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https://www.readbyqxmd.com/read/29052427/the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making-an-interview-with-marc-berger
#1
Marc L Berger
Marc L Berger, MD, is a retired, part-time consultant. He recently became Chair of the Real World Evidence Advisory Board for SHYFT Analytics. Over a 25-year industry career, Marc has held senior-level positions at Pfizer, Inc., OptumInsight, Eli Lilly and Company, and Merck & Co., Inc. His professional activities have included serving on committees for Center for Medicare and Medicaid Services (CMS), Agency for Healthcare Research and Quality (AHRQ), Patient-Centered Outcomes Research Institute (PCORI), the International Society for Pharmacoeconomics and Outcomes Research (ISPOR), Drug Information Association (DIA), and the editorial advisory boards of several journals...
October 20, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/29052155/special-edition-on-utility-measurement-pharmacoeconomics
#2
EDITORIAL
Andrew Lloyd
No abstract text is available yet for this article.
October 19, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/29044643/fidaxomicin-versus-vancomycin-as-a-first-line-treatment-for-clostridium-difficile-associated-diarrhea-cdad-in-specific-patient-populations-a-pharmacoeconomic-evaluation
#3
Kelly R Reveles, Jennifer L Backo, Frank A Corvino, Marko Zivkovic, Kelly C Broderick
OBJECTIVES: The reduction in recurrent Clostridium difficile-associated diarrhea (CDAD) with fidaxomicin therapy may reduce hospital readmissions and lead to lower overall CDAD costs. However, studies assessing the cost-effectiveness of fidaxomicin as first-line therapy from the United States (US) hospital perspective are lacking. This study evaluated the costs associated with utilizing fidaxomicin or vancomycin as a first-line therapy for CDAD in specific patient populations from a US hospital perspective...
October 17, 2017: Pharmacotherapy
https://www.readbyqxmd.com/read/29027315/cost-effectiveness-analysis-of-carbetocin-during-cesarean-section-in-a-high-volume-maternity-unit
#4
Hian Yan Voon, Asrul A Shafie, Mohamad A Bujang, Haris N Suharjono
AIM: To evaluate the cost effectiveness of carbetocin compared to oxytocin when used as prophylaxis against post-partum hemorrhage (PPH) during cesarean deliveries. METHODS: A systematic review of the literature was performed to identify randomized controlled trials that compared the use of carbetocin to oxytocin in the context of cesarean deliveries. Cost effectiveness analysis was then performed using secondary data from the perspective of a maternity unit within the Malaysian Ministry of Health, over a 24 h time period...
October 13, 2017: Journal of Obstetrics and Gynaecology Research
https://www.readbyqxmd.com/read/28993857/smabcare-study-subcutaneous-monoclonal-antibody-in-cancer-care-cost-consequence-analysis-of-subcutaneous-rituximab-in-patients-with-follicular-lymphoma
#5
Emilie Fargier, Florence Ranchon, Laure Huot, Pascale Guerre, Violaine Safar, Arthur Dony, Nathalie Hequet, Emmanuel Bachy, Stéphane Savouroux, Clémentine Fronteau, Patrick Tomaré, Jean-François Tournamille, Vérane Schwiertz, Nicolas Vantard, Steven Le Gouill, Emmanuel Gyan, Gilles Salles, Catherine Rioufol
Rituximab is used as a standard of care for follicular lymphoma and is usually administered intravenously. A novel subcutaneous formulation recently showed non-inferior efficacy with similar pharmacokinetic and safety profiles compared to intravenous rituximab in patients with follicular lymphoma. This new approach is promising in terms of comfort for patients and time-saving for hospital staff. To evaluate the real-life economic impact of subcutaneous rituximab as maintenance therapy in patients with follicular lymphoma in real life, we conducted a cost-consequence analysis from the hospital's point of view in three French teaching hospitals...
October 10, 2017: Annals of Hematology
https://www.readbyqxmd.com/read/28993334/choosing-optimal-antifungal-agents-to-prevent-fungal-infections-in-non-neutropenic-critically-ill-patients-trial-sequential-analysis-network-meta-analysis-and-pharmacoeconomic-analysis
#6
Yan Wang, Jiao Xie, Yuanming Xing, Lu Chen, Ying Li, Ti Meng, Weihua Dong, Xue Wang, Yalin Dong
The use of antifungal interventions in critically ill patients prior to invasive fungal infection (IFI) being microbiologically confirmed as well as the preferred drug are still controversial. A systematic literature search was performed to identify randomized controlled trials (RCTs) that have compared untargeted antifungal treatments applied to non-neutropenic critically ill patients. The primary outcomes were all-cause mortality and proven IFI rates. A random-effects model was used with trial sequential analyses (TSA), a network meta-analysis (NMA) was conducted to obtain indirect evidence, and a cost-effectiveness analysis using a decision-analytic model was completed from the patient perspective over a lifetime horizon...
October 9, 2017: Antimicrobial Agents and Chemotherapy
https://www.readbyqxmd.com/read/28980620/-pharmacoeconomic-aspects-of-combined-treatment-of-advanced-stage-of-parkinson-s-disease
#7
A V Rudakova, O S Levin
AIM: To assess the cost-efficiency of the fixed levodopa/carbidopa/entacapone combination and the free combination of levodopa/carbidopa with rasagiline. MATERIAL AND METHODS: An analysis was performed using the Markov model including three clinical states: duration of off-time ≤25%, duration of off-time >25% and fatal outcome. Costs of the drugs were calculated based on the results of auctions for 2016 by IMS Health data. RESULTS: In basic variant (drugs containing levodopa, 5-times a day), costs of treatment with the fixed levodopa/carbidopa/entacapone combination were 2...
2017: Zhurnal Nevrologii i Psikhiatrii Imeni S.S. Korsakova
https://www.readbyqxmd.com/read/28979151/current-recommendations-on-the-estimation-of-transition-probabilities-in-markov-cohort-models-for-use-in-health-care-decision-making-a-targeted-literature-review
#8
REVIEW
Elena Olariu, Kevin K Cadwell, Elizabeth Hancock, David Trueman, Helene Chevrou-Severac
OBJECTIVE: Although Markov cohort models represent one of the most common forms of decision-analytic models used in health care decision-making, correct implementation of such models requires reliable estimation of transition probabilities. This study sought to identify consensus statements or guidelines that detail how such transition probability matrices should be estimated. METHODS: A literature review was performed to identify relevant publications in the following databases: Medline, Embase, the Cochrane Library, and PubMed...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28964430/good-practices-for-real-world-data-studies-of-treatment-and-or-comparative-effectiveness-recommendations-from-the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making
#9
Marc L Berger, Harold Sox, Richard J Willke, Diana L Brixner, Hans-Georg Eichler, Wim Goettsch, David Madigan, Amr Makady, Sebastian Schneeweiss, Rosanna Tarricone, Shirley V Wang, John Watkins, C Daniel Mullins
PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies...
September 2017: Value in Health: the Journal of the International Society for Pharmacoeconomics and Outcomes Research
https://www.readbyqxmd.com/read/28959910/a-systematic-review-of-pharmacoeconomic-guidelines
#10
Ye Zhao, Hai-Ming Feng, Ji Qu, Xiu Luo, Wen-Juan Ma, Jin-Hui Tian
OBJECTIVE: To review, summarize, and analyze both similarities and differences of pharmacoeconomic (PE) guidelines, to enable researchers to access their characteristics and the current state of PE guidelines; furthermore, to learn which methodological issues still remain contested and to promote the methodological development of PE guidelines. MATERIALS AND METHODS: We performed a search for PE guidelines using PubMed, the Cochrane library database, and the websites of the International Society for Pharmacoeconomics and Outcomes Research...
September 29, 2017: Journal of Medical Economics
https://www.readbyqxmd.com/read/28946800/the-value-of-innovation-in-decision-making-in-health-care-in-central-eastern-europe-the-sixth-international-conference-the-value-of-innovation-in-decision-making-in-health-care-in-central-eastern-europe-2-june-2017-belgrade-serbia
#11
Tanja Novakovic, Antony P Martin, Mark Parker, Alessandra Ferrario, Simo Vukovic, Krzysztof Łanda, Jaroslav Duba, Dávid Dankó, Nikolaos Kotsopoulos, Brian Godman, Jelena Ristic, Danka Stefanovic, Danka Tesic
The Pharmacoeconomics Section of the Pharmaceutical Association of Serbia organised a one day international conference on the value of innovation in decision-making in health care in Central and Eastern Europe. The focus of the conference was on reimbursement decisions for medicines using health technology assessment and the use of managed entry agreements (MEAs). The objectives of this conference were firstly to discuss the challenges and opportunities with the use of MEAs in Central and Eastern European countries; secondly the role of patient registries especially with outcome based schemes, and finally new approaches to improve accessibility to new medicines including better managing their entry...
September 26, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
https://www.readbyqxmd.com/read/28919794/parenteral-nutrition-including-an-omega-3-fatty-acid-containing-lipid-emulsion-for-intensive-care-patients-in-china-a-pharmacoeconomic-analysis
#12
Yufei Feng, Chao Li, Tian Zhang, Lorenzo Pradelli
BACKGROUND/OBJECTIVES: Parenteral nutrition (PN) incorporating omega-3 fatty-acid-enriched lipid emulsions has been shown to be cost effective in Western populations. A pharmacoeconomic evaluation was performed within the Chinese intensive care unit (ICU) setting. This assessed whether the additional acquisition cost of PN with omega-3 fatty-acid-enriched lipid emulsion (SMOFlipid) vs standard PN was offset by improved clinical outcomes that can reduce subsequent costs. MATERIALS AND METHODS: A pharmacoeconomic discrete event simulation model was developed, based on an update to efficacy data from a previous international meta-analysis, with China-specific clinical and economic input parameters...
2017: ClinicoEconomics and Outcomes Research: CEOR
https://www.readbyqxmd.com/read/28917227/pharmacoeconomics-of-parenteral-nutrition-in-surgical-and-critically-ill-patients-receiving-structured-triglycerides-in-china
#13
Guo Hao Wu, Alexandra Ehm, Marco Bellone, Lorenzo Pradelli
BACKGROUND AND OBJECTIVES: A prior meta-analysis showed favorable metabolic effects of structured triglyceride (STG) lipid emulsions in surgical and critically ill patients compared with mixed medium-chain/long-chain triglycerides (MCT/LCT) emulsions. Limited data on clinical outcomes precluded pharmacoeconomic analysis. We performed an updated meta-analysis and developed a cost model to compare overall costs for STGs vs MCT/LCTs in Chinese hospitals. METHODS AND STUDY DESIGN: We searched Medline, Embase, Wanfang Data, the China Hospital Knowledge Database, and Google Scholar for clinical trials comparing STGs to mixed MCT/LCTs in surgical or critically ill adults published between October 10, 2013 and September 19, 2015...
2017: Asia Pacific Journal of Clinical Nutrition
https://www.readbyqxmd.com/read/28913966/good-practices-for-real-world-data-studies-of-treatment-and-or-comparative-effectiveness-recommendations-from-the-joint-ispor-ispe-special-task-force-on-real-world-evidence-in-health-care-decision-making
#14
Marc L Berger, Harold Sox, Richard J Willke, Diana L Brixner, Hans-Georg Eichler, Wim Goettsch, David Madigan, Amr Makady, Sebastian Schneeweiss, Rosanna Tarricone, Shirley V Wang, John Watkins, C Daniel Mullins
PURPOSE: Real-world evidence (RWE) includes data from retrospective or prospective observational studies and observational registries and provides insights beyond those addressed by randomized controlled trials. RWE studies aim to improve health care decision making. METHODS: The International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and the International Society for Pharmacoepidemiology (ISPE) created a task force to make recommendations regarding good procedural practices that would enhance decision makers' confidence in evidence derived from RWD studies...
September 2017: Pharmacoepidemiology and Drug Safety
https://www.readbyqxmd.com/read/28905279/capturing-budget-impact-considerations-within-economic-evaluations-a-systematic-review-of-economic-evaluations-of-rotavirus-vaccine-in-low-and-middle-income-countries-and-a-proposed-assessment-framework
#15
REVIEW
Natalie Carvalho, Mark Jit, Sarah Cox, Joanne Yoong, Raymond C W Hutubessy
BACKGROUND: In low- and middle-income countries, budget impact is an important criterion for funding new interventions, particularly for large public health investments such as new vaccines. However, budget impact analyses remain less frequently conducted and less well researched than cost-effectiveness analyses. OBJECTIVE: The objective of this study was to fill the gap in research on budget impact analyses by assessing (1) the quality of stand-alone budget impact analyses, and (2) the feasibility of extending cost-effectiveness analyses to capture budget impact...
September 13, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28901346/-procurement-of-medical-devices-based-on-cost-effectiveness-data
#16
Sabrina Trippoli
The field of medical devices is characterized by a paucity of cost-effectiveness data that support their use. In this context, we have proposed a project based on the calculation of net monetary benefit (NMB) for each product subjected to procurement through tenders. This project consists of two steps: 1) calculation of NMB; 2) calculation of a value-based score to be used in the process of procurement and tendering. The NMB is defined as follows: NMB per patient= (monetary threshold of WTP) x (QALYs per patient) - (treatment cost per patient); WTP= willingness to pay]...
September 2017: Recenti Progressi in Medicina
https://www.readbyqxmd.com/read/28891346/lumacaftor-ivacaftor-a-novel-agent-for-the-treatment-of-cystic-fibrosis-patients-who-are-homozygous-for-the-f580del-cftr-mutation
#17
REVIEW
Marilyn N Bulloch, Cameron Hanna, Richard Giovane
Cystic Fibrosis (CF) is an autosomal recessive disease affecting up to 90,000 people worldwide. Approximately 73% of patients are homozygous for the F508del cystic fibrosis transmembrane conductance regulator [CFTR] mutation. Traditionally treatment has only included supportive care. Therefore, there is a need for safe and effective novel therapies targeting the underlying molecular defects seen with CF. Areas covered: In 2016, the Food and Drug Administration and the European Commission approved LUM/IVA (Orkambi), a CFTR modulator that includes both a CFTR corrector and potentiator, for CF patients homozygous for the F508del CFTR mutation...
October 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28875555/midazolam-vs-diazepam-in-prolonged-seizures-in-children-a-pharmacoeconomic-approach
#18
E Beghi, G Capovilla, E Franzoni, F Minicucci, A Romeo, A Verrotti, F Vigevano, E Perucca
OBJECTIVE: A previous European cost-utility study reported that use of buccal midazolam in the community setting for the treatment of prolonged seizures (ie, seizures lasting ≥5 minutes) in children was associated with an overall €12 507 399 reduction in annual costs charged to the Italian national health service compared with rectal diazepam. We re-evaluated these findings by applying a more conservative approach. METHODS: The Italian Delphi panel reconvened to apply a more conservative assessment of available reports...
September 6, 2017: Acta Neurologica Scandinavica
https://www.readbyqxmd.com/read/28857713/low-molecular-weight-heparins-for-the-prevention-of-recurrent-venous-thromboembolism-in-patients-with-cancer-a-systematic-literature-review-of-efficacy-and-cost-effectiveness
#19
George Dranitsaris, Lesley G Shane, Seth Woodruff
Background Patients with cancer have an elevated risk of venous thromboembolism. Importantly, patients with cancer, who have metastatic disease, renal insufficiency, or are receiving anticancer therapy, have an even higher risk of a recurrent event. Similarly, the risk of recurrent venous thromboembolism is higher than the risk of an initial event. To reduce the risk, extended duration of prophylaxis for up to six months with low-molecular-weight heparins such as dalteparin, enoxaparin, nadroparin, and tinzaparin is recommended by international guidelines...
January 1, 2017: Journal of Oncology Pharmacy Practice
https://www.readbyqxmd.com/read/28852832/down-titration-of-biologics-for-the-treatment-of-rheumatoid-arthritis-a-systematic-literature-review
#20
Chak Sing Lau, Allan Gibofsky, Nemanja Damjanov, Sadiq Lula, Lisa Marshall, Heather Jones, Paul Emery
Biologic therapies have improved the management of rheumatoid arthritis (RA) and the treat-to-target approach has resulted in many patients achieving remission. In the current treatment landscape, clinicians have begun considering dose reduction/tapering for their patients. Rheumatology guidelines in Asia, Europe, and the United States include down-titration of biologics but admit that the level of evidence is moderate. We conducted a systematic literature review to assess the published studies that evaluate down-titration of biologics in RA...
August 29, 2017: Rheumatology International
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