Feasibility study to characterize price and reimbursement decision-making criteria for the inclusion of new drugs in the Spanish National Health System: the cefiderocol example.

OBJECTIVES: The reimbursement of medicines by the Spanish National Health System (NHS) is based on a set of criteria included in the Royal Legislative Decree 1/2015 (RDL 1/2015). The Interministerial Committee on Pricing of Medicines and Healthcare Products (CIPM) is responsible for the final price and reimbursement (P&R) decision, including on its resolutions the criteria listed in the law by which the reimbursement of a drug is approved or denied. Nevertheless, the information behind its reasoning is not provided. The present study aims to characterize the P&R criteria of the RDL 1/2015 through criteria definitions from other countries to improve the P&R evaluation in Spain. RESULTS: A multidisciplinary experts panel with relevant experience in drug evaluation and decision making at national, regional, and local level in Spain was selected for this study. A literature review to characterize the criteria listed in the RDL 1/2015 was performed based on the most relevant and recognized Health Technology Assessment (HTA) agencies in Europe, UK, and Canada. Eventually, a feasibility study was performed to evaluate the novel drug cefiderocol using the characterized criteria, including a reflective discussion of the results. CONCLUSIONS: Consensus was reached among the multidisciplinary experts on the characterization of the criteria set by the law. The feasibility of their application to a new drug was exploratory, notwithstanding it showed the potential to improve the transparency as well as to offer a more structured rationale for the CIPM to evaluate the inclusion of new drugs in the Spanish NHS.

Improving the politics of biotechnological innovations in food security and other sustainable development goals.

The unwarranted interference of some environmental non-governmental organisations (ENGOs) in decision-making over genetically modified (GM) crops has prompted calls for politics to be removed from the regulatory governance of these products. However, regulatory systems are inevitably political because their purpose is to decide whether the use of particular products will help or hinder the delivery of public policy objectives. ENGOs are most able to interfere in regulatory decision-making when policy objectives and decision-making criteria are vague, making the process vulnerable to disruption by organisations that have a distinct agenda. Making regulatory decision-making about GM crops and other green biotechnology more resistant to interference therefore requires better politics not the removal of politics. Better politics begins with political leadership making a case for green biotechnology in achieving food security and other sustainable development goals. Such a policy must involve making political choices and cannot be outsourced to science. Other aspects of better politics include regulatory reform to set policy aims and decision-making criteria that encourage innovation as well as control risk, and engagement with civil society that discusses the values behind attitudes to the application of green biotechnology. In short, green biotechnology for sustainable development needs better politics to counter well-organised opposition, to encourage innovation, and to build the trust of civil society for these policies. Removing politics from regulatory governance would be a gift to ENGOs that are opposed to the use of biotechnology.

Decision-making criteria for medicine reimbursement in Slovenia: an expert panel discussion.

BACKGROUND: Rational and transparent Health Technology Assessment and reimbursement decision-making are crucial for healthcare system sustainability. A part of the reimbursement process are decision-making criteria which should be clearly defined. METHODS: The study aimed to obtain an insight into understanding and relevance of potential criteria for the medicine reimbursement decision-making process in Slovenia. A semi-structured guided focus panel was performed in June 2017 with five Slovenian experts covering principal healthcare system sectors. First, criteria understanding and relevance for medicine reimbursement decision-making were discussed. Second, healthcare priorities and societal values affecting decision-making were debated. The analysis was carried out with NVivo 11 by two independent researchers who coded the verbatim transcript in three coding steps based on the experts' interpretations and original ideas. RESULTS: Seven decision-making criteria were derived. Among those, the impact a disease has on the lives of patient family and caregivers and the indirect medicine benefit for them were new aspects comparing to the existing criteria set in Slovenia. The experts expressed that the same decision-making criteria are relevant for evaluating any health technology, allowing for different criteria weights. They also suggested a system that would allow re-evaluation of reimbursement decisions once real-world clinical data are available. CONCLUSIONS: As proposed by the international frameworks and tools, the Slovenian healthcare experts consider including multiple aspects more ethical and comprehensive than considering a single criterion, e.g. cost-effectiveness, existing in some healthcare systems. They recognize that in the existing decision-making process, health perspectives of the public represent a largely missed aspect.

Optimal weighting factor design based on entropy technique in finite control set model predictive torque control for electric drive applications.

In the conventional finite control set model predictive torque control, the cost function consists of different control objectives with varying units of measurements. Due to presence of diverse variables in cost function, weighting factors are used to set the relative importance of these objectives. However, selection of these weighting factors in predictive control of electric drives and power converters still remains an open research challenge. Improper selection of weighting factors can lead to deterioration of the controller performance. This work proposes a novel weighting factor tuning method based on the Multi-Criteria-Decision-Making (MCDM) technique called the Entropy method. This technique has several advantages for multi-objective problem optimization. It provides a quantitive approach and incorporates uncertainties and adaptability to assess the relative importance of different criteria or objectives. This technique performs the online tuning of the weighting factor by forming a data set of the control objectives, i.e., electromagnetic torque and stator flux magnitude. After obtaining the error set of control variables, the objective matrix is normalized, and the entropy technique is applied to design the corresponding weights. An experimental setup based on the dSpace dS1104 controller is used to validate the effectiveness of the proposed method for a two-level, three-phase voltage source inverter (2L-3P) fed induction motor drive. The dynamic response of the proposed technique is compared with the previously proposed MCDM-based weighting factor tuning technique and conventional MPTC. The results reveal that the proposed method provides an improved dynamic response of the drive under changing operating conditions with a reduction of 28% in computational burden and 38% in total harmonic distortion, respectively.

COST Action 'ImpARAS': what have we learnt to improve food allergy risk assessment. A summary of a 4 year networking consortium.

The growing world population and increased pressure on agricultural resources are driving a shortage of dietary protein sources. As a result, industry is developing more sustainable novel food protein sources such as insects, algae and duckweed and using new processing techniques. Consumer exposure to these novel or processed proteins, could cause new food allergies, exacerbating a public health issue which is already directly affecting an estimated 20 million Europeans. Introduction of novel foods should not add to the burden of food allergy and this calls for a reliable, harmonised, evidence-based and validated allergenicity risk assessment strategy. The COST (Cooperation in Science and Technology) Action ImpARAS (Improved Allergenicity Risk Assessment Strategy), a four-year networking project, identified gaps in current allergy risk assessment, and proposed new ideas and plans for improving it. Here, we report on the lessons learned from the ImpARAS network and suggestions for future research. The safe introduction of novel and more sustainable food protein sources, while protecting humans from food allergy, calls for a multidisciplinary approach based on an improved understanding of what determines the relative allergenic potency of proteins, novel testing and assessment methodologies, harmonized decision-making criteria, and a clear ranking approach to express the allergenicity of novel product relative to that of existing known allergenic proteins: (from 'non'/to weakly and to strongly allergenic proteins).

Drivers of vaccine decision-making in South Africa: A discrete choice experiment.

To increase vaccination coverage, it is essential to understand the vaccine decision-making process. High population coverage is required to obtain herd immunity and to protect vulnerable groups in terms of age (e.g. the very young) or health (e.g. immunodeficiency). Vaccine confidence and coverage in South Africa are relatively low, opening the window for sustained outbreaks of vaccine-preventable diseases in a country facing one of the most severe HIV epidemics in the world. To capture the vaccine-related decision-making process in South Africa, we performed a discrete choice experiment with 1200 participants in December 2017. We asked for their preferences with respect to (1) vaccine effectiveness, (2) vaccine-preventable burden of disease, (3) accessibility of the vaccine in terms of co-payment and prescription requirements, (4) frequency of mild vaccine-related side-effects, (5) population vaccination coverage and (6) local vaccination coverage. We distinguished between decision-making for vaccines administered to the participant, and for vaccines administered to their youngest child. We analyzed the data for each of these groups using a panel mixed logit model and found similar results for decisions to vaccinate oneself or one's child. Vaccine effectiveness was the most important attribute followed by population coverage and burden of disease. Local coverage and accessibility were also important determinants of vaccination behavior, but to a lesser extent. Regarding population and local coverage, we observed a positive effect on vaccine utility indicating the potential of peer influence. As such, social normative influence could be exploited to increase vaccination confidence and coverage. With respect to vaccine-preventable burden of the disease, the marginal utilities showed disease severity to be more important than frequency of disease. Policymakers and health care workers should stress the effectiveness of vaccines together with the severity of vaccine-preventable diseases.

Revealed preferences towards the appraisal of orphan drugs in Poland - multi criteria decision analysis.

BACKGROUND: A Multi Criteria Decision Analysis (MCDA) technique was adopted to reveal the preferences of the Appraisal Body of the Polish HTA agency towards orphan drugs (OMPs). RESULTS: There were 34 positive and 23 negative HTA recommendations out of 54 distinctive drug-indication pairs. The MCDA matrix consisted of 13 criteria, seven of which made the most impact on the HTA process. Appraisal of clinical evidence, cost of therapy, and safety considerations were the main contributors to the HTA guidance, whilst advancement of technology and manufacturing costs made the least impact. CONCLUSIONS: MCDA can be regarded as a valuable tool for revealing decision makers' preferences in the healthcare sector. Given that only roughly half of all criteria included in the MCDA matrix were deemed to make an impact on the HTA process, there is certainly some room for improvement with respect to the adaptation of a new approach towards the value assessment of OMPs in Poland.

Differences in multiple-target visual search performance between non-professional and professional searchers due to decision-making criteria.

Professional visual searches, such as those conducted by airport security personnel, often demand highly accurate performance. As many factors can hinder accuracy, it is critical to understand the potential influences. Here, we examined how explicit decision-making criteria might affect multiple-target search performance. Non-professional searchers (college undergraduates) and professional searchers (airport security officers) classified trials as 'safe' or 'dangerous', in one of two conditions. Those in the 'one = dangerous' condition classified trials as dangerous if they found one or two targets, and those in the 'one = safe' condition only classified trials as dangerous if they found two targets. The data suggest an important role of context that may be mediated by experience; non-professional searchers were more likely to miss a second target in the one = dangerous condition (i.e., when finding a second found target did not change the classification), whereas professional searchers were more likely to miss a second in the one = safe condition.

Introduction to health economics and decision-making: Is economics relevant for the frontline clinician?

In a climate of escalating demands for new health care services and significant constraints on new resources, the disciplines of health economics and health technology assessment (HTA) have increasingly been turned to as explicit evidence-based frameworks to help make tough health care access and reimbursement decisions. Health economics is the discipline of economics concerned with the efficient allocation of health care resources, essentially trying to maximize health benefits to society contingent upon available resources. HTA is a broader field drawing upon several disciplines, but which relies heavily upon the tools of health economics and economic evaluation. Traditionally, health economics and economic evaluation have been widely used at the political (macro) and local (meso) decision-making levels, and have progressively had an important role even at informing individual clinical decisions (micro level). The aim of this paper is to introduce readers to health economics and discuss its relevance to frontline clinicians. Particularly, the content of the paper will facilitate clinicians' understanding of the link between economics and their medical practice, and how clinical decision-making reflects on health care resource allocation.