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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6.
Alexander Stoff MD ; Angel A. Rivera PhD ; N. S. Banerjee PhD ; J. Michael Mathis PhD ; Antonio Espinosa-de-los-Monteros MD ; Long P. Le PhD ; Jorge I. De la Torre MD ; Luis O. Vasconez MD ; Thomas R. Broker PhD ; Dirk F. Richter MD ; Mariam A. Stoff-Khalili MD ; David T. Curiel MD PhD 《Wound repair and regeneration》2006,14(5):608-617
Genetically modified keratinocytes and fibroblasts are suitable for delivery of therapeutic genes capable of modifying the wound healing process. However, efficient gene delivery is a prerequisite for successful gene therapy of wounds. Whereas adenoviral vectors (Ads) exhibit superior levels of in vivo gene transfer, their transductional efficiency to cells resident within wounds may nonetheless be suboptimal, due to deficiency of the primary adenovirus receptor, coxsackie-adenovirus receptor (CAR). We explored CAR-independent transduction to fibroblasts and keratinocytes using a panel of CAR-independent fiber-modified Ads to determine enhancement of infectivity. These fiber-modified adenoviral vectors included Ad 3 knob (Ad5/3), canine Ad serotype 2 knob (Ad5CAV-2), RGD (Ad5.RGD), polylysine (Ad5.pK7), or both RGD and polylysine (Ad5.RGD.pK7). To evaluate whether transduction efficiencies of the fiber-modified adenoviral vectors correlated with the expression of their putative receptors on keratinocytes and fibroblasts, we analyzed the mRNA levels of CAR, alpha upsilon integrin, syndecan-1, and glypican-1 using quantitative polymerase chain reaction. Analysis of luciferase and green fluorescent protein transgene expression showed superior transduction efficiency of Ad5.pK7 in keratinocytes and Ad5.RGD.pK7 in fibroblasts. mRNA expression of alpha upsilon integrin, syndecan-1 and glypican-1 was significantly higher in primary fibroblasts than CAR. In keratinocytes, syndecan-1 expression was significantly higher than all the other receptors tested. Significant infectivity enhancement was achieved in keratinocytes and fibroblasts using fiber-modified adenoviral vectors. These strategies to enhance infectivity may help to achieve higher clinical efficacy of wound gene therapy. 相似文献
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Antonio Rivera Antonio Yáñez Gloria León-Tello Constantino Gil Silvia Giono Eduardo Barba Lilia Cedillo 《BMC musculoskeletal disorders》2002,3(1):15-7
Background
Mycoplasma fermentans has been associated with rheumatoid arthritis. Recently, it was detected in the joints and blood of patients with rheumatoid arthritis, but it is not clear yet how the bacteria enter the body and reach the joints. The purpose of this study was to determine the ability of M. fermentans to induce experimental arthritis in rabbits following inoculation of the bacteria in the trachea and knee joints. 相似文献9.
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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Gastrojejunostomy stricture after Roux-en-Y gastric bypass occurs in 3 to 27% of morbidly obese patients in the USA. We questioned
whether preoperative patient characteristics, including demographic attributes and comorbid disease, might be significant
factors in the etiology of stricture. In this study from November 2001 to February 2006 (51 months), at a high-volume bariatric
center, of the 1,351 patients who underwent laparoscopic gastric bypass, 92 developed stricture (6.8%). All but two were treated
successfully by endoscopic dilation. All patients stopped nonsteroidal anti-inflammatory medications 2 weeks prior to surgery
and did not restart them. The operative procedure included the use of a 21-mm transoral circular stapler to create the gastrojejunostomy;
the Roux limb was brought retrogastric, retrocolic. In an effort to reduce our center’s stricture rate, late in the study,
U-clips used at the gastrojejunostomy were replaced by absorbable sutures, and postoperative H2 antagonists were added to the treatment protocol. The change to absorbable polyglactin suture proved to be significant, resulting
in a lower stricture rate. The addition of H2 antagonists showed no significant effect. Following the retrospective review of the prospective database, univariate and
multivariate logistic regression analyses identified factors associated with the development of stricture. Gastroesophageal
reflux disease and age were each shown to be statistically significant independent predictors of stricture following laparoscopic
gastric bypass.
Presented at the 2006 Annual Meeting of the Society for Surgery of the Alimentary Tract, May 20–24, Los Angeles, CA (poster
presentation). 相似文献