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Elizabeth S Mearns, Aliki Taylor, Talia Boulanger, Kelly J Craig, Michele Gerber, Daniel A Leffler, Jennifer Drahos, David S Sanders, Benjamin Lebwohl
BACKGROUND: The prevalence of celiac disease (CD) has rapidly increased over recent decades, but costs related to CD remain poorly quantified. OBJECTIVE: This systematic review assessed the economic burden of CD in North America and Europe. METHODS: MEDLINE, EMBASE, EconLit, and the Cochrane Library databases were systematically searched to identify English-language literature from 2007 to 2018 that assessed costs, cost effectiveness, and health resource utilization for CD...
September 17, 2018: PharmacoEconomics
Jorge Mestre-Ferrandiz, Néboa Zozaya, Bleric Alcalá, Álvaro Hidalgo-Vega
For medicines with different valued indications (uses), multi-indication pricing implies charging different prices for different uses. In this article, we assess how multi-indication pricing could help achieve overall strategic objectives of pricing controls, summarise its advantages and disadvantages (vs. uniform pricing) and estimate the hypothetical impact on prices of moving towards multi-indication pricing for specific oncologic medicines in Spain. International experience shows that multi-indication pricing can be implemented in real practice, and indeed a few initiatives are currently in use, albeit mostly applied indirectly through confidential pricing agreements that offer a way to discriminate prices across countries without altering list prices...
September 10, 2018: PharmacoEconomics
Brendan Mulhern, Richard Norman, Deborah J Street, Rosalie Viney
BACKGROUND: Discrete-choice experiments (DCEs) are used in the development of preference-based measure (PBM) value sets. There is considerable variation in the methodological approaches used to elicit preferences. OBJECTIVE: Our objective was to carry out a structured review of DCE methods used for health state valuation. METHODS: PubMed was searched until 31 May 2018 for published literature using DCEs for health state valuation. Search terms to describe DCEs, the process of valuation and preference-based instruments were developed...
September 8, 2018: PharmacoEconomics
Mark Bounthavong, Javed Butler, Chantal M Dolan, Jeffrey D Dunn, Kathryn A Fisher, Nina Oestreicher, Bertram Pitt, Paul J Hauptman, David L Veenstra
BACKGROUND AND OBJECTIVE: Certain patients with heart failure (HF) are unable to tolerate spironolactone therapy due to hyperkalemia. Patiromer is a novel agent used to treat hyperkalemia and has been shown to be efficacious, safe, and well-tolerated. The potential clinical outcomes and economic value of using patiromer and spironolactone in patients with HF unable to otherwise tolerate spironolactone due to hyperkalemia are unclear. The objective of this analysis was to model the potential pharmacoeconomic value of using patiromer and spironolactone in patients with a history of hyperkalemia that prevents them from utilizing spironolactone...
September 8, 2018: PharmacoEconomics
Nasuh C Büyükkaramikli, Saskia de Groot, Rob Riemsma, Debra Fayter, Nigel Armstrong, Piet Portegijs, Steven Duffy, Jos Kleijnen, Maiwenn J Al
The National Institute for Health and Care Excellence, as part of the institute's single technology appraisal process, invited the manufacturer of ribociclib (Kisqali® , Novartis) to submit evidence regarding the clinical and cost effectiveness of the drug in combination with an aromatase inhibitor for the treatment of previously untreated, hormone receptor-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. Kleijnen Systematic Reviews Ltd and Erasmus University Rotterdam were commissioned as the Evidence Review Group for this submission...
September 8, 2018: PharmacoEconomics
Salah Ghabri, Matt Stevenson, Jörgen Möller, J Jaime Caro
Models have become a nearly essential component of health technology assessment. This is because the efficacy and safety data available from clinical trials are insufficient to provide the required estimates of impact of new interventions over long periods of time and for other populations and subgroups. Despite more than five decades of use of these decision-analytic models, decision makers are still often presented with poorly validated models and thus trust in their results is impaired. Among the reasons for this vexing situation are the artificial nature of the models, impairing their validation against observable data, the complexity in their formulation and implementation, the lack of data against which to validate the model results, and the challenges of short timelines and insufficient resources...
September 6, 2018: PharmacoEconomics
Katharina Kähm, Michael Laxy, Udo Schneider, Rolf Holle
BACKGROUND: In the context of an aging population with increasing diabetes prevalence, people are living longer with diabetes, which leads to increased multimorbidity and economic burden. OBJECTIVE: The primary aim was to explore different strategies that address the economic impact of multiple type 2 diabetes-related complications and their interactions. METHODS: We used a generalized estimating equations approach based on nationwide statutory health insurance data from 316,220 patients with type 2 diabetes (baseline year 2012, 3 years of follow-up)...
August 30, 2018: PharmacoEconomics
Maria Gheorghe, Renske J Hoefman, Matthijs M Versteegh, Job van Exel
BACKGROUND: Families and friends provide a considerable proportion of care for patients and elderly people. Caregiving can have substantial effects on caregivers' lives, health, and well-being. However, because clinical trials rarely assess these effects, no information on caregiver burden is available when evaluating the cost effectiveness of treatments. OBJECTIVE: This study develops an algorithm for estimating caregiver time using information that is typically available in clinical trials: the EQ-5D scores of patients and their gender...
August 28, 2018: PharmacoEconomics
Namita Joshi, Marja Hensen, Sachin Patel, Weiwei Xu, Kathy Lasch, Elly Stolk
OBJECTIVES: Acute myeloid leukaemia (AML) is an aggressive haematological cancer associated with significant humanistic impact. The current study assessed how the general public in the United Kingdom (UK) values AML health states. METHODS: The composite time trade-off (cTTO) methodology was employed to elicit health state utilities in AML. Pertinent AML literature related to symptom and quality-of-life impact including physical, functional and emotional well-being, as well as the safety profile of AML treatments, were taken into consideration for drafting health state descriptions...
August 23, 2018: PharmacoEconomics
Samantha Husbands, Susan Jowett, Pelham Barton, Joanna Coast
INTRODUCTION: Decision-analytic models play an essential role in informing healthcare resource allocation decisions; however, their value to decision makers will depend on model structures being clinically valid to determine cost-effectiveness recommendations. Clinician involvement can help modellers to develop clinically valid but straightforward structures; however, there is little guidance available on methods for clinician input to model structure. This study aims to provide an in-depth exploration of clinician involvement in structural development, highlighting key issues and generating recommendations to optimise practices...
August 17, 2018: PharmacoEconomics
Ros Wade, Alessandro Grosso, Emily South, Claire Rothery, Pedro Saramago, Laetitia Schmitt, Kath Wright, Stephen Palmer
As part of the National Institute for Health and Care Excellence single technology appraisal process, brodalumab was assessed to determine the clinical and cost effectiveness of its use in the treatment of moderate-to-severe plaque psoriasis. The Centre for Reviews and Dissemination and the Centre for Health Economics Technology Assessment Group at the University of York were commissioned to act as the independent Evidence Review Group. This article provides a summary of the Evidence Review Group's review of the company's submission, the Evidence Review Group report and the National Institute for Health and Care Excellence Appraisal Committee's subsequent guidance issued in March 2018...
August 16, 2018: PharmacoEconomics
Becky Pennington, Monica Hernandez-Alava, Stephen Pudney, Allan Wailoo
BACKGROUND: The EuroQol-5 Dimension (EQ-5D) instrument is the National Institute for Health and Care Excellence (NICE)'s preferred measure of health-related quality of life (QoL) in adults. The three-level (3L) value set is currently recommended for use, but the five-level (5L) set is increasingly being used in practice. OBJECTIVE: We aimed to explore the impact of moving from 3L to 5L in NICE appraisals. METHODS: We adapted our existing mapping for use with health state utility values derived from a population where the original distribution of utilities was unknown...
August 9, 2018: PharmacoEconomics
Patricia M Danzon
Differential pricing-manufacturers varying prices for on-patent pharmaceuticals across markets-can, in theory, lead to increased patient access and improved research and development (R&D) incentives compared with charging a uniform price across markets. Theoretical models of price discrimination and Ramsey pricing support differentials based inversely on price elasticities, which are plausibly related to average per capita income. However, these models do not address absolute price levels and dynamic efficiency...
July 30, 2018: PharmacoEconomics
Anthony J Hatswell, Ash Bullement, Andrew Briggs, Mike Paulden, Matthew D Stevenson
Probabilistic sensitivity analysis (PSA) demonstrates the parameter uncertainty in a decision problem. The technique involves sampling parameters from their respective distributions (rather than simply using mean/median parameter values). Guidance in the literature, and from health technology assessment bodies, on the number of simulations that should be performed suggests a 'sufficient number', or until 'convergence', which is seldom defined. The objective of this tutorial is to describe possible outcomes from PSA, discuss appropriate levels of accuracy, and present guidance by which an analyst can determine if a sufficient number of simulations have been conducted, such that results are considered to have converged...
July 27, 2018: PharmacoEconomics
Anna Hobbins, Luke Barry, Dan Kelleher, Koonal Shah, Nancy Devlin, Juan Manuel Ramos Goni, Ciaran O'Neill
OBJECTIVE: Our objective was to develop a value set based on Irish utility values for the EuroQol 5-Dimension, 5-Level instrument (EQ-5D-5L). METHODS: The research design and data collection followed a protocol developed by the EuroQol Group. The EuroQol Valuation Technology (EQ-VT) software was administered using computer-assisted personal interviews to a representative sample of adults resident in Ireland between 2015 and 2016. Utility values were elicited using two stated-preference techniques: time trade-off (TTO) and discrete-choice experiment (DCE)...
July 26, 2018: PharmacoEconomics
Jean-Hugues Salmon, Anne-Christine Rat, Isabelle Charlot-Lambrecht, Jean-Paul Eschard, Damien Jolly, Bruno Fautrel
BACKGROUND: The place of disease-modifying osteoarthritis drugs (DMOADs) and intra-articular hyaluronic acid (IAHA) in the therapeutic arsenal for knee osteoarthritis (OA) remains uncertain. Indeed, these treatments have demonstrated symptomatic efficacy but no efficacy for disease modification. OBJECTIVE: This report reviews the cost effectiveness of IAHA and DMOADs used in the treatment of knee OA. METHODS: A systematic literature search of the MEDLINE, Scopus, EMBASE and Cochrane databases was performed independently by two rheumatologists who used the same predefined eligibility criteria to identify relevant articles...
July 26, 2018: PharmacoEconomics
Sesil Lim, Marcel F Jonker, Mark Oppe, Bas Donkers, Elly Stolk
BACKGROUND: Discrete choice experiments (DCEs) are increasingly used for health state valuations. However, the values derived from initial DCE studies vary widely. We hypothesize that these findings indicate the presence of unknown sources of bias that must be recognized and minimized. Against this background, we studied whether values derived from a DCE are sensitive to how well the DCE design spans the severity range. METHODS: We constructed an experiment involving three variants of DCE tasks for health state valuation: standard DCE, DCE-death, and DCE-duration...
July 21, 2018: PharmacoEconomics
Daniel Gallacher, Xavier Armoiry, Peter Auguste, Rachel Court, Theodoros Mantopoulos, Jacoby Patterson, Maria De Santis, Joanne Cresswell, Hema Mistry
Pembrolizumab is an intravenously administered monoclonal antibody licensed for locally advanced or metastatic urothelial carcinoma after platinum-containing chemotherapy. This summary presents the perspective of Warwick Evidence, the Evidence Review Group (ERG) appointed by the National Institute of Health and Care Excellence (NICE) for the single technology appraisal of pembrolizumab for this indication. Pembrolizumab is manufactured by Merck, Sharp and Dohme (MSD). The major source of clinical effectiveness was the KEYNOTE-045 trial, where 542 patients received either pembrolizumab or clinician's choice of docetaxel, paclitaxel or vinflunine as a second-line treatment...
July 21, 2018: PharmacoEconomics
Hossein Haji Ali Afzali, Laura Bojke, Jonathan Karnon
In countries such as Australia, the UK and Canada, decisions on whether to fund new health technologies are commonly informed by decision analytic models. While the impact of making inappropriate structural choices/assumptions on model predictions is well noted, there is a lack of clarity about the definition of key structural aspects, the process of developing model structure (including the development of conceptual models) and uncertainty associated with the structuring process (structural uncertainty) in guidelines developed by national funding bodies...
July 20, 2018: PharmacoEconomics
Haruhisa Fukuda, Takahisa Yano, Nobuyuki Shimono
BACKGROUND: Hospital-onset Clostridium difficile infections (CDIs) have a considerable clinical and economic impact on patients and payers. Quantifying the economic impact of CDIs can guide treatment strategies. However, previous studies have generally focused on acute care hospitals, and few have included cost estimates from non-acute care hospitals such as long-term care facilities. AIM: This study aimed to quantify the hospital-onset CDI-attributable inpatient expenditures and length-of-stay durations in all healthcare institutions that provide inpatient care (including acute and non-acute care) in Japan...
July 18, 2018: PharmacoEconomics
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