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Expert Review of Pharmacoeconomics & Outcomes Research

Jörg Mahlich, Isao Kamae, Rosarin Sruamsiri
BACKGROUND: Drug price setting is one of the key challenges faced by the Japanese health care system. This study aims to identify the determinants of drug price in Japan using the example of the rheumatoid arthritis (RA) treatment market. RESEARCH DESIGN AND METHODS: In order to compare prices across different products, we calculated prices per defined daily dose using WHO methodology. Price determinants were calculated both at launch and over time using IMS quarterly data on medicines approved for RA treatment in Japan from 2012 to 2015...
November 3, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Ellen M Janssen, Deborah A Marshall, A Brett Hauber, John F P Bridges
The recent endorsement of discrete-choice experiments (DCEs) and other stated-preference methods by regulatory and health technology assessment (HTA) agencies has placed a greater focus on demonstrating the validity and reliability of preference results. Areas covered: We present a practical overview of tests of validity and reliability that have been applied in the health DCE literature and explore other study qualities of DCEs. From the published literature, we identify a variety of methods to assess the validity and reliability of DCEs...
October 23, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
J Rehm, C Barbosa
Alcohol use is a major risk factor for mortality and morbidity burden, and alcohol use disorders contribute markedly to this burden. Effective interventions for alcohol use disorders improve health, and are potentially cost-effective or even cost saving. Areas covered: We searched the literature for the cost-effectiveness of alcohol interventions. We included behavioral, pharmacological and combined interventions, and research from both a health care provider and a societal perspective. Overall, many economic research studies pointed towards existing cost-beneficial therapies from the perspective of a health care provider; i...
October 20, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Samir V Patel, Rajesh Sonani, Vikas Singh, Palak Patel, Apurva Badheka
Patients with bicuspid aortic valve (BAV) have traditionally been excluded from large randomized clinical trials involving transcatheter aortic valve replacements (TAVR). Technical enhancements, availability of new generation devices and improved outcomes have led to a marked increase in TAVR volume across the world including off label use in patients with BAV stenosis. Areas covered: In this manuscript, we have reviewed the currently available data regarding safety, efficacy, and outcomes of TAVR in patients with BAV stenosis...
October 16, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Nagesh Kamat, Ganesh Pai, Surulivel Rajan Mallayasamy, Asha Kamath, Rajasulochana S
BACKGROUND: Chronic pancreatitis (CP) is a leading cause of hospitalization among gastrointestinal diseases resulting in considerable financial burden to patients. However the direct costs for nonsurgical management in CP remains unexplored. METHODS: A cross sectional study was carried out (2011-14) in the Department of Gastroenterology, Kasturba Hospital, Manipal, India. Demographic and clinical data on laboratory investigations, interventions and follow up were obtained from the medical records department...
October 12, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Ana V Pejcic, Georgi Iskrov, Ralitsa Raycheva, Rumen Stefanov, Mihajlo Michael Jakovljevic
А series of European Union (EU) political decisions have made rare diseases one of the cornerstones of the common European health policy. Adopted in 2009, Council Recommendation on an action in the field of rare diseases aimed to serve as a policy-making guideline. However, the implementation report, which followed it, neither performed detailed cross-country comparison, nor assessed the impact of the policies. Areas covered: A 10-indicator set was elaborated to structure the review and to describe rare disease activities in 14 Eastern European countries...
October 10, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Henry W C Leung, Agnes L F Chan, Chih-Hsin Muo, John Hang Leung
OBJECTIVE: To provide perspective for the National Health Insurance Bureau (NHIB), we determined the cost-effectiveness of pertuzumab combined with trastuzumab and docetaxel (TDP) versus trastuzumab and docetaxel (TD) as a first-line treatment for HER-2 positive metastatic breast cancer. METHODS: We used a Markov model to simulate cost-effectiveness, disease progression, and survival, based on clinical data and transition probabilities extracted from the CLEOPATRA study...
October 10, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Justine Defreyne, Joz Motmans, Guy T'sjoen
Options for gender affirming therapy in trans men include social transitioning, mental coaching, hormonal therapy and gender affirming surgery. Research has concluded that gender affirming therapy is safe and feasible and generally leads to high satisfaction rates. However, research regarding the cost-effectiveness is scarce. Areas covered: A literature research was conducted on PubMed, Google scholar and Scopus, searching for relevant articles on the subject of the effects of gender affirming hormone therapy, gender affirming surgery and fertility in trans persons...
October 9, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
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...
October 9, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Onwipa Rochanathimoke, Arthorn Riewpaiboon, Maarten J Postma, Wirawan Thinyounyong, Montarat Thavorncharoensap
BACKGROUND: Rotavirus diarrhea is a major health problem among young children worldwide with potential negative impacts on health-related quality of life (HRQoL). This study assessed the impact of rotavirus diarrhea on HRQoL of children and their caregivers. METHODS: We performed a cross-sectional study among 460 hospitalized children with diarrhea aged under 5 years and their family caregivers at three hospitals in Phetchabun province, Thailand during May 2013 and February 2014...
October 6, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Dagmara Kuliś, Cheryl Whittaker, Eva Greimel, Andrew Bottomley, Michael Koller
In the process of translating patient-reported outcomes measures (forward translation(s), reconciliation, back translation(s), review, pilot-testing, review, final translation), there is a general consensus amongst the key players in the field that the back translation review is an important step. Despite this, there has been little guidance published on how to perform it. Areas covered: Having assessed the most recent back translation reports reviewed by the Translation Unit at the European Organisation for Research and Treatment of Cancer (EORTC) in Brussels, we have identified two concepts to help guide the back translation review process: the underlying issue (the problem that the item measures) and the structure (the linguistic and formal construction of the item)...
October 5, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Ann M Moyer, Pedro J Caraballo
Pharmacogenomic testing has the potential to greatly benefit patients by enabling personalization of medication management, ensuring better efficacy and decreasing the risk of side effects. However, to fully realize the potential of pharmacogenomic testing, there are several important issues that must be addressed. Areas covered: In this expert review we discuss current challenges impacting the implementation of pharmacogenomic testing in the clinical practice. We emphasize issues related to testing methods, reporting of the results, test selection, clinical interpretation of the results, cost-effectiveness, and the long-term use of pharmacogenomic results in clinical practice...
October 3, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Paweł Kawalec, Krzysztof Piotr Malinowski, Wojciech Trąbka
OBJECTIVE: To assess changes in the involvement of advisory bodies in the reimbursement decision-making process in Poland, and to evaluate variables that influenced health technology assessment (HTA) recommendations in the years 2013-2015. RESEARCH DESIGN AND METHODS: Two independent contributors reviewed the statements of the Transparency Council (TC), recommendations issued by the president of the Agency for Health Technology Assessment and Tariff System (Agencja Oceny Technologii Medycznych i Taryfikacji [AOTMiT]), and reimbursement decisions of the Ministry of Health (MoH) for the years 2013-2015 and publicly available online...
September 27, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Mickael Hiligsmann, Jean-Yves Reginster
BACKGROUND: There is a paucity of research that projects the public health and economic impact of healthcare interventions in the future. In this study, we aimed to estimate the public health and economic impact of vitamin D fortified dairy products for the years 2020, 2030, 2040, 2050 and 2060. METHODS: We used a previously validated Markov microsimulation model that was designed to assess the public health and economic impact of dairy products for fracture prevention in the French general population aged over 60 years in the year 2015...
September 7, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Chiara Feig, Kei Long Cheung, Mickaël Hiligsmann, Silvia M A A Evers, Judit Simon, Susanne Mayer
BACKGROUND: Although Health Technology Assessment (HTA) is increasingly used to support evidence-based decision-making in health care, several barriers and facilitators for the use of HTA have been identified. This best-worst scaling (BWS) study aims to assess the relative importance of selected barriers and facilitators of the uptake of HTA studies in Austria. METHODS: A BWS object case survey was conducted among 37 experts in Austria to assess the relative importance of HTA barriers and facilitators...
September 1, 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Pedro Mezquita-Raya, Josep Darbà, Meritxell Ascanio, Antonio Ramírez de Arellano
BACKGROUND: The objective of this study was to assess the cost-effectiveness of insulin degludec versus insulin glargine, from the Spanish NHS in three groups of patients. METHODS: A short-term cost utility model was developed to estimate effectiveness results in terms of the total number of hypoglycaemic events and their disutility impact throughout the year on the initial level of quality of life for patients in each treatment. RESULTS: Degludec was the dominant strategy for T2DM BOT and exhibited an incremental cost-effectiveness ratio of 52...
December 2017: Expert Review of Pharmacoeconomics & Outcomes Research
David D Kim, Colby L Wilkinson, Elle F Pope, James D Chambers, Joshua T Cohen, Peter J Neumann
BACKGROUND: Debates persist on the appropriate time horizon from a payer's perspective and how the time horizon in cost-effectiveness analysis (CEA) influences the value assessment. METHODS: We systematically reviewed the Tufts Medical Center CEA Registry and identified US-based studies that used a payer perspective from 2005-2014. We classified the identified CEAs as short-term (time horizon ≤ 5 years) and long-term (> 5 years), and examined associations between study characteristics and the specified time horizon...
December 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Junjie Liu, Liming Wang, Chenxi Liu, Xinping Zhang
BACKGROUND: A new policy which required deregulation on prices of off-patent medicines for women's health during procurement was introduced in China in September 2015. The current study examines this policy's impact on the affordability of essential medicines for women's health. METHODS: Based on product-level panel data, a fixed effect regression model is employed by using procurement records from Hubei Centralist Tender for Drug Purchase platform. In the model, Affordability was measured with prices...
December 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Fanni Rencz, László Gulácsi, Márta Péntek, Krisztina B Gecse, Axel Dignass, Jonas Halfvarson, Fernando Gomollón, Petra Baji, Laurent Peyrin-Biroulet, Peter L Lakatos, Valentin Brodszky
BACKGROUND: This study aims to compare the cost-effectiveness of treatment sequences with available biologics, including adalimumab (ADA), biosimilar infliximab (bsIFX), originator infliximab (IFX) and vedolizumab (VEDO) for luminal Crohn's disease in nine European countries. METHODS: A Markov-model was constructed to simulate five-year medical costs and quality-adjusted life years (QALYs). Data on clinical efficacy were obtained from randomised controlled trials...
December 2017: Expert Review of Pharmacoeconomics & Outcomes Research
Cristiane Roberta Dos Santos Teodoro, Rosângela Caetano, Brian Godman, André Luís Almeida Dos Reis, Aurélio de Araújo Maia, Mariana de Carvalho Barbosa Ramos, 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)...
December 2017: Expert Review of Pharmacoeconomics & Outcomes Research
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