The early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products (AMNOG)

A critical analysis from the perspective of the stakeholders at the end of the 17th legislative period

Bachelorarbeit , 2013 , 68 Seiten , Note: 1,4

Gesundheit - Sonstiges

The Act on the Reform of the Market for Medicinal Products, which entered into force on the 1st of January 2011, brought about a fundamental change in the balance of power on the pharmaceutical market. This thesis therefore sets out to answer the following question: What impact does the early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products have on the stakeholders of the healthcare system?
To answer this question, this work 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.
The following findings were reached: As the representative of the statutory health insurance funds, the Central Federal Association of Statutory Health Insurance Funds has gained in power and now decides, as a member of the Federal Joint Committee, on the added benefit of a drug and, depending on this decision, also on the future reimbursement rate. Pharmaceutical companies, however, are losing clout and must comply with the guidelines and assessments of the early benefit assessment. Patients stand to gain and lose out from the early benefit assessment. They are the ones who are ultimately dependent on the medicinal product and its improvement and benefit from a proven benefit. However, they have no say in the early benefit assessment procedure.

Inhaltsverzeichnis

• List of abbreviations
• 1. Introduction
  • 1.1 Scope
  • 1.2 The central research question
  • 1.3 Methodology
• 2. The Act on the Reform of the Market for Medicinal Products
  • 2.1 The background of the Act
  • 2.2 The objectives of the Act
  • 2.3 The Federal Joint Committee (G-BA)
  • 2.4 The Institute for Quality and Efficiency in Healthcare
  • 2.5 The manufacturer dossier
  • 2.6 Early benefit assessment
  • 2.7 The special case of orphan drugs
• 3. Evaluation, findings and experience – Critical analysis
  • 3.1 Evaluation of the added benefit classifications
    • 3.1.1 Methodology
    • 3.1.2 Frequency distribution of the added benefit categories
    • 3.1.3 Comparison of the added benefit classifications
  • 3.2 The impact on the statutory health insurance funds
    • 3.2.1 Overview of the statutory health insurance funds in Germany
    • 3.2.2 Challenges facing the health insurance funds
    • 3.2.3 The Central Federal Association of Statutory Health Insurance Funds
    • 3.2.4 The early benefit assessment from the perspective of the Central Federal Association of Statutory Health Insurance Funds
  • 3.3 The impact on the pharmaceutical industry
    • 3.3.1 The pharmaceutical industry in Germany
    • 3.3.2 A critical assessment from the perspective of the pharmaceutical industry
  • 3.4 The impact on patients
    • 3.4.1 Patient organisation in Germany
    • 3.4.2 A critical analysis from the patient's perspective
  • 3.5 Conclusion
• 4 Summary and Outlook
• Bibliography
• List of figures
• List of tables
• List of appendixes:
  • Appendix

Zielsetzung und Themenschwerpunkte

This thesis aims to critically analyze the impact of the early benefit assessment in the context of the Act on the Reform of the Market for Medicinal Products (AMNOG) on the stakeholders of the healthcare system. It examines the theoretical foundations of the law, the early benefit assessment process, and the involved bodies. The work then analyzes the impact of the early benefit assessment on the statutory health insurance funds, the pharmaceutical industry, and patients.

• The impact of the early benefit assessment on the power dynamics within the pharmaceutical market
• The role of the Federal Joint Committee (G-BA) in determining the added benefit of new drugs
• The challenges and opportunities presented by the early benefit assessment for the statutory health insurance funds
• The impact of the early benefit assessment on the pharmaceutical industry's profitability and innovation
• The implications of the early benefit assessment for patient access to new and innovative treatments

Zusammenfassung der Kapitel

Chapter 1 introduces the scope of the thesis, the central research question, and the methodology employed. It provides a brief overview of the AMNOG and its significance for the pharmaceutical market.

Chapter 2 delves into the theoretical foundations of the AMNOG, including its background, objectives, and key provisions. It examines the roles of the Federal Joint Committee (G-BA) and the Institute for Quality and Efficiency in Healthcare (IQWIG) in the early benefit assessment process. The chapter also discusses the manufacturer dossier and the process of early benefit assessment.

Chapter 3 presents a critical analysis of the early benefit assessment, evaluating the added benefit classifications and their impact on the stakeholders. It examines the frequency distribution of the added benefit categories and compares the classifications across different drugs. The chapter then analyzes the impact of the early benefit assessment on the statutory health insurance funds, the pharmaceutical industry, and patients.

Schlüsselwörter

The keywords and focus themes of the text include the Act on the Reform of the Market for Medicinal Products (AMNOG), early benefit assessment, added benefit, statutory health insurance funds, pharmaceutical industry, patients, healthcare system, and the impact of the AMNOG on the stakeholders.

• Hochschule: Hochschule Zittau/Görlitz; Standort Görlitz
• Veranstaltung: V282129
• Note: 1,4
• Autor: Sara Schlenkrich (Autor:in)
• Erscheinungsjahr: 2013
• Seiten: 68
• Katalognummer: V282129
• ISBN (eBook): 9783656766018
• ISBN (Buch): 9783656766025
• Sprache: Englisch
• Schlagworte: AMNOG, frühe Nutzenbewertung, Arzneimittelmarktneuordnungsgesetz, Gemeinsamer Bundesausschuss, G-BA, Arzneimittel, Arzneimittelbewertung, Gesundheitspolitik, Gesundheitsökonomie, Nutzenbewertung, early benefit assessment, Reform of the Market for Medicinal Products, Germany, Federal Joint Committee, Pharmaceutical companies, benefit assessment, German Healthcare System