Is FDA-Approved Bevacizumab Cost-Effective When Included in the Treatment of Platinum-Resistant Recurrent Ovarian Cancer?

Purpose: Although the Food and Drug Administration has approved incorporation of bevacizumab (BEV) into the treatment of platinum-resistant ovarian cancer (PROC), cost-value measures are an essential consideration, as evidenced by the recent ASCO Value Framework initiative. We assessed the cost-effectiveness and reviewed the net health benefit (NHB) of this expensive treatment. Methods: A cost-effectiveness decision model was constructed using results from a phase III trial comparing BEV plus cytotoxic chemotherapy with chemotherapy alone in patients with PROC. The Avastin Use in Platinum-Resistant Epithelial Ovarian Cancer (AURELIA) trial demonstrated improvement in progression-free survival and quality of life in patients receiving BEV. Costs, paracentesis rates, and adverse events were incorporated, including subgroup analysis of different partner chemotherapy agents. Results: Inclusion of BEV in the treatment of platinum-resistant recurrent ovarian cancer meets the common willingness-to-pay incremental cost-effectiveness ratio (ICER) threshold of $100,000 per progression-free life-year saved (LYS) for 15-mg/kg dosing and approaches this threshold for 10-mg/kg dosing, with an ICER of$160,000. In sensitivity analysis, reducing the cost of BEV by 13% (from $9,338 to$8,100 per cycle) allows 10-mg/kg dosing to reach a $100,000 ICER. Exploratory analysis of different BEV chemotherapy partners showed an ICER of$76,000 per progression-free LYS (6.5-month progression-free survival improvement) and $54,000 per LYS (9.1-month overall survival improvement) for the addition of BEV to paclitaxel once per week. Using the ASCO framework for value assessment, the NHB score for BEV plus paclitaxel once per week is 48. Conclusion: Using a willingness-to-pay threshold of$100,000 ICER, the addition of BEV to chemotherapy either demonstrates or approaches cost-effectiveness and NHB when added to the treatment of patients with PROC. </jats:sec

Evaluating the Impact of Office Hysteroscopy in a Military Treatment Facility

Abstract Introduction Office hysteroscopy has become a cornerstone of modern gynecologic care through the advent of advanced technology and emphasis on an efficient healthcare system. In 2017, Medicare announced an increase in office hysteroscopy reimbursement by 237%, giving an incentive for gynecologists to move from the operating room into the clinic. The U.S. military medical system needs more cost-effective and efficient healthcare, given that the cost of military healthcare increased by 130% between 2000 and 2012 (accounting for 10% or $52 billion of the Department of Defense budget). Within our institution, we have moved to conducting a regularly scheduled outpatient hysteroscopy clinic. Increased healthcare costs, decreased available operating room time, and efforts to boost patient and provider satisfaction drove the change. Materials and Methods After institutional review board approval, we performed a retrospective observational cost-benefit analysis of 235 outpatient and 45 inpatient records that included female military healthcare beneficiaries age 18 or older who had diagnostic or operative hysteroscopy performed in the operating room or office setting from January 2015 to October 2018. We specifically focused on diagnostic hysteroscopy, hysteroscopic biopsy and polypectomy, and hysteroscopic foreign body removal (intrauterine device removal). We then compared admission time, procedure time, reimbursement, and cost for each of the hysteroscopic procedure groups to yield a total cost-benefit value (TCBV). TCBV was defined as cost savings plus difference in reimbursement rate. Results This study analyzes the costs and benefits of a regularly scheduled hysteroscopy clinic within the U.S. military medical system. We performed a cost-benefit analysis that indicated a substantial difference between clinic and operating room TCBV, total relative value units or reimbursement rates, and total patient care time. We found the average admission time for an inpatient procedure was 6.23 hours compared to our standard 1-hour clinic time. The average success rate for procedure completion in the clinic was 89$64,220, $159,940, and$66,709 for diagnostic hysteroscopy, hysteroscopic biopsy and polypectomy, and hysteroscopic foreign body (intrauterine device) removal, respectively. Conclusions Compared to traditional operating room hysteroscopy, we were able to demonstrate reduced costs with increased reimbursement while performing the same scope of care for patients undergoing office hysteroscopy. Decreased total time in performing office hysteroscopy suggests the potential benefit of increased patient and provider satisfaction. Our study indicated substantial incentive for military gynecologists to incorporate office hysteroscopy into their practice given the increased relative value units generated. Our office hysteroscopy protocol is discussed to encourage other military facilities to follow in our footsteps. </jats:sec

Piperazine Oxadiazole Inhibitors of Acetyl-CoA Carboxylase

Acetyl-CoA carboxylase (ACC) is a target of interest for the treatment of metabolic syndrome. Starting from a biphenyloxadiazole screening hit, a series of piperazine oxadiazole ACC inhibitors was developed. Initial pharmacokinetic liabilities of the piperazine oxadiazoles were overcome by blocking predicted sites of metabolism, resulting in compounds with suitable properties for further in vivo studies. Compound <b>26</b> was shown to inhibit malonyl-CoA production in an in vivo pharmacodynamic assay and was advanced to a long-term efficacy study. Prolonged dosing with compound <b>26</b> resulted in impaired glucose tolerance in diet-induced obese (DIO) C57BL6 mice, an unexpected finding

The MicroArray Quality Control (MAQC)-II study of common practices for the development and validation of microarray-based predictive models

Gene expression data from microarrays are being applied to predict preclinical and clinical endpoints, but the reliability of these predictions has not been established. In the MAQC-II project, 36 independent teams analyzed six microarray data sets to generate predictive models for classifying a sample with respect to one of 13 endpoints indicative of lung or liver toxicity in rodents, or of breast cancer, multiple myeloma or neuroblastoma in humans. In total, >30,000 models were built using many combinations of analytical methods. The teams generated predictive models without knowing the biological meaning of some of the endpoints and, to mimic clinical reality, tested the models on data that had not been used for training. We found that model performance depended largely on the endpoint and team proficiency and that different approaches generated models of similar performance. The conclusions and recommendations from MAQC-II should be useful for regulatory agencies, study committees and independent investigators that evaluate methods for global gene expression analysis. © 2010 Nature America, Inc. All rights reserved.0SCOPUS: ar.jinfo:eu-repo/semantics/publishe