The Act on the Reform of the Market for Medicinal Products (AMNOG): A question of power?!
(Sprache: Englisch)
In the past, high costs have been incurred in particular by the market launch of new medicinal products. To date, it was not necessary to demonstrate an additional therapeutic benefit. This changed with the Act on the Reform of the Market for Medicinal...
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In the past, high costs have been incurred in particular by the market launch of new medicinal products. To date, it was not necessary to demonstrate an additional therapeutic benefit. This changed with the Act on the Reform of the Market for Medicinal Products (AMNOG), which entered into force on the 1st of January 2011. It brought about a fundamental change in the balance of power on the pharmaceutical market.This study therefore sets out to answer the following question: What impact does the early benefit assessment in the context of the AMNOG have on the stakeholders of the healthcare system? To answer this question, this survey first presents the theoretical foundations of the law, of the early benefit assessment and the bodies involved. It then takes stock of the decisions taken to date before describing the impact on the selected stakeholders.
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Text Sample:Chapter 1. Introduction:
The German healthcare system is underpinned by the principle of solidarity. A health insurance fund, financed by contributions from employers and employees, forms the financial basis of the system. This fund is used to pay all diagnostic and therapeutic benefits for citizens insured under statutory insurance schemes (Busse, et al., 2013, p 114). Healthcare resources are therefore limited. The financing of the fund faces a number of challenges: an increasingly aging population with increased morbidity, a decreasing number of young contributors and increased costs due to actual or supposed pharmaceutical innovations.
It is only natural therefore that the health insurance funds should be interested in scientifically proven treatments. The Federal Joint Committee (G-BA), a centralised body, decides on the eligibility of treatments for reimbursement. In order to reach a decision on the benefits of treatments that is as scientifically substantiated as possible, the G-BA commissions so-called Health Technology Assessments (HTA). HTAs are benefit assessments entailing the evaluation of existing studies and medical publications. The Institute for Quality and Efficiency in Healthcare (IQWiG) is one of the bodies entrusted with such HTAs in Germany.
In the past, high costs have been incurred in particular by the market launch of new medicinal products. To date, it was not necessary to demonstrate an additional therapeutic benefit. This changed with the Act on the Reform of the Market for Medicinal Products (AMNOG), which entered into force on the 1st of January 2011. This Act regulates the pricing of newly authorised medicinal products and thus their eligibility for reimbursement by statutory health insurance (GKV). In future, the manufacturer must demonstrate proof of an added benefit over a comparator therapy for all new medicinal products. The G-BA thus decides on the extent of the added benefit. It is assisted in ist
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decision-making by an IQWiG benefit assessment.
Chapter 1.1 Scope:
The early benefit assessment in the context of AMNOG has consequences for all stakeholders within the healthcare system. Two and a half years after ist entry into force, the impact of the Act is becoming more apparent, now allowing a more discriminating analysis. This survey starts out by examining the theoretical foundations of the law and the bodies involved. This is followed by a critical analysis of the early benefit assessment of pharmaceuticals from the perspective of the health insurance funds, the pharmaceutical industry and the patients.
Chapter 1.2 The central research question:
What impact does the early benefit assessment in the context of AMNOG have on the stakeholders of the healthcare system in the light of the available data?
Chapter 1.3 Methodology:
The first part of the book will set out the theoretical background. For this purpose, the necessity of adopting the Act and ist objectives will be elucidated. One aspect of the Act is the early benefit assessment, which will be explained in greater detail below. To ease understanding, the two bodies involved - the G-BA and the IQWiG will first be presented and the structure and content of the dossier underlying an early benefit assessment clarified.
The second part of the survey will go through the available data relating to the practical experience garnered to date. It will begin with an analysis of benefit assessments already concluded, which will provide a deeper insight into the frequencies and differences observed in the granting of added benefits, illustrated by diagrams accompanied by comments. The views of three stakeholders in the assessment procedure are subsequently set out. These are: pharmaceutical companies as manufacturers of the medicinal products subject to the assessment, the health insurance funds as administrators of the finances of the healthcare system and the patients who rely on pharmaceutical innovations. This should mak
Chapter 1.1 Scope:
The early benefit assessment in the context of AMNOG has consequences for all stakeholders within the healthcare system. Two and a half years after ist entry into force, the impact of the Act is becoming more apparent, now allowing a more discriminating analysis. This survey starts out by examining the theoretical foundations of the law and the bodies involved. This is followed by a critical analysis of the early benefit assessment of pharmaceuticals from the perspective of the health insurance funds, the pharmaceutical industry and the patients.
Chapter 1.2 The central research question:
What impact does the early benefit assessment in the context of AMNOG have on the stakeholders of the healthcare system in the light of the available data?
Chapter 1.3 Methodology:
The first part of the book will set out the theoretical background. For this purpose, the necessity of adopting the Act and ist objectives will be elucidated. One aspect of the Act is the early benefit assessment, which will be explained in greater detail below. To ease understanding, the two bodies involved - the G-BA and the IQWiG will first be presented and the structure and content of the dossier underlying an early benefit assessment clarified.
The second part of the survey will go through the available data relating to the practical experience garnered to date. It will begin with an analysis of benefit assessments already concluded, which will provide a deeper insight into the frequencies and differences observed in the granting of added benefits, illustrated by diagrams accompanied by comments. The views of three stakeholders in the assessment procedure are subsequently set out. These are: pharmaceutical companies as manufacturers of the medicinal products subject to the assessment, the health insurance funds as administrators of the finances of the healthcare system and the patients who rely on pharmaceutical innovations. This should mak
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Bibliographische Angaben
- Autor: Sara Schlenkrich
- 2015, Erstauflage, 68 Seiten, Maße: 15,5 x 22 cm, Kartoniert (TB), Englisch
- Verlag: Anchor Academic Publishing
- ISBN-10: 3954893592
- ISBN-13: 9783954893591
Sprache:
Englisch
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