tbuckley/cabot-search huggingface dataset:
Healthcare spending after a cancer diagnosis among working-aged adults.
Authors: Helen M. Parsons, Marcelo C Perraillon, Roxanne Clark, Cathy J Bradley, Samuel Greenwald, Jingxuan Zhao, Robin Yabroff
Journal: Journal of Clinical Oncology (2024)

11071 Background: The cost of cancer care has increased dramatically over the past decades, increasing the financial burden on patients. However, current estimates of healthcare spending and out-of-pocket burden rely heavily on data from older populations, which may not reflect contemporary treatment patterns in working-aged adults given the rise in use of novel therapies and increased incidence at younger ages. Methods: We used the 2012-2021 Colorado Central Cancer Registry linked to the All-Payer Claims Database to identify adults aged 22-63 newly diagnosed with cancer. We examined median health plan payments and out-of-pocket spending across the most common insurance and cancer types in six months after diagnosis. Results: Among 20,460 individuals newly diagnosed with cancer, the median total spending in the six months after diagnosis was $60,123 for those insured by private fee-for-service (FFS) plans and $26,326 for those insured by Medicaid. The majority of spending was for medical care. Among individuals insured by private FFS plans, those with lymphoma had the highest total median spending at $125,892, followed by lung ($99,823), breast ($87,121), leukemia ($86,776), and colorectal cancer ($76,273). Although total spending was markedly lower among those insured by Medicaid, individuals with leukemia ($52,591) and lymphoma ($46,787) experienced the highest median spending. Out-of-pocket spending was substantially higher for the privately insured ($3,751 or approximately $625/month) across all cancer types, and highest for lymphomas ($4,262), breast ($4,706) and colorectal ($4,216) cancers. Conclusions: Total healthcare spending after a cancer diagnosis is significant in the working-aged population and creates a substantial out-of-pocket burden, even among those privately insured. [Table: see text]
Overlapping and non-overlapping indications for checkpoint inhibitors in the US.
Authors: Jeddeo Paul, Aaron Philip Mitchell, Aaron S Kesselheim, Benjamin N Rome
Journal: Journal of Clinical Oncology (2024)

11057 Background: Since the first checkpoint inhibitor was approved in 2014, this class of cancer drug has revolutionized the treatment of several malignancies. As of January 2024, 11 checkpoint inhibitors have been approved by the US Food and Drug Administration (FDA), each with its own particular indications. We assessed the overlap of approved indications, which has implications for competition and price negotiation by payers. Methods: In this cross-sectional study, we evaluated the FDA-approved indications for 11 checkpoint inhibitors as of January 2024. Indications were defined by cancer tissue type (or mutation status for non-tumor-type indications), stage, and line of treatment (first-line, second-line, third-line, or fourth-or-greater-line). Non-overlapping indications were defined as those with only a single drug approved; for overlapping indications, we tabulated the number of approved drugs. Results: The 11 FDA-approved checkpoint inhibitors were associated with 43 distinct indications, ranging from 2 (retifanlimab, toripalimab, and tremelimumab) to 35 (pembrolizumab) indications per drug. Fifteen (43%) indications were non-overlapping. Pembrolizumab had 11 non-overlapping indications (e.g., certain breast, cervical, and urothelial cancers); all other drugs had between 0 and 2 non-overlapping indications (Table). Among the 28 overlapping indications, 15 (54%) had approvals for 2 drugs, 9 (32%) had approvals for 3 drugs, 3 (11%) had approvals for 4 drugs, and 1 (3%; non-small cell lung cancer) had approvals for 7 of the 11 drugs. Conclusions: Checkpoint inhibitors are FDA-approved for a total of 43 different indications, but most indications were included on the labeling of 3 or fewer drugs in this class. Over 1 in 3 indications had only 1 approved drug, most commonly pembrolizumab. This limited overlap of indications suggests that manufacturers may avoid seeking approval for indications that already have multiple approved drugs of the same class, which may decrease competition and lead to sustained high drug prices. To provide patients with better information about the checkpoint inhibitor most appropriate for their cancer, the NIH could fund, and the FDA could encourage, more direct comparative effectiveness trials. [Table: see text]
Real-world assessment of treatment-related symptoms and associated burden among African American and Caucasian patients receiving chemotherapy in the US.
Authors: Aaron Galaznik, Emelly Rusli, Tracy Holt, Mordecai Kramer, Peter Trask
Journal: Journal of Clinical Oncology (2024)

11102 Background: In the treatment of breast cancer, research has identified racial differences in the ability to receive the full dose of prescribed chemotherapy which may be due in part to cancer-treatment symptom burden. In clinical trials, evaluation by race is challenging due to enrollment disparities, with African Americans (AA) accounting for 7% of trial participants, but comprising 12% of the US total population. The objective of this study is to evaluate treatment-related symptoms and treatment burden among patients treated with chemotherapy through an electronic remote symptom monitoring system, and explore whether there were any racial differences. Methods: Patients (pts) diagnosed with multiple myeloma, breast, ovarian, or lung cancer in academic cancer practices were enrolled in Carevive’s Patient Reported Outcomes Mobile Platform (Carevive PROmpt) between September 2020 and June 2023. A total of 1000 pts received chemotherapy alone or in combination. PRO-CTCAE-derived weekly surveys assessed severity, frequency, and interference for 16 symptoms: anxiety, constipation, cough, decreased appetite, diarrhea, fatigue, general pain, insomnia, mouth/throat sores, muscle pain, nausea, numbness and tingling, rash, sadness, shortness of breath, and vomiting. The GP5 assessed weekly overall burden from treatment. Results: The mean age of pts was 60.9 (SD=12.8) years, with 75% female, and 20% AA. At the time of enrollment, fatigue was reported by roughly 48% of AA and Caucasian (C) pts. Muscle pain was noted in 38% of AA pts, followed by general pain (33%), and anxiety (30%), with constipation, decreased appetite, insomnia, nausea, and numbness/tingling occurring in over 20% of pts. A different pattern was observed in C pts, with anxiety occurring in 38%, followed by cough, decreased appetite, general pain, insomnia, muscle pain, nausea, and numbness/tingling present in 20% of pts. The proportion of pts at least “somewhat” bothered by the side effects of treatment were similar (44% AA, 45% C). Conclusions: This study enabled evaluation of symptom burden in cancer in a population closer in racial representation to the real world than in clinical trials; with AA representation being three-fold that seen in clinical trials. Consistent with a qualitative study of AA breast cancer pts, fatigue was identified as the most frequent symptom among those treated with chemotherapy either alone or in combination in the real world. Racial differences in the proportions of pts reporting pain (muscle or general) and anxiety suggest that treating physicians should consider these symptoms to ensure they do not interfere with patients’ ability to receive full chemotherapy courses. Additionally, the levels of anxiety reported in patients highlights the importance of considering concomitant psycho-oncology treatments in cancer therapy.
Cost trends in standard-of-care cancer treatments, 2017-2021.
Authors: Judy J. Wang, Sonia Persaud, Sara Tabatabai, Nirjhar Chakraborty, Pranam Dey, Niti U. Trivedi, Aaron Philip Mitchell
Journal: Journal of Clinical Oncology (2024)

11073 Background: Financial burden of cancer care in the United States is substantial. Prior studies have explored price trends at the level of individual cancer drugs but not that of clinical indications, which can be impacted not only by changes in drug prices but also changes in standard-of-care. This study evaluates temporal trends in the cost of providing the contemporary best guideline-concordant therapy for each cancer indication. Methods: We analyzed trends in the cost of the standard-of-care treatments for the 20 most prevalent cancer types, using NCCN Guidelines to identify the standard-of-care (SOC) treatment for each indication. Our primary comparison of interest was the cost of providing the SOC treatment regimen for each indication in 2021 vs. 2017. All solid tumor treatment indications present in the NCCN Guidelines at both study time points, 7/1/2017 and 7/1/2021, were included. Indications that involved radiotherapy or stem cell transplant among the treatment options were excluded. Costs of all recommended treatment options for each included indication were calculated using Medicare reimbursement rates. We included costs of the antineoplastic agents themselves as well as necessary supportive medications. Costs were inflation-adjusted to 2021 USD. We identified the SOC treatment for every indication at both time points by referring to NCCN Evidence Blocks and identifying the regimen(s) with the highest scores (prioritizing Efficacy, then Safety, then Quality, then Consistency, in that order). If multiple SOC treatments for a single indication had identical scores, we chose the least-costly treatment. Results: 83 clinical indications across 16 solid tumor cancer types (bladder, brain, breast, colon, kidney, liver, lung, melanoma, oropharyngeal, ovary, pancreas, prostate, rectal, soft tissue, stomach, and uterus) were included. Median SOC cost was $8,364 (IQR = $3,838, $15,783) in 2017, compared to a median of $4,290 (IQR = $1,438, $14,947) in 2021. 57 indications (68.7%) had lower SOC costs in 2021 vs 2017, with median change of -$935 (IQR = -$4,432, +$452), representing a 31% decrease (IQR = -50%, 8%). Gastric cancer perioperative chemotherapy had the biggest absolute cost decrease at $65,612 (-90%), while extensive stage small cell lung cancer had the biggest absolute increase at $37,213 (706%). 45 indications (54.2%) had the same SOC regimen across this study period, of which 75.6% saw price drops. Of the 38 indications with new SOCs, 60.5% had lower costs. Conclusions: Majority of the best SOC treatments decreased in cost over a 4 year period. Although introduction of newly approved drugs can cause large price increases for some indications, more commonly the financial cost of delivering the standard-of-care treatment for a given cancer trended down due to slower-than-inflation price increases and new generic entrants.
Systemic anti-cancer therapy and cost at end of life: A SEER Medicare analysis.
Authors: Kerin B. Adelson, Lee Cheng, Yu-Ting Huang, Jiangong Niu, Hui Zhao, Nico Nortje, Jenny Jing Xiang, Sharon H. Giordano, Maureen Canavan
Journal: Journal of Clinical Oncology (2024)

11092 Background: Systemic anticancer therapy (SACT) administered near the end of life (EOL) is associated with higher costs, driven by pharmaceuticals and associated acute care use that occurs when patients continue treatment in lieu of transition to hospice. Since 2015 overall rates of systemic therapy at the EOL have remained stable, while some chemotherapy has been replaced by costly immunotherapy. It is not known whether immunotherapy is associated with the same impact on total cost of care (TCOC) as chemotherapy. We evaluated the relationship between type of SACT vs no SACT within 30 days of death on categories of cost. Methods: We identified patients from the SEER-Medicare database diagnosed between 2005 and 2019 with solid tumors (ST) and liquid tumors (LT) who died from 2015-2020. We assessed differences in Medicare cost within 30 days of death by subtype of SACT: combination chemo-immunotherapy (CI), immunotherapy only (IO), chemotherapy only (CO) and no SACT. Dependent variables were TCOC (including all Medicare claims), as well as cost of drugs, hospitalizations, emergency department (ED), and hospice normalized and adjusted for inflation. Results: 6.2% (27,317/440,349) of ST decedents and 12.7% (7,544/59,449) LT decedents received SACT at EOL. See table. Among ST patients who received SACT, the mean TCOC was $26,282 (standard deviation (SD) $26,700) and was highest among patients receiving CI, $27,973 (SD: $26,285) vs. $17,642 (SD: $29,798) for patients without SACT ( p &lt;.001). Among LT patients who received SACT, the mean TCOC was $26,282 (SD $26,700) and was highest among CI patients $33,632 (SD: $26,283) vs. $24,689 (SD: $39,735) for patients with no SACT ( p&lt;.001). We observed higher cost for drugs, hospitalizations (except for LT patients receiving CI vs. no SACT), ED and lower hospice costs for patients receiving each SACT subgroup compared with no SACT. All results except those noted in table were significant (p &lt;.001). Conclusions: Receipt of SACT within 30 days of death was associated with significantly higher Medicare costs. Higher TCOC in those who received SACT is only partially explained by drug costs; most acute care costs were also significantly higher among patients who received any type of SACT including CI, IO, CO than among those who did not. [Table: see text]
Use of artificial intelligence (Al) in augmenting prior authorisation process for financial support in hemato-lymphoid malignancies: Joint project of Navya Al and Indian Cancer Society Cancer Cure Fund (ICS-CCF).
Authors: Nehal Rishi Khanna, Anant Gokarn, Manju Sengar, Ann Rawat, Usha Thorat
Journal: Journal of Clinical Oncology (2024)

11086 Background: Hemato-lymphoid malignancies have a special urgency on time to initiate treatment and prior authorisation has relied on rapid review by domain experts. Since 2011, ICS-CCF has contributed over $32 million to cover the treatment costs of 14,600 underprivileged patients, including hematolymphoid malignancies. A mandate of ICS-CCF for this philanthropic funding is to choose beneficiaries who have a high chance of cure with standard of care. For this, a Due Diligence Team (DDT) of expert oncologists and the Governing Advisory Council (GAC) of ICS-CCF sequentially adjudicate every application. To augment and scale up this process, in Feb 2021, ICS-CCF evaluated and implemented the use of Al for prior-authorizations. Navya Al is a clinically validated Al model that matches clinical data of applicants with available evidence and registry data to predict survival, and generates payor/national guidelines based optimal treatment plans. Since Feb 2021, 80% of applications are adjudicated by Navya Al with a 99% concordance with GAC. Methods: This study was planned to assess the impact of Navya Al on the process of prior authorisation in a cohort of adult and pediatric hemato-lymphoid malignancies. All patients evaluated by Navya AI alone or with DDT from February 2021 to July 2023 were analyzed. Adjudication rates reflecting effort and time savings were calculated as the % of patients for whom Navya Al could make a decision on its own without referring to the DDT for review. Results: Of the 5775 applications reviewed by Navya Al, 2255(39.04%) were hematolymphoid malignancies. 37.16%(838/2255) of patients were pediatric (Age&lt;=15years) and 62.8%(1417/2255) were adults (Age&gt;15 years). Of these 2255, Navya AI alone adjudicated 73.61%(1660/2255) cases and 25.36%(572/2255) were referred to DDT for adjudication. Analysis was done on 2232 cases excluding the 1.01%(23/2255) reapplication cases. Details in table. Conclusions: With Al, only one fourth of beneficiary applications with hematolymphoid malignancies need expert review for prior authorisation. Implementation of AI has potential to save time in the authorization process for philanthropic funding for governmental and non governmental health care schemes. [Table: see text]
Patient reported colonoscopy barriers: A cross sectional survey.
Authors: Stanley Ozogbo, Isabella Francisco, David Gemmel
Journal: Journal of Clinical Oncology (2024)

e23149 Background: As a leading cause of cancer-related death in the United States, colorectal cancer (CRC) screening is an acceptable cost-effective strategy to reducing mortality indices in the country. 10-yearly colonoscopy screening is the most effective with a mortality reduction of 73%. Despite this, CRC screening rates remain low. The purpose of this study was to describe barriers associated with colonoscopy screening in primary care settings. Methods: Postage pre-paid return envelopes and surveys were sent to all established patients aged &gt; 50 from primary care practices (n = 4) in an employed physician group; the group also serves as a residency continuity clinic for a community teaching hospital. Variables included demographics and literature-reported barriers to colonoscopy screening. Whether or not a patient had a colonoscopy (including if &gt; 10 years since a colonoscopy) was compared to patient reported barriers and demographics. Statistical significance was set at p &lt; 0.05; strength of association was measured by Cramer’s V. Results: Average age of patients was 62 + 6 years; 61.4% were female; 35.3% were privately insured; and 10.3% were non-white. Older patients were slightly more likely to get screened, 63 + 6 years vs. 60 + 7 years (p = 0.006). Neither race, sex, insurance guarantor, education, marital status or income were associated with screening. Rate of colonoscopy screening in this series was 76.7% (n = 276/360), which was greater than rates reported by CDC for Ohio. In those screened, the rate of colonic or rectal polyps was remarkably noted to be up to 47.5% (131/276). The most important barriers to colonoscopy screening were knowledge of insurance coverage (p &lt; 0.001; Cramer’s V = 0.216, p &lt; 0.001); transportation to procedure (p = 0.001; Cramer’s V = 0.172, p = 0.001); someone to accompany patient (p = 0.002; Cramer’s V = 0.164, p = 0.002); and unaware of screening or lack of perceived health threat (p = 0.019; Cramer’s V = 0.150, p = 0.019). The remaining barriers were not associated with increased likelihood of colonoscopy: fear of finding cancer, belief in screening effectiveness, embarrassment or anxiety, or fear of invasive test. While bowel prep is often cited as a barrier to colonoscopy, this factor was not statistically significant. Likewise, physician-initiated discussion and time off from employment were not associated with screening. The most important colonoscopy barrier was patient knowledge regarding insurance for the procedure; overall, 29% of patients reported that they were unsure if colonoscopy was covered. Among those not screened, the rate rose to 47%. Conclusions: The most important colonoscopy barrier identified was patient knowledge regarding insurance for the procedure. While physician counseling for colonoscopy needs to include bowel prep and procedure risks, greater awareness of insurance coverage and social factors may facilitate physician understanding of colonoscopy screening hesitancy.
Patient-reported outcomes corresponding to most common symptomatic adverse events in lung cancer clinical trials.
Authors: Erica Horodniceanu, Tejaswi Datla, Erin A. Larkins, Harpreet Singh, Paul Gustav Kluetz, Vishal Bhatnagar
Journal: Journal of Clinical Oncology (2024)

11103 Background: FDA recommends assessing the most relevant expected symptomatic adverse events (AEs) with patient-reported outcomes (PROs) in cancer clinical trials (CTs) to complement traditional safety data. To inform selection of symptomatic AEs, we previously identified the most common (i.e., all-grade, clinician-reported in ≥20% of patients) symptomatic AEs from FDA-approved lung cancer product approvals from 2015 through 2021 based on CT monotherapy experimental arm safety data from US Prescribing Information (USPI). The present research aims to assess whether these CTs included PROs which adequately captured common symptomatic AEs. Methods: We assessed 30 CTs that supported lung cancer approvals from 2015 through 2021. We reviewed the study protocol, statistical analysis plan, and/or clinical study report to determine the PRO measures included. We matched symptoms included within PRO measures and items to the most common clinician-reported symptomatic AEs per the USPI to determine the extent to which the PROs and symptomatic AEs corresponded. Results: Twenty-three out of 30 (77%) CTs supporting non-small cell lung cancer (NSCLC) approvals included PRO(s). Nineteen included more than one PRO measure. The most frequently used PRO measures were the European Organisation for Research and Treatment of Cancer-Core Questionnaire (EORTC QLQ-C30; n=19), EORTC-Lung Cancer (EORTC QLQ-L13; n=17), EuroQoL 5-Dimension (EQ-5D; n=12), and selected items from the Patient-reported Outcomes version of the Common Terminology Criteria for Adverse Events item library (PRO-CTCAE; n=4). Nearly all (20 of 23) CTs included PRO items corresponding to more than half of the common symptomatic AEs reported. Symptomatic AEs for types of pain corresponded to general pain PRO items (e.g., “musculoskeletal pain” matched to EORTC item for “pain”). However, PRO items for specific types of pain were not often used. While important symptomatic AEs such as fatigue, diarrhea, nausea, and decreased appetite were often assessed by PROs, others including rash and edema were not usually captured. Ultimately, only 4 of 23 (17%) CTs with PROs included items that assessed all symptomatic AEs that occurred in ≥20% of patients. Of the 4 CTs which included an item library, 3 (75%) comprehensively assessed patient-reported symptomatic AEs, compared to 3 of 19 (16%) CTs that did not employ an item library for patient-reported symptom collection. Conclusions: Based on USPI safety data and PRO measures from CT monotherapy experimental arms of recently approved NSCLC cancer drugs, we determined that while the majority of CTs include PRO items for some relevant symptomatic AEs, other important expected symptomatic AEs (e.g., edema, rash, specific types of pain) were not measured. Future NSCLC CTs should include PRO items for common expected symptomatic AEs which is feasible using well-established PRO item libraries.