Availability, affordability and drug utilization of biosimilar medicinal products, containing monoclonal antibodies in Bulgaria

2021 ◽  
pp. 174113432110176
Author(s):  
Stefka Stoyanova ◽  
Emanuil Yordanov ◽  
Emil Hristov ◽  
Iva Parvova ◽  
Hristo Tzachev ◽  
...  
Keyword(s):  
Monoclonal Antibodies ◽  
Drug Utilization ◽  
National Standards ◽  
Insurance Fund ◽  
National Council ◽  
Medicinal Products ◽  
The Public ◽  
Data Exclusivity ◽  
Public Data ◽  
Costs Of Treatment

The entry of the biological medicinal products (BMPs) in the clinical practice more than 10 years ago raised complex regulatory issues as well as significant pharmacoeconomic concerns, because the costs of treatment is higher than the costs of the conventional products. The “data exclusivity” of BMPs expired and biosimilar medicinal products (BSMPs) are available on the market. The market share of BSMPs is expected to increase gradually and lead to cost reductions of biological treatment. Aim: To analyze the availability, affordability and drug utilization of BSMPs containing monoclonal antibodies in Bulgaria. Materials and methods: Retrospective study of the public data from EMA, National Council on Prices and Reimbursement and National Health Insurance Fund for 2015–2019. Descriptive statistical analysis was performed. Results and Discussion: On the ЕU level, BSMPs with Marketing Authorization are Adalimumab, Infliximab, Rituximab, Bevacizumab and Trastuzumab. In the Bulgarian Positive Drug List, there are 12 BSMPs with the same INN, excluding Bevacizumab. The total cost of BMPs is 691 673 158 BGN – the share of BSMPs is 34 139 639 BGN (4.7%). The access of BSMPs in Bulgaria is still very limited. BSMPs are available with the lower price, but the reference products are the preferred treatment. The reason for this could be the lack of national standards for the switching/interchangeability of BMPs with BSMPs, and the prescribers distrust of the so-called replacement therapies and aggressive drug promotion to the healthcare professionals are also of great importance.

scholarly journals An analysis of potential costs of adverse events based on Drug Programs in Poland. Pulmonology focus

2014 ◽  
Vol 27 (1) ◽  
pp. 32-36
Author(s):  
Monika Szkultecka-Debek ◽  
Mariola Drozd ◽  
Karina Jahnz-Rozyk ◽  
Nina Kiepurska ◽  
Joanna Mazurek ◽  
...  
Keyword(s):  
Side Effects ◽  
Adverse Events ◽  
Medicinal Products ◽  
Disease Area ◽  
Significant Cost ◽  
The Public ◽  
Polish Society ◽  
Costs Of Treatment ◽  
The Common ◽  
Public Payer

Abstract The project was performed within the Polish Society for Pharmacoeconomics (PTFE). The objective was to estimate the potential costs of treatment of side effects, which theoretically may occur as a result of treatment of selected diseases. We analyzed the Drug Programs financed by National Health Fund in Poland in 2012 and for the first analysis we selected those Programs where the same medicinal products were used. We based the adverse events selection on the Summary of Product Characteristics of the chosen products. We extracted all the potential adverse events defined as frequent and very frequent, grouping them according to therapeutic areas. This paper is related to the results in the pulmonology area. The events described as very common had an incidence of ≥ 1/10, and the common ones ≥ 1/100, <1/10. In order to identify the resources used, we performed a survey with the engagement of clinical experts. On the basis of the collected data we allocated direct costs incurred by the public payer. We used the costs valid in December 2013. The paper presents the estimated costs of treatment of side effects related to the pulmonology disease area. Taking into account the costs incurred by the NHF and the patient separately e calculated the total spending and the percentage of each component cost in detail. The treatment of adverse drug reactions generates a significant cost incurred by both the public payer and the patient.

Pembangunan Web Service Data Masyarakat Menggunakan REST API dengan Access Token

2018 ◽  
Vol 10 (1) ◽  
pp. 19-26 ◽  
Author(s):  
Muhammad Iqbal Perkasa ◽  
Eko Budi Setiawan
Keyword(s):  
Web Service ◽  
Job Search ◽  
Population Data ◽  
The Public ◽  
Public Data ◽  
Community Data ◽  
The Government ◽  
Rest Api ◽  
Service Application ◽  
Service Data

Data is one of the most important things in this information and information technology era that evolving now. Currently, the government still has not used the public data maximally for administrative purposes. Utilization of this big population data is the creation of a web service application system with REST API where this data will be open and accessible to those who have access. One of the institutions that use this service is the Manpower and Transmigration Service where this system can make the Dinas staff more efficient to create and register job search cards using available community data. This application is able to provide and facilitate many parties, such as data administrators to monitor data usage, registration employee in input data, and people able to register independently. Index Terms—Web service, API, Rest api, People data

How Good Is the Public Data on Sovereign Bond Contracts?

2018 ◽  
Author(s):  
Andrea Kropp ◽  
Gaurang Mitu Gulati ◽  
Mark C. Weidemaier
Keyword(s):  
The Public ◽  
Sovereign Bond ◽  
Public Data

Anniversary of the first national standards for geodetic instruments

2019 ◽  
Vol 946 (4) ◽  
pp. 20-25
Author(s):  
O. K. Golubkova ◽  
A.I. Spiridonov
Keyword(s):  
Public Service ◽  
Positive Impact ◽  
State Standards ◽  
National Standards ◽  
Technical Level ◽  
Instrument Making ◽  
The Public ◽  
Technical Requirements ◽  
Basic Parameters ◽  
Technical Specifications

State standards on the types, basic parameters of levels and theodolites as well as technical requirements were developed in CNIIGAiK in 1962–1963. The authors indicate the experience of developing the first State standards for geodetic instrument making, the difficulties encountered in developers. In this article the main stages of preparation of State standards, including action algorithm from technical specifications to submissions for the approval of the public service are marked step-by-step. The types of levels and theodolites, and the basic technical characteristics for each type are described. During 55 years the positive impact in the areas of production and application of standardized levels and theodolites, inter alia, streamlining the issuance of standard sizes of devices, increased production and improved their quality and technical level was revealed.

scholarly journals Authentic and Reliable Data in the Service of National Public Data Asset

2021 ◽  
Vol 66 (Special edition 2021/1) ◽  
pp. 52-67
Author(s):  
Gergely Pálmai ◽  
Szabolcs Csernyák ◽  
Zoltán Erdélyi
Keyword(s):  
Artificial Intelligence ◽  
Public Sector ◽  
Public Information ◽  
Reliable Data ◽  
Financial Loss ◽  
National Data ◽  
The Public ◽  
Efficient Management ◽  
Public Data ◽  
Authentic Data

The analysis focused on how efficient management of the national data asset is supported by the Hungarian regulatory framework concerning the use of public information, and whether public data constituting part of the national data asset can be deemed authentic and reliable to support the efforts for the digitalisation and artificial intelligence-based developments of the public sector. The analysis shows why the availability of authentic and reliable data in terms of the national data asset has outstanding significance. In support of this assertion, it presents the different levels of data asset use, the role of using artificial intelligence in the public sector, and the significance, risks and challenges of the authenticity and reliability of public data, from both a data protection and a public finance aspect. Inaccuracy, unreliability of input data predestines the generation of incorrect result products (conclusion, decision), even if the appropriate algorithm is used, which could lead to direct financial loss, for both the citizens and the state. The authors of the analysis therefore suggest that a paradigm shift is necessary in the strategies targeting the efficient use of the public sector’s data, with the necessity to record the fundamental precondition that the national data asset must be based on reliable and authentic data.

scholarly journals Evaluasi Pembangunan Pendidikan Keaksaraan

2020 ◽  
Vol 15 (1) ◽  
pp. 25-36
Author(s):  
Rosyidatuzzahro Anisykurlillah
Keyword(s):  
Formal Education ◽  
Development Program ◽  
Model Analysis ◽  
Input Process ◽  
The Public ◽  
Interactive Model ◽  
Descriptive Research ◽  
Global Issue ◽  
Public Data ◽  
Use Context

Illiteracy is a global issue that must be addressed immediately. In Malang Regency, there were 18,535 people who were illiterate. The effort of the Malang Regency Education Office to improve AMH is through Non-Formal Education Program (PNF). The assessment of the literacy development program through the PNF Program can use Context, Input, Process, and Product (CIPP) evaluation assessments. This research uses descriptive research with a qualitative approach. The purpose of this research is to describe and analyze the evaluation of literacy education through the PNF Program in Malang Regency using the CIPP methods. Data analysis techniques used in this study are interactive model analysis of Miles, Huberman, and Saldana. Based on the evaluation results using the CIPP (Context, Input, Process, and Product) method, there are still obstacles that must be resolved for the success of the PNF program. These obstacles include learning time that is not on schedule, lack of awareness of citizens in following the program, incapability of citizens, the difficulty of convincing the public, data collection of prospective citizens who fail to meet expectations. Abstrak Isu permasalahan buta huruf merupakan isu global yang harus segera ditangani. Pendidikan keaksaraan (belajar membaca dan menulis) diukur dengan Angka Melek Huruf (AMH) dapat menggambarkan jumlah orang yang memperoleh akses pendidikan sebagai hasil pembangunan. Di Kabupaten Malang terdapat 18.535 orang yang buta huruf. Upaya Dinas Pendidikan Kabupaten Malang untuk meningkatkan AMH adalah dengan Program Pendidikan Non Formal (PNF). Untuk menilai pembangunan pendidikan keaksaraan melalui Program PNF dapat menggunakan penilaian evaluasi Context, Input, Process, and Product (CIPP). Penelitian ini menggunakan jenis penelitian deskriptif dengan pendekatan kualitatif. Teknik analisis data yang digunakan dalam penelitian ini adalah interactive model analysis Miles, Hubermana, dan Saldana. Jika dilihat dari hasil Evaluasi menggunakan metode CIPP (Context, Input, Process, dan Product), masih ada hambatan-hambatan yang harus diselesaikan demi keberhasilan program PNF. Hambatan tersebut diantaranya waktu pembelajaran yang tidak sesuai jadwal, kurang kesadaran warga Belajar (WB) dalam mengikuti program, ketidakmampuan Warga Belajar (WB), sulitnya meyakinkan masyarakat, pendataan calon warga belajar yang tidak sesuai harapan.

scholarly journals Linked government administrative data: Public or Private?

2019 ◽  
Vol 4 (3) ◽  
Author(s):  
Joel Stafford
Keyword(s):  
Public Good ◽  
Communication Networks ◽  
Administrative Data ◽  
Public Service ◽  
Policy Development ◽  
Data Linkage ◽  
The Public ◽  
Government Services ◽  
Service Contracts ◽  
Public Data

Background with rationaleIt is commonplace in policy discussions concerning administrative data linkage to presuppose that the data referred to is government services data. But this is not always the case. Much of the data public services hold is now collected via intermediaries, such as Non-Government Organisations, operating under service contracts with one or multiple government departments. Nor are these the only administrative data holdings applicable to clients of government services. There are also vast private administrative data holdings – including utility data, and consumer behaviour data. Creating and amending legislation that governs public service practices in this domain is increasingly made complex when private companies partner with governments agencies on policy development and evaluation work. Understanding the concept of public data for public good in light of this expanded sense of administrative data opens the door to deeper questions about the role linked data can play in government decision making. Main aimThe paper problematizes how legislation governing the linking of government administrative data is scoped and discusses how public service work can be affected by the opaque communication networks that increasingly span the public-private sector divide. Methods/ApproachAfter contextualising the challenge of legislating for administrative data linkage in the current work of the Office of the National Data Commissioner (ONDC) in Australia, this paper tests aspects of the proposed legislation against the extent to which it permits the possibility of ‘data laundering’. ResultsThe presentation demonstrates the need for greater sophistication in the specification of data linkage and sharing legislation in service of the public good. Conclusions This paper indicates that contemporary practices governing the linkage of government administrative data holdings is porous to the aims of extra-governmental organisations and may benefit by better incorporating legislative structures that govern private analytical services entities.

scholarly journals Exploring the Reliability of Research Indicators Reported by Romanian Universities in 2019

2021 ◽  
Vol 5 (1) ◽  
pp. 96-122
Author(s):  
Vlad Ștefan Barbu ◽  
Florentina Furtunescu ◽  
Bogdan Murgescu ◽  
Carmen Pintilescu
Keyword(s):  
Higher Education ◽  
Research Performance ◽  
National Council ◽  
Comparative Performance ◽  
Research Section ◽  
Education Financing ◽  
Public Data ◽  
Additional Funding ◽  
Higher Education Financing ◽  
Verification Process

"The paper focuses on the aggregate data published by the National Council for Higher Education Financing regarding the research section of the quality indicators reported by Romanian public universities in 2019 and used for the allocation of the performance-based additional funding. The research section includes 4 indicators, which amount to 46% of the additional funding, i.e. to an average of about 10% of the total institutional funding from the public budget. The data are reported by the Romanian universities each odd year since 2015, and for the first time in 2020 national rankings for most indicators and some national averages have been made public. The data is extremely valuable for a diagnosis of the Romanian higher education system and for highlighting the performance of various universities. Therefore, the accuracy of these data is crucial. The authors of this paper acknowledge the efforts of the National Council for Higher Education Financing and of its staff provided by the Executive Unit for Financing Higher Education, Research, Development and Innovation to check the data reported by the universities, but also the limits of the current verification process. The paper uses statistical methods to identify outliers and investigates the rankings for a selection of fields of science, by using three among the four research indicators. Thus, it discusses some of the more blatant reporting anomalies which contradict the pre-existing conceptions regarding the comparative performance of universities. While the statistical findings do not support the suspicions of systematic attempts of over-reporting the research outcomes at university-level, they still outline several persisting errors. These errors highlight the need to strengthen the verification process, which will require additional resources; the authors suggest that enhanced transparency and organised cross-verification among universities can significantly improve the outcome, and help providing a significant set of reliable public data on the research performance of the Romanian universities."

Methods for Utilising Local Government’s Public Data Released to The Public Data Portal

2021 ◽  
Vol 22 (3) ◽  
pp. 445-452
Author(s):  
Dongjun Kim ◽  
Hyeonji Kim ◽  
Chaeeun Song ◽  
Jiwoo Yang ◽  
Haklae Kim
Keyword(s):  
The Public ◽  
Public Data ◽  
Data Portal
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