Value assessment of antimicrobials and the implications for development, access, and funding of effective treatments: Australian stakeholder perspective

Author(s):  
Nadine T. Hillock ◽  
Tracy L. Merlin ◽  
Jonathan Karnon ◽  
John Turnidge ◽  
Jaklin Eliott

Abstract Background The frameworks used by Health Technology Assessment (HTA) agencies for value assessment of medicines aim to optimize healthcare resource allocation. However, they may not be effective at capturing the value of antimicrobial drugs. Objectives To analyze stakeholder perceptions regarding how antimicrobials are assessed for value for reimbursement purposes and how the Australian HTA framework accommodates the unique attributes of antimicrobials in cost-effectiveness evaluation. Methods Eighteen individuals representing the pharmaceutical industry or policy-makers were interviewed. Interviews were transcribed verbatim, coded, and thematically analyzed. Results Key emergent themes were that reimbursement decision-making should consider the antibiotic spectrum when assessing value, risk of shortages, the impact of procurement processes on low-priced comparators, and the need for methodological transparency when antimicrobials are incorporated into the economic evaluation of other treatments. Conclusions Participants agreed that the current HTA framework for antimicrobial value assessment is inadequate to properly inform funding decisions, as the contemporary definition of cost-effectiveness fails to explicitly incorporate the risk of future resistance. Policy-makers were uncertain about how to incorporate future resistance into economic evaluations without a systematic method to capture costs avoided due to good stewardship. Lacking financial reward for the benefits of narrower-spectrum antimicrobials, companies will likely focus on developing broad-spectrum agents with wider potential use. The perceived risks of shortages have influenced the funding of generic antimicrobials in Australia, with policy-makers suggesting a willingness to pay more for assured supply. Although antibiotics often underpin the effectiveness of other medicines, it is unclear how this is incorporated into economic models.

2017 ◽  
Vol 3 (2) ◽  
pp. 7
Author(s):  
Saida Parvin

Women’s empowerment has been at the centre of research focus for many decades. Extant literature examined the process, outcome and various challenges. Some claimed substantial success, while others contradicted with evidence of failure. But the success remains a matter of debate due to lack of empirical evidence of actual empowerment of women around the world. The current study aimed to address this gap by taking a case study method. The study critically evaluates 20 cases carefully sampled to include representatives from the entire country of Bangladesh. The study demonstrates popular beliefs about microfinance often misguide even the borrowers and they start living in a fabricated feeling of empowerment, facing real challenges to achieve true empowerment in their lives. The impact of this finding is twofold; firstly there is a theoretical contribution, where the definition of women’s empowerment is proposed to be revisited considering findings from these cases. And lastly, the policy makers at governmental and non-governmental organisations, and multinational donor agencies need to revise their assessment tools for funding.


2003 ◽  
Vol 19 (2) ◽  
pp. 407-420 ◽  
Author(s):  
Taghreed Adam ◽  
David B. Evans ◽  
Marc A. Koopmanschap

Objectives: The need for consistency and standardization of methods for economic appraisals has been recognized for some time and has led to the development of several sets of guidelines for economic evaluations and for costs. Despite this, considerable diversity is still apparent in applied studies. Some of these diversities might be defensible, and some might not. The objectives of this study are to explore sources of variations in the methods used in applied studies and to discuss the nature of these variations and the possibility of reducing some of them.Methods: We first use a systematic approach to identify the major sources of variation in costing methods used in applied economic evaluations. We then compare the methods used with the recommendations made in available guidelines.Results: Four possible sources of variation are identified. The first is where guidelines do not agree in their recommendations; therefore, it is not surprising that applied studies use different methods. The second is where guidelines agree in principle but provide little detail on how to comply with their recommendations; and the third is where a particular methodological issue is not discussed in guidelines. The fourth reason is simply lack of compliance with accepted guidelines.Conclusions: Variability in costing methods used in applied studies raises questions about the validity of their results and makes it difficult to compare the results of different studies. We discuss the implications for the transferability and generalizability of results and suggest ways to minimize the variability in the methods so that the results of costing studies and economic evaluations can be of more value to policy-makers.


2015 ◽  
Vol 6 (1) ◽  
pp. 113 ◽  
Author(s):  
Anna Wildowicz-Giegiel ◽  
Adam Wyszkowski

Competitiveness at the firm level is a subject of interest not only to managers and policy makers but also academics. An effective functioning under the conditions of new economy requires from the enterprises to develop their core capabilities and talents along with the ability to quickly identify and seize the opportunities generated by market environment. The implementation of such an approach allows the creation and sustain of economic surpluses in the long-run. The paper aims to examine the profitability of enterprises in Poland which is regarded in the context of absorption of EU funds in years 2007–2013. Taking into account that Poland became one of the largest beneficiaries, it is worth analyzing the impact of EU funding on the economic performance of Polish enterprises. The paper offers a critical reflection on the relationship between the absorption of EU funds and Polish enterprises competitiveness on the basis of  the content analysis literature and statistical data derived from the European Commission, the Central Statistical Office and the Ministry of Regional Development. It is assumed simultaneously that the competitiveness of enterprises is expressed in the term of profitability rates. In spite of limitations which relate to the adopted definition of competitiveness and the short period of the conducted analysis concerning the key relationship, the paper contributes to the debate on the significance of EU Funds in the process of building modern and innovative economy.


2021 ◽  
Author(s):  
Elizabeth Mutubuki ◽  
Mohamed El Alili ◽  
Judith Bosmans ◽  
Teddy Oosterhuis ◽  
Frank Snoek ◽  
...  

Abstract Background: Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations. Methods: Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness. Results: In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to -7,502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively.Conclusions: Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.


This chapter provides a brief introduction to the primary concepts of the book: technology, profession, and identity. Understanding these concepts will provide insight into how the central question of the book will be addressed: What impact does a constant contact with technology have on the professional identities of librarians? Information technology has changed the way librarians perform their work and the expectations of library users. The role technology plays in the work lives of librarians is complex, but the impact it has had on their professional identity is even more so. First, the historical impact of technology on society is examined to highlight that many technologies we encounter on a daily basis are often not even considered technology in today’s technology-rich world. This is followed by examinations of the concepts of profession and identity. Together, these definitions provide the working definition of professional identity that will guide the remainder of the book. Professional identity is a description of the self within the professional practices and discourses of librarianship. By drawing attention to the role that technology plays in the professional lives of librarians, this book provides insights into how librarians interact with their patrons, policy makers, and society in general.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Elizabeth N. Mutubuki ◽  
Mohamed El Alili ◽  
Judith E. Bosmans ◽  
Teddy Oosterhuis ◽  
Frank J. Snoek ◽  
...  

Abstract Background Baseline imbalances, skewed costs, the correlation between costs and effects, and missing data are statistical challenges that are often not adequately accounted for in the analysis of cost-effectiveness data. This study aims to illustrate the impact of accounting for these statistical challenges in trial-based economic evaluations. Methods Data from two trial-based economic evaluations, the REALISE and HypoAware studies, were used. In total, 14 full cost-effectiveness analyses were performed per study, in which the four statistical challenges in trial-based economic evaluations were taken into account step-by-step. Statistical approaches were compared in terms of the resulting cost and effect differences, ICERs, and probabilities of cost-effectiveness. Results In the REALISE study and HypoAware study, the ICER ranged from 636,744€/QALY and 90,989€/QALY when ignoring all statistical challenges to − 7502€/QALY and 46,592€/QALY when accounting for all statistical challenges, respectively. The probabilities of the intervention being cost-effective at 0€/ QALY gained were 0.67 and 0.59 when ignoring all statistical challenges, and 0.54 and 0.27 when all of the statistical challenges were taken into account for the REALISE study and HypoAware study, respectively. Conclusions Not accounting for baseline imbalances, skewed costs, correlated costs and effects, and missing data in trial-based economic evaluations may notably impact results. Therefore, when conducting trial-based economic evaluations, it is important to align the statistical approach with the identified statistical challenges in cost-effectiveness data. To facilitate researchers in handling statistical challenges in trial-based economic evaluations, software code is provided.


Vaccines ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 111
Author(s):  
Tanja Fens ◽  
Pieter T. de Boer ◽  
Eugène P. van Puijenbroek ◽  
Maarten J. Postma

(1) Background: Vaccines for seasonal influenza are a good preventive and cost-effective strategy. However, it is unknown if and how these economic evaluations include the adverse events following immunization (AEFI), and what the impact of such inclusion is on the health economic outcomes. (2) Methods: We searched the literature, up to January 2020, to identify economic evaluations of seasonal influenza vaccines that considered AEFIs. The review protocol was published in PROSPERO (CDR42017058523). (3) Results: A total of 52 economic evaluations considered AEFI-related parameters in their analyses, reflecting 16% of the economic evaluations on seasonal influenza vaccines in the initial study selection. Most studies used the societal perspective (64%) and evaluated vaccination of children (37%). Where considered, studies included direct medical costs of AEFIs (90%), indirect costs (27%), and disutilities/quality-adjusted life years loss due to AEFIs (37%). The majority of these studies accounted for the effects of the costs of AEFI on cost-effectiveness for Guillain–Barré syndrome. In those papers allowing cost share estimation, direct medical cost of AFEIs was less than 2% of total direct costs. (4) Conclusions: Although the overall impact of AEFIs on the cost-effectiveness outcomes was found to be low, we urge their inclusion in economic evaluations of seasonal influenza vaccines to reflect comprehensive reports for the decision makers and end-users of the vaccination strategies.


Author(s):  
Rosanna Cataldo ◽  
Maria Gabriella Grassia ◽  
Paolo Mazzocchi ◽  
Claudio Quintano ◽  
Antonella Rocca

Society and policy makers demand innovation systems oriented towards several goals of sustainable development. Therefore, recent literature has dedicated a growing interest to both innovation and sustainability in the pursuit of environmental, economic and social development; in addition, the emerging topic of ‘sustainable innovation’ (and ‘eco-innovation’) seems to combine the main features of them. The definition of these concepts has been significantly changed during the last decades, and a broad discussion continues today about which indicators should be used to measure innovation, sustainability and their combination. The current paper investigates this relationship, and - in the authors’ opinion - the research question connected to the impact of the innovative product (and service and process) solutions on sustainability can be addressed by means of a stable theoretical framework. To study the interaction between innovation and sustainability, the usage of specific territorial features might represent a useful perspective to manage short-and long-term environmental and economic issues. As for the theoretical model, the present article considers a specific technique suitable for investigating the entire set of characteristics involved in the model. From a public makers and managerial point of view, the possibility of improving the firm’ efficiencies in terms of several dimensions of sustainable innovation represents a relevant topic that must be encouraged.


2016 ◽  
Vol 12 (4) ◽  
pp. e369-e379 ◽  
Author(s):  
Karen Lien ◽  
Matthew C. Cheung ◽  
Kelvin K.W. Chan

Purpose: As costs of cancer care rise, there has been a shift to focus on value. Drug wastage affects costs to patients and health care systems without adding value. Historically, cost-effectiveness analyses have used models that assume no drug wastage; however, this may not reflect real-world practices. We sought to identify the frequency of drug wastage modeling in economic evaluations of modern parenteral therapies for hematologic malignancies. Methods: We conducted a systematic literature review of economic evaluations of new US Food and Drug Administration–approved parenteral chemotherapies with indications for the treatment of hematologic malignancies. The primary outcome of interest was the proportion of studies that modeled drug wastage in base-case analyses. If wastage was considered in primary analyses, we reported the impact of wastage on incremental cost-effectiveness ratios (ICERs) and drug acquisition costs. Results: Wastage was considered in base-case analyses in less than one third of all publications reviewed (12 of 38; 32%). Of these, two studies went on to complete sensitivity analyses and reported significant changes in the calculated ICER as a result. In one study, the ICER increased by 32%, and in the second, accounting for wastage changed a positive ICER to a dominant result. Conclusion: Potential costs associated with drug wastage are considered in only one third of modern cost-effectiveness models. The impact of wastage on calculated ICERs and drug acquisition costs is potentially substantial. The modeling of wastage in base-case and sensitivity analyses is recommended for future economic evaluations of new intravenous therapies for hematologic malignancies.


2017 ◽  
Vol 35 (15_suppl) ◽  
pp. 6607-6607
Author(s):  
Judy Truong ◽  
Matthew C. Cheung ◽  
Helen Mai ◽  
Jessa Letargo ◽  
Alexandra Chambers ◽  
...  

6607 Background: Intravenous drugs administered through body-surface area (BSA) or weight-based dosing may cause wastage due to large and/or limited fixed vial sizes, and vial sharing restrictions. Drug wastage leads to incremental costs without incremental value to patients. Bach et al. (2016) estimated 10% of revenue ($1.8 billion) from cancer drugs would result from wastage in 2016. The pan-Canadian Oncology Drug Review (pCODR) committee provides recommendations on which drugs to publicly reimburse by reviewing clinical and economic evidence. There is considerable potential that drug wastage could impact the economic evaluations. We sought to determine the impact of modeling cancer drug wastage on the results of economic evaluations. Methods: Economic evaluations submitted by drug manufacturers and reviewed by the pCODR Economic Guidance Panel (EGP) were assessed for frequency of wastage reporting and modeling. Cost-effectiveness analyses and budget impact analyses were conducted for scenarios in which “no wastage” and “wastage” of drugs occurred. Sensitivity analyses were performed to determine the effects of BSA and weight variation. Results: 12 drugs for use in 17 indications were analyzed. Wastage was reported in 71% and incorporated in 53% of manufacturer’s models, resulting in a mean incremental cost-effectiveness ratio (ICER) increase of 6.1% (range: 1.3% to 14.6%). EGP reported and incorporated wastage for 59% of models, resulting in a mean ICER increase of 15.0% (2.6% to 48.2%). When maximum wastage (i.e. the entire unused portion of each vial is discarded) was incorporated in our independent analysis, the mean ICER increased by 24.0% (0.0% to 97.2%) and the mean 3-year total incremental costs increased by 26.0% (0.0% to 83.1%). Over a 3-year period, wastage can increase the total incremental drug budget cost by CAD $102 million nationally. Changing the mean BSA or body weight caused 45% of the drugs to use a different vial size (if available) and/or quantity, resulting in further increased drug costs. Conclusions: Wastage can have an under-recognized and significant impact on economic evaluations of intravenous chemotherapy drugs. Guidelines are needed to promote uniform and optimal modeling of drug wastage in economic evaluations.


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