scholarly journals New drug pricing criteria in Italy: considerations and proposals to support value and innovation

2021 ◽  
Vol 8 ◽  
pp. 131-133
Author(s):  
Francesca Patarnello ◽  
Federico Villa
Keyword(s):  
Unmet Need ◽  
Cost Benefit ◽  
Official Journal ◽  
Levels Of Care ◽  
Early Access ◽  
Italian Market ◽  
Drug Policies ◽  
Assessment Time ◽  
Definition Of ◽  
Equity Of Access

The definition of criteria and processes for the submission of price and reimbursement requests (P&R) of a drug in Italy cannot be separated from the definition of an overall “Pharmaceutical Policy” that includes, in an organic vision: (i) the governance related to the research, marketing and monitoring of drugs in the Italian market; (ii) the availability of drugs on the national territory as an element included in the essential levels of care (LEA) and the related conditions in terms of timing and equity of access between different regions, as well as towards other European countries; (iii) the assessment criteria used. The decree published in the Italian Official Journal in the summer of 2020, which defines the new criteria for the regulation of P&R of medicines in Italy, focuses on the final part of the process, i.e. the price negotiation. It would be necessary to frame this last step within a broader and more organic structure of drug policies aimed at: 1. optimising healthcare funding by encouraging competition between healthcare technologies; 2. reducing assessment time by simplifying processes; 3. improving early access to drugs for unmet need; 4. increasing the quality of P&R dossiers by improving interaction with the companies; 5. encouraging innovative agreements and complementary elements to the price; 6. encouraging the reproducibility of assessment methodologies in a value-based pricing system; 7. considering cost-benefit analyses as tools for the definition of price and conditions of reimbursability; 8. creating a place for discussion on drug policies.

scholarly journals MEASURING THE EFFICIENCY OF SOCIAL ENTREPRENEURSHIP

2020 ◽  
pp. 193-198
Author(s):  
A. N. Timokhovich ◽  
O. I. Nikuradze
Keyword(s):  
Social Entrepreneurship ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
Social Value ◽  
Social Entrepreneurs ◽  
Long Term Effect ◽  
The Social ◽  
Common Problems ◽  
Definition Of

The problems of measuring the efficiency of social entrepreneurship have been affected. The aim of the study is to identify the most relevant methods for measuring social value and evaluating the effects that arise as a result of the activities of social organizations. Various interpretations of the definition of the term “social entrepreneurship” have been given in the article. The main elements of the process of social entrepreneurship, features of the goal setting and risks of activities in the study area have been emphasized. The stages of planning activities in the field of social entrepreneurship have been described. The most common problems of measurements and evaluation of social effects that social entrepreneurs have to deal with in the process of carrying out activities related to the implementation of social projects: difficulty in achieving a quantitative evaluation, difficulty in predicting the long-term effect of activities, limitations on costs, time resources, indicators of accuracy and interpretation of results have been revealed. Problems in forecasting the effectiveness of social projects have been identified. The main methods that can be used by social entrepreneurs and organizations for measuring the social value and assessing impact of ongoing activities (method of cost-benefit analysis, method of social accounting, method of social return on investment, method of analysis of the main resources of efficiency) have been analysed. Recommendations for social entrepreneurs have been formulated.

Secondary Immunodeficiency Related to Kidney Disease (SIDKD) - Definition, Unmet Need and Mechanisms

2021 ◽  
pp. ASN.2021091257
Author(s):  
Stefanie Steiger ◽  
Jan Rossaint ◽  
Alexander Zarbock ◽  
Hans-Joachim Anders
Keyword(s):  
Kidney Disease ◽  
Immune Responses ◽  
Host Defense ◽  
Unmet Need ◽  
Secondary Immunodeficiency ◽  
Research Activities ◽  
Medical Need ◽  
Rigorous Research ◽  
Serious Infections ◽  
Definition Of

Kidney disease is a known risk factor for poor outcome of COVID-19 and many other serious infections. Vice versa, infection ranks second as cause of death in patients with kidney disease. However, little is known about the underlying secondary immunodeficiency related to kidney disease (SIDKD). In contrast to cardiovascular disease related to kidney disease, which has triggered countless epidemiological, clinical, and experimental research activities or interventional trials, investments in tracing, understanding, and therapeutically targeting SIDKD have been sparse. As a call for more awareness of SIDKD as an immanent unmet medical need that requires rigorous research activities at all levels, too, we review the epidemiology of SIDKD and the numerous aspects of the abnormal immunophenotype of patients with kidney disease. We propose a definition of SIDKD and discuss the pathogenic mechanisms of SIDKD known so far, including more recent insights into the unexpected immunoregulatory roles of elevated levels of FGF23 and hyperuricemia as well as shifts in the secretome of the intestinal microbiota in kidney disease. As an ultimate goal, we should aim to develop therapeutics that can reduce mortality due to infections in patients with kidney disease by normalizing host defense to pathogens and immune responses to vaccines.

scholarly journals An economic model of risk assessment for water projects

2020 ◽  
Vol 20 (6) ◽  
pp. 2054-2068
Author(s):  
Antonio Nesticò ◽  
Gianluigi De Mare ◽  
Gabriella Maselli
Keyword(s):  
Risk Assessment ◽  
Cost Benefit Analysis ◽  
Cost Benefit ◽  
Investment Risk ◽  
Limit Set ◽  
Benefit Analysis ◽  
Water Projects ◽  
Project Risk ◽  
Environmental Decision Making ◽  
Definition Of

Abstract The projects that concern water resources are characterized by the multiple risk rates – even extra–financial – that significantly affect their concrete feasibility. Although the risk assessment is decisive for expressing economic convenience judgements on these project initiatives, the decision-maker does not have precise references to determine whether the residual investment risk is acceptable. Thus, the purpose of the paper is to overcome the limit set by characterizing a model for the acceptability of project risk, also considering the plurality of environmental effects that the water projects generate on the community. The idea is to integrate the logic ‘As Low As Reasonably Practicable’ (ALARP) into the procedural schemes of Cost–Benefit Analysis (CBA). In accordance with this principle, widely applied in high-risk sectors such as those of industrial engineering, a risk is ALARP when the costs to further reduce it are disproportionate to the obtainable benefits. The application of the model to an irrigation reconversion intervention in a Municipality in the Province of Salerno (Italy) shows that the ALARP logic defines a general way of thinking and can contribute to the definition of effective forecasting protocols. In this sense, the proposed methodology becomes a useful support for environmental decision-making. (The paper is to be attributed in equal parts to the three authors.)

scholarly journals Te Acercamos El Mundo Por Que Tus Sueños Viajan Con Nosotros. Estudio De Caso: Implementación De Una Agencia De Viajes Y Operadora De Turismo En La Ciudad De Riobamba Provincia De Chimborazo

2016 ◽  
Vol 12 (17) ◽  
pp. 349
Author(s):  
Rita Sulema Lara Vásconez ◽  
Flor Quinchuela ◽  
Jenry Ernesto López Romero
Keyword(s):  
Cost Benefit ◽  
Economic Benefits ◽  
Travel Agency ◽  
First Year ◽  
Commercial Viability ◽  
Fundamental Point ◽  
Travel Agencies ◽  
Definition Of ◽  
The City ◽  
The Universe

The study of the facility permitted to determine that the implementation of the travel agency and the operator of tourism Sumak TourismRio in the city of Riobamba, in Chimborazo Province is possible or viable. Techiques of documentary and local investigations were used. In order to accomplish this investigation, a fundamental point of reference, the commercial viability of the project, was taken, which is based on the study of the market. This study was done considering the analysis of the demand. For this an instrument of investigation that in this case was the inquest guide was applied, which permitted the direct collection of information. On the other hand an analysis of the competition considering the local investigation was made considering the tourism organizations (travel agencies and operators of tourism) of the city of Riobamba which offer tourist products of similar characters. Furthermore the projection of the future demand and future competition, using the method of combined increment whose mathematatic method is: Cn=Co(1+i) . Also the unsatisfacatory existence, that is the confrontation of these factors considering un a difference. It is valid review the importance of the analysis of the demand, since it contributes to the definition of the description of the tourist. Considering all the information collected, the following was defined: the universe of the study shows different requirements in reference to tourist packets that the company offers, which permits economic benefits and by this means activate the economy of the city. Finally, it was shown that the sale of tourist packets Will permit the capitalization of the organization, producing a positive financial profit, since the investment produced will be recuperated in the first year of operation, producing an internal profit of 1,493%, an actual net amount of $2,625610.27(dollars) and a cost benefit of $104.19.

scholarly journals Research on Risk Assessment of Science and Technology Data in Network Finance Based on Portfolio Empowerment

2021 ◽  
Vol 2021 ◽  
pp. 1-10
Author(s):  
Qi Zhao
Keyword(s):  
Risk Assessment ◽  
Data Analysis ◽  
Decision Tree ◽  
Bayesian Network ◽  
Risk Index ◽  
Experimental Results ◽  
Characteristic Quantity ◽  
The Status ◽  
Assessment Time ◽  
Definition Of

At present, the proposed network finance technology data risk assessment time is too long, leading to low accuracy. In order to solve the above problems, this paper puts forward the research on the risk assessment of network financial S&T data based on portfolio weighting, determines the risk index of network financial S&T data, calculates the weight of risk data in network S&T data, searches the risk data characteristic quantity in networks according to network S&T risk index, and completes the extraction of risk data. According to the risk data characteristics of network finance, a decision tree is constructed, the data entropy involved in the decision tree is calculated, the types of risk data characteristics are induced, the nodes of the decision tree are created, and the status of risk data of network finance is obtained. The state of risk data is brought into the definition of Bayesian network probability, and the risk degree of risk data is analyzed to improve the precision of risk data analysis. The experimental results show that the risk assessment of network financial S&T data based on portfolio weighting can effectively shorten the assessment time and improve the accuracy.

scholarly journals Figuras e facetas da lógica proibicionista-medicalizante nas políticas sobre drogas no Brasil / Figures and facets of the prohibitionist-medicalinzg logic in Brazilian drug policies

2017 ◽  
Vol 6 (3) ◽  
pp. 59 ◽  
Author(s):  
José de Araújo Brito Neto ◽  
Flavia Cristina Silveira Lemos ◽  
Dolores Cristina Gomes Galindo ◽  
Alcindo Antônio Ferla ◽  
Michelle Ribeiro Côrrea
Keyword(s):  
Drug Use ◽  
Drug Policy ◽  
Criminal Policy ◽  
Social Practices ◽  
Law And Order ◽  
The Core ◽  
Drug Policies ◽  
Central Argument ◽  
Definition Of ◽  
Política Criminal

ResumoEste artigo visa apresentar uma análise teórica a respeito da lei e norma na definição da opção política proibicionista no Brasil, nas últimas décadas. O debate central é como as políticas sobre drogas têm sido embasadas na perspectiva proibicionista. No bojo dessa postura de proibição legal, a tática repressiva ganhou expressão social e foi inscrita no plano da soberania jurídica normatizadora. Os movimentos de lei e ordem cada vez maisse entrecruzaram e passaram a requisitar a criminalizaçãodo uso e do comércio de drogas, em especial as consideradas ilícitas em um intricado campo de governamentalidades resultante de uma política criminal encarceradora e de umaperspectiva medicalizante do consumo de drogas legais, taiscomo os psicofármacos. Paralelamente, um conjunto de práticas discursivas e de poderoperaram conjuntamente na definição do que são drogas e de quais são lícitas e quais são ilícitas, por meio de um sistema de repartição complexo.Palavras-chave: Proibicionismo; Governamentalidades; Medicalização; Práticas sociais; Política sobre Drogas.AbstractThis paper offers a theoretical analysis of law and norm in the definition of Brazil’s prohibitionist drug policy in recent decades. The central argument advances that drug policies have been based on a prohibitionist perspective. At the core of this stance of legal prohibition, repressive tactics gained social acceptanceand were inscribed in a plan towards a normalizing judicial sovereignty. Law and order movements increasingly intercrossed and instituted the criminalization of drug use and the drug trade- particularly for those deemed illegal - by means of an intricate field of governmentalities which resulted in a carceral criminal policy and a medicalized view of legal drug use, including psychotropics. In parallel, a set of discursive and powerpractices operated jointly to define through a complex system of classification what constitutes a drug and which drugs are to be considered legal or illegal.Keywords: Prohibition; Governmentalities; Medicalization; Social Practices; Drug Policy.

scholarly journals TRANSFORMATION OF TOOLS AND CONSERVATION OF ARCHITECTURE

2020 ◽  
Author(s):  
DONATELLA FIORANI ◽  
MARTA ACIERNO ◽  
SILVIA CUTARELLI ◽  
ADALGISA DONATELLI
Keyword(s):  
Methodological Approach ◽  
Cost Benefit ◽  
Risk Map ◽  
Computer Tools ◽  
Cost Benefit Ratio ◽  
History Of ◽  
History Of Architecture ◽  
Definition Of ◽  
New Research ◽  
Architectural Research

The use of digital technologies to study architecture and landscape has begun to represent an innovative aspect of the research when it started to allow the dynamic association (as input and output) of images and alphanumeric data: the different combination of this information through inferences and algorithms and the consequent generation of new data has freed digitisation from a strictly instrumental role making it a new methodological approach in itself.As a matter of fact, recently architectural research has begun to take an interest in the problem ‘from within’, working not only on the application of computer tools but, more consciously, on their configuration. The work carried out by the Sapienza research group is aimed at developing ontologies and inferential models specifically dedicated to the representation of historical buildings and is devoted to the implementation of a national GIS platform for the historical centres, the Risk Map of the Italian Ministry of Cultural Heritage and Activities and Tourism.This kind of work involves a series of methodological issues specially oriented to the definition of the role of the history of architecture in itself and its use for the conservation project. These arguments are developed within this essay, mainly focused on: type and quality of information deriving by the new procedures; interpretative components that fuel the new research methods; cost/benefit ratio in the use of ‘analogue’ and ‘digital’ approaches; future prospects of the two different (traditional and digital) investigative strategies. Moreover, both of the fields of digital research developed by the group (ontology and Risk Map) are here summarised.

scholarly journals Quality Control for Biomarker Determination in Oncology: The Experience of the Italian Network for Quality Assessment of Tumor Biomarkers (INQAT)

2002 ◽  
Vol 17 (3) ◽  
pp. 201-214 ◽  
Author(s):  
A. Paradiso ◽  
S. Volpe ◽  
A. Iacobacci ◽  
E. Marubini ◽  
P. Verderio ◽  
...  
Keyword(s):  
Quality Control ◽  
Quality Assessment ◽  
National Research Council ◽  
Cost Benefit ◽  
Biomarker Analysis ◽  
Cost Benefit Ratio ◽  
Analytical Phase ◽  
Definition Of ◽  
New Biomarkers ◽  
The Cost

Biomarker analysis and evaluation in oncology is the product of a number of processes (including managerial, technical and interpretation steps) which need to be monitored and controlled to prevent and correct errors and guarantee a satisfactory level of quality. Several biomarkers have recently moved to clinical validation studies and successively to clinical practice without any definition of standard procedures and/or quality control (QC) schemes necessary to guarantee the reproducibility of the laboratory information. In Italy several national scientific societies and single researchers have activated – often on a pilot level – specific external quality assessment protocols, thereby potentially jeopardizing the clinical reality even further. In view of the seriousness of the problem, in 1998 the Italian Ministry of Health sponsored a National Survey Project to coordinate and standardize the procedures and to develop QC programs for the analysis of cancer biomarkers of potential clinical relevance. Twelve QC programs focused on biomarkers and concerning morphological, immunohistochemical, biochemical, molecular, and immunoenzymatic assays were coordinated and implemented. Specifically, external QC programs for the analytical phase of immunohistochemical p53, Bcl-2, c-erb-2/neu/HER2, and microvessel density determination, of morphological evaluation of tumor differentiation grade, and of molecular p53 analysis were activated for the first time within the project. Several hundreds of Italian laboratories took part in these QC programs, the results of which are available on the web site of the Network ( www.cqlaboncologico.it ). Financial support from the Italian Government and the National Research Council (CNR) will guarantee the pursuit of activities that will be extended to new biomarkers, to preanalytical phases of the assays, and to revision of the criteria of clinical usefulness for evaluating the cost/benefit ratio.

scholarly journals Access to unlicensed medicines, who should pay when they are not provided for free?

2021 ◽  
Vol 5 ◽  
pp. 239920262110400
Author(s):  
Kieron David Lewis
Keyword(s):  
Unmet Need ◽  
Commercial Product ◽  
Access To Treatment ◽  
Unlicensed Medicines ◽  
Early Access ◽  
Life Threatening ◽  
Product Launches ◽  
Company Physician ◽  
New Treatments ◽  
Physician Patient

The rising cost of clinical development, license submissions, commercial product launches, and affiliate management in all countries around the world, coupled with the ethical obligation to ensure that eligible patients have access to new treatments, has led some pharmaceutical and biopharmaceutical companies to review their approach to access to medicine. The traditional US first launch, followed by European Union approval and then a strategic launch process, can eventually ensure access in the key markets with developed healthcare systems. For many other countries, providing access via the current legislation available for unlicensed medicine supply can provide a solution for increasing access. This option can be considered for broadening access to a greater number of eligible patients in more countries where unlicensed supply may be the only option, for example, if no clinical trials or commercial product supplies are available. This article looks specifically at the key financial and reimbursement considerations for unlicensed medicines and how some companies are adopting a “charged for” early access model that can be sustainable and affordable from their perspective. It is also important to consider how sustainable a charged program would be for the patient and the relevant payer, as they may expect an unlicensed treatment is provided free of charge. However, if the sponsor or manufacturer simply cannot afford to run a free supply program, the patient is faced with a more serious problem, that of no access at all, either charged or free. The objective of this article is to raise awareness amongst interested stakeholders from different perspectives, including the patients. Unlicensed medicines are usually only prescribed when there is a serious or life-threatening unmet need, and the implications for the company, physician, patient, and payer should be clear if access to treatment depends on the ability to pay.

scholarly journals Understanding Equity of Access in Engineering Education Making Spaces

2021 ◽  
Vol 10 (10) ◽  
pp. 384
Author(s):  
Idalis Villanueva Alarcón ◽  
Robert Jamaal Downey ◽  
Louis Nadelson ◽  
Yoon Ha Choi ◽  
Jana Bouwma-Gearhart ◽  
...  
Keyword(s):  
Engineering Education ◽  
Exploratory Study ◽  
Equitable Access ◽  
Multiple Points ◽  
Expanded Access ◽  
Nuanced Understanding ◽  
Definition Of ◽  
Equity Of Access

The goal of our exploratory study was to examine how management and staff in engineering education making spaces are enacting equitable access amongst their users (e.g., students). We examined six different making space types categorized by Wilczynsky’s and Hoover’s classification of academic makerspaces, which considered scope, accessibility, users, footprint (size), and management and staffing. We reviewed research memos and transcripts of interviews of university makerspace staff, student staff, and leaders/administrators during two separate visits to these places that took place between 2017 and 2019. We inductively and deductively coded the data, and the findings suggested that equity of access was situational and contextual. From the results, we identified four additional considerations needed to ensure equitable access for engineering education making spaces: (a) spaces designed and operated for multiple points of student entry; (b) spaces operated to facilitate effective student making processes and pathways; (c) threats to expanded access: burdens and consequences; and (d) elevating student membership and equity through a culture of belonging. Together, the findings point toward a need for developing a more nuanced understanding of the concept of access that far supersedes a flattened definition of access to just space, equipment, and cost.

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