified ITP cases. These phenomena may be related to the presence of autoantibodies against glycoprotein IIb/IIIa, or to IgG4, microparticle obstruction, or sclerosis. We noted a direct association between ITP and the development of pancreatitis in Taiwan population.

Real-World Treatment Patterns and Overall Survival Among Medicare Fee-for-Service Beneficiaries Newly Diagnosed with Peripheral T-Cell Lymphoma

Background: Peripheral T-cell lymphomas (PTCL) are a rare and heterogeneous group of lymphoid malignancies characterized by a clinically aggressive course with poor prognosis. A majority of PTCL patients are ≥60 years of age and typically present with advanced stage disease and multiple comorbidities. There remains no consensus standard of care for patients with most PTCL subtypes. Multi-agent chemotherapy, consisting of CHOP (cyclophosphamide, doxorubicin, vincristine, and prednisone) or CHOP with etoposide (CHOEP), are guideline recommended options for nodal subtypes. Limited contemporary real-world data exist on the treatment patterns and overall survival (OS) of PTCL patients treated with CHOP or non-CHOP regimens in the United States before the FDA approval of brentuximab vedotin in combination with chemotherapy in November 2018 based on the ECHELON-2 trial. Objective: To evaluate treatment patterns and OS prior to the approval of brentuximab vedotin among Medicare Fee-for-Service (FFS) beneficiaries newly diagnosed with PTCL. Methods: The 100% sample of Medicare FFS claims (Parts A/B/D) was used to identify patients aged ≥65 years with ≥1 inpatient or ≥2 distinct outpatient diagnosis claims for PTCL (index event) from January 2011 to December 2017. Patients were required to have a least 6 months prior and 12 months post-index continuous Medicare enrollment, and were followed until disenrollment, death, or the end of the study period, whichever occurred first. OS, defined as the time from initial episode or treatment start date to the validated date of death, was measured using the Kaplan-Meier method; patients without a death date were assumed to be alive at the time of analysis and were censored. Results: A total of 2551 Medicare FFS beneficiaries with a PTCL diagnosis met study criteria and were included for analysis. The majority of patients were white (86.9%), over half were male (52.9%), and mean age was 75 years. Patients had multiple comorbidities at diagnosis (Charlson Comorbidity Index (CCI) score 4.47), including hypertension (77.3%), diabetes (32.9%), and chronic obstructive pulmonary disease (28.1%). Among the 2551 patients in the study cohort, 62.4% (n=1593 of 2551) received at least one identifiable drug regimen; 25.5% of treated patients received CHOP (n=407), 3.1% CHOEP (n=50) and 71.2% (n=1134) other regimens. Of patients treated with other regimens, 37.7% (n=427) received steroids only, 22.4% (n=254) steroids with unidentifiable chemotherapy, 6.9% (n=78) cyclophosphamide, 6.2% (n=70) methotrexate, 4.6% (n=52) brentuximab vedotin, 3.6% (n=41) bendamustine, 3.5% (n=40) romidepsin, and 15.2% (n=172) other therapy combinations. Among patients who were treated with CHOP, 16.6% (n=66) received an identifiable second line of therapy (LoT), 48.7% (n=194) an unidentifiable second LoT, and the remainder (34.7%, n=138) had no evidence of further anti-cancer treatment. The median time from CHOP initiation to a subsequent LoT was 5.6 months. The mean baseline CCI score for patients treated with CHOP was 4.33 (±2.93) compared with 4.76 (±2.97) for patients treated with other therapies (p=0.0118). In patients receiving an identifiable first LoT, median OS among CHOP and non-CHOP recipients was 4.8 years (95% CI 3.0-6.1) and 4.4 years (95% CI 3.0-4.9), respectively (Table). The 5-year OS estimate was 49% in patients receiving CHOP compared with 46% for non-CHOP recipients. Conclusions: Fewer than 30% of Medicare beneficiaries newly diagnosed with PTCL were treated with intensive chemotherapy as first LoT. Acknowledging a possible selection bias for more fit PTCL patients receiving CHOP, this group had increased OS compared with patients receiving non-CHOP therapy. However, the 5-year OS across all cohorts was less than 50%. New therapies such as brentuximab vedotin may fill the need for PTCL Medicare beneficiaries who may not be able to tolerate CHOP or CHOP-based regimens. Disclosures Shah: Avalere Health, An Inovalon Company: Employment. Petrilla:Avalere Health, An Inovalon Company: Employment. Rebeira:Seattle Genetics: Employment. Feliciano:Seattle Genetics: Employment, Equity Ownership. LeBlanc:Astra Zeneca: Consultancy, Research Funding; Duke University: Research Funding; Jazz Pharmaceuticals: Research Funding; Daiichi-Sankyo: Membership on an entity's Board of Directors or advisory committees; Helsinn: Consultancy; Agios: Honoraria, Membership on an entity's Board of Directors or advisory committees, Speakers Bureau; NINR/NIH: Research Funding; Amgen: Membership on an entity's Board of Directors or advisory committees; AbbVie: Membership on an entity's Board of Directors or advisory committees; Otsuka: Consultancy, Membership on an entity's Board of Directors or advisory committees; Seattle Genetics: Consultancy, Research Funding; CareVive: Consultancy; Celgene: Honoraria; Flatiron: Consultancy; American Cancer Society: Research Funding; Heron: Membership on an entity's Board of Directors or advisory committees; Medtronic: Membership on an entity's Board of Directors or advisory committees; Pfizer Inc: Consultancy. Lisano:Seattle Genetics, Inc.: Employment, Equity Ownership.

889. Impact of an Infectious Disease Telehealth (IDt) Service on S. aureus Bacteremia (SAB) Outcomes in 15 Small Community Hospitals

BackgroundInfectious diseases (ID) consultation improves SAB readmission rates, compliance with care bundles and mortality. Small community hospitals (SCHs) (which comprise 70% of US hospitals) often lack access to on-site ID physicians. IDt is one way to overcome this barrier, but it is unknown if IDt provides similar clinical benefits to traditional ID consultation. Our study aims to evaluate the impact of IDt on patient outcomes at 15 SCHs (bed range: 16–146) within the Intermountain Healthcare system in Utah.MethodsBaseline demographics, Charlson Comorbidity Index (CCI), hospital length of stay (LOS), and mortality (in-hospital, 30- and 90-day) were collected using an electronic health record database and health department vital records on all patients with a positive S. aureus blood culture from January 1, 2009 through December 31, 2018. Data from January 2014 through Sep 2016 were excluded to avoid potential influence of a concurrent antimicrobial stewardship study. Starting in October 2016 an IDt program (staffed by an ID physician and pharmacist) provided consultation for SCH providers and patients using electronic consultation and encrypted two-way audiovisual communication.Statistical analyses were performed using Fisher’s exact test or χ 2 test for categorical variables and Mann–Whitney U test for nonparametric continuous data.ResultsIn total, 625 patients with SAB were identified: 127 (20%) received IDt and 498 (80%) did not (non-IDt). The two groups (IDt vs. non-IDt) were similar in median age (66 vs. 62 years; P = 0.76), percent male (62% vs. 58%; P = 0.35), and median baseline CCI (4 vs. 4; P = 0.54). There were no statistically significant differences in median LOS (5 vs. 5 days; P = 0.93) or in-hospital mortality (2% in both groups). The IDt group had a lower 30-day (9% vs. 15%; P = 0.049) and 90-day mortality (13% vs. 21%; P = 0.034).ConclusionIDt consultation was associated with a decrease in 30- and 90-day mortality for SCH SAB cases. Early transfer of critically ill patients might have affected LOS and in-hospital mortality. Post-discharge care factors might also contribute to 30- and 90-day mortality. While more work is needed to identify other factors associated with the effect of IDt on SAB, these data support the use of IDt to increase access to care and improve SAB outcomes in SCHs.Disclosures All Authors: No reported Disclosures.

Identification of herpes zoster high-risk group using Charlson comorbidity index: A nationwide retrospective cohort study.

The incidence of herpes zoster (HZ) is mainly affected by age. Various comorbidities could influence the risk of HZ, but a general guideline for evaluating their effect on HZ is lacking. The purpose of this study was to determine whether the Charlson comorbidity index (CCI) is useful in evaluating the risk of HZ in the general population. This retrospective cohort study analyzed data from 1016580 random multistage representative samples in Korea, recorded from 2004 to 2013 in the South Korean National Health Insurance Service-National Sample Cohort database. We calculated the baseline CCI score of comorbidities and compared the hazard ratio (HR) of HZ according to the calculated CCI scores. A total of 340124 eligible subjects aged 40-79years and 35874 HZ patients were identified. After adjustment of age, sex and income, the HR of HZ and odds ratio of postherpetic neuralgia in the CCI score of 1 or more group was found to be significantly higher than that of the CCI score 0 group. Compared with the 60s age group with a CCI score of 0, the 50s age group with a CCI score of 1 had a higher risk of HZ, and the 40s age group with a CCI score of 3 or more had a similar risk of HZ. Scoring systems of comorbidities such as the CCI could be useful in identifying the high-risk group for HZ, especially among the 40-59-year age group. Further studies are required to establish the usage of a HZ-specific comorbidity scoring system in a large multinational population.

157 Clinical Burden of Recurrent Clostridioides difficile Infection: A Real-World Data Analysis

INTRODUCTION: Clostridioides difficile infection (CDI), especially recurrent CDI (rCDI), is associated with high morbidity and resource utilization, imposing significant burden on the US healthcare system. This study evaluated the association of rCDI with medical procedures, complications, and medication use after an index CDI episode. METHODS: We performed a retrospective analysis of commercial claims data from the IQVIA PharMetrics Plus™ database for patients aged 18–64 years with CDI episodes requiring inpatient stay with CDI diagnosis code (ICD-9-CM 008.45; ICD-10-CM A04.7, A04.71, A04.72) or an outpatient medical claim for CDI plus a CDI treatment. We considered index CDI episodes from 1/1/2010 to 6/30/2017, including only those patients who were observable 6 months a priori and 12 months after the index episode. Each CDI episode was followed by a 14-day claim-free period after the end of treatment to distinguish rCDI from continuous CDI. rCDI was defined as another CDI episode within an 8-week window immediately after the claim-free period. Medication use, procedures, and complications were calculated over 12 months and stratified by number of rCDI episodes. RESULTS: 46,571 patients with an index CDI episode were included, of whom 3,129 (6.7%) experienced 1 rCDI, 472 (1.0%) experienced 2 rCDI, and 134 (0.3%) had 3 or more rCDI episodes. Mean (SD) age was 47.4 (12.7) years, and 62.4% were female (similar across rCDI groups; Table 1). Mean baseline Charlson Comorbidity Index (CCI) scores were 1.15, 1.54, 1.83, and 2.29 for those with no rCDI, 1 rCDI, 2 rCDI, and 3+ rCDI episodes, respectively. Vancomycin was the most commonly prescribed antibiotic during follow-up (Table 2). Follow-up prescription rates of metronidazole decreased with increasing rCDI episodes. In the 12-month follow up, sepsis occurred in 16.5% of patients with no rCDI, 27.3% with 1 rCDI, 33.1% with 2 rCDI, and 43.3% with 3+ rCDI episodes; subtotal colectomy or diverting loop ileostomy was performed as a follow-up procedure for 4.6%, 7.3%, 8.9%, and 10.4% of patients, respectively, in the four study groups (Figure 1). CONCLUSION: There appears to be a stepwise increase in number of rCDI episodes associated with increasing baseline CCI score. During the 12 months after index CDI episode, the frequency of sepsis and colectomy increased in parallel to the number of CDI recurrences. Prevention of rCDI is an important step to reduce the burden of such complications.

Primary non-adherence to adjuvant endocrine therapy in older women with breast cancer.

285 Background: Adjuvant endocrine therapy (AET) improves survival in hormone receptor positive breast cancer (HR+BC). Challenges with adherence to AET in seniors are well documented; however, there is limited knowledge on primary non-adherence (PNAD). PNAD is defined as non-initiation of a prescribed medication. Our aim is to characterize PNAD rates in women aged ≥ 65 with HR+BC and identify potential predictors, using real-time treatment information. Methods: Optimum is an e-health platform integrating real-time analysis of administrative claims data combined to patient-level clinical information on breast cancer. Optimum tracks care trajectories to identify deviations from best practice, using data from Quebec’s universal health insurance plan that covers all medical and pharmaceutical care. In this single-center feasibility study, we characterized PNAD as a non-initiation of AET within 10 days from the first prescription. Descriptive analyses were used to assess potential predictors. Results: Of the 57 patients enrolled, 9 were excluded due to lack of &gt; 30 day follow up. In the remaining 48 patients, PNAD was 21 %. Baseline Charlson comorbidity index (0 vs 13 %), psychotropic drug use (20 % vs 26 %) and polypharmacy rate (10 % vs 11 %) were lower in PNAD patients, compared to primary-adherent patients. PNAD patients had larger average tumor size (1.8 cm vs 1.6 cm), more often overexpressing HER2NEU (10 % vs 3 %), more negative progesterone receptor (10 % vs 5 %). They also more often had lumpectomy (70 % vs 65 %), SLNB (70 % vs 58 %) and more frequent margin revisions (30 % vs 16 %). They more often received chemotherapy (30 % vs 0 %). At 30-day follow-up, 40 % of PNAD patients had not yet initiated AET. Conclusions: This study confirms the feasibility of combining real-time administrative data and patient-level clinical information to assess breast cancer quality care. PNAD in women with HR+BC was higher than expected. PNAD patients had less comorbidities and drug use, but more aggressive cancers and more often also had quality challenges with surgical care (margin revision). PNAD predictors can potentially be used to identify patients that may require additional support to optimize disease management.

Incidence of Long-term Opioid Use Among Opioid-Naive Patients With Hidradenitis Suppurativa in the United States

Risk of long-term opioid use among patients with hidradenitis suppurativa (HS), who experience pain that substantially impairs quality of life, is unknown to date. To compare overall and subgroup incidence of long-term opioid use in a population of opioid-naive patients with HS and control patients. This retrospective cohort study was based on a demographically heterogeneous population-based sample of more than 56 million unique patients from January 1, 2008, through December 10, 2018. Patients with HS (n = 22 277) and controls (n = 828 832) were identified using electronic health records data. Data were analyzed from December 13, 2018, through January 28, 2019. The primary outcome was incident long-term opioid use. Among the 22 277 patients with HS, mean (SD) age was 40.8 (14.6) years, 16 912 (75.9%) were women, and 13 190 (59.2%) were white. Crude 1-year incidence of long-term opioid use among opioid-naive patients with HS was 0.33% (74 of 22 277), compared with 0.14% (1168 of 828 832) among controls (P < .001). In adjusted analysis, patients with HS had 1.53 (95% CI, 1.20-1.95; P < .001) times the odds of new long-term opioid use compared with controls. Among patients with HS, advancing age (odds ratio [OR], 1.02 per 1-year increase; 95% CI, 1.00-1.03; P = .05), ever smoking (OR, 3.64; 95% CI, 2.06-6.41; P < .001), history of depression (OR, 1.97; 95% CI, 1.21-3.19; P = .006), and baseline Charlson comorbidity index score (OR, 1.15 per 1-point increase; 95% CI, 1.03-1.29; P = .01) were associated with higher odds of long-term opioid use. Among patients with HS and long-term opioid use, 4 of 74 (5.4%) were diagnosed with opioid use disorder during the study period. The most frequent schedule II opioid prescriptions included oxycodone hydrochloride (55 of 74 patients [74.3%]), hydrocodone bitartrate (44 [59.5%]), hydromorphone hydrochloride (16 [21.6%]), morphine sulfate (13 [17.6%]), and fentanyl citrate (6 [8.1%]). Tramadol hydrochloride (32 [43.2%]) represented the most frequent non-schedule II prescription. Disciplines prescribing the most opioids to patients with HS included primary care (398 [72.8%]), anesthesiology/pain management (48 [8.8%]), gastroenterology (25 [4.6%]), surgery (23 [4.2%]), and emergency medicine (10 [1.8%]). In this study, patients with HS were at higher risk for long-term opioid use. These results suggest that periodic assessment of pain and screening for long-term opioid use may be warranted, particularly among patients who are older, who smoke tobacco, or who have depression and other medical comorbidities.

Evaluation of Amiodarone Use for New-Onset Atrial Fibrillation in Critically Ill Patients With Septic Shock.

Objective: To describe the use of amiodarone in critically ill, septic shock patients experiencing new-onset atrial fibrillation (NOAF) during the acute resuscitative phase of septic shock. Methods: Single-center, retrospective review of adult medical or surgical intensive care unit (ICU) patients with septic shock and NOAF. All patients received amiodarone for NOAF during the acute resuscitative phase of septic shock. The cohort was analyzed via descriptive statistics. Associations between amiodarone exposure and clinical outcomes were analyzed via a Cox proportional-hazards model. An a priori defined sensitivity analysis of hospital survivors was also employed. Main Results: A total of 239 patients were included in the analysis. Patients had a median baseline Charlson Comorbidity Index of 4 (interquartile range [IQR]: 2-6) and were acutely ill with a median Acute Physiology and Chronic Health Evaluation II (APACHE II) score of 18 (IQR: 13-22) and an incidence of mechanical ventilation of 85%. In-hospital mortality was 56% with median ICU and hospital length of stay (LOS) of 9 and 15 days, respectively. Included patients received a median of 2760 (IQR: 1110-6415) mg of intravenous (IV) amiodarone during their ICU stay. Receipt of more than or equal to 2700 mg of amiodarone was identified as an independent factor associated with longer ICU LOS (hazard ratio [HR]: 1.30; 95% confidence interval [CI], 1.10-2.28). In a sensitivity analysis of hospital survivors (n = 105), receipt of more than or equal to 2700 mg of amiodarone remained independently associated with longer ICU LOS (HR: 1.64; 95% CI, 1.05-2.58). Conclusions: Exposure to more than or equal to 2700 mg of amiodarone in the setting of NOAF and septic shock is positively correlated with longer ICU LOS. Identifying opportunities to limit amiodarone exposure and address/resolve potential precipitating causes of NOAF in this clinical scenario may reduce the morbidity associated with septic shock.

Incidence of Clostridioides difficile infections among young and middle-aged adults: Veterans Health Administration.

Clostridioides difficile infection (CDI) remains a significant public health concern, resulting in excess morbidity, mortality, and costs. Additional insight into the burden of CDI in adults aged &lt;65 years is needed. A 6-year retrospective cohort study was conducted using data extracted from United States Veterans Health Administration electronic medical records. Patients aged 18-64 years on January 1, 2011, were followed until incident CDI, death, loss-to-follow-up, or December 31, 2016. CDI was identified by a diagnosis code accompanied by metronidazole, vancomycin, or fidaxomicin therapy, or positive laboratory test. The clinical setting of CDI onset was defined according to 2017 SHEA-IDSA guidelines. Of 1,073,900 patients, 10,534 had a CDI during follow-up. The overall incidence rate was 177 CDIs per 100,000 person years, rising steadily from 164 per 100,000 person years in 2011 to 189 per 100,000 person years in 2016. Those with a CDI were slightly older (55 vs 51 years) and sicker, with a higher baseline Charlson comorbidity index score (1.4 vs 0.5) than those without an infection. Nearly half (48%) of all incident CDIs were community associated, and this proportion rose from 41% in 2011 to 56% in 2016. The findings from this large retrospective study indicate that CDI incidence, driven primarily by increasing community-associated infection, is rising among young and middle-aged adult Veterans with high service-related disability. The increasing burden of community associated CDI in this vulnerable population warrants attention. Future studies quantifying the economic and societal burden of CDI will inform decisions surrounding prevention strategies.

PRO12 ECONOMIC BURDEN OF PROGRESSIVE SUPRANUCLEAR PALSY: HEALTH RESOURCE UTILIZATION IN THE UNITED STATES

Progressive supranuclear palsy (PSP) is a rare and progressive neurodegenerative tauopathy, exhibiting frequent falls. The objective was to characterize health resource utilization (HRU) for PSP patients in the U.S. utilizing claims data. A retrospective analysis was conducted using IBM® MarketScan® Commercial and Medicare Supplemental Databases (2012-2017). PSP patients were identified using ICD-9 code 333.0 and ICD-10 code G23.1. Index date was defined as the first observed diagnostic date for PSP. For inclusion, PSP patients required ≥12 months of continuous enrollment both pre- and post-index. For each PSP case, 3 controls were selected, matched on birth year, sex, geographical region, health plan, and pharmacy benefit eligibility. Comparisons were made between PSP and control groups on HRU (total, by service type), adjusted for baseline Charlson Comorbidity Index. 341 PSP patients were identified for inclusion in this analysis (mean age 73.3 years; 53.1% male). The mean total cost per PSP patient 12-month post-index was $35,261 (95% CI: $27,467-$43,055) compared with $15,062 for controls (95% CI: $12,883-$17,241) (p<0.0001). The largest cost driver was outpatient services (mean for PSP: $18,751, controls: $6,982; p=0.0003), due to more frequent outpatient visits among PSP patients (mean for PSP: 43.1, controls: 16.4; p<0.0001). Emergency room (ER) visits for PSP patients and their related costs were significantly higher (p<0.0001). Inpatient admissions (p<0.0001), inpatient length of stay (p=0.0109) and pharmacy prescriptions per patient (p<0.0001) were also significantly higher among PSP patients. This study provides further knowledge about HRU among PSP patients in the U.S. before availability of disease modifying therapies. The total costs for PSP patients were significantly higher compared to non-PSP patients with similar characteristics, largely driven by the higher number of hospitalizations, outpatient and ER visits, and prescriptions. Future studies should investigate both direct and indirect costs of PSP, including those incurred by caregivers.

Emerging treatment patterns and checkpoint inhibitor (CPI) use among newly diagnosed Merkel cell carcinoma (MCC) patients in the United States veteran population.

139 Background: MCC is a rare and aggressive skin cancer with annual incidence of 2,500 in the U.S. Checkpoint inhibitors (CPIs) demonstrated durable disease response historically not seen with chemotherapy among MCC patients in clinical trials. Avelumab, a PD-L1 antibody, became the first and only approved treatment for metastatic MCC by the U.S. FDA in March 2017. This study evaluated emerging treatment patterns among MCC patients using the US Veterans Health Administration (VHA) database. Methods: This retrospective study identified newly-diagnosed MCC patients who initiated ≥1 systemic therapy from Oct. 2013 to Jan. 2018 and had continuous enrollment from ≥6 months pre-initial MCC diagnosis date until ≥2 months post-index date with follow-up until the earliest of death, disenrollment, or study end. The index date was defined as the start date of first-line (1L) systemic therapy. A subsequent line of therapy (2L) was defined by the earliest of new therapy addition, regimen switch, or a new/existing regimen after a &gt;60-day gap from the prior cycle end. Duration of 1L therapy was evaluated among patients treated with CPIs, National Cancer Comprehensive Network (NCCN)-recommended chemotherapy (recCTs), and other chemotherapy (oCTs). The median duration of therapy was estimated using the Kaplan Meier method. Results: Of the 120 MCC patients (72% pre-2017) with 1L systemic therapy, 17%, 45%, and 38% were treated with CPIs, recCTs and oCTs, respectively. More than 75% were white men aged ≥65 years with mean baseline Charlson comorbidity index scores ≥5. Carboplatin-etoposide (56%) and cisplatin-etoposide (26%) were the most commonly-used recCTs. The median duration of 1L therapy in patients treated with CPI, recCTs and oCTs was 300, 91, and 21 days, respectively. 2L therapy was initiated in 33% of all 1L patients. Conclusions: Among 1L MCC patients, CPIs treated patients appear to be on treatment longer than both recCTs and oCTs patients. These descriptive findings provide important insights into the emerging real-world treatment patterns amongst MCC patients in the VHA population.

The impact of Charlson Comorbidity Index on survival outcomes in men with prostate cancer who underwent definitive prostate radiotherapy.

114 Background: Life expectancy is very essential in deciding treatment options in men with prostate cancer (PCa); however, the impact of comorbidities on outcomes is not well-established. We investigated the influence of Charlson Comorbidity Index (CCI) on survival endpoints in men with localized PCa who were treated with prostate radiotherapy (RT). Methods: Men with intermediate and high risk PCa who were treated with definitive RT between 1/2007 and 12/2012 were included. Groups were created according to their baseline CCI score at diagnosis into no, mild and severe comorbidity (CCI 0, 1 or 2+). The groups were then compared based on patients’ characteristics and prognostic factors. Kaplan-Meier curves and Uni/multivariate analyses (MVA) were used to examine the impact of CCI groups on overall (OS), disease specific (DSS), and biochemical relapse free (BRFS) survival. Results: 257 patients were identified after excluding low risk, metastatic cases and those with inadequate follow up. Median follow-up was 92 months (range: 2-135) and median age was 73 years (range: 48-85). 53% of the cases were black and 67% were of intermediate risk. Median RT dose was 76 Gy and 47% received androgen deprivation therapy. CCI groups 0, 1 and 2+ encompassed 76 (30%), 54 (21%) and 127 (49%) patients, respectively. Groups were generally well-balanced. 10 and 15 years OS was significantly different across CCI groups (76% &amp; 53%, 46% &amp; 31% and 55% &amp; 14%, for CCI-0, 1 and 2+ respectively; p &lt; 0.001). CCI-0 had better DSS than CCI-2+ ( p = 0.03) with no difference for CCI-0 vs 1 ( p = 0.1). BRFS was non-different among CCI groups ( p = 0.99). On MVA, increased CCI was deterministic for OS ( p &lt; 0.001) after adjusting for age, Gleason’s score and T-stage. For DSS, only age and T3 vs T1/2 were independently prognostic ( p &lt; 0.001); whereas CCI-1 vs 0 was only marginal ( p = 0.05). Conclusions: Higher CCI was a significant predictor of shorter OS in intermediate and high-risk PCa. Baseline comorbidities should be taken into consideration during patient counselling for treatment options and in designing prospective trials for men with localized prostate cancer.

Comparison of real-world treatment patterns, persistence, healthcare resource utilization (HRU) and costs between octreotide and lanreotide for the treatment of neuroendocrine tumors (NET).

105 Background: There has been limited research assessing differences between somatostatin analogues (SSAs) as treatments for NET. This study aims to assess treatment pattern, persistence, HRUs and costs among patients (pts) with NET receiving long-acting octreotide versus lanreotide. Methods: Retrospective claims data from Symphony Health Solutions were analyzed for NET pts who initiated octreotide or lanreotide (index date) between 01/2015–11/2017 for ≥ 90 days. Pts with continuous clinical activity (≥ 180 pre and ≥ 90 days post index date) and without prior non-surgical NET treatment were included. A 1:1 propensity score matched sample was used to compare the two SSA groups with respect to treatment persistence (time to treatment discontinuation [TTD] using Kaplan-Meier) and to all cause and NET related HRUs and costs (provider charges for medical services and insurance payments for prescription drugs) using rate ratio (RR) and mean cost difference (CD) with 95% confidence interval (CI). Results: Among 2,043 NET pts identified, a balanced matched cohort of octreotide and lanreotide pts (N = 543 each) was achieved. In both cohorts, mean age was 65 years and baseline Charlson Comorbidity Index was 5.7. Approximately 80% of matched pts initiated monotherapy; others used SSAs in combination with chemo-, targeted or liver-directed therapy as first line therapy. Median TTD was directionally longer but did not reach statistical significance among octreotide vs lanreotide (19.2 vs 17.5 months, p = 0.6). Numerically lower hospitalization rates were observed among octreotide pts (RR [CI]: all cause = 0.87 [0.73, 1.05]; NET related = 0.85 [0.63, 1.15]). Statistically significantly fewer NET related outpatient visits (1.05 vs 1.10 per pts per month [PPPM]; RR [CI]: 0.95 [0.92, 0.99]) and lower total mean costs PPPM were observed for octreotide than lanreotide (CD [CI]: all cause = -$3,701 [-$5,205, -$2,355]; NET related = -$3,752 [-$4,948, -$2,455]). Conclusions: This study shows similar treatment patterns and persistence between SSA cohorts. Octreotide appeared to be associated with less HRU and total costs compared with lanreotide.

Real World Treatment Patterns, Adverse Events and Healthcare Resource Utilization and Costs Among Chronic Lymphocytic Leukemia (CLL) Patients in the United States

Background: CLL is one of the most common types of leukemia among adults. Treatment options for CLL have expanded in recent years, but few studies provide contemporary real-world data on treatment patterns, treatment-related adverse events (AEs) and the economic burden associated with these agents. This study aimed to evaluate treatment-related AEs and the healthcare resource utilization (HCRU) and cost associated with the current treatment for chronic lymphocytic leukemia (CLL).Methods: This retrospective study used medical and pharmacy claims from the Optum Research Database, a large national US database, to identify adults (≥ 18 years old) commercially insured and Medicare Advantage (MA) enrollees. The study included patients with CLL (≥ 2 medical claims at least 7 days apart between July 1, 2012, through May 30, 2017), at least 1 claim for systemic CLL-directed therapy and continuous enrollment for 12 months prior to (baseline period) and ≥ 1 month after the first observed CLL-directed therapy (index date). Patients with systemic CLL-directed therapy during the baseline period or undergoing stem cell transplantation during the entire study period were excluded from analysis. Up to 3 line of therapy (LOT) periods were captured based on timing and receipt of systemic CLL-directed therapy. Cohorts based on the most common regimens received, regardless of LOT sequence, were created. Potential treatment-related AEs (prevalent and incident conditions) during regimen cohorts were identified by ICD-9 and ICD-10 diagnosis codes in position 1 or 2 on claims. All-cause and AE-related healthcare resource utilization and costs (per patient per month (PPPM)) were examined. All analyses were descriptive.Results: A total of 3292 patients with CLL met all study criteria; 65% were MA enrollees and 35% were commercially insured. Mean age (standard deviation, [SD]) was 71 years (SD 11) with a baseline Charlson comorbidity index score of 3.5 (SD 1.9). During the study period, 31% of patients had ≥ 2 LOTs and 10% had ≥ 3 LOTs. The most common regimens (excluding rituximab maintenance therapy) observed by LOT were; bendamustine + rituximab (23%) during LOT1, ibrutinib (22%) during LOT2 and ibrutinib (17%) during LOT3. Among the study patients, 4,509 LOT periods (LOT1-LOT3) were observed. Of these periods, 3177 accounted for the 5 most common treatment regimens observed: rituximab (excluding maintenance therapy) (30%); bendamustine + rituximab (28%); ibrutinib (20%); obinutuzumab ± chlorambucil (14%); and cyclophosphamide + fludarabine + rituximab (8%). The most common AEs associated with these treatment regimens are reported in the Table.Conclusions: The most common regimen during LOT1 was bendamustine + rituximab, and was ibrutinib during LOT2 and LOT3.This study provides evidence that occurrence of AEs among patients with CLL receiving systemic anti-cancer therapy in the real-world setting is substantial and associated with significant health care cost. The economic burden associated with increased AEs underscores the need for treatments with fewer AEs. DisclosuresKabadi:AstraZeneca: Employment. Le:Optum: Employment; Optum/United Health Group: Equity Ownership. Dacosta Byfield:Optum/United Health Group: Equity Ownership; Optum: Employment. Olufade:AstraZeneca: Employment; AstraZeneca: Equity Ownership.

Assessment of health care resource utilization (HRU) in patients with castration-resistant prostate cancer (CRPC).

89 Background: Although patients with CRPC frequently develop metastasis within 3 years following castration resistance, the impact of metastasis on HRU in these patients is not well understood. Methods: The Optum de-identified electronic health record database (1/1/2007 – 4/30/2016) was used in this single cohort observational study comparing HRU after metastasis with HRU before metastasis. The cohort included only non-metastatic CRPC (nmCRPC) patients who later developed metastasis. The pre-metastasis period spanned from nmCRPC identification to development of metastasis; the post-metastasis period spanned from metastasis until death or end of data availability. Per-patient per-month (PPPM) HRU was estimated during both pre- and post-metastasis periods by a generalized linear mixed model adjusted for log-transformed baseline PSA, age, testosterone levels, and Charlson Comorbidity Index. Results: With a mean time of 11 and 17 months of pre- and post-metastasis periods, respectively, 540 CRPC men were included, with a mean age at nmCRPC identification of 75 years. Higher HRU was seen across all service types during the post-metastasis period. There was a 2.5-fold increase in inpatient admissions and a 6.4-fold increase in inpatient length-of-stay in the post-metastasis period compared to the pre-metastasis period (p &lt; 0.01). For emergency department (ED) visits, there was a 2.0-fold increase from the pre- to post-metastasis periods (p &lt; 0.01). For observation unit visits, a 2.7-fold increase was seen in the post-metastasis period (p &lt; 0.01). Finally, patients were 40% more likely to have an office visit after developing metastasis (p &lt; 0.01). The PPPM use of intensive care unit, hospice or skilled nursing facility were too low for meaningful comparison between the pre- and post-metastasis periods. Conclusions: Shorter time to metastasis was observed in this cohort vs. other nmCRPC studies, likely due to delayed disease identification. CRPC patients incurred substantially higher HRU after developing metastasis, attributable to inpatient, ED, observation unit as well as office visits, suggesting that delaying metastasis may reduce or delay the increased HRU in patients with nmCRPC.