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Hornberger J.,Stanford University | Hornberger J.,Cedar Associates LLC | Hirth R.A.,University of Michigan
American Journal of Kidney Diseases | Year: 2012

Background: In 2011, the Medicare Improvements for Patients and Providers Act replaced the case-mix-adjusted composite payment system for Medicare outpatient dialysis facilities with a bundled end-stage renal disease prospective payment system (PPS). We assessed the economic implications for modality choice of the revised Medicare payment system. Study Design: Microeconomic analyses. Setting & Population: Patients eligible for dialysis in the United States. Model, Perspective, & Timeframe: The perspective of this analysis is that of a financial administrator of a representative dialysis center in the United States. Data were obtained from the Medicare Payment Advisory Commission, the US Renal Data System, the DOPPS (Dialysis Outcomes and Practice Patterns Study) Practice Monitor, the US Bureau of Labor Statistics, and Medicare fee schedules. Interventions: Recently implemented end-stage renal disease PPS versus the prior case-mix composite payment system. Outcomes: Medicare payment per month, center fixed and variable costs per month, net difference in revenue and variable costs (direct contribution), and net difference in revenue and total costs (operating margin). Results: The direct contribution and operating margin for in-center hemodialysis and peritoneal dialysis are expected to be positive under the new bundled PPS. For Medicare fiscal intermediaries/administrators, paid treatments for home hemodialysis vary from 3.2 to more than 4.8 per week. The direct contribution and operating margin are expected to be negative for home hemodialysis if the number of paid treatments is similar between in-center and home hemodialysis; they are almost identical when the number of paid treatments increases for home hemodialysis by approximately 1 per week. Limitations: Experience across centers and intermediaries/administrators may vary. Sensitivity analyses were conducted to assess the robustness of findings and determine which variables most influenced results. Conclusions: The new bundled PPS created a financial incentive for increased use of peritoneal dialysis. Use of home hemodialysis may be influenced by number of paid treatments per week. © 2012 National Kidney Foundation, Inc. Source

Hornberger J.,Cedar Associates LLC | Hornberger J.,Stanford University | Doberne J.,Cedar Associates LLC | Chien R.,Cedar Associates LLC | Chien R.,Columbia University
Genetic Testing and Molecular Biomarkers | Year: 2012

Since the late 1990s, there has been an unprecedented growth in the development of new molecular and proteomic assays for clinical decision making. Despite the thousands of tests available, a standardized, well-defined, and coherent evaluation framework for these molecular assays is still lacking. We aim to summarize the publicly available appraisal criteria and to develop a succinct and accessible set of criteria that can provide a roadmap for the appraisal of gene-based laboratory developed tests (LDTs). We conducted a systematic literature review of the available molecular diagnostic framework in PubMed MD and CINAHL and identified 91 articles on existing appraisal criteria. We provided a summary of the historical appraisal system and developed an analysis of these appraisal systems, LDT-SynFRAME, which details the major criteria for evaluating molecular diagnostics in the clinical setting. Our goal with the LDT-SynFRAME system is to promote a well-informed dialog among all the stakeholders responsible for the development, approval, reimbursement, and use of new molecular classifiers. © Copyright 2012, Mary Ann Liebert, Inc. Source

Klang S.H.,Clalit Health Services | Hammerman A.,Clalit Health Services | Liebermann N.,Clalit Health Services | Efrat N.,Kaplan Medical Center | And 3 more authors.
Value in Health | Year: 2010

Objective: Oncotype DX, a 21-gene assay, was clinically validated as a predictor of 10-year recurrence-free survival and treatment response in patients with early-stage estrogen-receptor-positive, lymph-node negative breast cancer (ER+ LN- ESBC). This study determined "real-life" alteration in treatment decision and economic implications of Oncotype DX use in women with ER+ LN- ESBC. Methods: Clalit Health Services (CHS, Tel Aviv, Israel), determined the proportion of women in low, intermediate and high-risk groups in the first 368 Oncotype DX assays performed, the change of adjuvant therapy recommendation following the recurrence (RS) results from Oncotype DX use, and associated chemotherapy costs. The risk of recurrence-free survival was derived from prespecified statistical protocols of NCI-sponsored trials conducted by NSABP (B-14 and B-20). Utilities were literature based. A 3% discount rate was employed. Results: Oncotype DX altered recommendations of 40% of patients, 84% of whom were changed from hormone + chemotherapy to hormonal therapy alone. Among high-risk women, 8% switched actual treatment from hormonal therapy to hormone + chemotherapy. By reducing the chemotherapy disutility, quality-adjusted life-years (QALY) increased 0.170 years. Use of Oncotype DX costs $10,770 per QALY gained. Sensitivity analyses revealed that risk reduction in the low-risk population, the cost of adverse events, and the relative risk reduction of recurrence were the most influential variables. Conclusion: Oncotype DX resulted in net QALY gain and increased overall costs, with an incremental cost-effectiveness ratio of $10,770. For CHS, Oncotype DX represents an effective and affordable approach to favorably affect the lives of women with ESBC. © 2010, International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Source

Badani K.,Columbia University | Thompson D.J.S.,EMMES Canada | Buerki C.,GenomeDx Biosciences | Davicioni E.,GenomeDx Biosciences | And 6 more authors.
Oncotarget | Year: 2013

Background: Only a minority of prostate cancer patients with adverse pathology and biochemical recurrence (BCR) post radical prostatectomy (RP) experience metastasis and die from prostate cancer. Improved risk prediction models using genomic information may enable clinicians to better weigh the risk of metastasis and the morbidity and costs of treatment in a clinically heterogeneous population. Purpose: We present a clinical utility study that evaluates the influence on urologist treatment recommendations for patients at risk of metastasis using a genomic-based prediction model (Decipher™). Methods: A prospective, pre-post design was used to assess urologist treatment recommendations following RP in both the adjuvant (without any evidence of PSA rise) and salvage (BCR) settings. Urologists were presented de-identified pathology reports and genomic classifier (GC) test results for 24 patients from a previously conducted GC validation study in high-risk post-RP men. Participants were fellowship trained, high-volume urologic oncologists (n=21) from 18 US institutions. Treatment recommendations for secondary therapy were made based solely on clinical information (pre-GC) and then with genomic biomarker information (post-GC). This study was approved by an independent IRB. Results: Treatment recommendations changed from pre-GC to post-GC in 43% of adjuvant, and in 53% of salvage setting case evaluations. In the adjuvant setting, urologists changed their treatment recommendations from treatment (i.e. radiation and/or hormones) to close observation post-GC in 27% of cases. For cases with low GC risk (<3% risk of metastasis), observation was recommended for 79% of the case evaluations post-GC. Consistent trends were observed in the salvage setting. Conclusion: These results indicate that urologists across a range of practice settings are likely to change treatment decisions when presented with genomic biomarker information following RP. Implementation of genomic risk stratification into routine clinical practice may better direct treatment decision-making post-RP. Source

Hornberger J.,Cedar Associates LLC | Hornberger J.,Stanford University | Chien R.,Cedar Associates LLC | Friedmann M.,Columbia University | And 5 more authors.
Leukemia and Lymphoma | Year: 2012

A recent phase III trial demonstrated that maintenance rituximab® therapy after response to first-line treatment with rituximab plus chemotherapy (R-chemo) increases progression-free survival (PFS) for follicular non-Hodgkin lymphoma (f-NHL). A cost-effectiveness analysis of R-maintenance versus observation was conducted from a US payer perspective to estimate PFS and overall survival (OS) over a representative patient's lifetime. Primary outcomes were cost per life-year gained (LYG) and cost per quality-adjusted life-year (QALY) gained. Compared with observation, R-maintenance increased mean PFS by 1.50 years, OS by 1.21 years and QALYs gained by 1.11 years. The incremental cost of maintenance therapy was $38 545. The costs per LYG and QALY gained were $31 934 and $34 842, respectively. Within the limitations of modeling long-term outcomes, R-maintenance therapy in patients who received R-chemo for previously untreated f-NHL compared with observation alone after R-chemo for first-line treatment for f-NHL is cost-effective from the US payer perspective. © 2012 Informa UK, Ltd. Source

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