bluuebunny/crossref_metadata_2025 huggingface dataset:
Influence of health insurance type on time to breast cancer diagnosis and treatment among members of a large national payor.
Authors: Reddy Shirisha , Byrd Brooke , Craig Kelly , Zaleski Amanda , Rutter Cliff , McKeever Shannon , Bhandari Meghana , Dalton Karla , Altieri-Alger Leah , Verbrugge Dorothea J. , Avalos-Reyes Elisea , Johnson Kjel Andrew , Brito Rogelio
Published: June 2024

e23049

Background: Delays in breast cancer diagnosis and treatment can decrease early screening benefits. This study investigates the relationship between health insurance type and time from cancer screening to biopsy and biopsy to treatment initiation in members of a national health plan diagnosed with breast cancer. Methods: De-identified administrative records of Medicare, Medicaid and Commercial fully insured (C-FI) members with a claim for breast cancer between January 2020 and December 2022 were retrospectively analyzed. Poisson regression modeling determined duration (days) from screening to biopsy and biopsy to treatment initiation by insurance type group controlling for covariates. Between-group differences in duration were estimated by exponentiating the model estimate and converting to a percentage change, which was then applied to the mean days to event. P< 0.05 was considered significant. Results: 29,731 members (C-FI: 5,256; Medicare: 22,304; Medicaid: 2,171) with a diagnosis of breast cancer were evaluated. Mean duration from screening to biopsy was 21.5 days (95% confidence interval [CI]: 20.9-22.0). Insurance type was associated with time from screening to biopsy. Compared to C-FI members, Medicaid members experienced a longer duration between screening and biopsy by +12.6 days (95% CI: 11.7-13.6; P< 0.0001). Compared to C-FI members, Medicare members received biopsies 3.4 days sooner (95% CI: 3.0-3.8; P< 0.0001). Mean duration from biopsy to treatment was 35.4 days (95% CI: 34.9-35.9) with similar differences by insurance type. Compared to C-Fl members, Medicaid members experienced a longer duration between biopsy and treatment by +7.9 days (95% CI: 6.9-9.0; P< 0.0001). Compared to C-FI, Medicare members received treatment 3.6 days sooner (95% CI: 3.0-4.1; P< 0.0001). Conclusions: Health insurance type appears to impact time from breast cancer screening to biopsy and treatment initiation. Medicaid members may experience longer duration for both time from screening to biopsy and biopsy to treatment. Future studies will explore if these variations translate to clinically meaningful health outcomes and identify opportunities to provide additional support for individuals experiencing breast cancer.
Economic analysis of combined multi-cancer detection blood test and usual care.
Authors: Dong Liangqing , Shi Yezhen , Zhao Jing , Gao Qiang
Published: June 2024

e23055

Background: A previous multi-cancer detection blood test (MCDBT) in six prevalent and deadly cancers including colorectal, esophageal, liver, lung, ovarian, and pancreatic cancers, has been reported to decrease late-stage incidence and increase 5-year survival rate. However, the economic cost-effectiveness of integrating the MCDBT with usual care and the factors influencing it have not been investigated. Methods: An interception model was utilized to estimate the stage distribution at the time of cancer diagnosis, while a decision-tree model was developed to assess the clinical and economic outcomes of annual MCDBT for individuals aged 50 to 79 in the United States. The performance metrics for the MCDBT were based on the findings of a previous study called THUNDER. The incidence data were derived from the Surveillance, Epidemiology, and End Results Program (SEER), and the associated costs were obtained from SEER-Medicare. Other input data was estimated based on information available in the published literature. Results: In addition to the usual care, the integration of the MCDBT resulted in a shift of 27.9% in cancer cases from stage III-IV to stage I-II, which led to a decrease in per-cancer treatment cost by $5971 and an increase in quality-adjusted life-years by 0.10 per cancer case. The major factors that influenced the incremental cost-effectiveness ratio (ICER) included price, incidence, specificity, and sensitivity. The MCDBT with a price less than $800 showed cost-effectiveness with an ICER below three times the per capita GDP of the United States in the average-risk population. In a high-risk population with the incidence two-fold higher than the average-risk population, the ICER decreased by 58.3%. When compared the influence of specificity and sensitivity on the ICER of the MCDBT, a 5% increase in specificity resulted a decrease in ICER by 48.8%, while a 5% increase in sensitivity only reduced the ICER by 12.7%, suggesting the importance of high specificity in MCDBT. Conclusions: The MCDBT with a price less than $800 showed cost-effectiveness in the detection of colorectal, esophageal, liver, lung, ovarian, and pancreatic cancers. Price, incidence of the intended-use population, specificity and sensitivity were the major factors that influenced the cost-effectiveness.
Adherence for members taking oral oncolytic agents undergoing dose modification strategies.
Authors: Barnett Timothy , Rutter Cliff , Zaidi Shehla , Avalos-Reyes Elisea , McAuliff Kelly , Shah Dipti , Grover Rashmi , Feczko Lucia , Cavers William , Johnson Kjel Andrew
Published: June 2024

e23058

Background: The use of oral oncolytic agents has transformed oncology care. Previous studies have reported that patient, treatment, and health system-related factors may influence adherence rates in patients prescribed oral oncolytic agents. The purpose of this study is to assess adherence rates in members of a large national pharmacy benefit manager taking oral oncolytic agents who experienced a modification to their dosing regimen. Methods: Adult members receiving palbociclib, abemaciclib, ribociclib, axitinib, lenvatinib, or cabozantinib between 01/01/2021 and 12/31/2022 were eligible for the study. Members who did not maintain continuous eligibility for 180 days prior to and 2 years after the first fill in the study period were excluded. Members were stratified by presence of dose modification, defined by a change in daily dose from one prescription to the next. Adherence was assessed via the proportion of days covered (PDC) which is the total days with medication coverage divided by the number of days between the index fill and exhaust of the final fill in the study period. Optimal adherence was defined as PDC ≥ 0.85. Standard statistical tests for continuous and categorical variables were utilized. Logistic regression was performed with the endpoint of optimal adherence. P values < 0.05 are significant. Results: 13,641 members were included in the final analysis, with 7,093 (52%) experiencing a modification to their dosing regimen during the study period. Several significant differences in sociodemographic variables were present in this study with members experiencing a dose modification being older (mean [standard deviation (SD)]: 65.7 [11.9] vs. 64.9 [13.0] yr; p < 0.001), more likely to be male (23.3% vs. 15.0%; p < 0.001), more likely to reside in high socioeconomic status (SES) regions (23.7% vs. 21.5%; p = 0.005) and more likely to receive tyrosine kinase inhibitors (TKIs) (37.6% vs. 23.6%; p < 0.001). Adherence was high overall with 74.6% of members achieving a PDC ≥ 0.85; however, members with dose modifications were less likely to be adherent (69.7% vs. 80.0%; p < 0.001). Holding other confounders constant, having a dose modification was associated with a decreased likelihood of adherence (Odds Ratio [95% Confidence Interval]: 0.6 [0.55-0.65]; p < 0.001). Conclusions: Dose modification was associated with significant decreases in adherence to oral oncolytic medications. Interventions designed to minimize dose modifications or to provide additional member support during a dose modification may optimize oral oncolytic adherence.
Correlation of cost in teaching hospital with outcomes in patients with cardiac myxoma: A retrospective study using the national in-patient data sample (NIS).
Authors: Chapiolkina Volha , Perez Esmirna , Guevara-Rodriguez Nehemias Antonio , Ghimire Manoj , Ghimire Kalpana , Olazagasti Coral
Published: June 2024

e23062

Background: Cardiac myxoma (CM) is a rare cancer, benign but functionally malignant. It is the most common cardiac tumor and is more frequent in females in North America and Europe. Mortality has been associated with cardiac burden complications and the resolving capacity of the medical center to diagnose and treat these complications. Methods: A retrospective cohort analysis focused on adults admitted to hospitals between 2016 and 2020 with a primary diagnosis of CM. Data for this study were obtained from the NIS Database. The primary outcome was to determine if higher cost in teaching hospitals has an impact on mortality outcomes compared with non-teaching teaching hospitals. We looked at sociodemographic characteristics, length of stay (LoS), and complications as secondary outcomes. Hypothesis testing for categorical variables was tested with Chi-Square. Continuous variables were tested with a Student t-test. Statistical significance was defined as a two-tailed P value of < 0.05. Results: A total of 3,744 patients met inclusion criteria: 3014 were within teaching hospitals (TH), and 730 were within no-teaching hospitals (NTH). The median age was similar in both settings: 64 years in TH and 68 years in NTH (p < 0.001). LoS was higher in TH, 7.6 days, vs. NTH, 6.3 days (p = 0.05). Hospitalization costs were higher in TH, for a mean of $156,658 than in NTH, for a mean of $109,328 (p < 0.001). Most patients were females, 1850 in TH and 405 in NTH (p = 0.24). Mortality was higher in TH 75 vs. NTH 45 (p = 0.02). The population was composed of mostly White patients (68% in TH vs. 73% in NTH), followed by Back (14% in TH vs. 9% in NTH), Hispanics (11% in TH vs. 9% in NTH), Asian (3% in TH vs. 6% in NTH) and Native American patients (5% in TH vs. 0% in NTH) (p = 0.22). Patients were located mainly in the south region (39% in TH vs. 43% in NTH), followed by a similar distribution between the West (20% in TH vs. 27% in NTH), Central (23% in TH vs. 20% in NTH) and East regions (20% in TH vs. 10% in NTH) (p = 0.02). The most frequent payer was Medicare, 56% in TH vs 64% in NTH and private insurance, 28% in TH vs 24% in NTH (p < 0.001). Cardiac pathologies were the most frequent comorbidities: Congestive Heart Failure (p = 0.39), Cardiovascular disease (p = 0.18), hypertension (p = 0.1), and coronary artery disease (p = 0.44). The most common complications were cardiovascular, as demonstrated in previous studies. Conclusions: Cardiac Myxoma is a benign tumor with fatal severe complications that affect the more elderly female white population. Our study revealed a lack of significance between the outcome and the type of hospital in which patients received treatment. Similarly, mortality was not found to be driven by sociodemographic characteristics in our analysis.
Assessing the impact of unmeasured confounding in external control arms via tipping point analyses.
Authors: Yin Xiang , Stuart Elizabeth , Burcu Mehmet , Stewart Mark , Lamont Elizabeth B. , Davi Ruthanna
Published: June 2024

e23065

Background: Estimates of the comparative efficacy of new therapies from single-arm settings can be obtained in advance of RCTs through use of external control arms (ECAs).[1] ECAs are collections of patients with the index disease who were treated outside of the single-arm trial, whose measured baseline attributes are matched to the single-arm trial patients and whose outcomes are compared to trial patients’ to estimate comparative efficacy. Without randomization, observed treatment-outcome associations may be confounded by unmeasured patient attributes. Applying established statistical methods, we estimate the magnitude and prevalence of unmeasured confounding required to move an apparently favorable hazard ratio (HR) to the “tipping point” where the new drug is no longer associated with a favorable survival statistically or clinically. Methods: Studying previously reported patients with multiple myeloma treated with an experimental therapy in a clinical trial (N = 290) and patients treated with standard of care therapy from a rigorously matched ECA (N = 290), we applied the method of Lin et al. to adjust the observed treatment effect (HR and 95% CIs) for overall survival to reflect the impact of a (set of) unmeasured confounder(s).[1,2] Lin’s formula incorporates both the unmeasured confounder’s theoretical association with mortality and its prevalence according to treatment group (i.e., single-arm trial vs. ECA). Results: The observed treatment effect for the single-arm trial treated vs. ECA patients was HR 0.76 (95% CI 0.63-0.91). We estimated the impact of an unmeasured confounder (where HR for overall survival of those patients with and without the confounder is set to 1.5) by its prevalence in each group. When the prevalence of the unmeasured confounder is balanced across groups there is no change in the observed treatment effect. When the presence of the confounder is 70% for ECA patients and absent in the trial patients, the clinical tipping point occurs with loss of the favorable HR (i.e., HR 1.02, 95% CI: 0.85-1.23). Conclusions: While novel analytic methods like ECAs have the potential to accelerate drug development, the lack of randomization raises concern for potential unmeasured confounding. Applying Lin’s method, we illustrate that the impact of unmeasured confounding on HR estimates from a single-arm trial vs.an ECA is a function of both the association with mortality and asymmetries in prevalence. Consistency in the efficacy conclusion for all clinically tenable assumptions indicates a qualitatively reliable conclusion. Friends of Cancer Research whitepaper (2019): available online at https://www.focr.org/sites/default/files/Panel-1_External_Control_Arms2019AM.pdf. Lin D, Psaty B, Kronmal R. Assessing the sensitivity of regression results to unmeasured confounders in observational studies. Biometrics.1998; 54:948–963.
Epidemiology of rare endocrine tumors in a developing Middle Eastern country over 18 years.
Authors: Abdulelah Ahmed A , Abdulelah Zaid A. , Alhajahjeh Abdulrahman Ahmad , Saadeh Aseel , Al-Dqour Mohammad , Abdel-Razeq Hikmat
Published: June 2024

e23069

Background: Despite that thyroid and adrenal malignancies compose the vast majority of endocrine tumors, several other tumors could arise with significant resultant morbidity and mortality. Given the rarity of these tumors, thorough evaluation of the epidemiological features is of consequential significance in the diagnosis and management especially in the Middle East and Middle Eastern populations where adequate experience in such rare tumors is immensely limited. Methods: Extensive data on various endocrine tumors, other than thyroid and adrenal, diagnosed in patients from different nationalities residing in Jordan during the period of 2000-2018 were retrieved from the national institutionalized reporting body of cancer epidemiology in Jordan, the Jordan Cancer Registry. A total of 34 patients were included in the comprehensive epidemiological analysis performed to establish the epidemiological characteristics of these rare endocrine tumors. Results: A total of 34 patients with a mean age of 43.1 ± 18 years old with a female predominance of 64.7% have been enrolled. 11.8% of the patients were smokers at the time of diagnosis. Pituitary gland tumors were the most commonly encountered, 52.9%, followed by parathyroid gland malignancies reported in 32.4% of the patients, and craniopharyngioma in 14.7% of the patients. 29.4% of the patients had localized malignancy. There is a statistically nonsignificant increase in the crude incidence of these endocrine tumors with a crude incidence estimated effect of 0.001 (P-value = 0.21). Conclusions: Jordan has witnessed over the 18 years a range of rare endocrine tumors, mostly involving the pituitary gland. These rare endocrine tumors impose an unpredictable pattern in presentation and outcomes, and thus the determination of these epidemiological features will enable targeted diagnosis and management interventions.
Association of social determinant of health (SDOH) with clinical outcomes in patients with cancer: Opioid use, emergency admission, anxiety, depression, and length of hospital stays.
Authors: Poolakkad Sankaran Satheesh kumar , Epstein Joel Brian , Mohan Minu , Alam Naheed , Pili Roberto
Published: June 2024

e23072

Background: As cancer patients are overburdened by disease, treatment, access to care, and other demographic factors, the obstacles become increasingly significant with SDOH. Patients hospitalized in the United States in 2017 for the treatment of prostate (PC), breast (BC), and lung (LC) cancer were evaluated to characterize further and contrast variations between SDOH and clinical outcomes. Methods: We utilized the generalized linear models to assess the association between homelessness and problem-related living alone (PrbLA) and clinical outcomes–– opioid abuse/long-term use, anxiety and depression, and burden of illness (length of stay) while controlling for patients’ characteristics. Results: In the study among PC, there were 425 homeless, 355 PrbLA; BC, 320 homeless and 225 PrbLA; LC, 1345 homeless and 820 PrbLA. In the adjusted analysis, PC homelessness was significantly associated with anxiety and depression (5.15, 95%CI: 3.17-8.35); emergency admission (5.57; 95%CI: 2.63-11.82); opioid abuse (3.75,95%CI: 1.27-11.13) and longer LOS, unadjusted (2.49; 95%CI: 1.58-3.92), adjusted analysis (1.96; 95%CI: 1.03-3.74). These findings were comparable in the BC and LC cohorts. Further in the adjusted analysis, PC patients with PrbLA were associated with higher combined anxiety and depression, adjusted (2.7, 95%CI: 1.64-4.46); emergency admission, adjusted (5.86; 95%CI: 2.66-12.91); opioid long-term use, adjusted (3.74,95%CI: 1.02-6.88) and longer LOS, adjusted analysis (1.44; 95%CI: 1.11-1.88). These findings were comparable in the BC cohort. In the LC cohort, when stratified to females, the PrbLA was associated with longer LOS (1.29; 95%CI: 1.02-1.63). In all cancer cohorts, when compared to Whites, SDOH was associated with poor outcomes––Blacks had a higher burden of illness. And when compared to Whites, Hispanics, Asians, and Others were associated with lesser opioid abuse among all cancer cohorts with homelessness. Conclusions: According to this study, PC, BC, and LC patients with poor SDOH presented with the worst clinical outcomes, including higher opioid abuse, emergency admission, anxiety and depression, and longer LOS in the hospital. The findings of this study highlight a vacuum in the literature, and the recommendations stress the value of social support for cancer patients in achieving a better prognosis and quality of life.
Recent trends in incidence, survival and mortality of female breast in the US: A Surveillance, Epidemiology, and End Results (SEER) database study 2010-2020.
Authors: Asif Samia , Kesireddy Meghana
Published: June 2024

e23078

Background: We examined epidemiological trends and patient characteristics including age, race, incidence and survival in female breast cancer (BC) using the updated largest population-based cancer registry in the US. Methods: Female patients diagnosed with breast cancer between 2010-2020 were identified in SEER registries. We incorporated SEER 22 registries to calculate incidence, race, disease characteristics and overall survival. Results: Incidence Rate (IR) for BC has been increasing by 0.4%/year and mortality rates (MR) have declined 1.3%/year during 2010-2020 for all patients. 5-&10-year overall survival (OS) has increased by 0.1 and 0.2% respectively. For ages < 50 years,IR increased by 0.9% vs 0.4% for those 65 and above. No statistically significant change in IR was noted for ages 50-64y. For ages < 50 and between 50-64y, MR overall decreased by 1.4%/y each vs by 1.1%/y for those 65+. However, no statistically significant change in MR was noted for women < 50y between 2016-2020. IR increased by 1.6%/year in Asian/Pacific Islanders (API), 1.1%/y in Hispanics (H),0.6% in Blacks (B) and 0.4% in Non-Hispanic White (NHW) and. MR declined 1.5%/y in B, 1.2%/y NHW, 1% H and by 0.3% in API.IR for HR+/HER2- BC increased by 1.9%. No statistically significant change in IR was noted for triple negative or HER2+ only BC. IR for HR+/HER2+ BC increased overall during this time period by 1.4%; however, IR increased by 3.6% between 2010-2016 and decreased by 2.9% after 2016. 5y-OS was 91% in 2015 (CI 90.7-91.3) for all women, improved from 89.7% in 2010 (CI 89.4-90.0). 5yOS was 90.7% vs 91.3% vs 91.0% for < 50, 50-64 and 65+ age groups. When compared to 2010 and 2005, 5yOS was consistently improved across all age groups. 5yOS in B was 82.5% (CI 81.6-83.4) vs 92.1% (CI 91.8-92.5) in NHW. This discrepancy existed across all age groups: for < 50, 50-64 and 65+y, 91.6 vs 92.5 vs 92.1% for W women vs 82.7 vs 82.9 vs 82.0% for their B counterparts. 5yOS for localized, regional and distant disease at diagnosis for all women was 99.2%, 86.7% and 31.5%. 5yOS for B vs W females was 95.9 vs 99.7% localized, 78.3 vs 88% regional and 23.4 vs 33.0% for distant disease. Conclusions: Epidemiological trends show improved OS in BC among all groups. B females and patients with advanced stage have worse outcomes. Greater increase in IR was noted for women < 50 years of age. Greater IR increase was noted in H and API women but decline in MR was smallest in these women. IR for HR/HER2 + BC increased initially followed by a decline. 5r survival in B women was lower compared to NHW across all age groups. 5y survival for B women was worse, irrespective of stage at diagnosis. We hypothesize underlying disease biology may be a potential factor for worse outcome in B women.
Atrial flutter in a patient population with cancer: Comparison of incidence, mortality, and readmission rates.
Authors: Afzal Muhammad Sohaib , Farooq Faryal , Kumar Manoj , Sultan Muhammad , Nasir Bilal , Devarkonda Vishal , Byreddi Laxman Yashwant , Atluri Sundeep , Ali Shafaqat
Published: June 2024

e23079

Background: Cardiac tachyarrhythmias are common in cancer patients. Much has been studied regarding atrial fibrillation, but the impact of atrial flutter (AFL) in different malignancies is under-studied. We aim to compare the occurrence of atrial flutter (AFL), its mortality, and readmission rates in cancer patients stratified by different types. Methods: The National Readmission Database (2016-2020) was queried to identify all-cause admissions for patients with active malignancy of any origin. The study population was divided into six subgroups based on the type of cancer (colorectal, renal, lung, breast, prostate, and hematological). Multivariate regression analysis was utilized for adjusted odds of mortality. A propensity score matching (PSM) model matched malignancy of interest with other malignancies to obtain incidence rates. Results: Among 10.6 million all-cause cancer-related hospitalizations, about 0.4% developed AFL. After propensity matching, when compared to other malignancies, AFL had the highest incidence in hospitalizations associated with lung malignancies (0.75%), followed by hematological (0.66%), prostrate (0.57%), renal (0.49%), colorectal (0.38%) and breast (0.31%) malignancies [p < 0.05]. Moreover, cancer hospitalizations complicated by AFL were associated with higher mortality. AFL was associated with the highest odds of mortality in colorectal malignancies (aOR:2.80), followed by hematological (aOR:2.67), renal (aOR:2.66), lung (aOR:2.22), breast (aOR:2.12), & prostate (aOR:1.76) malignancies [p < 0.001]. AFL was also associated with frequent readmissions in cancer patients. The rates of 30-day AFL-related recurrent admission were highest in lung malignancies (18.3%), followed by hematological (18%), renal (16.6%), prostate (15.1%), colorectal (14.7%) & breast (14.2%) malignancies [p < 0.05]. Conclusions: The incidence of AFL in nationwide hospitalizations among cancer patients was ~ 0.4%. AFL was found to have the highest incidence and readmission rates in lung malignancies, while AFL-related mortality was highest in colorectal malignancies.
The outcome of COVID-19 infection among Saudi oncology patients.
Authors: Badran Ahmed Ali , Arabi Tarek , Ba Theeb Ahmed , Ba Wazir Abdulmalik , Ateya Heba Aly , Shaheen Amgad , Sabbah Belal Nedal , Tlayjeh Mohamed , Aldabbagh Ziyad , Alaswad Marwan , Elshenawy Mahmoud Abdelsatar , Nofal Marwa , Badran Judy , Bazarbashi Shouki
Published: June 2024

e23085

Background: Little data are available surrounding the outcomes and risk factors of COVID-19 in Saudi oncological patients. This study aims to elucidate the outcomes of COVID-19 infection among Saudi oncology patients and associated risk factors. Methods: We retrospectively reviewed the medical files of oncology patients who were diagnosed with COVID-19 at the King Faisal Specialist Hospital and Research Centre. The time from a positive PCR until death or last follow-up was calculated as COVID-specific survival. A p-value less than 0.05 was selected as the threshold for statistical significance. Results: 161 oncological patients were included in our analysis. The mean age was 53.83±15.81. 85 (52.8%) patients were female, 17 (10.6%) had a positive history of smoking, and 57 (35.4%) were obese. 70 (43.5%) patients had diabetes mellitus, 64 (39.8%) had hypertension, and 25 (15.5%) had dyslipidemia. The most common cancer in the group was breast cancer, which was present in 24 (14.9%), followed by non-Hodgkin lymphoma, colon cancer, and acute leukemia, respectively. 57 (35.4%) patients had no evidence of disease (NED) at presentation. Furthermore, 65 (40.4%) patients had received antineoplastic therapy within 30 days before infection. 25 (15.5%) patients had stage A COVID-19, 59 (36.6%) had stage B, 48 (29.8%) had stage C, and 29 (18%) had stage D. There was no difference between active and no NED patients in remission in regard to the stages of COVID-19 infection at presentation (p = 0.05). However, the stages of COVID were less severe in patients who received antineoplastic therapy (p = 0.02). 32 (19.9%) patients received tocilizumab during the acute phase of infection. Only 5 (3.1%) patients suffered COVID-specific death. Therefore, the median COVID-specific survival was not reached. Tocilizumab (p = 0.34), corticosteroids (p = 0.77), ACE inhibitors (p = 0.45) had no impact on COVID-specific death in our patient population. In patients who received steroid treatment, the duration of corticosteroid had no impact on survival (HR: 0.76, p = 0.39). Ventilation also had no impact on survival (p = 0.55). There was no difference between patients who received antineoplastic therapy within 30 days from infection and those who did not (p = 0.99). Finally, we noted no difference in survival between patients with active disease and NED patients (p = 0.17). Conclusions: COVID-related mortality is lower in Saudi oncology patients compared to other countries. Early management and admission of oncological patients may result in overall improved outcome. In line with some studies, antineoplastic therapy can reduce COVID-19 severity, possibly due to reduced ACE receptor expression.
Oral oncolytics medically integrated dispensing: Impact on medical spending compared to non-integrated dispensing.
Authors: Urick Ben , Marshall Landon , Gleason Patrick P. , Atherton Brady , Leach Joseph W.
Published: June 2024

e23098

Background: Medically integrated dispensing, consisting of multidisciplinary care teams dispensing drugs within clinics, has been associated with reduced medical spending for members receiving oral oncolytics (OO). However, there is little understanding of how medical spending differs across sites of care by dispensing channel. Objective: To compare 6-month pre/post all-cause medical spending by site of care between integrated and non-integrated dispensing channels among commercially insured members initiating OO therapy. Methods: Prime Therapeutics’ integrated pharmacy and medical claims database was used to identify members newly initiating an OO of interest between 1/1/2019 and 12/1/2022. Members were required to be continuously enrolled 6 months before and after index, had a cancer diagnosis, and had > $0 medical spending. Dispensing channel Integrated Health System Specialty Pharmacy (Int-HSSP), Integrated Physician Office (Int-Phys), Non-Integrated (Non-Int) was assigned using index OO fill. The primary outcomes were change in all-cause medical spending, medical drug spending, and non-drug medical spending divided into five site of care categories: inpatient, outpatient facility, emergency department, provider office visits, and other. Regression analysis was used to compare change in spending across channels, adjusting for demographics, health status, and cancer type. Results: A total of 30,928 (Int-HSSP: N = 5,500; Int-Phys: N = 2,550; Non-Int: N = 22,878) commercially insured members met all study criteria. Mean age ranged from 53.9 (Int-HSSP) to 56.1 years (Int-Phys). Compared to Non-Int (Unadjusted All Medical Pre: $56,214, Post: $67,050), significant cost savings were observed in the Int-Phys (Unadjusted All Medical Pre: $64,794 Post: $64,670; adj. diff -$5,672 [-9,384 to -1,960; p = 0.003]). Across categories of medical spending, the largest decreases were observed for inpatient medical spending (adj. diff -$2,663 [-5,000 to -326; p = 0.026]) and medical drug spending (adj. diff -$2,082 [-$4,248 to 84; p = 0.060]) with the remaining $927 in savings coming from differences across all other sites of care combined. No significant differences were observed for other medical spending categories or for Int-HSSP compared to Non-Int. Conclusions: Int-Phys dispensing channel for OO drugs was associated with a $5,672 reduction in medical spending compared to Non-Int, nearly half of which was driven by changes in inpatient non-drug medical spending alone. These findings support managed care models which include integrated oncology dispensing as a potential opportunity to reduce medical spending. Future work should assess the impact of dispensing channel on total cost of care and differences in healthcare utilization and in patient care experiences by dispensing channel.
Hospitalization risk in multiple myeloma episodes of care.
Authors: Liu Haibei , Indurlal Puneeth , Ye Ping , Turnwald Brian , Garey Jody S.
Published: June 2024

e23101

Background: The Enhancing Oncology Model (EOM) is a total cost of care (TCOC) program that was initiated in July 2023. Participating groups are expected to reduce expenditures while delivering high-quality care. Hospitalization (IP) is an important quality metric and cost driver in TCOC programs such as EOM. Understanding how cancer treatment may impact IP is essential for success. Multiple Myeloma (MM) treatment has transformed with multi-agent treatment as the standard of care (SOC), routinely incorporating 3 or more drugs used concurrently to maximize response. We examined the impact multi-drug treatment had on IP rates in MM patients. Methods: Using Parts A, B and D Medicare claims data from EOM baseline period (January 2019 - June 2022) for 12 participating practices, we extracted a unique count of chemotherapy drugs and IP admissions attributed to 6-month episodes of care. Dexamethasone (dex) was included even if claims were not found. Planned and cancer-surgery related IP were excluded using the Clinical Classifications Software Planned Admission Procedure Categories and per EOM specifications. IPs were dichotomized as Yes/No. A logistic regression model was developed to evaluate the association between the number of unique drugs and the unplanned IP, adjusting for variables: prior chemo, age at episode start, race, and HCC count. A 3-drug regimen was established as the reference (including dex) based on SOC. Results: 11,613 episodes had a primary diagnosis of MM, with at least one IP occurring in 2,382 episodes. The number of episodes (% IP) per drug count group are 1-2: 6636(16.3%); 3: 3772 (23.6%); 4: 863 (30.8%); 5+: 342 (40.9%). Detailed statistics are provided in Table 1. Compared to a 3-drug regimen, 4+ drugs increased the risk of IP, while episodes with 1-2 drugs had a lower risk of IP after adjusting for age, race, HCC count and prior treatment. Conclusions: Our findings can guide the design of care transforming interventions aimed at avoiding unnecessary IP while using guideline concordant SOC treatments for MM, driving TCOC reduction. Identifying patients with a higher likelihood of IP helps practices target patient monitoring programs. To understand why patients with prior treatment had lower IP identifying maintenance following initial treatment and patients receiving 3 or more drugs after failure of prior therapy, are worth exploring further. CMMI Disclaimer: The statements contained in this document are solely those of the authors and do not necessarily reflect the views or policies of CMS. The authors assume responsibility for the accuracy and completeness of the information contained in this document. [Table: see text]
Factors influencing the clinical added value (CAV) in France over more than a decade.
Authors: Duriez Lucas
Published: June 2024

e23102

Background: The rise of cancer drug prices has raised alarm over the need to base pricing decisions on the clinical added value (CAV). The French National Authority for Health (HAS) is responsible for health technology assessment (HTA) in France. For each indication retained for reimbursement, the HAS assesses the CAV on a 5-point scale ranging from I (Major) to V (absence of clinical added value). This assessment is primarily based on medical evidence. The CAV score is one of the factors contributing to price negotiations between the French ministry and pharmaceutical companies. Methods: A retrospective and descriptive study analysis of all indications in oncology (hematology and solid tumors), excluding accelerated approvals for innovative treatments, was conducted by the HAS comparing the 2010-2015 and 2016-2022 periods. For each assessment, information relative to the level of evidence and the clinical effect of the drug from the HAS opinion were collected and focused on the study’s conclusive endpoints and design. Results: The global distribution of CAV score between the two studied periods (2010-2015 and 2016-2022) was similar. However, the distribution of CAV score based on study design differed between the two periods. Regarding non comparative studies, the proportion of indications that were attributed a CAV score V increased 1.7 times between 2010-2015 and 2016-2022 and those with a CAV score I-III was nearly divided by 3. Differences were equally observed for the distribution of CAV score between the two periods based on the conclusive endpoints in the pivotal study. For the studies with a conclusive endpoint on overall survival, the rate of CAV I-III was multiplied by 1.68 (an increase from 6 to 36 cases). Concerning the cases with a progression-free survival endpoint, an observed increase of 1.3 times was noted for the CAV I-III. Lastly, studies with a conclusive overall response rate (ORR) saw an increase of 1.4 times for the CAV V as well as a decrease of 0.76 times for the CAV I-III. Over the most recent period (2016-2022), the conclusive endpoints identified in the evaluated studies were predominantly the overall response rate (93%, n = 42/45) for phase II studies. For phase III studies, progression-free survival and overall survival were respectively identified in 45% and 30% of the cases. Conclusions: Thisstudy shows that the number of indications evaluated has increased and that the assessment of the CAV is closely correlated with the choices of the study design (comparative or not) and the primary endpoint (clinically relevant or not). However, other elements underpin and qualify its valuation such as the medical need. These elements are reviewed in the HAS Guidance which emphasises overall survival as a primary endpoint and comparative data.
The journey of patients with lung cancer: The gap between symptom onset and treatment.
Authors: Linaras Maistros , Skampardonis Konstantinos , Chantzara Evangelia , Leontopoulou Vasiliki , Christodoulopoulos George , Kotsakis Athanasios , Koinis Filippos
Published: June 2024

e23119

Background: Prompt access to health care services is a priority in public health policies. The aim of this study was to map the journey of patients (pts) diagnosed with lung cancer (LC) and determine the time interval (TI) from symptom onset (SO) to treatment initiation and assess the impact on survival. Methods: A retrospective cohort study was conducted at the University Hospital of Larissa. Pts’ demographic and disease-related data were captured from medical records. The TI from SO to first doctor visit (StD), SO to first oncologist visit (StO), diagnosis to treatment initiation (DtT) and SO to treatment initiation (StT) were estimated. Overall survival (OS) was defined as the TI between treatment initiation and the date of death or the date of last follow-up. OS were estimated using the Kaplan–Meier analysis and the comparisons were computed with the log-rank test. Results: Overall, 251 sequential pts with metastatic LC were included in the study. Pts’ mean age was 71 years (range 35-88). The majority were men (82%) and 24%, 32%, 28% and 16% were diagnosed with small cell lung cancer (SCLC), squamous cell (SCC), adenocarcinoma (ADC) and large cell (LCC) LC, respectively. The median StD and StO was 32 (0-212) days and 102 (11-608) days, respectively. No difference was detected across genders, age ( > or < 70), family history of cancer or not, and area of residence (rural, urban). The median StT and DtT was 123 (30-851) days and 26 (1-105) days, respectively, with this time intervals being shorter among pts with SCLC compared to pts with non-small cell LC (NSCLC) ( p: 0.006 and p< 0.001, respectively). Pts with sort StT intervals had significantly improved OS, compared to pts with longer StT intervals (SCLC p:0.044, NSCLC p:0.004). Conclusions: To the best of our knowledge, this is the first study aiming to determine specific TI from SO to treatment initiation for pts with LC in Greece and assess the potential impact on OS. Our data revealed a substantially prolonged StT (~4months) that is associated with worse survival rates. This indicates a need to improve public awareness of LC symptoms, enable pts’ access to specialized health care services and facilitate earlier diagnosis and treatment.
Costs and access barriers to ondansetron: A national analysis of Medicare part D and Medicare Advantage plans.
Authors: Jiang Changchuan , Liao Joshua , Hu Xin , Hong Arthur S. , Niyogi Sonali , Mullins Megan A. , Zheng Zhiyuan , Han Xuesong , Nipp Ryan David , Yabroff Robin , Shih Ya-Chen Tina
Published: June 2024

e23126

Background: Seniors living with cancer and receiving prescription drug benefits through Medicare Part D Prescription Drug Plans (PDPs) can face cost and access barriers in the forms of prior authorization and quantity limit policies. While over half of Medicare beneficiaries are now insured with drug benefits through Medicare Advantage, it remains unclear how costs and access barriers compare between PDPs and MA drug plans (MADPs). This study compared plan-level costs and prevalence of prior authorization or quantity limit policies between PDPs and MADPs for oral ondansetron, an essential and widely used antiemetic for patients with cancer. Methods: We used 2023 Q3 MA and PDP data from the Center for Medicare and Medicaid Services, excluding employer-sponsored and Supplemental Need Plans (including dual-eligible plans) and plans with < 10 enrollees. We focused on the four most common generic ondansetron forms: 4mg and 8mg tablets, and 4mg and 8mg orally disintegrating tablets (ODT). To compare medication quantities, we calculated the median (IQR) cost of 30-day supply (90 dosage units), defining plan-level price as the average unit cost for each formulation. Price benchmarks were defined using Mark Cuban Cost-plus Drug Company cash prices, which reflect fixed markup to negotiated wholesale prices. T-test and Chi-square tests were used for comparison. Results: Across 813 PDPs and 3512 MADPs, MAPDs had lower median costs for a 30-day supply of ondansetron than PDP plans (4mg tab: $16.1 vs $29.2; 4mg ODT: $38.0 vs $56.4; 8mg tab: $24.7 vs $35.6; 8mg ODT: $37.2 vs $54.4, all p < 0.01). Median costs for both PDPs and MAPDs were higher than benchmarks (66-155% across formulations; all p < 0.01). PDPs and MAPDs had similarly high prior authorization rates (83.6% vs 83.4%, p = 0.89), but MAPDs used quantity limits more frequently (22.5% vs 16.5%, p < 0.01). There was little variation in prior authorization and quantity limit policies across formulations. Conclusions: Ondansetron costs in both PDPs and MAPDs were higher than benchmarks. Compared to PDPs, MAPDs offered ondansetron at lower costs but used policies creating access barriers for patients either at similar (prior authorization) or higher (quantity limit) frequency, burdening patients, physicians, health systems, and pharmacies. [Table: see text]
Financial toxicity screening preferences in patients with breast cancer.
Authors: Gharzai Laila A. , Liu Yingzhe , Sun Zequn , Mady Leila , Mohn Michelle , Larson Alexis , Kircher Sheetal Mehta , Yanez Betina , Jagsi Reshma , Carlos Ruth C. , Sadigh Gelareh
Published: June 2024

e23132

Background: Financial toxicity is an important issue for cancer patients that affects quality of life and treatment adherence. Screening can help identify patients at risk but consensus on appropriate timing or methods for screening is lacking. We conducted a survey to assess preferences for financial toxicity screening among a cohort of cancer patients. Methods: An anonymous cross-sectional survey was sent to email newsletter subscribers of a breast cancer-specific philanthropic organization with a nationwide reach in July 2023. Participants were asked about financial toxicity screening preferences; all questions were optional. Frequencies, percentages, means, and standard deviations were calculated for categorical and continuous variables, respectively. Comparative analyses, including chi-square and t-tests, were used to identify differences across demographic groups. Statistical significance was determined at p < 0.05. Results: Of 5774 potential participants who clicked on the email link, 825 respondents with confirmed prior or current cancer diagnosis participated in the survey (14.3% response rate). These participants were 84% female (n = 690) with a median age of 50 years (IQR 44-57), were 51% non-Hispanic White (n = 418), 18% Black or African-American (n = 149), 8.2% Hispanic (n = 68). 84% confirmed a breast cancer (n = 689), and 53% were currently undergoing treatment (n = 441). Most participants were not asked about financial stressors by their care team (52%, n = 429) and most did not receive assistance from their care team (61%, n = 501). Most preferred for their providers to reach out to them regarding financial needs (75%, n = 615). Most wished for these discussions to take place early on in their treatment course (when first diagnosed [40%, n = 334] or when treatment course was selected [33%, n = 275]), and for these questions to be asked frequently (each appointment [38%, n = 312] or once per month [32%, n = 268]). Participants felt most comfortable discussing financial needs with a social worker or patient/financial navigator (82%, n = 679). Most wished to discuss financial concerns in person (67%, n = 553) or via telephone (58%, n = 479). Conclusions: Patients with cancer desire financial screening to occur early, often, and to be initiated by their providers. Patient preferences can guide optimal implementation of financial toxicity screening practices. Continued work refining best practices for financial toxicity screening should incorporate these patient preferences.
Substance use among individuals with cancer: A US population-based cohort study.
Authors: Bakhtiar Mina , Lam Miranda B.
Published: June 2024

e23133

Background: The prevalence of concurrent substance use or comorbid substance use disorder (SUD) among individuals with a cancer diagnosis, and their participation in substance use treatment, has not yet been described in a large US population-based cohort. Methods: A population-based cohort study was conducted using cross-sectional survey data collected by the National Survey on Drug Use & Health (NSDUH) between 2015-2022. Descriptive statistics were calculated to describe two populations: those with any kind of cancer diagnosis within the preceding 12 months and either comorbid SUD as defined by the Diagnostic and Statistical Manual of Mental Illness (DSM)-5 or concurrent use of any of the following substances: alcohol, marijuana, cocaine, crack, heroin, methamphetamines, or misuse of prescription drugs. Chi-square tests were conducted to describe associations with the demographic and geographic characteristics of these individuals. Results: Between 2015-2022, 432,764 individuals (53% female) completed the survey. A total of 2,547 respondents had a cancer diagnosis in the preceding 12 months; the most common cancer types were breast cancer (17.0%), non-melanoma skin cancers (16.2%), and prostate or testicular cancer (11.0%). Among this cohort, 1,664 (65%) reported concurrent alcohol use, 354 (14%) reported marijuana use, and 82 (3%) reported illicit use of other substances. Among those with an active cancer diagnosis in the preceding 12 months, 103 (4%) met DSM-5 criteria for a comorbid SUD based on survey responses. Among individuals with a past-year cancer diagnosis, there was a statistically significant association between concurrent substance use and income bracket (X2 = 92.67, p < 0.001), concurrent substance use and race (X2=46.12, p< 0.001), and between concurrent substance use and population density (X2= 7.05, p = 0.029). Zero respondents with cancer and either concurrent substance use or comorbid SUD received outpatient treatment for substance use in the preceding year, three (0.002%) received inpatient treatment, and seven (0.004%) participated in a support group. Among respondents with comorbid SUD, many reported being recently asked by a healthcare professional about their alcohol (83%) or drug use (67%), while only 1.9% reported recently receiving information from a healthcare professional about substance use treatment. Conclusions: There is overlap between the population with a cancer diagnosis and that with concurrent substance use or comorbid SUD. Based on population-level survey data, these individuals have low rates of participation in outpatient or inpatient substance treatment, and report that they do not often receive information about substance use treatment from healthcare professionals. Describing this population may inform how providers approach their unique healthcare needs.