Incorporating Tumor Characteristics to Maximize 21-Gene Assay Utility: A Cost-Effectiveness Analysis.

Background: Literature suggests that Oncotype DX (ODX) is cost-effective. These studies, however, tend to ignore clinical characteristics and have not incorporated population-based data regarding the distribution of ODX results across different clinical risk groups. Accordingly, this study assessed the cost-effectiveness of ODX across strata of clinical risk groups using population-based ODX data. Methods: We created state-transition models to calculate costs and quality-adjusted life years (QALYs) gained over the lifetime for women with estrogen receptor (ER)-positive, HER2-negative, lymph node-negative breast cancer from a US payer perspective. Using the Connecticut Tumor Registry, we classified the 2,245 patients diagnosed in 2011 through 2013 into 3 clinical risk groups according to the PREDICT model, a risk calculator developed by the National Health Service in the United Kingdom. Within each risk group, we then determined the recurrence score (RS) distributions (<18, 18-30, and ≥31). Other input parameters were derived from the literature. Uncertainty was assessed using deterministic and probabilistic sensitivity analyses. Results: Approximately 82.5%, 11.9%, and 5.6% of our sample were in the PREDICT low-, intermediate-, and high-risk groups, respectively. When combining these 3 groups, ODX had an incremental cost-effectiveness ratio (ICER) of $62,200 per QALY for patients aged 60 years. The ICERs, however, differed across clinical risk groups, ranging from $124,600 per QALY in the low-risk group, to $28,700 per QALY in the intermediate-risk group, to $15,700 per QALY in the high-risk group. Results were sensitive to patient age: the ICER for patients aged 45 to 75 years ranged from $77,100 to $344,600 per QALY in the PREDICT low-risk group, and was lower than $100,000 per QALY in the intermediate- and high-risk groups. Conclusions: ODX is not cost-effective for women with clinical low-risk breast cancer, which constitutes most patients with ER-positive disease.

Cost-Effectiveness Analyses of the 21-Gene Assay in Breast Cancer: Systematic Review and Critical Appraisal.

Purpose Prior studies examining cost effectiveness of the 21-gene assay (Oncotype DX [ODX]) for women with hormone receptor-positive, early-stage breast cancer have yielded disparate results. We aimed to explore why these analyses may have yielded different conclusions. Methods We conducted a systematic literature review of cost-effectiveness analyses (CEAs) of ODX. We examined the extent to which the structure of CEA modeling, the assumptions of the models, and the selection of input parameters influenced cost-effectiveness estimates. We also explored the prevalence of industry funding and whether industry funding was associated with study designs favoring ODX. Results We identified 27 analyses, 15 of which received industry funding. In 18 studies, the clinical characteristics (eg, tumor size and grade) commonly used to make chemotherapy decisions were not incorporated into simulation modeling; thus, these studies would favor ODX being cost effective and might not reflect clinical practice. Most studies ignored the heterogeneous effect of ODX on chemotherapy use; only five studies assumed that ODX would increase chemotherapy use for clinically low-risk patients but decrease chemotherapy use for clinically high-risk patients. No study used population-based joint distributions of ODX recurrence score and tumor characteristics, and 12 studies inappropriately assumed that chemotherapy would increase distant recurrence for the low recurrence score group; both approaches overestimated the benefits of ODX. Industry-funded studies tended to favor ODX; all five studies that reported ODX as being cost saving were industry funded. In contrast, two studies that reported an incremental cost-effectiveness ratio > $50,000 per quality-adjusted life-year were not funded by industry. Conclusion Although a majority of published analyses indicated that ODX is cost effective, they incorporated study designs that can increase the risk of bias.

Associations Between Sentinel Lymph Node Biopsy and Complications for Patients with Ductal Carcinoma In Situ.

PURPOSE: To examine the associations between sentinel lymph node biopsy (SLNB) and complications among older patients who underwent breast-conserving surgery (BCS) for ductal carcinoma in situ (DCIS). METHODS: We identified women from the Surveillance, Epidemiology, and End Results-Medicare dataset aged 67-94 years diagnosed during 1998-2011 with DCIS who underwent BCS as initial treatment. We assessed incidence of complications, including lymphedema, wound infection, seroma, or pain, within 9 months of diagnosis. We used Mahalanobis matching and generalized linear models to estimate the associations between SLNB and complications. RESULTS: Our sample consisted of 15,515 beneficiaries, 2409 (15.5%) of whom received SLNB. Overall, 16.8% of women who received SLNB had complications, compared with 11.3% of women who did not receive SLNB (p < 0.001). Use of SLNB was associated with subsequent mastectomy but not radiotherapy. Multivariate analyses of the matched sample showed that, compared with no SLNB, SLNB use was significantly associated with incidence of any complication [adjusted odds ratio (AOR) 1.39; 99% confidence interval (CI) 1.18-1.63], lymphedema (AOR 4.45; 99% CI 2.27-8.75), wound infection (AOR 1.24; 99% CI 1.00-1.54), seroma (AOR 1.40; 99% CI 1.03-1.91), and pain (AOR 1.31; 99% CI 1.04-1.65). Sensitivity analyses excluding patients who underwent mastectomy yielded qualitatively similar results regarding the associations between SLNB and complications. CONCLUSIONS: Among older women with DCIS who received BCS, SLNB use was associated with higher risks of short-term complications. These findings support consensus guidelines recommending against SLNB for this population and provide empirical information for patients.

Cost-Effectiveness of Multidisciplinary Management Program and Exercise Training Program in Heart Failure.

Heart failure causes significant health and financial burdens for patients and society. Multidisciplinary management program (MMP) and exercise training program (ETP) have been reported as cost-effective in improving health outcomes, yet no study has compared the 2 programs. We constructed a Markov model to simulate life year (LY) gained and total costs in usual care (UC), MMP, and ETP. The probability of transitions between states and healthcare costs were extracted from previous literature. We calculated the incremental cost-effectiveness ratio (ICER) over a 10-year horizon. Model robustness was assessed through 1-way and probabilistic sensitivity analyses. The expected LY for patients treated with UC, MMP, and ETP was 7.6, 8.2, and 8.4 years, respectively. From a societal perspective, the expected cost of MMP was $20,695, slightly higher than the cost of UC ($20,092). The cost of ETP was much higher ($48,378) because of its high implementation expense and the wage loss it incurred. The ICER of MMP versus UC was $976 per LY gained, and the ICER of ETP versus MMP was $165,702 per LY gained. The results indicated that, under current cost-effectiveness threshold, MMP is cost-effective compared with UC, and ETP is not cost-effective compared with MMP. However, ETP is cost-effective compared with MMP from a healthcare payer's perspective.

Associations of Hospice Disenrollment and Hospitalization With Continuous Home Care Provision.

OBJECTIVES: To examine rates of hospice disenrollment and posthospice hospitalization among patients who are enrolled in hospices that provide continuous home care (CHC) (CHC hospices) compared with patients who are enrolled in hospices that do not offer CHC (non-CHC hospices). METHODS: We performed a retrospective cohort study among Medicare fee-for-service decedents between July and December 2011, who were 66 years and older and had used hospice in their last 6 months of life. We used propensity score matching to account for potential confounding characteristics of hospices. Generalized estimating equation models were applied to estimate between CHC hospices and non-CHC hospices the associations of hospice disenrollment/hospitalization, adjusted for patient characteristics. We also conducted subgroup analyses to examine how the association might have differed by hospice size, and by the percentage of enrollees who received CHC. RESULTS: After matching, we identified 936 pairs of CHC and non-CHC hospices, well balanced in terms of organizational characteristics. In fully adjusted models, compared with non-CHC hospices, CHC hospices had significantly lower disenrollment rates (adjusted rate ratio, 0.73; 95% confidence interval, 0.60-0.87), and lower hospitalization rates (adjusted rate ratio, 0.79; 95% confidence interval, 0.66-0.95). These associations were significantly more pronounced among larger hospices (those with >175 enrollees during study period), and among hospices in which at least 7.3% of enrollees used CHC. CONCLUSIONS: CHC hospices had significantly lower rates of hospice disenrollment and posthospice hospitalization, suggesting CHC service available may enable higher quality of end-of-life care.