Real-World Utilization of Oral Anticancer Agents and Related Costs in Older Adults with Metastatic Renal Cell Carcinoma in the United States

BACKGROUND: Substantial racial and socioeconomic disparities in metastatic RCC (mRCC) have persisted following the introduction of targeted oral anticancer agents (OAAs). The relationship between patient characteristics and OAA access and costs that may underlie persistent disparities in mRCC outcomes have not been examined in a nationally representative patient population. METHODS: Retrospective SEER-Medicare analysis of patients diagnosed with mRCC between 2007-2015 over age 65 with Medicare part D prescription drug coverage. Associations between patient characteristics, OAA receipt, and associated costs were analyzed in the 12 months following mRCC diagnosis and adjusted to 2015 dollars. RESULTS: 2,792 patients met inclusion criteria, of which 32.4%received an OAA. Most patients received sunitinib (57%) or pazopanib (28%) as their first oral therapy. Receipt of OAA did not differ by race/ethnicity or socioeconomic indicators. Patients of advanced age (>80 years), unmarried patients, and patients residing in the Southern US were less likely to receive OAAs. The mean inflation-adjusted 30-day cost to Medicare of a patient's first OAA prescription nearly doubled from $3864 in 2007 to$7482 in 2015, while patient out-of-pocket cost decreased from $2409 to$1477. CONCLUSION: Race, ethnicity, and socioeconomic status were not associated with decreased OAA receipt in patients with mRCC; however, residing in the Southern United States was, as was marital status. Surprisingly, the cost to Medicare of an initial OAA prescription nearly doubled from 2007 to 2015, while patient out-of-pocket costs decreased substantially. Shifts in OAA costs may have significant economic implications in the era of personalized medicine

Validity of breast cancer surgery treatment information in a state-based cancer registry

Purpose: Surgery is an important part of early stage breast cancer treatment that affects overall survival. Many studies of surgical treatment of breast cancer rely on data sources that condition on continuous insurance coverage or treatment at specified facilities and thus under-sample populations especially affected by cancer care inequities including the uninsured and rural populations. Statewide cancer registries contain data on first course of cancer treatment for all patients diagnosed with cancer but the accuracy of these data are uncertain. Methods: Patients diagnosed with stage I–III breast cancer between 2003 and 2016 were identified using the North Carolina Central Cancer Registry and linked to Medicaid, Medicare, and private insurance claims. We calculated the sensitivity, specificity, positive predictive value, negative predictive value, and Kappa statistics for receipt of surgery and type of surgery (breast conserving surgery or mastectomy) using the insurance claims as the presumed gold standard. Analyses were stratified by race, insurance type, and rurality. Results: Of 26,819 patients who met eligibility criteria, 23,125 were identified as having surgery in both the claims and registry for a sensitivity of 97.9% (95% CI 97.8%, 98.1%). There was also strong agreement for surgery type between the cancer registry and the insurance claims (Kappa: 0.91). Registry treatment data validity was lower for Medicaid insured patients than for Medicare and commercially insured patients. Conclusions: Cancer registry treatment data reliably identified receipt and type of breast cancer surgery. Cancer registries are an important source of data for understanding cancer care in underrepresented populations

An updated systematic review of the cost-effectiveness of therapies for metastatic breast cancer

Purpose: The goal of this systematic review is to provide an update to the review by Pouwels et al. by conducting a systematic review and an assessment of the reporting quality of the economic analyses conducted since 2014. Methods: This systematic review identified published articles focused on metastatic breast cancer treatment using the Medline/PubMed and Scopus databases and the following search criteria: (((cost effectiveness[MeSH Terms]) OR (cost effectiveness) OR (cost-effectiveness) OR (cost utility) OR (cost–utility) OR (economic evaluation)) AND ((“metastatic breast cancer”) OR (“advanced breast cancer”))). The reporting quality of the included articles was evaluated using the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) Consolidated Health Economic Evaluation Reporting Standards (CHEERS) checklist. Results: Of the 256 identified articles, 67 of the articles were published after October 2014 when the prior systematic review stopped its assessment (Pouwels et al. in Breast Cancer Res Treat 165:485–498, 2017). From the 67 articles, we narrowed down to include 17 original health economic analyses specific to metastatic or advanced breast cancer. These articles were diverse with respect to methods employed and interventions included. Conclusion: Although each of the articles contributed their own analytic strengths and limitations, the overall quality of the studies was moderate. The review demonstrated that the vast majority of the reported incremental cost-effectiveness ratios exceeded the typically employed willingness to pay thresholds used in each country of analysis. Only three of the reviewed articles studied chemotherapies rather than treatments targeting either HER2 or hormone receptors, demonstrating a gap in the literature

Patterns and Predictors of Oral Anticancer Agent Use in Diverse Patients with Metastatic Renal Cell Carcinoma

PURPOSE Availability of targeted oral anticancer agents (OAAs) has transformed care for patients with metastatic renal cell carcinoma (mRCC). Our objective was to identify patterns and predictors of OAA use within 12 months after mRCC was detected to understand real-world adoption of OAAs. METHODS We used a novel, North Carolina cancer registry–linked multipayer claims data resource to examine patterns of use of five oral therapies among patients with mRCC diagnosed in 2006-2015, with claims through 2016. Patients were required to have 12 months of continuous enrollment before metastatic index date. Log-Poisson models estimated unadjusted and adjusted risk ratios (RRs) for associations between patient characteristics and OAA use. In sensitivity analyses, we used a competing risk framework to estimate adjusted risk differences in OAA use. RESULTS Our population-based study of 713 patients demonstrated low (37%) OAA use during the first year after metastatic index date among both publicly and privately insured patients, with shifting patterns of use consistent with regulatory approvals over time. Compared with patients age 18-49 years, patients age 70-74 years were half likely to use OAAs (95% confidence limit [CL], 0.34 to 0.78) and patients age 801 years were 71% less likely to use OAAs (95% CL, 0.17 to 0.50). Patients with two comorbidities (RR, 0.73; 95% CL, 0.55 to 0.98) and those with 31 comorbidities (RR, 0.68; 95% CL, 0.50 to 0.91) were less likely to receive OAA than those without comorbidities. Patients with higher frailty also had lower OAA utilization (RR, 0.67; 95% CL, 0.52 to 0.85). CONCLUSION These findings suggest a need to better understand the system-level and provider-level drivers of OAA underuse, as well as OAA adherence and associated survival

Evaluating the urban-rural paradox: The complicated relationship between distance and the receipt of guideline-concordant care among cervical cancer patients

Objective: Urban-rural health disparities are often attributed to the longer distances rural patients travel to receive care. However, a recent study suggests that distance to care may affect urban and rural cancer patients differentially. We examined whether this urban-rural paradox exists among patients with cervical cancer. Methods: We identified individuals diagnosed with cervical cancer from 2004 to 2013 using a statewide cancer registry linked to multi-payer, insurance claims. Our primary outcome was receipt of guideline-concordant care: surgery for stages IA1–IB1; external beam radiation therapy (EBRT), concomitant chemotherapy, and brachytherapy for stages IB2–IVA. We estimated risk ratios (RR) using modified Poisson regressions, stratified by urban/rural location, to examine the association between distance to nearest facility and receipt of treatment. Results: 62% of 999 cervical cancer patients received guideline-concordant care. The association between distance and receipt of care differed by type of treatment. In urban areas, cancer patients who lived ≥15 miles from the nearest surgical facility were less likely to receive primary surgical management compared to those <5 miles from the nearest surgical facility (RR: 0.77, 95% CI: 0.60–0.98). In rural areas, patients living ≥15 miles from the nearest brachytherapy facility were more likely to receive treatment compared to those <5 miles from the nearest brachytherapy facility (RR: 1.71, 95% CI: 1.14–2.58). Distance was not associated with the receipt of chemotherapy or EBRT. Conclusions: Among cervical cancer patients, there is evidence supporting the urban-rural paradox, i.e., geographic distance to cancer care facilities is not consistently associated with treatment receipt in expected or consistent ways. Healthcare systems must consider the diverse and differential barriers encountered by urban and rural residents to improve access to high quality cancer care

Oral Anticancer Agent (OAA) Adherence and Survival in Elderly Patients With Metastatic Renal Cell Carcinoma (mRCC)

Objective: To examine real-world adherence to oral anticancer agents (OAAs) and its association with outcomes among Medicare beneficiaries with metastatic renal cell carcinoma (mRCC). Methods: SEER-Medicare retrospective cohort study of patients with metastatic renal cell carcinoma (mRCC) who received an OAA between 2007 and 2015. We examined A) adherence and B) overall and disease-specific 2-year survival landmarked at 3 months after OAA initiation. Adherence was assessed by calculating the proportion of days covered (PDC) within 3 months of OAA initiation, with adherent use being defined as PDC > 80%. Results: A total of 905 patients met study criteria, of whom 445 patients (49.2%) were categorized as adherent to initial OAA treatment. Adjusting for clinical and demographic factors revealed decreased odds of adherence associated with living within an impoverished neighborhood (OR 0.49, CI 0.0.33 – 0.74) and out-of-pocket costs > $200 (OR 0.68, CI 0.47-.98). Adherence was associated with improved 2-year survival in univariate analysis (logrank test, P = .01) and a non-significant trend toward an association with decreased all-cause (HR 0.87, CI 0.72 – 1.05) and RCC-specific survival (HR 0.84, CI 0.69 – 1.03) in multivariable analysis. Conclusion: Local poverty levels and high out-of-pocket costs are associated with poor initial adherence to OAA therapy in Medicare beneficiaries with mRCC, which in turn, suggests a trend toward poor overall and disease-specific survival. Efforts to improve outcomes in the broader mRCC population should incorporate OAA adherence and economic factors

Examining urban and rural differences in how distance to care influences the initiation and completion of treatment among insured cervical cancer patients

Background: Although rural cancer patients encounter substantial barriers to care, they more often report receiving timely care than urban patients. We examined whether geographic distance, a contributor to urban-rural health disparities, differentially influences treatment initiation and completion among insured urban and rural cervical cancer patients. Methods: We identified women diagnosed with cervical cancer from 2004 to 2013 from a statewide cancer registry linked to multipayer, insurance claims. Primary outcomes were initiation of guideline-concordant care within 6 weeks of diagnosis and, among stage IB2-IVA cancer patients, completion of concurrent chemoradiotherapy (CCRT) in 56 days. We estimated risk ratios using modified Poisson regressions, stratified by urban/rural status, to examine the association between distance and treatment timing (initiation or completion). Results: Among 999 stage IA-IVA patients, 48% initiated guideline-concordant care within 6 weeks of diagnosis, and 37% of 492 stage IB2-IVA cancer patients completed CCRT in 56 days. In urban areas, stage IA-IVA patients who lived 15 miles from the nearest treatment facility were less likely to initiate timely treatment compared with those <5 miles [risk ratio (RR): 0.72; 95% confidence intervals (CI), 0.54-0.95]. Among IB2-IVA stage cancer patients, rural women residing 15 miles from the nearest radiation facility were more likely to complete CCRT in 56 days (RR: 2.49; 95% CI, 1.12-5.51). Conclusions: Geographic distance differentially influences the initiation and completion of treatment among urban and rural cervical cancer patients. Impact: Distance was an access barrier for insured cervical cancer patients in urban areas whereas rural patients may require more intensive outreach, support, and resources, even among those living closer to treatment

Influence of provider factors and race on uptake of breast cancer gene expression profiling

BACKGROUND: Gene expression profiling (GEP) has been rapidly adopted for early breast cancer and can aid in chemotherapy decision making. Study results regarding racial disparities in testing are conflicting, and may reflect different care settings. To the authors' knowledge, data regarding the influence of provider factors on testing are scarce. METHODS: The authors used a statewide, multipayer, insurance claims database linked to cancer registry records to examine the impact of race and provider characteristics on GEP uptake in a cohort of patients newly diagnosed with breast cancer between 2005 and 2012. Incidence proportion models were used to examine the adjusted likelihood of testing. Models were stratified by lymph node status (N0 vs N1). RESULTS: Among 11,958 eligible patients, 23% of black and 26% of non-Hispanic white patients received GEP. Among patients with N0 disease, black individuals were 16% less likely to receive testing after adjustment for clinical factors and the provider's specialty and volume of patients with breast cancer (95% confidence interval, 0.77-0.93). Adjustment for provider characteristics did not attenuate the effect of race on testing. Patients of middle-volume providers were more likely to be tested compared with those with either high-volume or low-volume providers, whereas patients seeing a medical oncologist were more likely to be tested compared with those whose only providers were from surgical specialties. CONCLUSIONS: Provider volume and specialty were found to be significant predictors of GEP use, but did not explain racial disparities in testing. Further research concerning the key contributors to lagging test use among black women is needed to optimize the equitable use of GEPs and support personalized treatment decision making for all patients

Provider- and patient-level predictors of oral anticancer agent initiation and adherence in patients with metastatic renal cell carcinoma

Background: Improving oral anticancer agent (OAA) initiation and adherence is the important quality-of-care issues, particularly since one fourth of anticancer agents being developed will be administered orally. Our objective was to identify provider- and patient-level characteristics associated with OAA initiation and adherence among individuals with metastatic renal cell carcinoma (mRCC). Methods: We used state cancer registry data linked to multi-payer claims data to identify patients with mRCC diagnosed in 2004–2015. Provider data were obtained from North Carolina Health Professions Data System and the National Plan & Provider Enumeration System. We estimated risk ratios (RRs) and corresponding 95% confidence limits (CLs) using modified Poisson regression to evaluate factors associated with OAA initiation and adherence. Results: Among the 207 (out of 687) patients who initiated an OAA following mRCC diagnosis and survived 90 days, median proportion of days covered was 0.91. Patients with a modal provider specializing in hematology/medical oncology were much more likely to initiate OAAs than those seen by other specialties. Additionally, patients with a female provider were more likely to initiate OAAs than those with a male provider. Compared to patients treated by providers practicing in both urban and rural areas, patients with providers practicing solely in urban areas were more likely to initiate OAAs, after controlling for patient-level factors (RR = 1.37; 95% CL: 1.09–1.73). Medicare patients were less likely to be adherent than those with private insurance (RR = 0.61; 95% CL: 0.42–0.87). Conclusions: Our results suggest that provider- and patient-level factors influence OAA initiation in patients with mRCC but only insurance type was associated with adherence

Medical costs associated with metastatic breast cancer in younger, midlife, and older women

Purpose: We estimated average medical costs due to metastatic breast cancer (mBC) among younger (aged 18–44), midlife (aged 45–64), and older women (aged 65 and older) by phase of care: initial, continuing, and terminal. Methods: We used 2003–2014 North Carolina cancer registry data linked with administrative claims from public and private payers. We developed a claims-based algorithm to identify breast cancer patients who progressed to metastatic disease. We matched breast cancer patients (mBC and earlier stage) to non-cancer patients on age group, county of residence, and insurance plan. Outcomes were average monthly medical expenditures and expected medical expenditures by phase. We used regression to estimate excess costs attributed to mBC as the difference in mean payments between patients with mBC (N = 4806) and patients with each earlier-stage breast cancer (stage 1, stage 2, stage 3, and unknown stage; N = 21,772) and non-cancer controls (N = 109,631) by treatment phase and age group. Results: Adjusted monthly costs for women with mBC were significantly higher than for women with earlier-stage breast cancer and non-cancer controls for all age groups and treatment phases except the initial treatment among women with stage 3 breast cancer at diagnosis. The largest expected total costs were for women aged 18–44 with mBC during the continuing phase ($209,961 95$165,736–254,186). Conclusions: We found substantial excess costs for mBC among younger women and during the continuing and terminal phases of survivorship. It is important to assess whether this care is high value for these women