Objective: Data are scarce regarding the incidence of neuropsychiatric events (NPEs) in people living with human immunodeficiency virus (HIV)-1 taking integrase inhibitor (INI)- or protease inhibitor (PI)-based regimens. This study evaluated the prevalence, incidence, and economic burden of NPEs among people living with HIV-1 who were newly treated with INI- or PI-based regimens in a Medicaid population.Methods: A retrospective cohort study was conducted using administrative claims from the IBM MarketScan Multi-State Medicaid Database (January 1, 2014-December 31, 2018). Treatment-naive and treatment-experienced adults with HIV-1 newly treated with an INI- or PI-based regimen were included. Outcomes included NPE prevalence during the 12-month baseline period, prevalence of existing and incidence of new-onset NPEs during the 6-month post-index period, and total all-cause and NPE-related costs between treatment cohorts. Baseline characteristics between the 2 cohorts were balanced using inverse probability treatment weighting.Results: In the INI (n = 3,929) and PI (n = 3,916) cohorts, mean (SD) ages were 44.87 (12.81) and 44.36 (11.85) years, and 41.7% and 41.3% were female, respectively. High proportions of patients in both cohorts had NPEs during the 12-month baseline period. Among patients with no baseline NPEs, adjusted NPE incident rate ratios (95% CIs) during the post-index period were as follows: any, 1.15 (1.00-1.33); chronic, 1.18 (0.98-1.42); and acute, 1.16 (0.96-1.39). Mean all-cause and NPE-related costs were similar between cohorts.Conclusions: In this study of the Medicaid population, the prevalence and incidence of NPEs, as well as health care costs, were similar among people living with HIV-1 newly treated with an INI- or PI-based regimen.
e18003 Background: Through Anthem’s Cancer Care Quality Program (CCQP), oncologists can submit requests and accompanying clinical rationale for cancer treatments. Qualifying treatments within evidence-based pathways are eligible for enhanced reimbursement. The accuracy of clinical information within the CCQP is vital to the program’s overall effectiveness. This study evaluated the validity of the clinical information submitted to the CCQP compared with medical records of lung cancer patients obtained from treating providers. Methods: Data elements obtained relevant to this study include cancer type, stage, histology, and biomarkers (ie, ALK and EGFR mutation status). A sample of 200 lung cancer patients with CCQP requests for treatment within the HealthCore Integrated Research Environment (HIRE) – Oncology data were identified for medical record collection and review by a blinded board certified oncology pharmacist. Statistical measures of validity (agreement, positive & negative predictive value (PPV & NPV), sensitivity, and specificity) were used to compare clinical information between data sources. Results: Approximately 1300 patients with lung cancer were identified in the first year of the program (Jul 2014 – Jun 2015). Of the 200 records reviewed, 197 were confirmed to be lung cancer (PPV of 0.99) and 87% were identified as non-small cell lung cancer (NSCLC). All performance measures were ≥ 0.85, with the exception of the PPV for ALK status. Conclusions: Overall, the high agreement between the data entered for the CCQP and medical records support the validity of the clinical information for purposes of effective program implementation, administration, and research. Measures of validity (95% confidence intervals). Variable n* Agreement PPV NPV Sensitivity Specificity Stage (all) 194 0.90 (.86 - .94) - - - - Stage (NSCLC) 151 0.92 (.88 - .96) - - - - Histology 174 0.97 (.94 - .99) 0.92 (.81 - 1.00) 0.97 (.95 - 1.00) 0.85 (.71 - .98) 0.99 (.97 - 1.00) ALK mutation status 74 0.92 (.86 - .98) 0.54 (.27 - .81) 1.00 (1.0 - 1.0) 1.00 (1.0 - 1.0) 0.91 (.84 - .98) EGFR mutation status 69 0.97 (.93 - 1.00) 0.87 (.69 - 1.00) 1.00 (1.0 - 1.0) 1.00 (1.0 - 1.0) 0.96 (.92 - 1.00) *n includes the number of patients with observable data in both data sources
Background People with human immunodeficiency virus (HIV)-1 face challenges with treatment adherence for various reasons, including consideration of neuropsychiatric disorders and neuropsychiatric adverse reactions associated with antiretroviral therapy (ART). Methods A retrospective cohort study was conducted using administrative claims data from the IBM MarketScan ® Multi-State Medicaid Database (1/1/2014–12/31/2017). Adults (≥18 years) diagnosed with HIV-1 and newly initiated on antiretroviral therapy with continuous health plan enrollment were included. Primary outcome was the 6-month period prevalence of neuropsychiatric events (NPEs) of interest after ART initiation. Results Among 1971 newly treated patients included in the study, mean age (standard deviation [SD]) was 38.5 (12.7) years, and 41.4% were female. During the 6 months after ART initiation, 51.4% of patients had a claim for ≥1 NPE versus 30.3% of matched patients without HIV. Among newly treated patients, the most common (≥10%) NPE claims were for depression (42.2%), anxiety (15.8%), headache (11.9%), and bipolar/manic depression (10.1%). Also in this group, the mean (SD) total all-cause healthcare cost during the 6-month post-ART initiation was $16,632 ($33,928), of which $2914 ($18,233) was NPE-related. Conclusions In summary, in this Medicaid study of people newly initiated on ART, there was a high prevalence of NPEs, and incremental NPE-associated costs were considerable.
88 Background: Abiraterone acetate + prednisone and enzalutamide are approved oral targeted therapies (OTT) for metastatic castration-resistant prostate cancer (mCRPC) which have significant clinical benefit. However, their impact on healthcare cost relative to docetaxel (DOC) is not well understood. Methods: This retrospective cohort study used combined claims data from Truven MarketScan Commercial and Medicare Supplement Plan databases. Males ≥18 years with ≥1 prostate cancer diagnosis and a subsequent metastasis diagnosis were indexed on the first claim date of DOC or OTT between 1/1/2012 and 12/31/2016. ≥1 claim for an androgen deprivation therapy during the 12-month continuous enrollment period prior to metastasis was required; patients with end stage renal disease or other primary cancer were excluded. All-cause per patient per year (PPPY) costs were estimated in 2016 US dollars. A generalized linear model was used to compare adjusted costs between DOC and OTT cohorts. Results: A total of 1,159 and 200 mCRPC patients initiated on OTT and DOC, respectively. Mean follow up time for both cohorts was 1.2 years. Mean age of OTT patients was 75.1 (Standard Deviation = 10.7) years and mean Quan-Charlson Comorbidity Index (QCI) was 3.2 (1.9). Mean age of DOC patients was 65.9 (9.1) years; mean QCI was 2.9 (1.8). 21% of OTT and 56% of DOC patients were commercially insured. Following treatment initiation, total mean unadjusted all-cause PPPY costs were $144,350 ($80,606) and $137,814 ($84,405) for OTT and DOC cohort, respectively. The primary cost drivers were utilization of treatments indicated for mCRPC, outpatient encounters and inpatient hospitalizations. Total adjusted PPPY costs were higher for OTT than DOC patients ($141,008 vs. $125,318, p = 0.0012), mainly due to higher costs of treatments indicated for mCRPC ($80,443 vs. $55,820, p < .0001). Medical costs (excluding mCRPC treatment) for OTT initiated patients were lower ($54,570 vs. $64,614, p = 0.0128). Conclusions: In a real-world setting, initiation on OTT was associated with higher overall cost of care for mCRPC compared with DOC. However, the cost of medical services was significantly lower when initiated on OTT.
Chronic obstructive pulmonary disease (COPD) affects approximately 15 million people in the United States and accounts for approximately $36 billion in economic burden, primarily due to medical costs. To address the increasing clinical and economic burden, the Global Initiative for Chronic Obstructive Lung Disease emphasizes the use of therapies that help prevent COPD exacerbations, including inhaled corticosteroid/long-acting beta2-agonist (ICS/LABA).To evaluate health care costs and utilization among COPD patients newly initiating ICS/LABA combination therapy with budesonide/formoterol (BFC) or fluticasone/salmeterol (FSC) in a managed care system.COPD patients aged 40 years and older who initiated BFC (160/4.5 μg) or FSC (250/50 μg) treatment between March 1, 2009, and March 31, 2012, were identified using claims data from major U.S. health plans. BFC and FSC patients were propensity score matched (1:1) on age, sex, prior asthma diagnosis, prior COPD-related health care utilization, and respiratory medication use. COPD-related, pneumonia-related, and all-cause costs and utilization were analyzed during the 12-month follow-up period. Post-index costs were assessed with generalized linear models (GLMs) with gamma distribution. Health care utilization data were analyzed via logistic regression (any event vs. none) and GLMs with negative binomial distribution (number of visits) and were adjusted for the analogous pre-index variable as well as pre-index characteristics that remained imbalanced after matching.After matching, each cohort had 3,697 patients balanced on age (mean 64 years), sex (female 52% BFC and 54% FSC), asthma and other comorbid conditions, prior COPD-related health care utilization, and respiratory medication use. During the 12-month follow-up, COPD-related costs averaged $316 less for BFC versus FSC patients ($4,326 vs. $4,846; P = 0.003), reflecting lower inpatient ($966 vs. $1,202; P < 0.001), pharmacy ($1,482 vs. $1,609; P = 0.002), and outpatient/office ($1,378 vs. $1,436; P = 0.048) costs, but higher emergency department ($257 vs. $252; P = 0.033) costs. Pneumonia-related health care costs were also lower on average for BFC patients ($2,855 vs. $3,605; P < 0.001). Similarly, initiating BFC was associated with lower all-use health care costs versus initiating FSC ($21,580 vs. $24,483; P < 0.001, respectively). No differences in health care utilization were found between the 2 groups.In this study, although no difference was observed in rates of health care utilization, COPD patients initiating BFC treatment incurred lower average COPD-related, pneumonia-related, and all-cause costs versus FSC initiators, which was driven by cumulative differences in inpatient, outpatient, and pharmacy costs.
e18543 Background: Mesothelioma is a rare malignancy primarily attributed to asbestos exposure and has limited life expectancy. This study examined patient characteristics, and treatment patterns in commercially insured mesothelioma patients in real world setting. Methods: Patients aged ≥18 yrs with mesothelioma diagnosis were identified using ICD-9 and CPT codes/clinical algorithm between 7/1/2006 and 4/30/2011 from HealthCore Integrated Research Database. Patients with other cancers and without continuous insurance enrollment for ≤ 6-mos before or 12-mos post-diagnosis were excluded. Treatments were grouped into surgery, systemic chemotherapy (Ctx), and best supportive care (BSC) and were assessed descriptively. Results: A total of 184 patients were identified (mean age 64 yrs with 41% patients between 45 and 64 yrs old and 48% ≥65 yrs old, 64% males) with diagnosis of mesothelioma. 61% patients had pleural, 25% had peritoneal and 14% had pericardial disease. Only 10% patients received surgery, 27% received Ctx, while 50% received BSC (including radiation). Among patients who received 1 st line Ctx (mean duration 90 days), almost half of patients received pemetrexed based regimen {pemetrexed + cisplatin (18%) or carboplatin (10%) and pemetrexed alone (20%)} followed by carboplatin monotherapy (42%). Among 41% who received 2 nd line Ctx regimens (mean duration 105 days), most commonly used (65%) were pemetrexed based regimens {pemetrexed alone (35%) and pemetrexed + cisplatin (15%) or carboplatin (15%)} followed by single agent gemcitabine (15%). No patients received vinorelbine (0%). In patients who received Ctx, 35% died before receiving 2nd line Ctx and an additional 15% of patients died before receiving 3rd line Ctx. Only 16% received 3 rd line Ctx. Around 41% patients had at least one emergency room visit and 80% had at least one hospitalization. Conclusions: Mesothelioma is predominant in males and older adults in commercially insured patients in the United States. Systemic chemotherapy remains the main treatment strategy with pemetrexed based therapy being most commonly used regimen. This study highlights limited treatment options and high unmet need in this population.
PURPOSE Teclistamab is initiated with a step-up dosing (SUD) schedule to mitigate the risk of cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). Early teclistamab users commonly received SUD in a hospital setting. This study aimed to evaluate safety and health care resource utilization (HRU) in real-world patients with multiple myeloma who initiated teclistamab SUD in an outpatient setting. METHODS This was a retrospective study using Mayo Clinic's electronic medical records from October 26, 2022, to October 31, 2023. Patient characteristics were summarized for all patients treated with teclistamab and separately for patients who started SUD outpatient. SUD pattern, safety, HRU, and post-SUD dosing schedule were described in patients with complete SUD. RESULTS At data cutoff, 65 patients received ≥1 teclistamab dose, including 58 patients who initiated SUD outpatient (median age, 69.2 years; male, 63.8%; White, 89.7%). Among 57 patients who completed SUD in an outpatient setting, all received premedications on the days of teclistamab administrations per label recommendation; 18 (31.6%) developed CRS (13 grade 1, four grade 2, and one grade 4) and two developed ICANS (one each with grade 2 and 4). All CRS and ICANS resolved with supportive care and all patients continued treatment. Eighteen patients were admitted to the hospital for CRS treatment, with a median CRS-related hospital stay of 2 days per admission. Most (60%) doses during SUD required <1 hour clinic time between administration and checkout. Post-SUD, clinic time for treatment doses decreased to <30 minutes for most doses (82%). CONCLUSION Outcomes of this study support outpatient administration as a safe and feasible option for teclistamab SUD to potentially reduce HRU and improve patient experiences.
Topic: 14. Myeloma and other monoclonal gammopathies - Clinical Background: The emergence of B-cell maturation antigen (BCMA) targeted therapies in multiple myeloma (MM) has led to improvements in clinical outcomes in patients with heavily pretreated disease. Little is known about patients’ knowledge, decision-making process, and openness to these novel therapies that include chimeric antigen receptor (CAR) T-cell therapy and bispecific antibodies. Aims: This study aimed to gain insights into perspectives of patients with MM on BCMA-targeted therapies. By understanding patient preferences, values, knowledge gaps and willingness to try new therapies, healthcare providers can better support patients in making informed treatment decisions. Methods: This is a cross-sectional survey completed by patients with MM enrolled in HealthTree® Cure Hub, an online portal for patients with plasma cell dyscrasias to help navigate their disease. An 18-question survey was developed by the research team, then reviewed and adjusted by HealthTree’s Patient Advocacy Panel and a physician panel. Responses were analyzed descriptively and reported in aggregate. Results: From 10/28/2022 to 1/12/2023, 325 patients with MM participated in the survey (mean age: 66±8 years; 54% female; 90% White; years since diagnosis: 6.6±4.7; lines of therapy: 3.0±2.6). In general, 26% of patients were open to trying a new therapy right away and 43% were open but would like more information on safety and efficacy. BCMA-targeted therapies were well known with 92% of patients having heard about them. Among respondents for each question, 65% were likely or very likely to try a CAR T-cell therapy if offered and 74% were likely or very likely to try bispecific therapy; while 17% and 13%, respectively, needed more information to decide. The most requested domains of information were efficacy, side effects (SEs), eligibility, and administration process for both CAR T-Cell and bispecific therapies. “How soon can I receive it” was ranked higher for bispecific therapy while “where can I receive it” was ranked higher for CAR T-cell therapy, relatively. The top attributes of therapy profiles were prolonged life, improved quality of life, longer progression-free survival, and tolerable SEs. When two therapies with the same efficacy and duration of response were offered, 69% of patients would prefer the therapy with lower risk of severe SEs but requires continuous dosing with no treatment-free interval, as opposed to the therapy that is given once followed by a treatment-free interval but with a potentially higher risk of severe SEs (31%).To receive an effective therapy, the top acceptable trade-offs included frequent monitoring of SEs and initiating a new drug in a hospital setting, while patients were least willing to compromise on caregiver burden. Additionally, the most acceptable SEs were those that were asymptomatic but would need routine monitoring to prevent serious complications, and those that were cosmetic but non-life-threatening. Summary/Conclusion: This study found a high level of openness in patients with MM to try BCMA-targeted therapies if offered. Information on efficacy, safety, availability, and eligibility may assist patients on their decision-making. Patients were willing to accept certain trade-offs for a treatment that could be clinically beneficial. Incorporating patients’ goals, values, and preferences alongside clinical factors and other considerations may further optimize treatment decisions and improve patient outcomes. Keywords: B-cell maturation antigen, Multiple myeloma, Bispecific, CAR-T