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Julia Thornton Snider Jesse Sussell Mahlet Gizaw Tebeka Alicia Gonzalez Joshua T. Cohen Peter Neumann 《Value in health》2019,22(3):332-339
Background
Payers frequently rely on budget impact model (BIM) results to help determine drug coverage policy and its effect on their bottom line. It is unclear whether BIMs typically overestimate or underestimate real-world budget impact.Objective
We examined how different modeling assumptions influenced the results of 6 BIMs from the Institute for Clinical and Economic Review (ICER).Study Design
Retrospective analysis of pharmaceutical sales data.Methods
From ICER reports issued before 2016, we collected estimates of 3 BIM outputs: aggregate therapy cost (ie, cost to treat the patient population with a particular therapy), therapy uptake, and price. We compared these against real-world estimates that we generated using drug sales data. We considered 2 classes of BIM estimates: those forecasting future uptake of new agents, which assumed “unmanaged uptake,” and those describing the contemporaneous market state (ie, estimates of current, managed uptake and budget impact for compounds already on the market).Results
Differences between ICER's estimates and our own were largest for forecasted studies. Here, ICER's uptake estimates exceeded real-world estimates by factors ranging from 7.4 (sacubitril/valsartan) to 54 (hepatitis C treatments). The “unmanaged uptake” assumption (removed from ICER's approach in 2017) yields large deviations between BIM estimates and real-world consumption. Nevertheless, in some cases, ICER's BIMs that relied on current market estimates also deviated substantially from real-world sales data.Conclusions
This study highlights challenges with forecasting budget impact. In particular, assumptions about uptake and data source selection can greatly influence the accuracy of results. 相似文献5.
Tormo Nuria Giménez Estela Martínez-Navarro María Albert Eliseo Navalpotro David Torres Ignacio Gimeno Concepción Navarro David 《European journal of clinical microbiology & infectious diseases》2022,41(4):657-662
European Journal of Clinical Microbiology & Infectious Diseases - We compared the performance of an in-house-developed flow cytometry assay for intracellular cytokine staining (FC-ICS) and a... 相似文献
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Economic efficiency versus social equality? The U.S. liberal model versus the European social model.
This article begins by challenging the widely held view in neoliberal discourse that there is a necessary trade-off between higher efficiency and lower reduction of inequalities: the article empirically shows that the liberal, U.S. model has been less efficient economically (slower economic growth, higher unemployment) than the social model in existence in the European Union and in the majority of its member states. Based on the data presented, the authors criticize the adoption of features of the liberal model (such as deregulation of their labor markets, reduction of public social expenditures) by some European governments. The second section analyzes the causes for the slowdown of economic growth and the increase of unemployment in the European Union--that is, the application of monetarist and neoliberal policies in the institutional frame of the European Union, including the Stability Pact, the objectives and modus operandi of the European Central Bank, and the very limited resources available to the European Commission for stimulating and distributive functions. The third section details the reasons for these developments, including (besides historical considerations) the enormous influence of financial capital in the E.U. institutions and the very limited democracy. Proposals for change are included. 相似文献
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Antonio S. Salinas Sánchez Jesús Cifuentes Tebar Miguel Segura Martín José M. Giménez Bachs María J. Donate Moreno Héctor Pastor Navarro Julio A. Virseda Rodríguez 《American journal of transplantation》2005,5(8):2074-2077
Ureteral herniation is a rare entity. We report the first case of extraperitoneal ureteral herniation in a pediatric en bloc renal graft causing obstructive uropathy. A 70-year-old, obese patient with an en bloc renal transplant was found to have ureterohydronephrosis in the right renal graft on magnetic resonance imaging. Nephrostomy with insertion of a double-J catheter confirmed the presence of a ureteral loop within the inguinal tract. Surgery confirmed herniation of the ureter through the internal inguinal ring, crossing over the spermatic cord. We performed release, resection, ureteral reimplantation and hernioplasty. Four months later, renal function was normal and urinary tract dilation had diminished. This case illustrates an unusual cause of obstructive uropathy in a transplanted kidney. Apart from obesity, two other factors may have contributed to its development: presence of a redundant ureter, and the fact that the ureter had been placed over, rather than under, the spermatic cord. 相似文献
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Carlos Ferrer Albiach Antonio Conde Moreno Marta Rodríguez Cordón Virginia Morillo Macías Ana Bouché Babiloni Inmaculada Beato Tortajada Ángel Sánchez Iglesias Alicia Francés Muñoz 《Clinical & translational oncology》2010,12(1):22-26
Hypoxia is related to poor prognosis because it is associated to chemo-and radioresistance. During recent years the evolution
of imaging methods like PET/CT and MRI has meant the appearance of new perspectives with direct implications in radiation
therapy. We discuss previous experiences in staging, planning and in the follow-up process with these techniques for measuring
tumour hypoxia. 相似文献
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Laureano Fernández-Cruz Rebeca Cosa Laia Blanco Sammy Levi Miguel-Angel López-Boado Salvador Navarro 《Journal of gastrointestinal surgery》2007,11(12):1607-1622
Laparoscopic pancreatic surgery (LPS) has seen significant development but much of the knowledge refers to small and benign
pancreatic tumors. This study aims to evaluate the feasibility, safety, and long-term outcome of the laparoscopic approach
in patients with benign, premalignant, and overt malignant lesions of the pancreas. This study, currently, is the largest
single center experience worldwide. One hundred twenty-three consecutive patients underwent laparoscopic pancreatic surgery
from April 1998 to April 2007, 20 patients with cysts or pseudocysts for acute and chronic pancreatitis, laparoscopic pancreatic
drainage was performed, and were excluded from the analysis. The 103 patients were divided based on preoperative diagnosis:
group I, inflammatory tumors for chronic pancreatitis (eight patients); group II, cystic pancreatic neoplasms (29 patients);
group III, intraductal papillary mucinous neoplasms (10 patients); group IV, neuroendocrine pancreatic tumors (NETs) (43 patients);
and group V ductal adenocarcinoma (13 patients). The median tumor size was 5.3 cm. Pathologic data include R
0 or R
1 resection (transection margins on the specimen were inked). Perioperative data, postoperative complications, and resection
modalities were compared using statistical analysis. Long-term outcomes were analysed by tumor recurrence and patient survival.
The overall conversion rate was 7%. Laparoscopic distal pancreatic resection was performed in 82 patients (79.6%). Laparoscopic
spleen-preserving distal pancreatectomy (Lap SPDP) was performed in 52 patients (63.7%), but with splenic vessels preservation
in 22% and without splenic vessels preservation in 41.5%. Laparoscopic en-bloc splenopancreatectomy (Lap SxDP) was performed
in 30 patients (36.6%) and laparoscopic enucleation (Lap En) in 20 patients (19.4%). There was no mortality. The overall complication
rate was 25.2, 16.7, and 40% after Lap SPDP, Lap SxDP, and Lap En, respectively. The overall morbidity rate was significantly
higher (p > 0.05) in the group of Lap SPDP without splenic vessels preservation comparing with Lap SPDP with splenic vessels preservation
because of the occurrence of splenic complications (20.6%). The overall pancreatic fistulas was 7.7, 10, and 35% after Lap
SPDP, Lap SxDP, and Lap En, respectively; the severity of fistula was significantly higher in the Lap En group (p > 0.05). The mean hospital stay was within 1 week in all groups, except in the group of ductal adenocarcinoma, which is 8 days.
In this series, 27 patients (26.2%) had malignant disease. R
0 resection was achieved in 90% of ductal adenocarcinoma and 100% for other malignant tumors. The median survival for ductal
adenocarcinoma patients was 14 months. This series demonstrates that LPS is feasible and safe in benign-appearing and malignant
lesions of the pancreas. 相似文献