Assessing Telemental Health Uptake and Associated Health Care Resource Implications among Mississippi Medicaid Enrollees with Major Depression.

Objective: Investigate the association between Telemental Health (TMH) uptake and sociodemographic characteristics, and how TMH uptake relates to health care resource utilization and Medicaid expenditures among Mississippi Medicaid enrollees with major depression. Methods: A retrospective cohort study was conducted (2019-2020), comparing those who utilized TMH and those who did not. Results: Among the 21,239 identified enrollees, 806 (3.79%) utilized TMH. The TMH cohort was more likely to be of older age, non-Hispanic White, comprehensive managed care organization enrollees, rural residents, and from areas with a higher area deprivation index, and have higher Charlson comorbidity index scores. The TMH cohort also exhibited higher mental health-related and all-cause outpatient and emergency department utilization, along with higher Medicaid expenditures. Conclusion: As the first study investigating telehealth utilization among Mississippi Medicaid enrollees, this study highlights sociodemographic disparities in telehealth adoption. Addressing barriers hindering telehealth adoption among vulnerable populations and ensuring the availability of quality data are vital for future research.

Telemental Health Services Usage and Association with Health Care Utilization and Expenditures Among Vulnerable Medicare Beneficiaries in 2019: A Comparative Study Using Propensity Score Matching.

Background: Telemental health (TMH) offers a promising approach to managing major depressive disorder (MDD). The objective of our work was to evaluate TMH usage among a vulnerable population of MDD Medicare beneficiaries and its association with health care utilization and expenditures. Methods: This cohort study analyzed 2019 Mississippi Medicare fee-for-service data for adult beneficiaries with MDD. Subjects were matched by the use of TMH following 1:1 propensity score matching. Comparisons between TMH and non-TMH cohorts were made on health care utilization and expenditure outcomes, adjusting for provider types postmatching. Results: Among 7,673 identified beneficiaries, 551 used TMH and 7,122 did not. Prematching, TMH cohort showed greater proportions of dual beneficiaries, rural residents, subjects with income below $40,000, those with disability entitlement, and higher Charlson comorbidity index scores, compared to the non-TMH cohort (all p < 0.001). Moreover, the TMH cohort had fewer outpatient visits, but more inpatient admissions, emergency department (ED) visits, and higher medical, pharmacy, and total expenditures (all p < 0.001). Postmatching, TMH was associated with a 25% reduction in outpatient visits (p < 0.001) and a 20% reduction in pharmacy expenditures (p = 0.01), with no significant effect on inpatient admissions, ED visits, medical expenditures, or total expenditures. Conclusions: These results underscore the potential of TMH in enhancing accessible health care services for vulnerable populations and affordable services for Medicare. Our results provide a robust baseline for future policy discussions concerning TMH. Future studies should consider identifying barriers to TMH use among vulnerable populations and ensuring equitable and high-quality patient care.

Feasibility of Remote Blood Pressure Monitoring for Detection and Management of Maternal Hypertension in a predominantly Black, Rural and Medicaid Population in Mississippi.

Background: Remote patient monitoring (RPM) has potential in hypertension management, but limited studies have focused on maternal hypertension, especially among vulnerable populations. The objective of this study was to integrate RPM into perinatal care for pregnant patients at elevated risk of hypertensive disorders to show feasibility, acceptability, and safety. Methods: A prospective pilot cohort study was conducted at the University of Mississippi Medical Center 2021-2023. Participants' blood pressure readings were remotely captured and monitored until 8-week postpartum, with timely assessment and intervention. Results: Out of 98 enrollees, 77 utilized RPM, and no maternal or neonatal deaths occurred within 60-day postpartum. High program satisfaction was reported at discharge. Conclusion: This study demonstrates the feasibility and acceptability of RPM for perinatal care in a vulnerable population. Positive outcomes were observed, including high patient satisfaction and no maternal or neonatal deaths. Further research should address patient engagement barriers and develop tailored protocols for improved clinical outcomes.

Economic evaluation and costs of remote patient monitoring for cardiovascular disease in the United States: a systematic review.

BACKGROUND: Remote patient monitoring (RPM) has emerged as a viable and valuable care delivery method to improve chronic disease management. In light of the high prevalence and substantial economic burden of cardiovascular disease (CVD), this systematic review examines the cost and cost-effectiveness of using RPM to manage CVD in the United States. METHODS: We systematically searched databases to identify potentially relevant research. Findings were synthesized for cost and cost-effectiveness by economic study type with consideration of study perspective, intervention, clinical outcome, and time horizon. The methodological quality was assessed using the Joanna Briggs Institute Checklist for Economic Evaluations. RESULTS: Thirteen articles with fourteen studies published between 2011 and 2021 were included in the final review. Studies from the provider perspective with a narrow scope of cost components identified higher costs and similar effectiveness for the RPM group relative to the usual care group. However, studies from payer and healthcare sector perspectives indicate better clinical effectiveness of RPM relative to usual care, with two cost-utility analysis studies suggesting that RPM relative to usual care is a cost-effective tool for CVD management even at the conservative $50,000 per Quality-Adjusted Life-Year threshold. Additionally, all model-based studies revealed that RPM is cost-effective in the long run. CONCLUSIONS: Full economic evaluations identified RPM as a potentially cost-effective tool, particularly for long-term CVD management. In addition to the current literature, rigorous economic analysis with a broader perspective is needed in evaluating the value and economic sustainability of RPM.

Framework for Evaluating and Developing Sustainable Telehealth Programs.

During the COVID-19 pandemic and public health emergency, telehealth programs vastly expanded with strong support from various federal and state agencies. However, the uncertainty regarding future reimbursement policies for telehealth services has resulted in concerns about long-term sustainability of innovative health service delivery models beyond the financial support. Given the limited literature on creating telehealth programs with long-term sustainability in consideration, we have developed a framework for gathering appropriate data during various stages of program implementation to evaluate clinical effectiveness and economic sustainability that is applicable across various settings, with additional attention to health equity. Recognizing the difficulty of sustaining telehealth programs solely through a fee-for-service payment model, we encourage all telehealth stakeholders, especially payers and policymakers, to consider cost-effectiveness of telehealth programs and support alternate payment models for ensuring long-term sustainability.

Thrombopoietin receptor agonist discontinuation rates and reasons among patients with immune thrombocytopenia: a study of administrative claims linked with medical chart review.

Administrative claims provide a rich data source for retrospective studies of real-world clinical practice, yet some important data may be inconsistent or unavailable. This study explored factors influencing discontinuation of thrombopoietin receptor agonists (TPO-RAs) among patients with immune thrombocytopenia (ITP), by adding medical chart abstraction for additional details. Adult (≥ 18 years) patients with continuous commercial or Medicare Advantage with Part D health insurance coverage were included. Inclusion criteria were ≥ 1 claim for eltrombopag or romiplostim and ≥ 2 diagnoses of ITP between December 31, 2017, and January 1, 2020. Providers were asked to provide access to medical charts for abstraction. The analyses included only patients who discontinued TPO-RA and described patient characteristics, treatment patterns, platelet values, and reasons for discontinuation. Among 207 ITP patients treated with a TPO-RA, 137 (66%) discontinued treatment during the observation period. The mean TPO-RA treatment duration was 185 days. Mean platelet count at the time of discontinuation was 197 × 109/L. The most common reason for discontinuation was improvement of the patient's condition (42%). Other reasons included worsening of ITP/lack of response (12%), adverse events (12%), and cost-related or social reasons (23%). No reason was reported for 10%. Notably 26% of patients who discontinued remained off all ITP therapy for the remainder of the study, with a mean treatment-free period of 262 days. These results emphasize that some patients with ITP are able to discontinue TPO-RA therapy and achieve durable treatment-free periods.

Eltrombopag treatment of patients with secondary immune thrombocytopenia: retrospective EHR analysis.

Immune thrombocytopenia (ITP) may occur in isolation (primary) or in association with a predisposing condition (secondary ITP [sITP]). Eltrombopag is a well-studied treatment for primary ITP, but evidence is scarce for sITP. We evaluated real-world use of eltrombopag for sITP using electronic health records. Eligible patients had diagnoses of ITP and a qualifying predisposing condition, and eltrombopag treatment. We described patient characteristics, treatment patterns, platelet counts, and thrombotic and bleeding events. We identified 242 eligible patients; the most common predisposing conditions were hepatitis C and systemic lupus erythematosus. Average duration of eltrombopag treatment was 6.1 months. Most (81.4%) patients achieved a platelet count ≥ 30,000/µL at a mean of 0.70 months, 70.2% reached ≥ 50,000/µL at a mean of 0.95 months, and 47.1% achieved a complete response of > 100,000/µL at a mean of 1.43 months after eltrombopag initiation. At eltrombopag discontinuation, 105 patients (43%) experienced a treatment-free period for a mean 3.3 months. Bleeding events occurred with similar frequency before and during eltrombopag treatment whereas thrombotic events were less frequent during eltrombopag treatment. Our results suggest similar rates of platelet response with eltrombopag in patients with sITP as compared with primary ITP. In addition, a treatment-free period is possible for a substantial minority of patients.

Adverse events and clinical outcomes in patients treated with PD-(L)1 blockade for advanced non-small-cell lung cancer.

Aims: To describe, in patients with advanced/metastatic non-small-cell lung cancer, the relationship between baseline immunosuppressive drug (ISD)/corticosteroid (CS) use, as well as the incidence of mild/moderate adverse events (AEs), and the clinical effectiveness of PD (L)-1 blockade. Patients & methods: This was a retrospective cohort study of patients with no evidence (n = 131) or positive evidence (n = 269) of ISD/CS use. Results: Duration of treatment, time to next treatment, progression-free survival and overall survival were significantly reduced for patients with evidence of prior ISD/CS use. Occurrence of mild/moderate AEs did not affect any clinical outcomes. Conclusion: Prior ISD/CS use was associated with a poorer prognosis in advanced/metastatic non-small-cell lung cancer patients treated with PD-(L)1 inhibitors, but the occurrence of AEs had no effect.

What is the article about? Patients with advanced/metastatic non-small-cell lung cancer (aNSCLC) are often treated with a class of drugs known as checkpoint inhibitors. There have been previous reports that treatment with corticosteroids and other drugs that suppress the immune system in the period leading up to treatment with checkpoint inhibitors may result in poorer outcomes, but most of these reports focus on serious adverse events leading to hospitalizations or emergency room visits that result from treatment. This study aimed to determine whether treatment with corticosteroids in these patients had any impact on the occurrence of mild or moderate adverse events and long-term treatment outcomes. What were the results? By looking back at deidentified medical insurance claims from patients with aNSCLC, we found that patients who were treated with corticosteroids or other immunosuppressive drugs (vs those who did not receive these drugs) in the months leading up to treatment with checkpoint inhibitors had poorer treatment outcomes (e.g., shorter overall survival). What do the results of the study mean? This study investigated the real-world outcomes in aNSCLC patients treated with checkpoint inhibitors and found that the use of corticosteroids or other immunosuppressive drugs may have an adverse effect. However, we are unable to rule out the possibility that there was an underlying difference between these two sets of patients that caused the difference in treatment outcomes. Further studies with larger sample sizes are needed.

The Impact of Adverse Events on Health Care Resource Utilization, Costs, and Mortality Among Patients Treated with Immune Checkpoint Inhibitors.

BACKGROUND: We investigated the association between adverse events (AEs) suspected to be immune-related and health care resource utilization, costs, and mortality among patients receiving programmed cell death 1/programmed cell death ligand 1 immune checkpoint inhibitor (ICI) monotherapy for urothelial carcinoma, renal cell carcinoma, non-small cell lung cancer, or Merkel cell carcinoma. PATIENTS AND METHODS: We conducted a retrospective cohort study using medical and pharmacy claims and enrollment information from U.S. commercial and Medicare Advantage with Part D enrollees in the Optum Research Database from March 1, 2014, through April 30, 2019. Claims were linked with mortality data from the Social Security Death Index and the National Death Index. Eligible patients had at least one ICI claim between September 1, 2014, and April 30, 2019. RESULTS: After adjusting for potential confounding variables, we found patients with AEs had more than double the risk of an inpatient stay (hazard ratio [HR], 2.2; 95% confidence interval [CI], 1.9-2.5) and an 80% higher risk of an emergency visit (HR, 1.8; 95% CI, 1.6-2.1) than patients without AEs. Adjusted 6-month total costs were $24,301 higher among patients with an AE versus those without ($99,037 vs. $74,736; 95% CI, $18,828-29,774; p < .001). Mean ± SD AE-related medical costs averaged $2,359 ± $7,496 per patient per month, driven by inpatient visits, which accounted for 89.9% of AE-related costs. Adjusted risk of mortality was similar in patients with and without AEs. CONCLUSION: Patients with AEs had higher risks of hospitalizations, emergency room visits, and higher health care costs, driven by inpatient stays, than patients without AEs. The adjusted risk of mortality was similar between the two cohorts. IMPLICATIONS FOR PRACTICE: Patients taking immune checkpoint inhibitors (ICIs) who had adverse events (AEs) had significantly higher health care costs and utilization, driven by inpatient stays, compared with patients who did not. Given this high cost associated with AEs and the differences in the side effect profile of ICIs versus traditional chemotherapy, it is important for physicians to be cognizant of these differences when treating patients with ICIs. Ongoing evaluation, earlier recognition, and more effective, multidisciplinary management of AEs may improve patient outcomes and reduce the need for costly inpatient stays.

Healthcare resource utilization and costs associated with acute graft-versus-host disease following allogeneic hematopoietic cell transplantation.

PURPOSE: The contribution of acute graft-versus-host disease (GVHD) to healthcare resource utilization (HCRU) and costs following allogeneic hematopoietic cell transplantation (HCT) has not been extensively investigated. The objective of this study was to estimate both inpatient and outpatient HCRU and costs associated with acute GVHD during the 100-day and 1-year periods after allogeneic HCT in the USA. METHODS: A retrospective analysis of administrative claims from the Optum® Research Database of patients aged ≥ 12 years who received HCT between 2010 and 2016 was conducted. Costs and HCRU among patients with acute GVHD and no GVHD were compared during the 100-day (acute GVHD, n = 723; no GVHD, n = 385) and 360-day (acute GVHD, n = 445; no GVHD, n = 227) periods after HCT. RESULTS: Patients with acute GVHD had significantly more (P < 0.001) mean office visits (47 vs 32), hospital outpatient visits (71 vs 35), and inpatient stays (2.8 vs 1.1) than patients with no GVHD during 360 days post-HCT; similar findings were observed over the 100-day period. Mean total all-cause costs were significantly higher (P < 0.001) for patients with acute GVHD versus no GVHD during both post-HCT periods (100-day, $316,458 vs $215,229; 360-day, $466,720 vs $263,568). Additional factors associated with increased 360-day costs included young age (12-17 years; P < 0.001) and peripheral blood as graft source (P = 0.03). CONCLUSION: Acute GVHD was associated with significant HCRU and costs in the first 100 days of transplant, increasing over the first year post-HCT. Inpatient care was the primary driver, but outpatient care and related costs were also increased.

The evaluation of comprehensive medication management for chronic diseases in primary care clinics, a Texas delivery system reform incentive payment program.

BACKGROUND: The Institute of Medicine reported that more than 1.5 million preventable adverse drug events occur annually in the United States. Comprehensive Medication Management (CMM) is the medication review process to improve clinical outcomes, enhance patient adherence, reduce drug therapy problems and reduce health care costs. University of Texas (UT) Physicians implemented a CMM program in several community-based clinics. We evaluated the effectiveness of CMM to reduce drug therapy problems and achieve medical cost savings. METHODS: This was a retrospective, observational study of CMM participants from October 2015 to September 2016. Program participants included patients aged 18 years or older who had taken more than 4 prescribed medications and were diagnosed with at least one of the following chronic diseases: hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma or diabetes. Under the CMM program, a clinical pharmacist reviewed patients' electronic health records and created action plans to resolve identified drug problems. As part of the evaluation of the clinical process, two independent physicians conducted peer review on the recommendations issued by the pharmacist in order to establish inter-rater reliability of drug therapy problems and potential consequent medical services. The drug therapy problems were identified and classified into four categories: indication, effectiveness, safety and/or compliance. The average cost of avoided medical services was obtained based on cost extrapolations from the literature, combined with hospital discharge data. Potential medical services avoided were linked to the average cost of those services to calculate the total cost savings of the program from the payers' perspective. RESULTS: By reviewing electronic health records of 3280 patients, the pharmacist identified 301 drug therapy problems and resolved 49.8% of these problems with collaboration from the patient's primary care physician or care team. The most commonly identified drug problems were related to potentially adverse drug reactions or inappropriate drug dosage. The CMM program resulted in potential cost savings of $1,143,015. CONCLUSIONS: The CMM program resolved medication therapy problems among program participants and achieved significant health care cost savings.

Racial differences in receipt of adjuvant hormonal therapy among Medicaid enrollees in South Carolina diagnosed with breast cancer.

Several factors contribute to the pervasive Black-White disparity in breast cancer mortality in the U.S., such as tumor biology, access to care, and treatments received including adjuvant hormonal therapy (AHT), which significantly improves survival for hormone receptor-positive breast cancers (HR+). We analyzed South Carolina Central Cancer Registry-Medicaid linked data to determine if, in an equal access health care system, racial differences in the receipt of AHT exist. We evaluated 494 study-eligible, Black (n = 255) and White women (n = 269) who were under 65 years old and diagnosed with stages I-III, HR+ breast cancers between 2004 and 2007. Bivariate and multivariate analyses were conducted to assess receipt of ≥1 AHT prescriptions at any point in time following (ever-use) or within 12 months of (early-use) breast cancer diagnosis. Seventy-two percent of the participants were ever-users (70 % Black, 74 % White) and 68 % were early-users (65 % Black, 71 % White) of AHT. Neither ever-use (adjusted OR (AOR) = 0.75, 95 % CI 0.48-1.17) nor early-use (AOR = 0.70, 95 % CI 0.46-1.06) of AHT differed by race. However, receipt of other breast cancer-specific treatments was independently associated with ever-use and early-use of AHT [ever-use: receipt of surgery (AOR = 2.15, 95 % CI 1.35-3.44); chemotherapy (AOR = 1.97, 95 % CI 1.22-3.20); radiation (AOR = 2.33, 95 % CI 1.50-3.63); early-use: receipt of surgery (AOR = 2.03, 95 % CI 1.30-3.17); chemotherapy (AOR = 1.90, 95 % CI 1.20-3.03); radiation (AOR = 1.73, 95 % CI 1.14-2.63)]. No racial variations in use of AHT among women with HR+ breast cancers insured by Medicaid in South Carolina were identified, but overall rates of AHT use by these women is low. Strategies to improve overall use of AHT should include targeting breast cancer patients who do not receive adjuvant chemotherapy and/or radiation.

Impact of Point-of-Care Implementation in Pharmacist-Run Anticoagulation Clinics Within a Community-Owned Health System: A Two-Year Retrospective Analysis.

BACKGROUND: Point-of-care (POC) testing devices allow laboratory monitoring to be performed in various settings and accessed immediately. OBJECTIVE: To evaluate the outcomes of monitoring anticoagulation patients in pharmacistmanaged, multicenter clinics utilizing i-STAT POC machines. METHODS: This study was a retrospective, multicenter chart review of 150 patients before and after implementation of the POC intervention for anticoagulation monitoring. Data collected included international normalized ratio (INR) results, indication for warfarin, minor and major bleeds, thromboembolic events, emergency room (ER) visits, and hospitalizations before and after i-STAT POC implementation. RESULTS: The time in therapeutic INR range (TTR) was significantly higher after i-STAT POC implementation than before implementation (60.4% ± 21.2% and 52.5% ± 21.5%, respectively; P = .0001). There were no reports of major bleeding during the study period. Twenty-three minor bleeds were reported after i-STAT POC implementation compared to 19 events before implementation (P < .0001). One thromboembolic event was reported after i-STAT POC implementation. There was a significant difference in the number of hospitalizations before i-STAT POC implementation as opposed to after implementation (2 and 0, respectively; P < .0001). There was also a significant increase in ER visits after i-STAT POC implementation (P < .0001). CONCLUSION: The results of the study indicate improvement in TTR in pharmacist-managed anticoagulation clinics by 7.8%. Although the use of the i-STAT POC machine detected an increase in minor bleeds, thromboembolic events, and ER visits, there was a decrease in hospitalization. The outcomes of this multicenter study indicate that implementation on this scale provides improvement in regard to safety and cost.

Cost minimization analysis of two treatment regimens for low-risk rhabdomyosarcoma in children: a report from the Children's Oncology Group.

BACKGROUND: Recent Children's Oncology Group trials for low-risk rhabdomyosarcoma attempted to reduce therapy while maintaining excellent outcomes. D9602 delivered 45 weeks of outpatient vincristine and dactinomycin (VA) for patients in Subgroup A. ARST0331 reduced the duration of therapy to 22 weeks but added four doses of cyclophosphamide to VA for patients in Subset 1. Failure-free survival was similar. We undertook a cost minimization comparison to help guide future decision-making. PROCEDURE: Addressing the costs of treatment from the healthcare perspective we modeled a simple decision-analytic model from aggregate clinical trial data. Medical care inputs and probabilities were estimated from trial reports and focused chart review. Costs of radiation, surgery and off-therapy surveillance were excluded. Unit costs were obtained from literature and national reimbursement and inpatient utilization databases and converted to 2012 US dollars. Model uncertainty was assessed with first-order sensitivity analysis. RESULTS: Direct medical costs were $46,393 for D9602 and $43,261 for ARST0331 respectively, making ARST0331 the less costly strategy. Dactinomycin contributed the most to D9602 total costs but varied with age (42-69%). Chemotherapy administration costs accounted for the largest proportion of ARST0331 total costs (39-57%). ARST0331 incurred fewer costs than D9602 under most alternative distributive models and alternative clinical practice assumptions. CONCLUSIONS: Cost analysis suggests that ARST0331 may incur fewer costs than D9602 from the healthcare system's perspective. Attention to the services driving the costs provides directions for future efficiency improvements. Future studies should prospectively consider the patient and family's perspective.

Telehealth Evaluation in the United States: Protocol for a Scoping Review.

BACKGROUND: The rapid expansion of telehealth services, driven by the COVID-19 pandemic, necessitates systematic evaluation to guarantee the quality, effectiveness, and cost-effectiveness of telehealth services and programs in the United States. While numerous evaluation frameworks have emerged, crafted by various stakeholders, their comprehensiveness is limited, and the overall state of telehealth evaluation remains unclear. OBJECTIVE: The overarching goal of this scoping review is to create a comprehensive overview of telehealth evaluation, incorporating perspectives from multiple stakeholder categories. Specifically, we aim to (1) map the existing landscape of telehealth evaluation, (2) identify key concepts for evaluation, (3) synthesize existing evaluation frameworks, and (4) identify measurements and assessments considered in the United States. METHODS: We will conduct this scoping review in accordance with the Joanna Briggs Institute (JBI) methodology for scoping reviews and in line with the PRISMA-ScR (Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews). This scoping review will consider documents, including reviews, reports, and white papers, published since January 1, 2019. It will focus on evaluation frameworks and associated measurements of telehealth services and programs in the US health care system, developed by telehealth stakeholders, professional organizations, and authoritative sources, excluding those developed by individual researchers, to collect data that reflect the collective expertise and consensus of experts within the respective professional group. RESULTS: The data extracted from selected documents will be synthesized using tools such as tables and figures. Visual aids like Venn diagrams will be used to illustrate the relationships between the evaluation frameworks from various sources. A narrative summary will be crafted to further describe how the results align with the review objectives, facilitating a comprehensive overview of the findings. This scoping review is expected to conclude by August 2024. CONCLUSIONS: By addressing critical gaps in telehealth evaluation, this scoping review protocol lays the foundation for a comprehensive and multistakeholder assessment of telehealth services and programs. Its findings will inform policy makers, health care providers, researchers, and other stakeholders in advancing the quality, effectiveness, and cost-effectiveness of telehealth in the US health care system. TRIAL REGISTRATION: OSF Registries osf.io/aytus; https://osf.io/aytus. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/55209.

Impact of interventions on medication adherence and blood pressure control in patients with essential hypertension: a systematic review by the ISPOR medication adherence and persistence special interest group.

OBJECTIVES: To systematically review the evidence on the impact of interventions to improve medication adherence in adults prescribed antihypertensive medications. METHODS: An electronic search was undertaken of articles published between 1979 and 2009, without language restriction, that focused on interventions to improve antihypertensive medication adherence among patients (≥18 years) with essential hypertension. Studies must have measured adherence as an outcome of the intervention. We followed standard guidelines for the conduct and reporting of the review and conducted a narrative synthesis of reported data. RESULTS: Ninety-seven articles were identified for inclusion; 35 (35 of 97, 36.1%) examined interventions to directly improve medication adherence, and the majority (58 of 97, 59.8%) were randomized controlled trials. Thirty-four (34 of 97, 35.1%) studies reported a statistically significant improvement in medication adherence. DISCUSSION/CONCLUSIONS: Interventions aimed at improving patients' knowledge of medications possess the greatest potential clinical value in improving adherence with antihypertensive therapy. However, we identified several limitations of these studies, and advise future researchers to focus on using validated adherence measures, well-designed randomized controlled trials with relevant adherence and clinical outcomes, and guidelines on the appropriate design and analysis of adherence research.

Risk of chemotherapy-induced febrile neutropenia in intermediate-risk regimens: Clinical and economic outcomes of granulocyte colony-stimulating factor prophylaxis.

BACKGROUND: Chemotherapy-induced neutropenia increases the risk of febrile neutropenia (FN) and infection with resultant hospitalizations, with substantial health care resource utilization (HCRU) and costs. Granulocyte-colony stimulating factor (GCSF) is recommended as primary prophylaxis for chemotherapy regimens having more than a 20% risk of FN. Yet, for intermediate-risk (10%-20%) regimens, it should be considered only for patients with 1 or more clinical risk factors (RFs) for FN. It is unclear whether FN prophylaxis for intermediate-risk patients is being optimally implemented. OBJECTIVE: To examine RFs, prophylaxis use, HCRU, and costs associated with incident FN during chemotherapy. METHODS: This retrospective study used administrative claims data for commercial and Medicare Advantage enrollees with nonmyeloid cancer treated with intermediate-risk chemotherapy regimens during January 1, 2009, to March 31, 2020. Clinical RFs, GCSF prophylaxis, incident FN, HCRU, and costs were analyzed descriptively by receipt of primary GCSF, secondary GCSF, or no GCSF prophylaxis. Multivariable Cox regression analysis was used to examine the association between number of RFs and cumulative FN risk. RESULTS: The sample comprised 13,937 patients (mean age 67 years, 55% female). Patients had a mean of 2.3 RFs, the most common being recent surgery, were aged 65 years or greater, and had baseline liver or renal dysfunction; 98% had 1 or more RFs. However, only 35% of patients received primary prophylaxis; 12% received secondary prophylaxis. The hazard ratio of incident FN was higher with increasing number of RFs during the first line of therapy, yet more than 54% of patients received no prophylaxis, regardless of RFs. Use of GCSF prophylaxis varied more by chemotherapeutic regimen than by number of RFs. Among patients treated with rituximab, cyclophosphamide, hydroxydaunorubicin hydrochloride (doxorubicin hydrochloride), vincristine, and prednisone, 76% received primary prophylaxis, whereas only 22% of patients treated with carboplatin/paclitaxel received primary prophylaxis. Among patients with a first line of therapy FN event, 78% had an inpatient stay and 42% had an emergency visit. During cycle 1, mean FN-related coordination of benefits-adjusted medical costs per patient per month ($13,886 for patients with primary prophylaxis and $18,233 for those with none) were driven by inpatient hospitalizations, at 91% and 97%, respectively. CONCLUSIONS: Incident FN occurred more often with increasing numbers of RFs, but GCSF prophylaxis use did not rise correspondingly. Variation in prophylaxis use was greater based on regimen than RF number. Lower health care costs were observed among patients with primary prophylaxis use. Improved individual risk identification for intermediate-risk regimens and appropriate prophylaxis may decrease FN events toward the goal of better clinical and health care cost outcomes. DISCLOSURES: This work was funded by Sandoz Inc., which participated in the design of the study, interpretation of the data, writing and revision of the manuscript, and the decision to submit the manuscript for publication. The study was performed by Optum under contract with Sandoz Inc. The author(s) meet criteria for authorship as recommended by the International Committee of Medical Journal Editors. The authors received no direct compensation related to the development of the manuscript. Dr Li is an employee of Sandoz Inc. Drs Bell and Lal and Mr Peterson-Brandt were employees of Optum at the time of the study. Ms Anderson and Dr Aslam are employees of Optum. Dr Lyman has been primary investigator on a research grant from Amgen to their institution and has consulted for Sandoz, G1 Therapeutics, Partners Healthcare, BeyondSpring, ER Squibb, Merck, Jazz Pharm, Kallyope, Teva; Fresenius Kabi, Seattle Genetics, and Samsung.

Patient profiles, treatment patterns, and outcomes among persistent, recurrent, or metastatic cervical cancer patients under routine care in the United States.

OBJECTIVE: Patients with persistent, recurrent, or metastatic cervical cancer have poor prognosis. While recent advances have expanded treatment options, real-world data on treatment patterns and outcomes in this population are lacking. METHODS: This retrospective study identified adult females with persistent, recurrent, or metastatic cervical cancer from the ConcertAI Oncology Dataset who received systemic therapy on or after August 15, 2014. Patients were followed from persistent, recurrent, or metastatic diagnosis through third-line (3 L) therapy, death, end of record, or study end (June 2021). Data collection included patient characteristics, treatment patterns, and clinical outcomes. Kaplan-Meier methods were used for the three most common first-line (1 L) regimens to analyze real-world time on treatment (rwToT), real-world progression-free survival (rwPFS), and real-world overall survival (rwOS). Analyses were stratified by bevacizumab receipt by treatment line. RESULTS: 307 patients were included (mean [standard deviation] age 51.5 [13.2] years, 70.7% White). 91.2% of patients had metastatic disease, 8.5% had persistent disease, and <1% had recurrent disease. The most common 1 L regimen was carboplatin+paclitaxel+bevacizumab (40.7%) with median (95% confidence interval [CI]) rwToT of 3.5 (2.9-4.4) months. 57.0% of patients proceeded to second line (2 L), and 25.7% went to 3 L. Median (95% CI) rwPFS was 7.2 (6.4-8.1) months, and median (95% CI) rwOS was 16.5 (14.2-19.9) months, from initiation of 1 L. CONCLUSIONS: 1 L regimens received in patients with persistent, recurrent, or metastatic cervical cancer generally followed clinical guidelines, and the rwOS agrees with clinical trials. This study highlights the burden of disease and unmet need for specific treatments in these patients.

Real-world outcomes among patients with metastatic colorectal cancer treated first line with a bevacizumab biosimilar (bevacizumab-awwb).

Background: Bevacizumab-awwb (MVASI®) was the first U.S. Food and Drug Administration-approved biosimilar to Avastin® (reference product [RP]) for the treatment of several different types of cancers, including metastatic colorectal cancer (mCRC), an indication approved based on extrapolation. Objectives: Evaluate treatment outcomes in mCRC patients who received first-line (1L) bevacizumab-awwb at treatment initiation or as continuing bevacizumab therapy (switched from RP). Design: A retrospective chart review study. Methods: Adult patients who had a confirmed diagnosis of mCRC (initial presentation of CRC on or after 01 January 2018) and initiated 1L bevacizumab-awwb between 19 July 2019 and 30 April 2020 were identified from the ConcertAI Oncology Dataset. A chart review was conducted to evaluate patient baseline clinical characteristics and effectiveness and tolerability outcomes during the follow-up. Study measures were reported stratified by prior use of RP: (1) naïve patients and (2) switchers (patients who switched to bevacizumab-awwb from RP without advancing the line of therapy). Results: At the end of study period, naïve patients (n = 129) had a median 1L progression-free survival (PFS) of 8.6 months [95% confidence interval (CI), 7.6-9.9] and a 12-month overall survival (OS) probability of 71.4% (95% CI, 61.0-79.5%). Switchers (n = 105) had a median 1L PFS of 14.1 months (95% CI, 12.1-15.8) and a 12-month OS probability of 87.6% (95% CI, 79.1-92.8%). During treatment with bevacizumab-awwb, 20 events of interest (EOIs) were reported in 18 naïve patients (14.0%) and 4 EOIs reported in 4 switchers (3.8%), of which the most commonly reported events were thromboembolic and hemorrhagic events. Most EOIs resulted in emergency department visit and/or treatment hold/discontinuation/switch. None of the EOIs resulted in death. Conclusion: In this real-world cohort of mCRC patients who were treated 1L with a bevacizumab biosimilar (bevacizumab-awwb), the clinical effectiveness and tolerability data were as expected and consistent with previously published findings from real-world studies of bevacizumab RP in mCRC patients.

Evaluation of drug interactions in patients treated with antidepressants at a tertiary care cancer center.

OBJECTIVE: We evaluated potential drug interactions in patients treated with antidepressants at a tertiary care cancer center to determine if it affects resource utilization. METHODS: We identified a cohort of patients with continuous care at the study institution by tagging patients who received at least three prescriptions for antidepressants within a continuous 6-month period. Data collected included demographics, cancer type and comorbidities, resource utilization (hospital and emergency room visits), and potential major drug interactions. Descriptive statistics and logistic regression were utilized in the analysis. RESULTS: The study population, which included 297 patients, was 70% female and 71% Caucasian; the mean age was 53 years (SD, 12 years), with a mean follow-up period (duration of therapy) of 403 days. Overall, 145 (49%) of the patients had a drug combination that could result in a potential major drug interaction with antidepressants. There were 118 (40%) patients with a potential major drug interaction that could lead to serotonin syndrome symptoms and 59 (20%) patients with a potential major drug interaction with anticoagulants. Potential major drug interactions were associated with an increased number of hospital and ER visits (odds ratio [OR], 2.37; 95% confidence interval [CI], 1.39-4.03). This finding was consistent for the two subanalysis groups as well, serotonin syndrome-inducing drugs (OR, 2.28; 95% CI, 1.33-3.92) and anticoagulants (OR, 3.66; 95% CI, 1.85-7.22). CONCLUSION: Potential drug interactions are frequent in patients receiving antidepressants in a tertiary care cancer center and are associated with an increase in resource utilization.