Real-World Outcomes of Trilaciclib Among Patients with Extensive-Stage Small Cell Lung Cancer Receiving Chemotherapy.

INTRODUCTION: Trilaciclib was recently approved in the USA for reducing chemotherapy-induced myelosuppression (CIM) among adults with extensive-stage small cell lung cancer (ES-SCLC) when administered prior to chemotherapy. There is limited understanding of real-world outcomes of trilaciclib. METHODS: A comprehensive literature review was conducted using a keyword search in the MEDLINE, Embase, and conference abstracts. Additional studies were identified through communications with the authors of relevant studies. Published and unpublished real-world studies of trilaciclib- and comparable non-trilaciclib-treated patients with ES-SCLC were included. Evidence on myelosuppressive hematologic adverse events (HAEs), cytopenia-related healthcare utilization, and other reported outcomes (e.g., hospitalizations, dose reduction, and treatment delay) were synthesized. If feasible, outcomes were compared qualitatively between the trilaciclib and historical reference groups, and between first-line trilaciclib initiators and the overall trilaciclib population. Weighted averages were estimated for selected outcomes using sample size as the weight. RESULTS: The literature search identified five unique studies based on eight records-two included trilaciclib only, two non-trilaciclib only, and one both. In trilaciclib cohorts, the weighted average prevalence of grade ≥ 3 myelosuppressive HAEs in ≥ 1 lineage, ≥ 2 lineages, and all three lineages was 40.5%, 14.5%, and 7.5%, respectively. All rates were numerically lower compared to the historical non-trilaciclib cohorts (58.8%, 28.0%, 13.0% respectively). Cytopenia-related healthcare utilization was also lower in the trilaciclib cohorts. In general, first-line trilaciclib initiators had numerically lower myelosuppressive HAEs and cytopenia-related healthcare utilization than the overall trilaciclib patients. CONCLUSIONS: The existing evidence suggests that trilaciclib may reduce single and multilineage grade ≥ 3 myelosuppressive HAEs and cytopenia-related healthcare utilization among patients with ES-SCLC in the real world. It is a promising new treatment for CIM prevention in ES-SCLC and may bring greater benefits to first-line trilaciclib initiators. Future studies are recommended to further evaluate the real-world effectiveness of trilaciclib.

Burden of chemotherapy-induced myelosuppression among patients with ES-SCLC in US community oncology settings.

Aim: To describe the burden of chemotherapy-induced myelosuppression among chemotherapy-treated patients with extensive-stage small-cell lung cancer (ES-SCLC). Materials & methods: Occurrence of grade ≥3 myelosuppressive hematological adverse events (HAEs), treatment patterns and healthcare resource utilization (HCRU) after chemotherapy initiation were evaluated using data from The US Oncology Network and Non-network clinics (1/1/2015-12/31/2020). Results: Among patients with laboratory values (Network: N = 1,374/1,574; Non-network: N = 661/959), over half-experienced grade ≥3 HAEs after chemotherapy initiation (Network = 56.6%; Non-network = 64.1%), and approximately one-third had grade ≥3 HAEs in at least two lineages (Network = 33.0%; Non-network = 31.3%). Patients with grade ≥3 HAEs had greater dose reductions, treatment delays and HCRU than those without. Conclusion: Myelosuppression is a burden to patients with ES-SCLC treated with chemotherapy and the healthcare system.

Our objective was to describe the burden of myelosuppression, a side effect of chemotherapy that results from damage to blood-forming cells in the bone marrow, among patients with extensive-stage small-cell lung cancer (ES-SCLC). We evaluated the prevalence of myelosuppression, chemotherapy treatment patterns and outpatient healthcare use and costs after chemotherapy initiation using data from The US Oncology Network and Non-network clinics between 1 January 2015 and 31 December 2020. Among patients with laboratory values, which were required to identify myelosuppression events, over half of patients experienced severe myelosuppression-related adverse events in one or more lineages after chemotherapy initiation, and approximately one-third experienced severe myelosuppression-related adverse events in at least two blood cell lineages. Patients with severe myelosuppression-related adverse events had greater dose reductions, treatment delays, and healthcare use and costs than those without. Myelosuppression is a burden to patients with ES-SCLC treated with chemotherapy and the healthcare system. Reduction of chemotherapy-induced myelosuppression has the potential to reduce burden on patients and healthcare organizations.

Cost-effectiveness of Check It: A Novel Community-Based Chlamydia Screening and Expedited Treatment Program for Young Black Men.

BACKGROUND: We assessed the cost-effectiveness of the Check It program, a novel community-based chlamydia screening and expedited partner treatment program for young Black men conducted in New Orleans since 2017. METHODS: We implemented a probabilistic cost-effectiveness model using a synthetic cohort of 16 181 men and 13 419 women intended to simulate the size of the Black, sexually active population in New Orleans ages 15-24 years. RESULTS: The Check It program cost $196 838 (95% confidence interval [CI]: $117 320-$287 555) to implement, saved 10.2 quality-adjusted life-years (QALYs; 95% CI: 7.7-12.7 QALYs), and saved $140 950 (95% CI: -$197 018 to -$105 620) in medical costs per year. The program cost $5468 (95% CI: cost saving, $16 717) per QALY gained. All iterations of the probabilistic model returned cost-effectiveness ratios less than $50 000 per QALY gained. CONCLUSIONS: The Check It program (a bundled seek, test, and treat chlamydia prevention program for young Black men) is cost-effective under base case assumptions. Communities where Chlamydia trachomatis rates have not declined could consider implementing a similar program.

Effects of medicaid expansion on poverty disparities in health insurance coverage.

BACKGROUND: More than 30 states have either expanded Medicaid or are actively considering expansion. The coverage gains from this policy are well documented, however, the impacts of its increasing coverage on poverty disparity are unclear at the national level. METHOD: American Community Survey (2012-2018) was used to examine the effects of Medicaid expansion on poverty disparity in insurance coverage for nonelderly adults in the United States. Differences-in-differences-in-differences design was used to analyze trends in uninsured rates by poverty levels: (1) < 138 %, (2) 138-400 % and (3) > 400 % federal poverty level (FPL). RESULTS: Compared with uninsured rates in 2012, uninsured rates in 2018 decreased by 10.75 %, 6.42 %, and 1.11 % for < 138 %, 138-400 %, and > 400 % FPL, respectively. From 2012 to 2018, > 400 % FPL group continuously had the lowest uninsured rate and < 138 % FPL group had the highest uninsured rate. Compared with ≥ 138 % FPL groups, there was a 2.54 % reduction in uninsured risk after Medicaid expansion among < 138 % FPL group in Medicaid expansion states versus control states. After eliminating the impact of the ACA market exchange premium subsidy, 3.18 % decrease was estimated. CONCLUSION: Poverty disparity in uninsured rates improved with Medicaid expansion. However, < 138 % FPL population are still at a higher risk for being uninsured.

Real-world Clinical Effectiveness of Lenvatinib/Everolimus in a Heavily Pretreated Advanced/Metastatic Renal Cell Carcinoma Population in the US Community Oncology Setting.

INTRODUCTION: Few studies have evaluated real-world effectiveness of lenvatinib (Len)/everolimus (Eve) for advanced/metastatic renal cell carcinoma (a/mRCC). This study evaluated patient profiles and clinical outcomes of second- and subsequent-line (≥ 2L) Len/Eve for a/mRCC. PATIENTS AND METHODS: A longitudinal retrospective study examined adult patients initiating ≥ 2L Len/Eve for a/mRCC from May 13, 2016, to July 31, 2019. Len/Eve clinical trial participants or those treated for other primary tumors were excluded. Outcomes included objective response rate, duration of response, progression-free survival (PFS), time to treatment discontinuation, and overall survival. Time-to-event outcomes were estimated using Kaplan-Meier methods. RESULTS: Seventy-nine patients were assessed: the median age was 64.8 years, 78.5% were Caucasian, 73.4% were male, 78.5% had an Eastern Cooperative Oncology Group performance status score of 0/1, 29.1% received 2L/3L Len/Eve, and the median number of prior lines of therapy was 3 (range, 1-8). At initial diagnosis, 55.7% had stage IV disease, 65.8% had International Metastatic risk scores of intermediate/poor, 19.0% favorable, and 15.2% with missing score. Thirty-one (39.2%) patients received immuno-oncology-based regimens, and 50.6% received tyrosine kinase inhibitors directly before Len/Eve initiation. The median time to treatment discontinuation was 5.7 months (95% CI, 3.3-6.9). The physician-assessed objective response rate was 55.7% (1.6% complete response and 54.1% with some degree of tumor shrinkage). The median duration of response was 9.7 months (95% CI, 5.8-17.1). The median PFS was 6.1 months (95% CI, 4.4-9.0). The median PFS for patients receiving Len/Eve post-immuno-oncology was 6.4 months (95% CI, 4.1-10.8) and for post-tyrosine kinase inhibitor 5.7 months (95% CI, 4.1-10.5). Median overall survival was 14.8 months (95% CI, 10.2-23.9). CONCLUSION: In this longitudinal retrospective study, Len/Eve showed real-world effectiveness in clinical practice in a heavily pretreated a/mRCC patient population.

Treatment preference among patients with spinal muscular atrophy (SMA): a discrete choice experiment.

OBJECTIVE: To examine patient/caregiver preference for key attributes of treatments for spinal muscular atrophy (SMA). BACKGROUND: In the rapidly evolving SMA treatment landscape, it is critically important to understand how attributes of potential treatments may impact patient/caregiver choices. DESIGN/METHODS: A discrete choice experiment survey was developed based on qualitative interviews. Patients with SMA (≥ 18 years) and caregivers of patients were recruited through a U.S. patient organization. Respondents made choices in each of 12 sets of hypothetical treatments. The relative importance of five treatment characteristics was compared (measured by regression coefficients [RC] of conditional logit models): (1) improvement or stabilization of motor function, (2) improvement or stabilization of breathing function, (3) indication for all ages or pediatric patients only, (4) route of administration [repeated intrathecal (IT) injections, one-time intravenous (IV) infusion, daily oral delivery] and (5) potential harm (mild, moderate, serious/life threatening). RESULTS: Patient ages ranged from less than 1 to 67 years (n = 101, 65 self-reported and 36 caregiver-reported) and 64 were female. Total SMA subtypes included: type 1 (n = 21), type 2 (n = 48), type 3 (n = 29), other (n = 3). Prior spinal surgery was reported in 47 patients. Nusinersen and onasemnogene abeparvovec-xioi use were reported in 59 and 10 patients, respectively. Improvement in motor and breathing function was highly valued [RC: 0.65, 95% confidence interval (CI): 0.47-0.83 and RC: 0.79, 95% CI: 0.60-0.98, respectively]. Oral medication and one-time infusion were strongly preferred over repeated IT injections (RC: 0.80, 95% CI: 0.60-0.98 and RC: 0.51, 95% CI: 0.30-0.73, respectively). Patients least preferred an age-restricted label/approved use (≤ 2 years of age) (RC: - 1.28, 95% CI: - 1.47 to - 1.09). Cross-attributes trade-off decision suggested a lower willingness for a high-risk therapy despite additional efficacy gain. For some patients, there may be willingness to trade off additional gains in efficacy for a change in route of administration from repeated intrathecal administration to oral medication. CONCLUSIONS: Improvements in motor/breathing function, broad indication, oral or one-time infusion, and minimal risk were preferred treatment attributes. Treatment decisions should be made in clinical context and be tailored to patient needs.

Continuity of Care for Patients with Obesity-Associated Chronic Conditions: Protocol for a Multisite Retrospective Cohort Study.

BACKGROUND: Obesity affects nearly half of adults in the United States and is contributing substantially to a pandemic of obesity-associated chronic conditions such as type 2 diabetes, hypertension, and arthritis. The obesity-associated chronic condition pandemic is particularly severe in low-income, medically underserved, predominantly African-American areas in the southern United States. Little is known regarding the impact of geographic, income, and racial disparities in continuity of care on major health outcomes for patients with obesity-associated chronic conditions. OBJECTIVE: The aim of this study is to assess, among patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes, (1) whether continuity of care is associated with lower overall and potentially preventable emergency department and hospital utilization, (2) the effect of geographic, income, and racial disparities on continuity of care and on health care utilization, (3) whether continuity of care particularly protects individuals at risk for disparities from adverse health outcomes, and (4) whether characteristics of health systems are associated with higher continuity of care and better outcomes. METHODS: Using 2015-2018 data from 4 practice-based research networks participating in the Southern Obesity and Diabetes Coalition, we will conduct a retrospective cohort analysis and distributed meta-analysis. Patients with obesity-associated chronic conditions and with type 2 diabetes will be assessed within each health system, following a standardized study protocol. The primary study outcomes are overall and preventable emergency department visits and hospitalizations. Continuity of care will be calculated at the facility level using a modified version of the Bice-Boxerman continuity of care index. Race will be assessed using electronic medical record data. Residence in a low-income area or a health professional shortage area respectively will be assessed by linking patient residence ZIP codes to the Centers for Medicare & Medicaid Services database. RESULTS: In 4 regional health systems across Tennessee, Mississippi, Louisiana, and Arkansas, a total of 53 adult hospitals were included in the study. A total of 147,889 patients with obesity-associated chronic conditions who met study criteria were identified in these health systems, of which 45,453 patients met the type 2 diabetes criteria for inclusion. Results are expected by the end of 2020. CONCLUSIONS: This study should reveal whether health system efforts to increase continuity of care for patients with obesity and diabetes have potential to improve outcomes and reduce costs. Analyzing disparities in continuity of care and their effect on major health outcomes can help demonstrate how to improve care and use of health care resources for vulnerable patients with obesity-associated chronic conditions, and within this group, patients with type 2 diabetes. Better understanding of the association between continuity and health care utilization for these vulnerable populations will contribute to the development of higher-value health systems in the southern United States. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/20788.

Qualitative Analysis of Health Systems Utilizing Non-Face-to-Face Chronic Care Management for Medicare-Insured Patients With Diabetes.

Chronic diseases impact 117 million adults in the United States and account for $3.3 trillion in health care spending. This qualitative study investigated experiences with reimbursement structure for non-face-to-face (NFF) chronic care management (CCM) through diverse health system approaches in primary care settings in Southeastern Louisiana. In-depth interviews were conducted with 16 purposively selected key informants, and reflexive thematic analysis was utilized to explore findings. Variation in health system approaches for implementing and quality of NFF CCM programs were identified. Results included differences in health system motivation and methods for financial structuring and quality of third-party vendor and alternative models.

The impact of Medicaid expansion on access to care and preventive care for adults with diabetes and depression.

AIMS: To assess if Medicaid expansion is associated with better access to care and increased utilization of preventive care for diabetes-related complications in adults with diabetes and depression. METHODS: Data were extracted from the Behavioral Risk Factor Surveillance System survey from 2010 to 2017. This is a retrospective cross-sectional study using difference-in-differences analysis to assess the relationship between expansion and access to care and healthcare utilization for Medicaid eligible respondents in expansion states, compared to those in non-expansion states. RESULTS: Medicaid expansion significantly increased insurance coverage (5.9 percentage points, p < .001) and the likelihood of having a personal doctor (1.9 percentage points, p < .01) for respondents in expansion states. For childless adults, these impacts were larger for having insurance and a personal doctor at 6.3 (p < .001) and 2.9 (p < .01) percentage points, respectively. When excluding the 9 substantial states and DC, these impacts increased further for insurance, having a personal doctor, and the ability to afford costs at 8.2 (p < .001), 1.9 (p < .05), and 2.8 (p < .05) percentage points, respectively. No significant improvements were seen in preventive care utilization. CONCLUSIONS: Compared to non-expansion states, Medicaid expansion led to improved access to care for Medicaid eligible adults in expansion states.

Does the Encounter Type Matter When Defining Diabetes Complications in Electronic Health Records?

BACKGROUND: Electronic health records (EHRs) and claims records are widely used in defining type 2 diabetes mellitus (T2DM) complications across different types of health care encounters. OBJECTIVE: This study investigates whether using different EHR encounter types to define diabetes complications may lead to different results when examining associations between diabetes complications and their risk factors in patients with T2DM. RESEARCH DESIGN: The study cohort of 64,855 adult patients with T2DM was created from EHR data from the Research Action for Health Network (REACHnet), using the Surveillance Prevention, and Management of Diabetes Mellitus (SUPREME-DM) definitions. Incidence of coronary heart disease (CHD) and stroke events were identified using International Classification of Diseases (ICD)-9/10 codes and grouped by encounter types: (1) inpatient (IP) or emergency department (ED) type, or (2) any health care encounter type. Cox proportional hazards regression was used to estimate associations between diabetes complications (ie, CHD and stroke) and risk factors (ie, low-density lipoprotein cholesterol and hemoglobin A1c). RESULTS: The incidence rates of CHD and stroke in all health care settings were more than twice the incidence rates of CHD and stroke in IP/ED settings. The age-adjusted and multivariable-adjusted hazard ratios for incident CHD and stroke across different levels of low-density lipoprotein cholesterol and hemoglobin A1c were similar between IP/ED and all settings. CONCLUSION: While there are large variations in incidence rates of CHD and stroke as absolute risks, the associations between both CHD and stroke and their respective risk factors measured by hazard ratios as relative risks are similar, regardless of alternative definitions.

Barriers and Facilitators in Implementing Non-Face-to-Face Chronic Care Management in an Elderly Population with Diabetes: A Qualitative Study of Physician and Health System Perspectives.

The burden of illness related to diabetes and its complications is exceedingly high and growing globally. Systematic approaches to managing chronic care are needed to address the complex nature of the disease, taking into account health system structures. This study presents data collected from interviews with physicians, health system administrators, and other healthcare staff about chronic care management for elderly people with diabetes co-morbid with other chronic conditions in light of new programs intended to reduce barriers by incentivizing care encounters that take place through telephone and electronic communications (non-face-to-face care). Results indicate that health system personnel view non-face-to-face care as potentially providing value for patients and addressing systemic needs, yet challenging to implement in practice. Barriers and facilitators to this approach for managing diabetes and chronic care management for its complications are presented, with consideration to different types of health systems, and recommendations are provided for implementation.

Cost Sharing of Disease-Modifying Treatments (DMTs) as Policy Lever to Improve DMTs' Access in Multiple Sclerosis.

OBJECTIVES: To understand the nonlinear relationship between out-of-pocket (OOP) payments and disease-modifying treatment (DMT) use and adherence, primarily to pinpoint the threshold at which the use of DMTs becomes price sensitive. METHODS: Individuals with more than two multiple sclerosis (MS) diagnoses (International Classification of Diseases, Ninth Revision code 340) were identified from the MarketScan database (2006-2009). Heterogeneity in treatment was normalized by calculating an annual OOP payment as the average OOP payment for purchasing a fixed basket of DMTs at the insurance plan level. A local linear regression with a model-based recursive partitioning algorithm was applied to explore the relationship between OOP and consequently lower DMT use and adherence as measured by days covered by DMT. RESULTS: We identified the inflection points in annual OOP payments as $442 for DMT use and $890 for DMT adherence. For patients with annual OOP payments of more than $442, a $100-increase in OOP payment was associated with a decline of 0.6% in DMT use; for annual OOP payments of more than $890, a $100-increase in OOP payment was associated with two fewer days of DMT treatments. CONCLUSIONS: Although the use of DMTs and DMT adherence appeared unassociated with OOP payment below $442 and $890, respectively, an excessive OOP payment was a barrier to DMT access. This information can inform maximum monthly and yearly payment caps when designing valued-based insurance plans.

Non-Face-to-Face Chronic Care Management: A Qualitative Study Assessing the Implementation of a New CMS Reimbursement Strategy.

Diabetes and its comorbidities are leading causes of morbidity and mortality in the United States and disproportionately in Louisiana. Chronic care management (CCM) efforts, such as care coordination models, are important initiatives in mitigating the impact of diabetes, such as poorer health outcomes and increased costs. This study examined one such effort, the Centers for Medicare & Medicaid Services' non-face-to-face CCM reimbursement program, for patients with diabetes and at least 1 other chronic condition in Louisiana. This qualitative study included interviews with patients in this program and health care providers and system leaders implementing the program. Results include lessons learned from health system leadership relating to CCM design and implementation, challenges experienced, overlapping initiatives, perceived benefits, performance, billing, and health information technology. Another key finding is that co-pays seem to be a barrier to patient interest in participation in non-face-to-face CCM, especially given that the value of the program is not completely clear to patients. A common strategy to address this co-pay barrier is to target dual eligibles, as Medicaid will cover the co-pay. However, widespread use of such strategies may indirectly exclude individuals who need and may also benefit from non-face-to-face CCM.

Ensuring access to prescription medications in the post-ACA healthcare access landscape: the essential role of FQHCs in the safety net for the underinsured.

OBJECTIVES: Federally qualified health centers (FQHCs) are essential to underinsured populations in the safety net by offering them several means of access to reduced cost medications. This study employed a 2-pronged approach to evaluate FQHCs' role, estimating both the need for patient assistance and the impact of the safety net. STUDY DESIGN: A multiyear panel data study for post-Affordable Care Act (ACA) years 2012 to 2016 and a 2016 cross-sectional analysis design were utilized to analyze FQHCs, their patient populations, and prescription assistance programs. METHODS: Publicly available Health Resources and Services Administration (HRSA) Uniform Data System data were merged with HRSA Office of Pharmacy Affairs Information System data on 340B programs. Descriptive statistics were produced to evaluate the need for patient assistance, costs, and conditions treated at FQHCs. RESULTS: There were 1337 FQHCs serving more than 2.5 million patients, nearly 29% of whom were uninsured. FQHCs utilized 2 programs to provide affordable, reduced-cost prescriptions for patients without insurance: 1) the HRSA 340B Drug Pricing Program and 2) prescription assistance programs, which rely on pharmaceutical manufacturer donations of reduced-cost medications or coupons. Although these programs were effective at providing affordable prescriptions, program accessibility varied widely by state and FQHC resources. CONCLUSIONS: Despite changes in the healthcare access landscape due to the ACA, underinsured populations remain prevalent and the need for financial assistance with medications persists. FQHCs are uniquely situated to provide access to these essential services. Further policy and funding efforts, such as expansion of 340B programs, could assist FQHCs in fulfilling the role of prescription safety-net providers.

Concordance of Adherence Measurement Using Self-Reported Adherence Questionnaires and Medication Monitoring Devices: An Updated Review.

INTRODUCTION: As medication adherence continues to be a prevalent issue in today's society, the methods used to monitor medication-taking behaviors are constantly being re-evaluated and compared in search of the 'gold standard' measure. Our review aimed to assess the current literature surrounding the correlation between self-reported questionnaires (SRQs) and electronic monitoring devices to determine if these measures produce similar results. METHODS: We performed a literature search from 2009 to 2017 using PubMed, PubMed In-Process and Non-Indexed, EMBASE, Ovid MEDLINE, and Ovid MEDLINE In-Process. A keyword search using the terms 'patient compliance', 'treatment compliance', 'medication adherence', 'drug monitoring', 'drug therapy', 'electronic', 'digital', 'computer', 'monitor', 'monitoring', 'drug', 'pharmaceutical preparations', 'compliance', and 'medications' was done to capture all articles. We included articles measuring adherence using both monitoring devices and SRQs. RESULTS: Thirty-five articles were included in this review. The average difference in measured adherence rates between the two measures was 9.2% (range -66.3 to 61.5). A majority (62.7%) of articles reported moderate (n = 12; 27.9%), high (n = 5, 11.6%), or significant (n = 10, 23.3%) correlations between SRQs and monitoring devices. CONCLUSION: Results from our review are consistent with previous studies, as we found that many of our studies produced moderate to high correlation between both SRQs and monitoring devices [Farmer, Clin Ther 21(6):1074-90 (1999), IMS Institute for Healthcare Informatics. Avoidable costs in US health care (2012), Patel et al., Respirology 18(3):546-52 (2013), Siracusa et al., J Cyst Fibros 14(5):621-6 (2015), Smith et al., Int J Cardiol 145(1):122-3 (2010)]. Our findings demonstrate that self-reported adherence produces comparable results to electronic monitoring devices. As there is not yet a 'gold standard' measure for monitoring patient adherence, SRQs and Medication Event Monitoring Systems (MEMS) operating together continue to emerge as the preferred effective method for measuring medication adherence.