Cost-effectiveness of palbociclib in early breast cancer patients with a high risk of relapse: Results from the PENELOPE-B trial.

Background: Patients with hormone receptor-positive, HER2-negative breast cancer who have residual invasive disease after neoadjuvant chemotherapy (NACT) are at a high risk of relapse. PENELOPE-B was a double-blind, placebo-controlled, phase III trial that investigated adding palbociclib (PAL) for thirteen 28-day cycles to adjuvant endocrine therapy (ET) in these patients. Clinical results showed no significant improvement in invasive disease-free survival with PAL. Methods: We performed a pre-planned cost-effectiveness analysis of PAL within PENELOPE-B from the perspective of the German statutory health insurance. Health-related quality of life scores, collected in the trial using the EQ-5D-3L instrument, were converted to utilities based on the German valuation algorithm. Resource use was valued using German price weights. Outcomes were discounted at 3% and modeled with mixed-level linear models to adjust for attrition, repeated measurements, and residual baseline imbalances. Subgroup analyses were performed for key prognostic risk factors. Scenario analyses addressed data limitations and evaluated the robustness of the estimated cost-effectiveness of PAL to methodological choices. Results: The effects of PAL on quality-adjusted life years (QALYs) were marginal during the active treatment phase, increasing thereafter to 0.088 (95% confidence interval: -0.001; 0.177) QALYs gained over the 4 years of follow-up. The incremental costs were dominated by PAL averaging EUR 33,000 per patient; costs were higher in the PAL arm but not significantly different after the second year. At an incremental cost-effectiveness ratio of EUR 380,000 per QALY gained, PAL was not cost-effective compared to the standard-of-care ET. Analyses restricted to Germany and other subgroups were consistent with the main results. Findings were robust in the scenarios evaluated. Conclusions: One year of PAL added to ET is not cost-effective in women with residual invasive disease after NACT in Germany.

Generosity and Duration of Medicaid Expansion Waivers and Access to Care.

INTRODUCTION: Prior to expansion of Medicaid under the Affordable Care Act, some states obtained Section 1115 waivers from the federal government that allowed them to expand eligibility for Medicaid to adult populations that were not covered previously. Expansion waivers in these states differed in their generosity and year of implementation, creating variation in coverage availability and program longevity across states. This study examined the association between generosity and duration of Medicaid expansion waivers and access to preventive services. METHODS: The 2012 Medical Expenditure Panel Survey data were used to estimate adjusted logistic models in 2016, comparing outcomes among low-income non-elderly adults living in generous (Medicaid eligibility threshold ≥138% federal poverty level) and moderate (Medicaid eligibility threshold <138% federal poverty level) waiver states, relative to no-waiver states. RESULTS: Moderate and generous waivers were associated with statistically significant (p<0.001) increases in probabilities of having a usual source of care and a blood pressure check, relative to states without a waiver to expand. Low-income individuals living in states with longer waiver durations had better access to healthcare services than a similar group living in comparison states. CONCLUSIONS: Not only is Medicaid waiver generosity associated with improving access to healthcare services, but the combination of generosity and longer duration of a waiver also intensifies the association. As states gain flexibility in designing their Medicaid programs, the healthcare benefits associated with both generosity and duration of waivers are important considerations for policy makers.

Impact of Medicaid disenrollment in Tennessee on breast cancer stage at diagnosis and treatment.

BACKGROUND: States routinely may consider rollbacks of Medicaid expansions to address statewide economic conditions. To the authors' knowledge, little is known regarding the effects of public insurance contractions on health outcomes. The current study examined the effects of the 2005 Medicaid disenrollment in Tennessee on breast cancer stage at the time of diagnosis and delays in treatment among nonelderly women. METHODS: The authors used Tennessee Cancer Registry data from 2002 through 2008 and estimated a difference-in-difference model comparing women diagnosed with breast cancer who lived in low-income zip codes (and therefore were more likely to be subject to disenrollment) with a similar group of women who lived in high-income zip codes before and after the 2005 Medicaid disenrollment. The study outcomes were changes in stage of disease at the time of diagnosis and delays in treatment of >60 days and >90 days. RESULTS: Overall, nonelderly women in Tennessee were diagnosed at later stages of disease and experienced more delays in treatment in the period after disenrollment. Disenrollment was found to be associated with a 3.3-percentage point increase in late stage of disease at the time of diagnosis (P = .024), a 1.9-percentage point decrease in having a delay of >60 days in surgery (P = .024), and a 1.4-percentage point decrease in having a delay of >90 days in treatment (P = .054) for women living in low-income zip codes compared with women residing in high-income zip codes. CONCLUSIONS: The results of the current study indicate that Medicaid disenrollment is associated with a later stage of disease at the time of breast cancer diagnosis, thereby providing evidence of the potential negative health impacts of Medicaid contractions. Cancer 2017;123:3312-9. © 2017 American Cancer Society.

Medicaid expansion and access to care among cancer survivors: a baseline overview.

PURPOSE: Medicaid expansion under the Affordable Care Act facilitates access to care among vulnerable populations, but 21 states have not yet expanded the program. Medicaid expansions may provide increased access to care for cancer survivors, a growing population with chronic conditions. We compare access to health care services among cancer survivors living in non-expansion states to those living in expansion states, prior to Medicaid expansion under the Affordable Care Act. METHODS: We use the 2012 and 2013 Behavioral Risk Factor Surveillance System to estimate multiple logistic regression models to compare inability to see a doctor because of cost, having a personal doctor, and receiving an annual checkup in the past year between cancer survivors who lived in non-expansion states and survivors who lived in expansion states. RESULTS: Cancer survivors in non-expansion states had statistically significantly lower odds of having a personal doctor (adjusted odds ratio [AOR] 0.76, 95 % confidence interval [CI] 0.63-0.92, p < 0.05) and higher odds of being unable to see a doctor because of cost (AOR 1.14, 95 % CI 0.98-1.31, p < 0.10). Statistically significant differences were not found for annual checkups. CONCLUSIONS: Prior to the passage of the Affordable Care Act, cancer survivors living in expansion states had better access to care than survivors living in non-expansion states. Failure to expand Medicaid could potentially leave many cancer survivors with limited access to routine care. IMPLICATIONS FOR CANCER SURVIVORS: Existing disparities in access to care are likely to widen between cancer survivors in Medicaid non-expansion and expansion states.

A Phase II Study of 3'-Deoxy-3'-18F-Fluorothymidine PET in the Assessment of Early Response of Breast Cancer to Neoadjuvant Chemotherapy: Results from ACRIN 6688.

UNLABELLED: Our objective was to determine whether early change in standardized uptake values (SUVs) of 3'deoxy-3'-(18)F-fluorothymidine ((18)F-FLT) using PET with CT could predict pathologic complete response (pCR) of primary breast cancer to neoadjuvant chemotherapy (NAC). The key secondary objective was to correlate SUV with the proliferation marker Ki-67 at baseline and after NAC. METHODS: This prospective, multicenter phase II study did not specify the therapeutic regimen, thus, NAC varied among centers. All evaluable patients underwent (18)F-FLT PET/CT at baseline (FLT1) and after 1 cycle of NAC (FLT2); 43 patients were imaged at FLT1, FLT2, and after NAC completion (FLT3). The percentage change in maximum SUV (%ΔSUVmax) between FLT1 and FLT2 and FLT3 was calculated for the primary tumors. The predictive value of ΔSUVmax for pCR was determined using receiver-operating-characteristic curve analysis. The correlation between SUVmax and Ki-67 was also assessed. RESULTS: Fifty-one of 90 recruited patients (median age, 54 y; stage IIA-IIIC) met the eligibility criteria for the primary objective analysis, with an additional 22 patients totaling 73 patients for secondary analyses. A pCR in the primary breast cancer was achieved in 9 of 51 patients. NAC resulted in a significant reduction in %SUVmax (mean Δ, 39%; 95% confidence interval, 31-46). There was a marginal difference in %ΔSUVmax_FLT1-FLT2 between pCR and no-pCR patient groups (Wilcoxon 1-sided P = 0.050). The area under the curve for ΔSUVmax in the prediction of pCR was 0.68 (90% confidence interval, 0.50-0.83; Delong 1-sided P = 0.05), with slightly better predictive value for percentage mean SUV (P = 0.02) and similar prediction for peak SUV (P = 0.04). There was a weak correlation with pretherapy SUVmax and Ki-67 (r = 0.29, P = 0.04), but the correlation between SUVmax and Ki-67 after completion of NAC was stronger (r = 0.68, P < 0.0001). CONCLUSION: (18)F-FLT PET imaging of breast cancer after 1 cycle of NAC weakly predicted pCR in the setting of variable NAC regimens. Posttherapy (18)F-FLT uptake correlated with Ki-67 on surgical specimens. These results suggest some efficacy of (18)F-FLT as an indicator of early therapeutic response of breast cancer to NAC and support future multicenter studies to test (18)F-FLT PET in a more uniformly treated patient population.

Insurance and inpatient care: differences in length of stay and costs between surgically treated cancer patients.

BACKGROUND: Early research demonstrated that patients' length-of-stay and inpatient costs varied according to their health insurance status. The authors of the current report studied a population-based sample of privately insured, Medicaid-insured, and uninsured inpatients ages 21 to 64 years who underwent surgical resection for either nonsmall cell lung cancer (NSCLC) (n = 781) or colorectal cancer (CRC) (n = 8190) or who underwent mastectomy (n = 6201) to compare length of stay and inpatient costs by insurance status. METHODS: Data for this study were derived from all civilian, acute-care hospitals in Virginia from 1999 to 2005. Hierarchical generalized linear models were used to estimate the relation between the explanatory variables and lengths of stay and costs. All analyses controlled for patient characteristics and hospital random effects. RESULTS: Medicaid-insured patients with NSCLC had longer lengths of stay (39% or 2.64 days longer) and higher inpatient costs (20% or $2479 higher costs). Uninsured and Medicaid-insured patients with CRC had longer lengths of stay and higher inpatient costs. In contrast, uninsured patients with breast cancer had 11% shorter lengths of stay and 12% lower inpatient costs than privately insured patients. Medicaid-insured patients had 10% lower inpatient costs than privately insured patients. Differences were no longer statistically significant when reconstruction was added to the models. CONCLUSIONS: Health insurance affected the need for health care and the amount of health care received. Uninsured and Medicaid-insured patients with lung cancer and colon cancer who underwent resection had longer lengths of stay and higher inpatient costs than privately insured patients, but they had shorter lengths of stay when reconstruction was not provided. Among the patients with breast cancer, patients and/or providers economized on discretionary procedures.

Breast conservation therapy rates are no different in medically indigent versus insured patients with early stage breast cancer.

PURPOSE: Multiple prospective, randomized studies show that breast conservation therapy (BCT) results in survival rates equal to mastectomy (Mx) for patients with early stage breast cancer (ESBC). Nevertheless, BCT remains underused in certain areas of the nation, without clearly definable reasons. Several studies have implicated socioeconomic status as one potential cause for this disparity in BCT usage. We sought to compare BCT rates in the medically indigent versus insured patients, within the same institution. METHODS: Data from 1993 to 2000, collected from the institutional tumor registry and the hospital's claims records, were analyzed for 928 patients with ESBC (Stages 0, I, and II), treated at a single medical center. The same surgeons treated both insured and indigent patients. Patients treated by BCT or Mx were compared for age, race, stage, insurance status, access to a radiation therapy center, surgeon, and year of diagnosis. RESULTS: Patient age, race, surgeon, or insurance status did not significantly affect the rate of mastectomy. Stage I patients (P < 0.001) and those treated after 1995 had higher BCT rates (54.9% in 1993-95 vs. 70.7% in 1996-2000; P < 0.001). Travel distance to a radiation therapy center had no significant impact on BCT rates, except for patients >40 miles distant. CONCLUSIONS: These data refute the hypothesis that socioeconomic status, as reflected by medical insurance, is a determinant of BCT in women with ESBC. Distance of <40 miles to a radiation therapy facility, Stage I disease, and diagnosis after 1995 were factors associated with higher BCT rates.