"Having cancer is very expensive": A qualitative study of patients with ovarian cancer and PARP inhibitor treatment.

OBJECTIVE: To examine patient barriers and facilitators to PARP inhibitor (PARP-I) maintenance therapy in ovarian cancer. PARP-I improves survival in ovarian cancer, but these multi-year therapies cost around $100,000 annually and are under-prescribed. METHODS: We recruited patients with ovarian cancer treated with PARP-I maintenance therapy at an academic health system for a semi-structured interview. Patient demographics, including genetics and PARP-I cost, were self-reported. We assessed patient experiences with barriers and facilitators of PARP-I usage. Two team members used a thematic approach to analyze and identify key themes. RESULTS: In May 2022, we interviewed 10 patients (mean age = 65 years; 80% White; 60% with a germline genetic mutation). Patients paid on average $227.50 monthly for PARP-I, straining resources for some participants. While sampled patients were insured, all patients identified having no or inadequate insurance as a major barrier to PARP-I. At the same time, all participants prioritized clinical effectiveness over costs of care. Patients identified PARP-I delivery from specialty pharmacies, separate and different from other medications, as a potential barrier, but each had been able to navigate delivery. Patients expressed significant initial side effects of PARP-I as a potential barrier yet reported clinician communication and prompt dose reduction as facilitating continuation. CONCLUSIONS: Patients identified cost, restrictive pharmacy benefits, and initial side effects as barriers to PARP-I usage. Having insurance and a supportive care team were identified as facilitators. Enhancing communication about PARP-I cost and side effects could improve patient experience and receipt of evidence-based maintenance therapy in ovarian cancer.

Ovarian Cancer Isn't Just a White Woman's Disease.

This Viewpoint highlights the need for recognition that ovarian cancer affects women from racial and ethnic minority groups worldwide and that the rates of ovarian cancer are increasing in those populations while decreasing among White women.

Addressing transportation barriers in oncology: existing programs and new solutions.

Transportation is an underrecognized, but modifiable barrier to accessing cancer care, especially for clinical trials. Clinicians, insurers, and health systems can screen patients for transportation needs and link them to transportation. Direct transportation services (i.e., ride-sharing, insurance-provided transportation) have high rates of patient satisfaction and visit completion. Patient financial reimbursements provide necessary funds to counteract the effects of transportation barriers, which can lead to higher trial enrollment, especially for low socioeconomic status and racially and ethnically diverse patients. Expanding transportation interventions to more cancer patients, and addressing knowledge, service, and system gaps, can help more patients access needed cancer care.

Financial toxicity in gynecologic oncology: a multi-practice survey.

BACKGROUND: Financial toxicity is associated with worse cancer outcomes, including lower survival. OBJECTIVE: To characterize the prevalence of, and patient risk factors for, financial toxicity among gynecologic oncology patients in a multi-site health system. METHODS: We identified patients seen in University of Pennsylvania gynecologic oncology practices between January 2020 and February 2022 with a patient portal account. We sent a survey to all alive patients twice between March and April 2022, including the 11-item Comprehensive Score for Financial Toxicity (COST) tool. We compared differences between patients reporting high (COST score <26) and low financial toxicity (COST score ≥26) in Χ2 and regression analyses. RESULTS: Of 8239 patients, 6925 had a portal account, and 498 completed the survey for 7.2% response rate. 44% had a COST score <26, indicating financial toxicity. Patients with high financial toxicity were more likely to be younger (mean age 54 vs 60), have cervical cancer (10% vs 4%; p=0.008), be privately insured (71% vs 57%; p=0.003) or have Medicaid (7% vs 3%; p=0.03), or be unemployed (18% vs 3%; p=<0.001), and less likely to be white (79% vs 90%, p=0.003) than those with low financial toxicity. Patients with Medicare were less likely to experience financial toxicity than privately insured patients (RR=0.59, 95% CI 0.37 to 0.95). CONCLUSION: In this study of patients with gynecologic cancer or pre-cancer, 44% had financial toxicity. Financial toxicity was higher in patients who were younger, did not identify as White, and had private insurance. Targeted measures to address financial toxicity are needed to minimize disparities in patient burden of cancer treatment.

Federal Transportation Regulations Limit Access to Clinical Trials and Oncology Care.

This Viewpoint discusses how improving accessibility to oncology services will lead to more equitable care for patients with cancer.

Prior authorization for FDA-approved PARP inhibitors in ovarian cancer.

Objectives: PARP inhibitors (PARP-I) improve survival in ovarian cancer, especially in patients with germline or somatic BRCA mutations or other homologous recombination deficiency (HRD). With high efficacy and costs, insurers may enact barriers or facilitators to PARP-I. Our objective was to examine the prevalence of prior authorization for PARP-I in ovarian cancer. Methods: We performed a retrospective cross-sectional study of patients with ovarian cancer prescribed a PARP-I within the University of Pennsylvania practices from December 2018 through May 2021. We assessed prevalence of prior authorization for PARP-I overall, by frontline or recurrent maintenance, and by genetic status. We then assessed approval and appeal rates and time to PARP-I start. Results: Of 180 patients with a PARP-I prescription and information regarding prior authorization, 116 (64 %, 95 % CI 57-71) experienced prior authorization. Of patients in the frontline setting, 60 of 90 (67 %, 95 % CI 56-76) experienced prior authorization. Of patients prescribed PARP-I in recurrence, 55 of 85 (65 %, 95 % CI 54-74) experienced prior authorization. Having a germline or somatic genetic mutation was associated with higher risk of prior authorization (adjusted risk ratio 1.35, 95 %CI 1.09-1.67). 102 patients (89 %, 95 % CI 83-94) required one appeal, 8 required two appeals and 5 cases required 3 appeals. Five patients were denied. Mean time from PARP-I prescription to PARP-I start was 10 days longer for patients who experienced prior authorization. Conclusions: 64% of patients experienced prior authorization for PARP-I. Risk of prior authorization was increased for patients with BRCA, despite greater clinical benefit. Prior authorization contributes to delays in care, and reform is needed.

Variation in telemedicine usage in gynecologic cancer: Are we widening or narrowing disparities?

INTRODUCTION: Telemedicine rapidly increased with the COVID-19 pandemic and could reduce cancer care disparities. Our objective was to evaluate sociodemographic (race, insurance), patient, health system, and cancer factors associated with telemedicine use in gynecologic cancers. METHODS: We conducted a retrospective cohort study of patients with endometrial cancer and epithelial ovarian cancer with at least one visit from March 2020 to October 2021, using a real-world electronic health record-derived database, representing approximately 800 sites in US academic (14%) and community practices (86%). We used multivariable Poisson regression modeling to analyze the association of ever using telemedicine with patient, sociodemographic, health system, and cancer factors. RESULTS: Of 3950 patients with ovarian cancer, 1119 (28.3%) had at least one telemedicine visit. Of 2510 patients with endometrial cancer, 720 (28.7%) had at least one telemedicine visit. At community cancer practices, patients who identified as Black were less likely to have a telemedicine visit than patients who identified as white in both ovarian and endometrial cancer (Ovarian: RR 0.62, 95% CI 0.42-0.9; Endometrial: RR 0.56, 95% CI 0.38-0.83). Patients in the Southeast, Midwest, West, and Puerto Rico were less likely to have telemedicine visits than patients in the Northeast. Uninsured patients were less likely, and patients with Medicare were more likely, to have one or more telemedicine visit than patients with private insurance. CONCLUSIONS: In this national cohort study, <30% of patients ever used telemedicine, and significant racial and regional disparities existed in utilization. Telemedicine expansion efforts should include programs to improve equity in access to telemedicine.

Insurance status and time to radiation care after pathologic diagnosis for cervical cancer patients.

Delays in starting potentially curative treatment for locally-advanced cervical cancer (LACC) decrease survival. Reasons for these delays are poorly understood. We conducted a retrospective chart review examining disparities in time from diagnosis of LACC to first clinic visit and to initiation of treatment based on insurance status within a single health system. We analyzed time to treatment using multivariate regression, adjusted for race, age, and insurance status. 25% of patients had Medicaid and 53% had private insurance. Having Medicaid was associated with delayed time from diagnosis to seeing a radiation oncologist (Mean 76.9 v. 31.3 days, p = 0.03). However, time from first radiation oncology visit to starting radiation was not delayed (Mean 22.6 v. 22.2 days, p = 0.67). Patients with locally-advanced cervical cancer and Medicaid had over double the time from pathologic diagnosis of cervical cancer to seeing radiation oncology; insurance disparities were not observed in treatment start after seeing radiation oncology. Improved referral and navigation processes for patients with Medicaid are needed to improve timely receipt of radiation and potentially improve survival.

Disparities in clinical trial participation in ovarian cancer: A real-world analysis.

BACKGROUND: Significant disparities exist in clinical trial participation in non-gynecologic cancers, but little is known about disparities in ovarian cancer trial participation. Our objective was to examine patient, sociodemographic (race/ethnicity, insurance), cancer, and health system factors associated with clinical trial participation in ovarian cancer. METHODS: We conducted a retrospective cohort study of patients with epithelial ovarian cancer diagnosed from 2011 to 2021, using a real-world electronic health record derived database, representing around 800 sites of care in US academic and community practices. We used multivariable Poisson regression modeling to analyze the association of ever participating in an ovarian cancer clinical drug trial with patient, sociodemographic, health system, and cancer factors. RESULTS: Of the 7540 patients with ovarian cancer, 5.0% (95% CI 4.5-5.5) ever participated in a clinical drug trial. Patients of Hispanic or Latino ethnicity were 71% less likely to participate in clinical trials (RR 0.29, 95% CI 0.13-0.61) than non-Hispanic patients, and patients whose race was unknown or other than Black or White were 40% less likely to participate in clinical trials (RR 0.68, 95% CI 0.52-0.89). Patients who had Medicaid insurance were 51% less likely (RR 0.49, 95% CI 0.28-0.87) and those with Medicare were 32% (RR 0.48-0.97) less likely to participate in clinical trials than privately-insured patients. CONCLUSION: In this national cohort study, only 5% of patients with ovarian cancer participated in clinical drug trials. Interventions are needed to decrease race, ethnicity, and insurance disparities in clinical trial participation.

Long-term impact of the Affordable Care Act's dependent coverage mandate on young women with gynecologic cancer.

BACKGROUND: The dependent coverage mandate in the 2010 Affordable Care Act (ACA) allows young adults to stay on a parent's private insurance through age 26. While this mandate is associated with gains in insurance and early-stage cancer diagnosis, its long-term impact on survival is unknown. OBJECTIVE: To compare insurance coverage, stage at diagnosis, and overall survival in patients with gynecologic cancer before and after the ACA's dependent coverage mandate. METHODS: Using difference-in-differences (DiD) analysis, we conducted a retrospective cohort study comparing outcomes before and after the implementation of the ACA's dependent coverage mandate in young patients with gynecologic cancer, ages 18-26 years (exposure group) to patients ages 27-35 (control group). We analyzed insurance coverage, stage at diagnosis, and 1, 2, and 3-year overall survival, adjusted for age and comorbidities, utilizing the 2004-2017 National Cancer Database. IRB exemption was obtained. RESULTS: A total of 3553 cases pre-reform and 4535 cases post-reform were identified for patients 18-26 years compared to 14,420 pre-reform and 19,821 post-reform for patients age 27-35. The ACA's dependent coverage mandate was associated with significant gains in insurance (DiD 2%, 95% CI 0.6-3.5) and early-stage diagnosis (3.1%, 95% CI 0.6-5.7). The ACA's dependent coverage mandate was associated with significant gains in 3-year survival (2.4%, 95% CI 0.4-4.3) and non-significant gains in 1 and 2-year survival. CONCLUSION: The ACA's dependent coverage mandate is associated with improvements in early-stage diagnosis and survival for young patients with gynecologic cancer. Maintaining insurance gains-and expanding to the remaining uninsured-are critical for the health of young patients with gynecologic cancer.

Insurance and racial disparities in prior authorization in gynecologic oncology.

While prior authorization aims to reduce unnecessary care, it may limit or delay medically necessary care. Delays in cancer care can impact survival and are more common in historically-marginalized populations. Our objective was to examine to what extent disparities occurred in prior authorizations for gynecologic oncology. Using electronic medical records, we performed a retrospective review of prior authorization occurrence during gynecologic oncology care and analyzed the association with patient race and insurance in a multivariate regression model. In this cohort of 1,406 patients treated at an academic gynecologic oncology practice, patients with Medicare Advantage and patients of Asian descent were more likely to experience prior authorization. Addressing insurance-mediate disparities, such as in the occurrence of prior authorization, may help reduce disparities in gynecologic cancer care.

Disparities in Diagnosis and Treatment of Cervical Adenocarcinoma Compared With Squamous Cell Carcinoma: An Analysis of the National Cancer Database, 2004-2017.

OBJECTIVES: The aim of the study are to compare trends in diagnosis and treatment of adenocarcinoma of the cervix (AC) to squamous cell carcinoma of the cervix (SCC) and to examine associations between stage at diagnosis and guideline-concordant treatment with race, age, and insurance type for AC and SCC. MATERIALS AND METHODS: We performed a retrospective cohort study of cervical AC ( n = 18,811) and SCC ( n = 68,421) from the 2004-2017 National Cancer Database. We used generalized linear models to evaluate trends in frequency of histologies and to evaluate associations between race, age, and insurance status with stage of diagnosis and receipt of National Comprehensive Cancer Network guideline-concordant treatment for AC and SCC. RESULTS: The proportion of AC relative to SCC increased from 19.4% (95% CI = 18.4-20.5) to 23.2% (95% CI = 22.2-24.2) from 2004 to 2017 ( p < .001). Compared with SCC, women with AC were younger, more likely to be White, and privately insured ( p < .001). Older women with AC were 44% less likely to be diagnosed with early-stage disease than younger women (adjusted relative risk = 0.56, 95% CI = 0.52-0.60); there was no significant difference for SCC. Black women with AC were 16% less likely to be diagnosed with early-stage disease (adjusted relative risk [aRR] = 0.84, 95% CI = 0.79-0.89) than White women. Women with public insurance were less likely to be diagnosed at an early stage for both AC (aRR = 0.81, 95% CI = 0.78-0.84) and SCC (aRR = 0.79, 95% CI = 0.77-0.81). Rates of guideline-concordant treatment were similar for AC and SCC, with minimal differences by age, race, and insurance. CONCLUSIONS: As the proportion of AC to SCC rises, important race and age-related disparities must be addressed to reduce unnecessary morbidity and death.

Effects of Dietary Habits on General and Abdominal Obesity in Community-dwelling Patients with Schizophrenia

Objective@#To investigate the effects of dietary habits on general and abdominal obesity in community-dwelling patients with schizophrenia spectrum disorder according to sex. @*Methods@#A total of 270 patients with schizophrenia spectrum disorder registered at mental health welfare centers and rehabilitation facilities were recruited. General obesity was defined as a body mass index ≥ 30 kg/m 2 , and abdominal obesity was defined as a waist circumstance ≥ 90 cm in men and ≥ 85 cm in women. Dietary habits were evaluated using dietary guidelines published by the Korean Ministry of Health and Welfare. Demographic and clinical characteristics along with dietary habits and information related to obesity were collected. Factors related to obesity were evaluated separately by sex. @*Results@#Dietary habits differed according to sex, in that scores for healthy eating habits were lower in men than in women. In men, the prevalences of general and abdominal obesity were 17.0% and 37.3%, respectively. In women, the prevalences of general and abdominal obesity were 23.1% and 38.5%, respectively. Regression analysis showed that the scores of regular eating habits were negatively associated with general and abdominal obesity in men, and the scores of healthy eating habits were negatively associated with general and abdominal obesity in women. @*Conclusion@#Among patients with schizophrenia, regular eating habits might reduce the risk of obesity in men, and healthy eating habits might reduce the risk of obesity in women. Nutrition education should be provided to community-dwelling patients with schizophrenia to prevent obesity in this population.

Effectiveness of Switching to Long-acting Injectable Aripiprazole in Patients with Recent-onset and Chronic Schizophrenia

Objective@#This study investigated the effectiveness of switching to once-monthly long-acting injectable (LAI) aripiprazole from other second-generation antipsychotics including LAI paliperidone palmitate in both recent-onset and chronic schizophrenia patients. @*Methods@#This was a 24-week prospective, open-label, flexible dose-switching study in patients with schizophrenia. Scores on the Positive and Negative Syndrome Scale (PANSS), Personal and Social Performance (PSP) scale, Clinical Global Impression (CGI), Subjective Well-being Under Neuroleptics−Short Form (SWN-K), and a computerized emotional recognition test (ERT) were evaluated. Subjects were divided into two groups (recent onset and chronic) based on 5 years’ duration of the illness. @*Results@#Among the 82 patients participating, 67 (81.7%) completed the 24-week study. The discontinuation rate after switching to LAI aripiprazole did not differ according to clinical characteristics including type of previous antipsychotics. Scores on the PANSS, PSP, SWN-K, CGI, and ERT were significantly improved after a switch to LAI aripiprazole without exacerbation of metabolic parameters and bodyweight. The improvements in the PANSS, PSP, and CGI scores were significantly greater in patients with recent-onset than in those with chronic schizophrenia; the improvement in metabolic parameters was significantly greater in the latter group. @*Conclusion@#High rates of successful switching to LAI aripiprazole from other antipsychotics suggest its good tolerability and effectiveness. Improvements in psychopathology and social functioning were more evident in patients with recent-onset schizophrenia, and improvements in metabolic abnormalities were more prominent in patients with chronic schizophrenia.

Prior authorization in gynecologic oncology: An analysis of clinical impact.

BACKGROUND: Prior authorization was designed to minimize unnecessary care and reduce spending but has been associated with delays in necessary care. Our objective was to estimate the occurrence of prior authorization, and impact on cancer care, in gynecologic oncology. METHODS: We performed a retrospective cross-sectional study of patients seen in University of Pennsylvania gynecologic oncology practices (January-March 2021). Using electronic medical records, we measured the incidence of prior authorization during the 3-month period and prior experience of prior authorization for cancer care overall and by type of order (chemotherapy, imaging, surgery, prescription drugs). We assessed the impact of prior authorization occurrence on clinical outcomes (time to service, changes in care). RESULTS: Of the 2112 clinic visits of 1406 unique patients, 5% experienced prior authorization during the 3-month study period. An additional 20% faced prior authorization requests earlier in cancer care. Of the 83 prior authorization requests, imaging accounted for the majority (54%) followed by supportive medications (29%) and chemotherapy (17%). After appeal, 79% of cases were approved. For patients whose prior authorizations were approved, there was a mean of 16 days from order placement to care delivery (95% CI 11-20, range 0-98 days). Of the 17 denials, 3 (18%) led to a substantial change in care (i.e., not receiving planned treatment). CONCLUSION: 25% of gynecologic oncology patients experienced prior authorization during their cancer care. While 80% of claims were ultimately approved, patients experienced over a 2-week delay in care when prior authorization occurred. Reform is needed to reduce the burden of prior authorization in oncology.

Association of the Affordable Care Act's Medicaid Expansion With 1-Year Survival Among Patients With Ovarian Cancer.

OBJECTIVE: The Affordable Care Act's (ACA) 2014 Medicaid expansion is associated with gains in insurance and early-stage diagnosis among patients with gynecologic cancer, but its association with mortality remains unknown. This study aims to assess whether the ACA's Medicaid expansion was associated with improved survival among patients with ovarian cancer. METHODS: In this retrospective cohort study of patients with newly diagnosed ovarian cancer, we compared 1-year survival before and after 2014 Medicaid expansion in patients aged 40-64 years in Medicaid expansion states (intervention group) to patients aged 40-64 years in non-Medicaid expansion states using a difference-in-difference analysis. Results were adjusted for age, comorbidities, treatment at an academic center, and variables associated with Medicaid insurance status (race, income, high-school education, distance traveled for care, and living in a rural area). RESULTS: Our sample included 19,558 patients with ovarian cancer: 9,013 in Medicaid expansion states and 10,545 in nonexpansion states. The ACA's Medicaid expansion was associated with increased 1-year survival among patients in expansion states compared with nonexpansion states (adjusted difference-in-difference 2.2%, 95% CI 0.4-4.1). After adding stage at diagnosis, the mortality difference between expansion and nonexpansion states was no longer evident. Medicaid expansion was associated with a significant improvement in 1-year survival for White patients (2.4%, 95% CI 0.4-4.4), but the difference was not significant for Black patients (1.3%, 95% CI -5.7 to 8.2) or rural patients (9.5%, 95% CI -8.0 to 26.9). CONCLUSION: The ACA's Medicaid expansion was associated with improvements in 1-year survival among patients with ovarian cancer, which was mediated by an earlier stage at diagnosis. Continued insurance expansion to nonexpansion states may improve survival and reduce disparities for patients with ovarian cancer.

Modifiable risk factors associated with long-term survival in women with serous ovarian cancer: a National Cancer Database study.

OBJECTIVE: To identify patient, clinical and hospital factors associated with long-term survival (≥10 years) in women with serous ovarian cancer. METHODS: This National Cancer Database cohort study included women with stage II-IV serous ovarian cancer. Multivariate logistic regression models were used to examine the association of long-term survival with patient (race, insurance, location, household income, education, distance traveled), clinical (age, comorbidities, stage, grade, primary treatment) and hospital factors (region, institution, hospital volume ≥20). RESULTS: Of the 4640 women identified, 12% (n=561) experienced long-term survival. Median overall survival was 41 months (95% CI 39 to 42). The odds of long-term survival were lower for women with public or no insurance (adjusted OR 0.71, 95% CI 0.55 to 0.92), age ≥75 years (0.33, 0.22 to 0.50), any comorbidities (0.70, 0.54 to 0.92), higher stage (stage III: 0.31, 0.25 to 0.41; stage IV: 0.16, 0.12 to 0.22), and moderately/poorly differentiated, undifferentiated, or tumors of unknown grade (moderately/poorly differentiated: 0.30, 0.20 to 0.47; undifferentiated: 0.28, 0.17 to 0.47; unknown: 0.30, 0.18 to 0.50). The odds of long-term survival among women who were publicly insured were lower with neoadjuvant chemotherapy (0.13, 0.04 to 0.044) and higher with optimal cytoreduction (2.24, 1.49 to 3.36). Among women who were privately insured, the odds of long-term survival were higher with optimal cytoreduction (1.99, 1.46 to 2.70) and unaffected by neoadjuvant chemotherapy. CONCLUSIONS: While immutable clinical factors such as age, stage, and grade are associated with long-term survival in women with serous ovarian cancer, modifiable factors, such as insurance type, optimal cytoreductive status, and neoadjuvant chemotherapy provide an opportunity for targeted improvement in care with potential to affect long-term patient outcomes.