bluuebunny/crossref_metadata_2025_split huggingface dataset:
Medicare coverage and cost-sharing for abiraterone following generic entry.
Authors: Gupta Arjun , Antonarakis Emmanuel S. , Blaes Anne Hudson , Booth Christopher M. , Dusetzina Stacie B 
Published: September 2022

13 Background: Generic competition lowers drug prices, but may not reduce out-of-pocket costs for patients. Abiraterone, first approved by the United States Food and Drug Administration in 2011, has two commonly used dosage units (250mg and 500mg) with multiple generic market entrants over the last 5 years. This makes it ideal to evaluate the association between generic competition and changes in product coverage and cost-sharing. Methods: We studied 4 abiraterone products (tablets): generic 250mg, generic 500mg, brand-name 250mg, and brand-name 500mg. We used the FDA’s Orange Book to identify market entry of generic products until May 2022. We used Part D formulary data from 2018 to 2022 to identify changes in product coverage and expected annual out-of-pocket costs for the average Part D beneficiary (daily dose of 1000mg). We also calculated “best-case” cost-sharing in 2022, using the Part D Plan Finder. Results: During 2018-2022, 12 generic 250mg and 4 generic 500mg abiraterone formulations came to market. The first 250mg generic came to market in October 2018, and 10 of the 12 formulations came to market by 2019. The first 500mg generic formulation came to market in December 2020. The proportion of Part D plans that covered generic products increased from 0% in 2018, to 100% for 250mg and 79% for 500mg in 2022. Expected annual out-of-pocket costs for a Part D beneficiary ranged from $7,491 to $10,148 across products and years. In 2022, the average out-of-pocket costs for generic 500mg tablets was $10,148, greater than that for brand-name 500mg tablets, which was $9,298. The same was true when using the Part D plan finder (generic, $11,093, brand-name, $9,476). For the 250mg product, however, out-of-pocket costs were much higher for the brand-name versus generic product (> $150,000 versus $1,139). Conclusions: During 2018-2022, market entry of generic abiraterone products led to their preferential coverage over brand-name products on Part D formularies, but this was associated with only modest savings for beneficiaries. In fact, in 2022 for the 500mg product, average out-of-pocket costs were higher for generic, versus brand-name products. For the 250mg generic product, a patient able to price-shop could pay approximately $1,100, 1/7th of what the average beneficiary spent. These data indicate that Part D beneficiaries do not immediately benefit from price reductions associated with generic entry of specialty drugs. Part D beneficiaries’ out-of-pocket costs with generics can be higher despite lower list prices (vs. brand-name). Proposals to redesign Part D correct this fundamental flaw that makes high-cost generic drugs more expensive to patients than brands. Affordable medications should be available to all patients, not just the most resourced and able to price-shop. Limitations include that formulary files capture data from the prior 3 months, and expected out-of-pocket costs are averaged across beneficiaries and plans.
“It’s just not easy to understand”: Health insurance literacy and insurance plan decision-making among cancer survivors.
Authors: Williams Courtney , Davidoff Amy J. , De Moor Janet , Vanderpool Robin C. , Platter Heather 
Published: September 2022

16 Background: Little is known about how cancer survivors choose health insurance plans and whether low health insurance literacy (HIL) may lead to inadequate coverage or high out-of-pocket (OOP) costs. Methods: This prospective, explanatory mixed methods study assessed health insurance decision-making in a sample of adult cancer survivors < 5 years from diagnosis. Quantitative eye-tracking data were collected from two simulated health insurance plan choice sets to gauge interest in plan benefits (measured by dwell time, or seconds of no eye movement; longer dwell time indicates more interest). Ranking of the most important and confusing plan benefit, HIL (HIL Measure; scored 20-84, higher scores indicate higher HIL), and sociodemographic data were also captured. Differences in benefit-specific dwell time by HIL were estimated using adjusted linear models. Qualitative, semi-structured interviews clarified a subset of survivors’ health insurance plan decision-making. Content analysis identified emergent patterns and themes. Results: With a median HIL score of 60 (IQR 50-70), survivors (N = 80) were 65% female, 59% non-Hispanic White, and a median age of 43 at diagnosis (IQR 34-52). Breast cancer diagnoses were most common (38%) and most survivors had received surgery (75%), radiation (55%), or systemic therapy (75%). In the choice set comparing a traditional and high-deductible health plan, survivors were most interested in prescription drug costs (median dwell time 58s, IQR 34-109), but no differences in interest were found comparing survivors with high and low HIL in adjusted models. In the choice set comparing a health maintenance organization and preferred provider organization plan, survivors were most interested in test and imaging costs (40s, IQR 14-67), with survivors with low vs. high HIL having more interest in deductible (β = 19s, 95% CI 2-38) and hospitalization costs (β = 14s, 95% CI 1-27) in adjusted models. Survivors with low vs. high HIL more often ranked low OOP maximums as the most important benefit (53% vs. 38%) and coinsurance as most confusing (68% vs. 53%). Interviews (n = 20) revealed survivors felt alone “ to do their own research” about insurance choices. OOP maximums were cited as the deciding factor since it’s “how much money is going to be taken out of my pocket.” Coinsurance was referred to “rather than a benefit, it's a hindrance.” Opinions about specialist gatekeeping were mixed; some survivors valued the accompanying lower OOP costs, while others worried about care delays. Survivors also reported issues with coverage and cost transparency post-insurance decision. Conclusions: Benefit considerations in health insurance decisions are varied and confusing for cancer survivors with both high and low HIL. Interventions to aid in health insurance understanding and choice are needed to optimize plan choice and prevent cancer-related financial hardship.
Comparison of health services utilization, medical costs, and activity limitations between cancer survivors with and without a disability.
Authors: Tak Hyo Jung , Lee Min Sok , Shih Ya-Chen Tina 
Published: September 2022

21 Background: Cancer survivors are one of the most vulnerable cohorts regarding health status and financial hardship. They are also more likely to have a disability than individuals without a cancer history. No prior research has systematically examined whether and how disability interacts with cancer survivorship. This study examines the association of disability with health services utilization, medical costs, and activity limitations among cancer survivors. Methods: We constructed a nationally representative cohort of cancer survivors using 2015-2019 Medical Expenditure Panel Survey Household Component File. Outcomes included health services utilization, measured by six service types (inpatient, institutional outpatient, office-based physician, office-based non-physician, ED, and prescription), total health care expenditure for all services combined and for each service type, and activity limitations (work at job, housework, and social relationship). Primary independent variables included six binary variables of functional disability conditions (hearing, vision, cognition, ambulation, self-care, and independent living) in the first model and a categorized total number of disabilities (0, 1, 2, 3, ≥4) in the second model. We employed multivariable generalized linear models and two-part models, adjusting for socio-demographics, general health status, and chronic conditions as well as accounting for complex survey design. Results: On average, cancer survivors (n = 9,359; weighted n = 21,046,285) had 0.57 days of hospital stays, 6.07 physician visits, and 16.3 prescriptions annually. The average annual health care expenditure for all services were $10,840, and 7.1% had one or more activity limitation. Notably, 38.8% of cancer survivors had at least one disability condition (ambulation 24.5%, hearing 13.8%, independent living 12.7%, cognition 11.5%). Compared to survivors without any disability, disability in self-care and ambulation was most strongly associated with the higher utilization of inpatient care (adjusted average marginal effect [AME] 0.85 days; 95% confidence interval [CI] 0.44-1.27) and physician visits (AME 1.03 visits; 95% CI 0.53-1.53), respectively. Disability in independent living (AME $5,046; 95% CI $2,638-7,455) and ambulation (AME $3,702; 95% CI $2,029-5,375) substantially increased total health care expenditure of all services. Survivors with four or more disabilities were 21.4 times more likely to have any activity limitations than those without a disability. Conclusions: Disability was associated with higher health services utilization and medical costs, and more activity limitations among cancer survivors, with the magnitude of increase varying by type of disability. Strategies to mitigate cancer disparities and financial hardship should take into account of the patients’ disability profiles.
International comparison of the impact of COVID on adherence with supportive care focused Choosing Wisely recommendations (CWR).
Authors: Li Huaqi , Powis Melanie Lynn , Saldanha Erick Figueiredo , Riechelmann Rachel Simoes , Baiad Abed , Cavalher Felicia Peterson , Chen Kevin , Costa Maria Rita Silva , Hack Saidah , Mohmand Zuhal , Nakhla Peter , Simões Maria Fernanda Evangelista , Krzyzanowska Monika K. 
Published: September 2022

28 Background: The reorganization of cancer care delivery during the COVID pandemic had the potential to catalyze improvement in CWR adherence by reducing provision of low value care to minimize in-person visits and mitigate potential issues with staff and resource shortages. We evaluated the impact of COVID on adherence with CWR for supportive care, relevant to colorectal and anal cancer patients with stage IV disease at Princess Margaret Cancer Centre (PM) in Canada and AC Camargo Cancer Center (AC) in Brazil. Methods: Eligible patients had a new patient consult 02/2020- 12/2020 (COVID) or the same period in 2019 (control). Performance on individual CWR in the 6 months following initial consultation was calculated as the proportion of eligible patients meeting the recommendation. Results: The PM and AC cohorts each consisted of 100 patients; demographic and disease characteristics of COVID and control cohorts were similar within each centre. Marginally fewer patients received surgery during COVID (PM: 38.3 vs 49.1%, p = 0.28; AC: 54.8 vs 55.2%, p = 0.97). At PM, more patients received radiation therapy during COVID (36.2 vs 24.5%, p = 0.21), whereas the opposite occurred at AC (7.1 vs 17.2%, p = 0.14). A higher proportion of both PM and AC patients treated during COVID died within 6 months of initial consult than in 2019 (PM: 10.6 vs 7.5%, p = 0.015; AC: 21.4 vs 8.6%, p = 0.029). Adherence to selected CWR is summarized below; whereby a higher proportion means higher concordance with CWR. Conclusions: There was low overall adherence to CWR across both centers with no significant changes to patterns of care for patients with stage IV disease during the COVID-19 pandemic.[Table: see text]
Association of community cancer centers key quality care recommendations for stage IB to IIIA non–small cell lung cancer.
Authors: Smeltzer Matthew , Stiles Brendon Matthew , Lee Percy , Kim Joseph , Lile Ashley , Megally Sandra , Boehmer Leigh 
Published: September 2022

30 Background: Early-stage diagnosis of non-small cell lung cancer (NSCLC) provides patients the best opportunity for long-term survival. There are documented deficiencies, however, in the quality of care many receive. Optimal care for persons with early-stage NSCLC requires a well-coordinated, multifaceted approach. The Association of Community Cancer Centers (ACCC) assembled a group of experts to create a quality document to guide care for persons with early-stage NSCLC. Methods: We convened an expert panel of lung cancer specialists with expertise in medical oncology, thoracic surgery, radiation oncology, oncology nursing, and epidemiology. The panel developed a document with 30 key quality recommendations for care of persons with stage IB to IIIA NSCLC. Evidence-based recommendations were incorporated from American Society of Clinical Oncology, International Association for the Study of Lung Cancer, American Society for Radiation Oncology, Commission on Cancer, and National Comprehensive Cancer Network guidelines and recommendations. A consensus decision-making model was utilized and recommendations were compiled in tabular format. Results: The key areas identified by the committee were: Care Coordination and Patient Education, Diagnosis and Biomarker Testing, Staging and Treatment Planning, and Post-Treatment Survivorship Care. Highlights of Care Coordination and Patient Education included shared decision-making, access to a care navigator, psychosocial support and patient education on NSCLC management, clinical trials, smoking cessation and tobacco dependence interventions, and community resources. Diagnosis and Biomarker Testing recommendations include multidisciplinary evaluation and care coordination, biomarker testing (eg, EGFR) in patients with stage IB to IIIA NSCLC who may be eligible for targeted therapy, PD-L1 testing in patients with resected stage II to IIIA NSCLC, and discussing post-resection targeted therapy. Staging and Treatment Planning recommendations include invasive staging, multimodality staging as appropriate, multidisciplinary treatment planning, and post-resection initiation of adjuvant therapy within 60 days when given. Recommendations for Post-Treatment Survivorship Care include implementation of standard surveillance, survivorship care plans, access to palliative care services, and sustained assessment of distress and referral to psychosocial support services. Conclusions: Well-coordinated, evidence-based care delivery is paramount to achieving the best outcome for individuals with early-stage NSCLC. The ACCC quality care document is an expert designed tool, combining evidence-based recommendations from multiple sources, to help achieve this goal.
Utilization of the Khorana score (KS) by hematology/oncology clinicians in the ambulatory setting.
Authors: Emmich Megan , Kidwai Neiha , Holle Lisa , Vankina Ritika 
Published: September 2022

31 Background: Patients with cancer are at an increased risk for venous thromboembolism (VTE). Though cancer-associated thrombosis is a major cause of mortality in patients, only second to disease progression, the optimal use of primary prophylaxis remains a clinical challenge. The KS, developed in 2008, is a validated tool to identify patients at low, intermediate, and high-risk for VTE. At the UConn Health Neag Comprehensive Cancer Center, we created a survey and administered it amongst our clinicians to assess KS knowledge and documentation practices. Methods: We conducted a 3-part quality improvement study that included a pre- and post-intervention retrospective chart review of eligible patients with cancer to examine rates of KS documentation. Eligibility included patients with cancer initiating a new chemotherapy. We excluded patients on anticoagulation, multiple myeloma, brain/central nervous system tumors, and patients in the Department of Corrections. The interventions included: 1) 9-question survey to assess clinician knowledge and utilization of KS; 2) KS education presented at a clinician meeting; 3) an electronic medical record (EMR) tool implemented to standardize KS documentation; and 4) reminder KS tip sheet created for clinicians. Descriptive statistics were used in data analysis. Results: Of 50 documented encounters, 40 met study criteria, with none having KS documentation. In a pre-tool implementation survey sent to 24 clinicians, of whom 20 had participated, 70% were physicians, 30% were advanced practice registered nurses (APRN), and 60% reported being in practice for 5 years or less. Most (90%) reported not using KS; only 10% reported being unfamiliar with the KS while 65% reported only sometimes talking to patients about VTE risk. Of the 10% of clinicians that did document KS, it was reported that they “document in the narrative of [the] note when appropriate.” The highest barriers to documentation were reported as “time constraints with extra documentation” and “not enough guidance.” Post-EMR tool implementation, a total of 58 of 99 (58.5%) encounters met study criteria and 1 KS was documented (1.7%). Conclusions: KS is underutilized in ambulatory clinical settings partly due to a lack of education and awareness despite availability of national guidelines which reflect the importance of primary VTE prophylaxis evaluation in all patients with cancer. This study demonstrates a continued deficiency in our clinical practice. We aim to further identify barriers and methods for improvement of KS documentation and VTE risk assessments. Additionally, a referral process is planned for all at-risk patients to enhance patient care, decrease hospital visits related to VTE, and attempt to reduce health-care costs related to VTE care.
Clinical uptake of precision medicine advances in NSCLC: A case study in RET fusions.
Authors: Marcello Krista , Owonikoko Taofeek K. , Reckamp Karen L. , Tafe Laura J. , Andrie Rachael , Obholz Kevin 
Published: September 2022

32 Background: Precision medicine has revolutionized cancer care in advanced NSCLC and new actionable biomarkers and targeted therapies are emerging at an unprecedented pace, creating myriad opportunities to improve care and mitigate the often-dire sequelae of traditional cancer therapy. Delays in uptake of testing and biomarker-guided treatment for patients with NSCLC and EGFR activating mutations or ALK fusions are well documented despite clear evidence-based practice, guidelines, and expert recommendations. In this study, we analyze healthcare professionals (HCPs) awareness and application of RET fusion testing and integration of recently approved selective RET inhibitors into practice for appropriate patients with advanced NSCLC. Methods: From 1/2020-6/2022, multiple educational activities were developed to provide HCPs with evidence-based expert and guideline recommendations on assessment of and therapy selection for RET fusion–positive NSCLC. The activities comprised live symposia associated with 4 major oncology and pathology conferences (AMP, USCAP, ASCO, AACR), 3 regional live workshop series across the US, 3 live webinars, and 2 on-demand videos. Baseline polling questions designed to assess key aspects of HCP knowledge and practice patterns were repeated at each activity. Results: Across all activities at baseline, on average only 38% of responding HCPs correctly identified RNA NGS as the most sensitive testing assay for detection of RET fusions and 36% accurately selected the appropriate targeted therapy for patient case with a KIF5B-RET gene fusion. From 2020 through 2022, with each new group of learners across different scopes of practice, we found suboptimal awareness of optimal RET fusion testing methodology and choice of therapy for patients with RET fusion–positive NSCLC (table). Optimal responses were slightly higher among learners attending conference-associated symposia vs live workshop series and online education. Conclusions: The use of optimal testing assays for RET alterations across patients with NSCLC remains low and many HCPs continue to lack awareness of appropriate targeted therapy for patients with RET–fusion positive NSCLC > 2 years after the first approved indication for this biomarker. These results underscore a lag in adoption of optimal precision medicine approaches for NSCLC among oncology HCPs and the need for expert guidance and educational activities to optimize individualized, biomarker-driven treatment approaches. An analysis of patterns by HCP role (MD, NP/PA, RN, Pharmacist) will be presented.[Table: see text]
A novel PA-led urgent care model for medical oncology patients at a large academic cancer center.
Authors: Gandhi Sonal , Lott Anthony Chuk Kae , Bryant Shirley , Whittingham Michelle , Woodard Cynthia , Stewart Janice , Mackay Helen , Nguyen Kim 
Published: September 2022

37 Background: Oncology patients are high users of the emergency department (ED), which often results in hospital admissions for management of cancer symptoms or cancer treatment toxicities. Interventions such as urgent care (UC) models can decrease such visits, and help improve patient management, health care utilization, and patient experience. Sunnybrook Health Sciences Centre, a large tertiary care hospital in Toronto, Canada has a high volume of medical oncology ED visits (average 4 per day) with about 50% admitted for management. Methods: A novel physician-assistant (PA) led and physician supervised UC model was developed to assist in medical oncology patient phone triage, assessment, and management of cancer or treatment related issues that would otherwise have been sent to the ED by the oncology team. There were two phases: 1) due to COVID, the patients were managed in a dedicated stream primarily using space and nursing in the ED, 2) a dedicated UC clinic with nursing support was opened for these patients. Results: In phase 1, there were 424 referrals over 24 months; 84% would have otherwise been sent through the usual ED process. 26% of patients were managed with PA navigation outside the UC program in other hospital settings. Of the 204 patients formally treated in the UC stream, 67.7% were discharged home. At 48 hours, 89% of discharged patients were stable or improved; this was 80% at 14 days, and 17.3% came back to the ED or were admitted within 14 days of the UC visit. In phase 2, there have so far been 214 referrals over 5 months; 83.6% would have otherwise been sent to the ED. Of the patients who were assessed, 77.9% were discharged home. Outcomes of these patients are being collected. The top 3 patient issues managed during both phases were: fever, pain, and dyspnea. Fifteen patient telephone surveys were completed, and 93.3% were either satisfied or highly satisfied with their UC experience. Conclusions: A novel PA-led triage and management model for urgent medical oncology patient issues was found in initial phase to be feasible and effective with streamlined care through the ED. Once a dedicated UC clinic was opened, referral volumes increased, and a high rate of ED diversion, patient discharge, and effective care was continued. Patients were also highly satisfied. Several ongoing process and outcome measures are being evaluated to help expand the scope and impact of this resource.