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Expert Review of Pharmacoeconomics & Outcomes Research

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https://www.readbyqxmd.com/read/28330384/federal-procurement-of-unlicensed-medicines-in-brazil-findings-and-implications
#1
Cristiane Roberta Dos Santos Teodoro, André Luís Almeida Dos Reis, Brian Godman, Rosângela Caetano, Claudia Garcia Serpa Osorio-de-Castro
BACKGROUND: There are safety concerns with using unlicensed medicines across countries including Brazil. Consequently this needs to be evaluated and concerns address if pertinent. AIM: Investigate such purchases by the Brazilian Federal Government from 2004 to 2013. METHODS: Procurement data from a public-access databank that contains procurement information of the Brazilian Federal Government. Each procured item was cross-referenced to its active drug approval status in the Brazilian National Register (DOU)...
March 23, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28287008/the-value-of-open-access-and-a-patient-centric-approach-to-oral-oncolytic-utilization-in-the-treatment-of-chronic-myelogenous-leukemia-a-u-s-perspective
#2
Lopamudra Das, Matthew Gitlin, Lisa R Siegartel, Dinara Makenbaeva
Since the introduction of tyrosine kinase inhibitors (TKIs), the treatment of patients with chronic myelogenous leukemia (CML) has resulted in significant improvement in patient survival but at a higher pharmaceutical cost to payers. The recent introduction of generic imatinib presents an opportunity to lower pharmacy costs within a population that is growing due to improved survival. Recent literature has focused on the likely benefits to payers of step therapy through generic imatinib. Areas covered: This review provides a perspective that is broader than the evaluation of financial savings or narrowly defined health economic metrics by incorporating factors such as CML patient heterogeneity, including varying levels of disease progression risk, comorbidities, and genetic mutation status, differences in TKI product profiles, clinical guideline recommendations, and the importance of individualized patient care...
March 13, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28283002/losing-a-foot-versus-losing-a-dollar-a-systematic-review-of-cost-studies-in-diabetic-foot-complications
#3
Ioannis Petrakis, Ilias J Kyriopoulos, Alexandros Ginis, Kostas Athanasakis
Diabetes mellitus is a chronic disease with high prevalence worldwide and a range of serious related complications. Amongst them, diabetic foot is one of the most disabling, posing a substantial health and economic burden on patients and healthcare systems. Areas Covered: According to projections, the expected lower limb morbidity is about to increase - in this light the present review aimed at identifying cost-of-illness studies on the management and treatment of conditions related to the diabetic foot, in an aim to provide a body of evidence for an increasing health care burden...
March 10, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28277852/the-treatment-patterns-of-castration-resistant-prostate-cancer-in-japan-including-symptomatic-skeletal-events-and-associated-treatment-and-healthcare-resource-use
#4
Hiroji Uemura, Marco DiBonaventura, Ed Wang, Dianne Athene Ledesma, Kristen Concialdi, Yasuko Aitoku
BACKGROUND: Real-world treatment patterns of bone metastatic castration-resistant prostate cancer (mCRPC) in Japan were examined, focusing on treatment patterns and resource use differences attributed to symptomatic skeletal events (SSEs). METHODS: Urologists (N=176) provided retrospective chart data for patients with mCRPC (N=445) via online surveys. Descriptive analyses and chi-square tests evaluated treatment patterns and their differences by SSE presence; generalized linear mixed models examined healthcare resource utilization differences as a function of SSEs...
March 6, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28277853/treatment-plan-comparison-in-acute-and-chronic-respiratory-tract-diseases-an-observational-study-of-doxophylline-vs-theophylline
#5
F S Mennini, P Sciattella, A Marcellusi, A Marcobelli, A Russo, A P Caputi
OBJECTIVES: To estimate the global cost related to the use of the two drugs (associated drugs, specialist visits, hospital admissions, plasma drug monitoring). METHODS: The drug prescriptions were extracted from the Information System of the Pharmaceutical Prescriptions of the Marche Region for each ATC code in the years 2008-2012 and the number of patients per year and other outcomes measure were obtained. RESULTS: 13,574 patients were treated with theophylline and 19,426 patients with doxophylline...
March 3, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28277854/economic-analysis-of-the-phase-iii-mensa-study-evaluating-mepolizumab-for-severe-asthma-with-eosinophilic-phenotype
#6
Anirban Basu, Anand Dalal, Giorgio Walter Canonica, Mark Forshag, Steven W Yancey, Saurabh Nagar, Christopher F Bell
BACKGROUND: Severe eosinophilic asthma patients are at risk of exacerbations, which are associated with substantial costs. Mepolizumab lowers eosinophil levels and reduces exacerbation risk in severe eosinophilic asthma. We evaluated asthma-related exacerbation costs in mepolizumab-treated patients (versus placebo). RESEARCH DESIGN AND METHODS: A within-trial economic analysis of the Mepolizumab as Adjunctive Therapy in Patients with Severe Asthma (MENSA) trial...
March 2, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28277855/using-lower-cost-statins-improves-outcomes-for-normal-cholesterol-non-diabetic-patients
#7
Ronen Arbel, Dan Greenberg
BACKGROUND The American College of Cardiology recommends considering initiation of cholesterol-lowering therapy in normal cholesterol adults aged 45-70, who are either diabetic or have a 10 year atherosclerotic cardiovascular disease higher than 7.5%. Although this policy was shown to be cost-effective, the multi-billion dollar budget impact may limit the adoption, diffusion and overall clinical impact of this therapy. OBJECTIVES We examined whether using a substantially lower cost statin (Simvastatin) in a much wider population, while accepting almost-as-good per-patient outcomes can provide better outcomes for the entire intended use population (IUP) under a pre-specified budget constraint...
February 21, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28133977/health-state-utility-estimates-for-health-technology-assessment-a-review-of-the-manufacturers-submissions-to-the-french-national-authority-for-health
#8
Francoise F Hamers, Salah Ghabri, Catherine Le Gales
OBJECTIVES: To review the selection and methods used for deriving health state utility (HSU) estimates included in the cost-utility analyses (CUA) submitted by manufacturers to the National Authority for Health (HAS) during the first 2 years after the introduction of the economic evaluation for price setting in France. METHODS: We reviewed all manufacturers' submissions that included a CUA and were assessed by HAS by the end of October 2015 (N=34). We reviewed the identification, selection, and methods used to estimate HSU and compared them with those recommended by HAS...
January 29, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28092210/the-insights-of-health-and-welfare-professionals-on-hurdles-that-impede-economic-evaluations-of-welfare-interventions
#9
J Schepers, J Plaete, I De Bourdeaudhuij, L Annemans, S Simoens
OBJECTIVES: Four hurdles associated with economic evaluations in welfare interventions were identified and discussed in a previous published literature review. These hurdles include (i) 'Ignoring the impact of condition-specific outcomes', (ii) 'Ignoring the impact of QoL externalities', (iii) 'Calculation of costs from a too narrow perspective' and (iv) 'The lack of well-described & standardized interventions'. This study aims to determine how healthcare providers and social workers experience and deal with these hurdles in practice and what solutions or new insights they would suggest...
January 16, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28019130/eliciting-societal-preferences-of-reimbursement-decision-criteria-for-anti-cancer-drugs-in-south-korea
#10
Sun-Hong Kwon, Sun-Kyeong Park, Ji-Hye Byun, Eui-Kyung Lee
INTRODUCTION: In order to look beyond the cost-effectiveness analysis, this study used a multi-criteria decision analysis (MCDA), which reflects societal values with regard to reimbursement decisions. This study aims to elicit societal preferences of the reimbursement decision criteria for anti cancer drugs from public and healthcare professionals. METHODS: Eight criteria were defined based on a literature review and focus group sessions: disease severity, disease population size, pediatrics targets, unmet needs, innovation, clinical benefits, cost-effectiveness, and budget impacts...
January 3, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28010146/national-reimbursement-listing-determinants-of-new-cancer-drugs-a-retrospective-analysis-of-58-cancer-treatment-appraisals-in-2007-2016-in-south-korea
#11
Eun-Sook Kim, Jung-Ae Kim, Eui-Kyung Lee
BACKGROUND: Since the positive-list system was introduced, concerns have been raised over restricting access to new cancer drugs in Korea. Policy changes in the decision-making process, such as risk-sharing agreement and the waiver of pharmacoeconomic data submission, were implemented to improve access to oncology medicines, and other factors are also involved in the reimbursement for cancer drugs. The aim of this study is to investigate the reimbursement listing determinants of new cancer drugs in Korea...
January 3, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27936981/the-impact-of-price-cap-regulations-on-market-entry-by-generic-pharmaceutical-firms
#12
Wei Zhang, Huiying Sun, Daphne Guh, Aslam H Anis
BACKGROUND: In 1998, the province of Ontario, Canada implemented price-cap '70/90' regulations: the first generic must be priced at ≤70% of the associated brand-name price and subsequent generics must be priced at ≤90% of the first generics' price. The price-cap was further lowered to 50% in 2006 and 25% in 2010 for all generic drugs regardless of the first or subsequent generic entrants. This study assessed the impact of such price-cap regulations on market entry by generic firms using the formulary database from 9 provinces (January 2004-March 2013)...
December 27, 2016: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28092207/healthcare-burden-of-depression-in-adults-with-arthritis
#13
REVIEW
Usha Sambamoorthi, Drishti Shah, Xiaohui Zhao
Arthritis and depression are two of the top disabling conditions. When arthritis and depression exist in the same individual, they can interact with each other negatively and pose a significant healthcare burden on the patients, their families, payers, healthcare systems, and society as a whole. Areas covered: The primary objective of this review is to summarize, identify knowledge gaps and discuss the challenges in estimating the healthcare burden of depression among individuals with arthritis. Electronic literature searches were performed on PubMed, Embase, EBSCOhost, Scopus, the Cochrane Library, and Google Scholar to identify relevant studies...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28064553/granulocyte-colony-stimulating-factors-in-the-prevention-of-febrile-neutropenia-review-of-cost-effectiveness-models
#14
REVIEW
Kelly Fust, Anju Parthan, Michael Maschio, Qing Gu, Xiaoyan Li, Gary H Lyman, Spiros Tzivelekis, Guillermo Villa, Milton C Weinstein
We reviewed the evolution of the methods used in cost-effectiveness analyses of granulocyte colony-stimulating factors (G-CSFs) in the primary and secondary prevention of febrile neutropenia (FN) in patients receiving myelosuppressive cancer chemotherapy. Areas covered: FN is a side effect of myelosuppressive chemotherapy associated with significant morbidity, mortality, and costs. The risk of FN may depend on the drugs used within a chemotherapy regimen, and an FN event may cause chemotherapy dose reductions or delays in subsequent cycles...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28043174/validation-and-calibration-of-structural-models-that-combine-information-from-multiple-sources
#15
REVIEW
Issa J Dahabreh, John B Wong, Thomas A Trikalinos
Mathematical models that attempt to capture structural relationships between their components and combine information from multiple sources are increasingly used in medicine. Areas covered: We provide an overview of methods for model validation and calibration and survey studies comparing alternative approaches. Expert commentary: Model validation entails a confrontation of models with data, background knowledge, and other models, and can inform judgments about model credibility. Calibration involves selecting parameter values to improve the agreement of model outputs with data...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27978765/a-systematic-review-and-checklist-presenting-the-main-challenges-for-health-economic-modeling-in-personalized-medicine-towards-implementing-patient-level-models
#16
REVIEW
Koen Degeling, Hendrik Koffijberg, Maarten J IJzerman
The ongoing development of genomic medicine and the use of molecular and imaging markers in personalized medicine (PM) has arguably challenged the field of health economic modeling (HEM). This study aims to provide detailed insights into the current status of HEM in PM, in order to identify if and how modeling methods are used to address the challenges described in literature. Areas covered: A review was performed on studies that simulate health economic outcomes for personalized clinical pathways. Decision tree modeling and Markov modeling were the most observed methods...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27935333/cost-utility-analysis-of-the-insufflation-of-warmed-humidified-carbon-dioxide-during-open-and-laparoscopic-colorectal-surgery
#17
Michelle Jenks, Matthew Taylor, Judith Shore
BACKGROUND: An evaluation was conducted to estimate the cost-effectiveness of insufflation of warmed humidified CO2 during open and laparoscopic colorectal surgery compared with usual care from a UK NHS perspective. METHODS: Decision analytic models were developed for open and laparoscopic surgery. Incremental costs per quality-adjusted life year (QALY) were estimated. The open surgery model used data on the incidence of intra-operative hypothermia and applied risks of complications for hypothermia and normothermia...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27927059/illness-perceptions-and-burden-of-disease-in-fibromyalgia
#18
REVIEW
Tracy L Skaer, Winghan Jacqueline Kwong
Fibromyalgia (FM) is a chronic syndrome that usually develops midlife. It is associated with a high burden of illness that causes significant disability. Areas covered: Diagnosis can be challenging, given the diverse clinical presentation among those with FM. Therefore, the typical health care journey for a patient with FM is lengthy and complex. There is no acknowledged treatment algorithm for FM, prescribing patterns vary markedly, and patients are likely to receive suboptimal or inappropriate pharmacotherapy...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27830967/the-european-society-for-medical-oncology-magnitude-of-clinical-benefit-scale-esmo-mcbs-applied-to-pivotal-phase-iii-randomized-controlled-trials-of-tyrosine-kinase-inhibitors-in-first-line-for-advanced-non-small-cell-lung-cancer-with-activating-epidermal-growth
#19
Jacopo Giuliani, Andrea Remo, Andrea Bonetti
To examine the magnitude of the clinical benefit from first-line tyrosine kinase inhibitors (TKIs) advanced non-small cell lung cancer (NSCLC) with activating epidermal growth factor receptor (EGFR)-mutations. Areas covered: The present evaluation was restricted to pivotal phase III RCTs in first-line for advanced NSCLC with activating EGFR-mutations. We have subsequently applied the European Society for Medical Oncology-Magnitude of Clinical Benefit Scale (ESMO-MCBS) to the above pivotal phase III RCTs, to derive a relative ranking of the magnitude of clinically meaningful benefit...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/27366939/an-estimate-of-the-public-health-impact-and-cost-effectiveness-of-universal-vaccination-with-a-9-valent-hpv-vaccine-in-germany
#20
Nathalie Largeron, Karl Ulrich Petry, Jorge Jacob, Florence Bianic, Delphine Anger, Mathieu Uhart
INTRODUCTION: Since 2007, the German Standing Vaccination Committee recommends HPV vaccination for girls aged 12-17 with a 2- (Cervarix®) or 4-valent (Gardasil®) vaccine. A 9-valent vaccine (Gardasil 9®) recently received a European market authorization in 2015. METHODS: A dynamic transmission model was calibrated to the German setting and used to estimate costs and QALYs associated with vaccination strategies. RESULTS: Compared to the current vaccination program, the 9-valent vaccine extended to boys shows further reductions of 24% in the incidence of cervical cancer, 30% and 14% in anal cancer for males and females, as well as over a million cases of genital warts avoided after 100 years...
February 2017: Expert Review of Pharmacoeconomics & Outcomes Research
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