Pharmacy Assistance Programs for Oral Anticancer Drugs: A Narrative Review.

Oral anticancer medications (OAMs) are high priced with a significant cost-sharing burden to patients, which can lead to catastrophic financial, psychosocial, and clinical repercussions. Cost-conscious prescribing and inclusion of low-cost alternatives can help mitigate this burden, but cost transparency at the point of prescribing remains a major barrier to doing so. Pharmacy assistance programs, including co-payment cards and patient assistance programs administered by manufacturers and foundation-based grants, remain an essential resource for patients facing prohibitive co-payments for OAMs. However, access to these programs is fraught with complexities, including lack of trained financial navigators, limited transparency on eligibility criteria, onerous documentation burdens, and limits in available funding. Despite these drawbacks and the potential for such programs to incentivize manufacturers to keep list prices high, assistance programs have been demonstrated to improve financial well-being for patients with cancer. The increasing development of integrated specialty pharmacies with dedicated, trained pharmacy staff can help improve and standardize access to such programs, but these services are disproportionately available to patients seen at tertiary care centers. Multistakeholder interventions are needed to mitigate the burden of cost sharing for OAMs, including increased clinician knowledge of financial resources and novel assistance mechanisms, investment of institutions in trained financial navigation services and centralized platforms to identify assistance programs, and policies to cap out-of-pocket spending and improve transparency of rates charged by pharmacy benefit managers to a health plan.

Access to Financial Assistance Programs and Their Impact on Overall Spending on Oral Anticancer Medications at an Integrated Specialty Pharmacy.

PURPOSE: Financial assistance (FA) programs are increasingly used to help patients afford oral anticancer medications (OAMs), but access to such programs and their impact on out-of-pocket (OOP) spending has not been well explored. This study aimed to (1) characterize the impact of receipt of FA on both OOP spending and likelihood of catastrophic spending on OAMs and (2) evaluate racial/ethnic disparities in access to FA programs. METHODS: Patients with a cancer diagnosis prescribed an OAM anytime between January 1, 2021, and December 31, 2021 were included in this retrospective, single-center study at an integrated specialty pharmacy affiliated with a tertiary academic cancer center. Fixed-effect regression models were used to characterize the impact of receipt of FA on overall spending and likelihood of catastrophic spending on OAMs, as well as explore the association of race/ethnicity with receipt of FA. RESULTS: Across 1,186 patients prescribed an OAM, 37% received FA. Receipt of FA was associated with lower annual spending on OAMs (ß = -$1,236 US dollars [USD; 95% CI, -$1,841 to -$658], P < .001) but not reduced risk of catastrophic spending (odds ratio [OR], 0.442 [95% CI, 0.755 to 3.199], P = .23). Non-White patients (OR, 0.60 [95% CI, 0.43 to 0.85], P = .004) and patients who spoke English as a second language (OR, 0.46 [95% CI, 0.23 to 0.90], P = .02) were less likely to receive FA compared with White and English-speaking patients, respectively. CONCLUSION: FA programs can mitigate high OOP spending but not for patients who spend at catastrophic levels. There are racial/ethnic and language disparities in access to such programs. Future studies should evaluate access to FA programs across diverse delivery settings.

Clinical validity and utility of circulating tumor DNA (ctDNA) testing in advanced non-small cell lung cancer (aNSCLC): a systematic literature review and meta-analysis.

Purpose: Circulating tumor DNA (ctDNA) testing has become a promising tool to guide first-line (1L) targeted treatment for advanced non-small cell lung cancer (aNSCLC). This study aims to estimate the clinical validity (CV) and clinical utility (CU) of ctDNA-based next-generation sequencing (NGS) for oncogenic driver mutations to inform 1L treatment decisions in aNSCLC through a systematic literature review and meta-analysis. Methods: A systematic literature search was conducted in PubMed/MEDLINE and Embase to identify randomized control trials or observational studies reporting CV/CU on ctDNA testing in patients with aNSCLC. Meta-analyses were performed using bivariate random-effects models to estimate pooled sensitivity and specificity. Progression-free/overall survival (PFS/OS) was summarized for CU studies. Results: Eighteen studies were identified: 17 CV only, 2 CU only, and 1 both. Thirteen studies were included for the meta-analysis on multi-gene detection. The overall sensitivity and specificity for ctDNA detection of any mutation were 0.69 (95% CI, 0.63-0.74) and 0.99 (95% CI, 0.97-1.00) respectively. However, sensitivity varied greatly by driver gene, ranging from 0.29 (95% CI, 0.13-0.53) for ROS 1 to 0.77 (95% CI, 0.63-0.86) for KRAS . Two studies compared PFS with ctDNA versus tissue-based testing followed by 1L targeted therapy found no significant differences. One study reported OS curves on ctDNA-matched and tissue-matched therapies but no hazard ratios were provided. Conclusion: ctDNA testing demonstrated an overall acceptable diagnostic accuracy in aNSCLC patients, however, sensitivity varied greatly by driver mutation. Further research is needed, especially for uncommon driver mutations, to better understand the CU of ctDNA testing in guiding targeted treatments for aNSCLC.

The Health Inequality Impact of Liquid Biopsy to Inform First-Line Treatment of Advanced Non-Small Cell Lung Cancer: A Distributional Cost-Effectiveness Analysis.

OBJECTIVES: To perform a distributional cost-effectiveness analysis of liquid biopsy (LB) followed by, if needed, tissue biopsy (TB) (LB-first strategy) relative to a TB-only strategy to inform first-line treatment of advanced non-small cell lung cancer (aNSCLC) from a US payer perspective by which we quantify the impact of LB-first on population health inequality according to race and ethnicity. METHODS: With a health economic model, quality-adjusted life-years (QALYs) and costs per patient were estimated for each subgroup. Given the lifetime risk of aNSCLC, and assuming equally distributed opportunity costs, the incremental net health benefits of LB-first were calculated, which were used to estimate general population quality-adjusted life expectancy at birth (QALE) by race and ethnicity with and without LB-first. The degree of QALYs and QALE differences with the strategies was expressed with inequality indices. Their differences were defined as the inequality impact of LB-first. RESULTS: LB-first resulted in an additional 0.21 (95% uncertainty interval: 0.07-0.39) QALYs among treated patients, with the greatest gain observed among Asian patients (0.31 QALYs [0.09-0.61]). LB-first resulted in an increase in relative inequality in QALYs among patients, but a minor decrease in relative inequality in QALE. CONCLUSIONS: LB-first to inform first-line aNSCLC therapy can improve health outcomes. With current diagnostic performance, the benefit is the greatest among Asian patients, thereby potentially widening racial and ethnic differences in survival among patients with aNSCLC. Assuming equally distributed opportunity costs and access, LB-first does not worsen and, in fact, may reduce inequality in general population health according to race and ethnicity.

Private Payer and Medicare Coverage Policies for Use of Circulating Tumor DNA Tests in Cancer Diagnostics and Treatment.

BACKGROUND: Circulating tumor DNA (ctDNA) is used to select initial targeted therapy, identify mechanisms of therapeutic resistance, and measure minimal residual disease (MRD) after treatment. Our objective was to review private and Medicare coverage policies for ctDNA testing. METHODS: Policy Reporter was used to identify coverage policies (as of February 2022) from private payers and Medicare Local Coverage Determinations (LCDs) for ctDNA tests. We abstracted data regarding policy existence, ctDNA test coverage, cancer types covered, and clinical indications. Descriptive analyses were performed by payer, clinical indication, and cancer type. RESULTS: A total of 71 of 1,066 total policies met study inclusion criteria, of which 57 were private policies and 14 were Medicare LCDs; 70% of private policies and 100% of Medicare LCDs covered at least one indication. Among 57 private policies, 89% specified a policy for at least 1 clinical indication, with coverage for ctDNA for initial treatment selection most common (69%). Of 40 policies addressing progression, coverage was provided 28% of the time, and of 20 policies addressing MRD, coverage was provided 65% of the time. Non-small cell lung cancer (NSCLC) was the cancer type most frequently covered for initial treatment (47%) and progression (60%). Among policies with ctDNA coverage, coverage was restricted to patients without available tissue or in whom biopsy was contraindicated in 91% of policies. MRD was commonly covered for hematologic malignancies (30%) and NSCLC (25%). Of the 14 Medicare LCD policies, 64% provided coverage for initial treatment selection and progression, and 36% for MRD. CONCLUSIONS: Some private payers and Medicare LCDs provide coverage for ctDNA testing. Private payers frequently cover testing for initial treatment, especially for NSCLC, when tissue is insufficient or biopsy is contraindicated. Coverage remains variable across payers, clinical indications, and cancer types despite inclusion in clinical guidelines, which could impact delivery of effective cancer care.

The costs and inequities of precision medicine for patients with prostate cancer: A call to action.

Financial toxicity is a growing problem in the delivery of cancer care and contributes to inequities in outcomes across the cancer care continuum. Racial/ethnic inequities in prostate cancer, the most common cancer diagnosed in men, are well described, and threaten to widen in the era of precision oncology given the numerous structural barriers to accessing novel diagnostic studies and treatments, particularly for Black men. Gaps in insurance coverage and cost sharing are 2 such structural barriers that can perpetuate inequities in screening, diagnostic workup, guideline-concordant treatment, symptom management, survivorship, and access to clinical trials. Mitigating these barriers will be key to achieving equity in prostate cancer care, and will require a multi-pronged approach from policymakers, health systems, and individual providers. This narrative review will describe the current state of financial toxicity in prostate cancer care and its role in perpetuating racial inequities in the era of precision oncology.

Impact of a Comprehensive Financial Resource on Financial Toxicity in a National, Multiethnic Sample of Adult, Adolescent/Young Adult, and Pediatric Patients With Cancer.

PURPOSE: Financial toxicity is a well-recognized problem for patients with cancer. However, a crucial gap remains in describing and implementing mitigation strategies. We conducted a national survey of a multiethnic adolescent/pediatric and adult patient population served by Family Reach, a nonprofit organization focused on removing financial barriers to cancer care, to evaluate the impact of a comprehensive financial resource on patient-reported financial toxicity. METHODS: An electronic survey was administered to characterize patients' current financial health and the impact of Family Reach's resources on financial toxicity. The survey was e-mailed to all patients or caregivers who received resources from Family Reach between January 1, 2020, and June 30, 2020. Factors associated with higher financial stress and higher potential impact of resources on financial burden were evaluated through separate multivariate regression models. Qualitative responses were analyzed using manual coding and thematic analysis. RESULTS: Three hundred thirty socioeconomically and racially diverse respondents (overall response rate 40%; 46% non-Hispanic White; 48% with incomes below the federal poverty line) completed the survey and were included in the analysis. More than half of respondents reported high financial stress in the previous week. Hispanic ethnicity, Black race, and low annual household income were associated with higher financial toxicity. A greater amount of financial assistance was associated with a higher confidence rating that resources provided would decrease financial stress. In open-ended comments, respondents highlighted the impact of the COVID-19 pandemic and resulting job loss on financial toxicity, the importance of financial navigation, the benefits of financial assistance, and anxiety about long-term financial health. CONCLUSION: A comprehensive financial resource, particularly financial assistance, alleviated financial toxicity in a multiethnic national sample of patients with cancer. Ongoing work is critical to address sustainable funding sources and financial navigation to support patients during treatment and survivorship.

Analysis of Serious Adverse Event Reporting for Patients Enrolled in Cancer Clinical Trials During the COVID-19 Pandemic.

This cross-sectional study assesses whether a change occurred in reporting of serious adverse events for patients in oncology clinical trials in the US during the COVID-19 pandemic.

Healthcare delivery interventions to reduce cancer disparities worldwide.

Globally, cancer care delivery is marked by inequalities, where some economic, demographic, and sociocultural groups have worse outcomes than others. In this review, we sought to identify patient-facing interventions designed to reduce disparities in cancer care in both high- and low-income countries. We found two broad categories of interventions that have been studied in the current literature: Patient navigation and telehealth. Navigation has the strongest evidence base for reducing disparities, primarily in cancer screening. Improved outcomes with navigation interventions have been seen in both high- and low-income countries. Telehealth interventions remain an active area of exploration, primarily in high income countries, with the best evidence being for the remote delivery of palliative care. Ongoing research is needed to identify the most efficacious, cost-effective, and scalable interventions to reduce barriers to the receipt of cancer care globally.

Association Between HEDIS Performance and Primary Care Physician Age, Group Affiliation, Training, and Participation in ACA Exchanges.

BACKGROUND: There are a limited number of studies investigating the relationship between primary care physician (PCP) characteristics and the quality of care they deliver. OBJECTIVE: To examine the association between PCP performance and physician age, solo versus group affiliation, training, and participation in California's Affordable Care Act (ACA) exchange. DESIGN: Observational study of 2013-2014 data from Healthcare Effectiveness Data and Information Set (HEDIS) measures and select physician characteristics. PARTICIPANTS: PCPs in California HMO and PPO practices (n = 5053) with part of their patient panel covered by a large commercial health insurance company. MAIN MEASURES: Hemoglobin A1c testing; medical attention nephropathy; appropriate treatment hypertension (ACE/ARB); breast cancer screening; proportion days covered by statins; monitoring ACE/ARBs; monitoring diuretics. A composite performance measure also was constructed. KEY RESULTS: For the average 35- versus 75-year-old PCP, regression-adjusted mean composite relative performance scores were at the 60th versus 47th percentile (89% vs. 86% composite absolute HEDIS scores; p < .001). For group versus solo PCPs, scores were at the 55th versus 50th percentiles (88% vs. 87% composite absolute HEDIS scores; p < .001). The effect of age on performance was greater for group versus solo PCPs. There was no association between scores and participation in ACA exchanges. CONCLUSIONS: The associations between population-based care performance measures and PCP age, solo versus group affiliation, training, and participation in ACA exchanges, while statistically significant in some cases, were small. Understanding how to help older PCPs excel equally well in group practice compared with younger PCPs may be a fruitful avenue of future research.

Exploring Care Attributes of Nephrologists Ranking Favorably on Measures of Value.

BACKGROUND: Despite growth in value-based payment, attributes of nephrology care associated with payer-defined value remains unexplored. METHODS: Using national health insurance claims data from private preferred provider organization plans, we ranked nephrology practices using total cost of care and a composite of common quality metrics. Blinded to practice rankings, we conducted site visits at four highly ranked and three average ranked practices to identify care attributes more frequently present in highly ranked practices. A panel of nephrologists used a modified Delphi method to score each distinguishing attribute on its potential to affect quality and cost of care and ease of transfer to other nephrology practices. RESULTS: Compared with average-value peers, high-value practices were located in areas with a relatively higher proportion of black and Hispanic patients and a lower proportion of patients aged >65 years. Mean risk-adjusted per capita monthly total spending was 24% lower for high-value practices. Twelve attributes comprising five general themes were observed more frequently in high-value nephrology practices: preventing near-term costly health crises, supporting patient self-care, maximizing effectiveness of office visits, selecting cost-effective diagnostic and treatment options, and developing infrastructure to support high-value care. The Delphi panel rated four attributes highly on effect and transferability: rapidly adjustable office visit frequency for unstable patients, close monitoring and management to preserve kidney function, early planning for vascular access, and education to support self-management at every contact. CONCLUSIONS: Findings from this small-scale exploratory study may serve as a starting point for nephrologists seeking to improve on payer-specified value measures.

Barriers to timely discharge from the general medicine service at an academic teaching hospital.

BACKGROUND: Reducing delays for patients who are safe to be discharged is important for minimising complications, managing costs and improving quality. Barriers to discharge include placement, multispecialty coordination of care and ineffective communication. There are a few recent studies that describe barriers from the perspective of all members of the multidisciplinary team. STUDY OBJECTIVE: To identify the barriers to discharge for patients from our medicine service who had a discharge delay of over 24 hours. METHODOLOGY: We developed and implemented a biweekly survey that was reviewed with attending physicians on each of the five medicine services to identify patients with an unnecessary delay. Separately, we conducted interviews with staff members involved in the discharge process to identify common barriers they observed on the wards. RESULTS: Over the study period from 28 October to 22 November 2013, out of 259 total discharges, 87 patients had a delay of over 24 hours (33.6%) and experienced a total of 181 barriers. The top barriers from the survey included patient readiness, prolonged wait times for procedures or results, consult recommendations and facility placement. A total of 20 interviews were conducted, from which the top barriers included communication both between staff members and with the patient, timely notification of discharge and lack of discharge standardisation. CONCLUSIONS: There are a number of frequent barriers to discharge encountered in our hospital that may be avoidable with planning, effective communication methods, more timely preparation and tools to standardise the discharge process.

Scheduled surgery admissions and occupancy at a children's hospital: variation we can control to improve efficiency and value in health care delivery.

OBJECTIVE: Describe variability in admission, discharge, and occupancy patterns for surgical patients at a large children's hospital and assess the relationship between scheduled admissions and occupancy. BACKGROUND: High hospital occupancy degrades quality of care and access, whereas low levels of occupancy use hospital resources inefficiently. Variability in scheduling patients for surgical procedures may affect occupancy and be amenable to alteration. METHODS: This is a retrospective administrative data analysis that took place at 1 urban, tertiary-care children's hospital. A total of 8552 surgical patients hospitalized from July 1, 2009, to June 30, 2010, were included in the analysis, and admission-discharge-transfer data for 1 fiscal year were abstracted for analysis of admission and occupancy patterns. RESULTS: Among 6257 surgical admissions for non-intensive care unit (ICU) patients, 49% were emergent and 51% were scheduled. Variation in admission volume by day of week was more than 3 times higher for scheduled admissions than for emergent admissions. For non-ICU surgical patients with length of stay 7 days or less (97%), Mondays and Tuesdays generated 42% of scheduled patient occupancy time. Thursdays and Fridays often had high occupancy of surgical patients (>90% of designated beds filled), whereas Saturdays, Sundays, and Mondays were often at low occupancy for those beds (<80% filled). Only 20% of all days in the year had designated non-ICU surgery beds with occupancy between 80% and 95%. CONCLUSIONS: Scheduled admissions contribute significantly to variability in occupancy. Predictable patterns of admissions lead to high occupancy on some days and unused capacity on others, with few days being at an optimal level of occupancy. These predictable patterns suggest opportunities to improve hospital operations with changes in scheduled admission patterns, which present a different problem than random demand.