Health Technology Assessments (HTAs) in Germany are essential to evaluating the benefits, risks, and economic implications of medical technologies and interventions. The process involves several key institutions. These bodies have distinct roles in evaluating and deciding on the inclusion and reimbursement of health technologies within the healthcare system. Before looking at the process, let’s explore the different parties involved and the respective role and responsabilities.
The primary bodies involved in HTAs in Germany include:
1. Federal Joint Committee (G-BA)
Role: The G-BA is the highest decision-making body in the German healthcare system. It comprises representatives from health insurance funds, healthcare providers, and patient organizations.
Responsibilities:
- Making final decisions on the inclusion of new medical technologies, procedures, and pharmaceuticals in the statutory health insurance (SHI) benefits catalog.
- Establishing the framework for the quality and efficiency of healthcare services.
- Setting reimbursement prices and conditions for use.
Composition:
- Statutory health insurance funds representatives
- Physicians
- Hospitals representatives
- Patient organizations representatives
2. Institute for Quality and Efficiency in Health Care (IQWiG)
Role: IQWiG conducts scientific assessments focusing on of the medical benefits, quality, cost-effectiveness and economic aspects of healthcare services.
Responsibilities:
- Performing systematic reviews of existing literature and data.
- Preparing reports on the effectiveness, safety, and cost-effectiveness of medical technologies.
- Providing recommendations to the G-BA based on their assessments.
Activities: Includes public consultations and stakeholder involvement in the assessment process.
3. Federal Institute for Drugs and Medical Devices (BfArM)
Role: BfArM is responsible for the approval and regulation of pharmaceuticals and medical devices in Germany.
Responsibilities:
- Assessing the safety, efficacy, and quality of new pharmaceuticals and medical devices.
- Monitoring the market to ensure compliance with regulatory standards.
- Providing post-market surveillance and vigilance.
4. Paul Ehrlich Institute (PEI)
Role: PEI is a federal agency responsible for the approval and regulation of vaccines and biomedicines.
Responsibilities:
- Evaluating the safety, efficacy, and quality of vaccines and biological medicinal products.
- Conducting research to support regulatory activities.
- Providing post-market surveillance and risk assessment for vaccines and biomedicines.
5. Statutory Health Insurance Funds (SHIs)
Role: SHIs are responsible for providing health insurance coverage to the majority of the German population.
Responsibilities:
- Funding healthcare services and reimbursing providers.
- Participating in the decision-making process within the G-BA.
- Implementing G-BA decisions on the coverage and reimbursement of health technologies.
6. Federal Ministry of Health (BMG)
Role: The BMG oversees the healthcare system and ensures the implementation of health policies.
Responsibilities:
- Providing regulatory oversight and guidance to healthcare bodies.
- Ensuring that the healthcare system operates efficiently and meets the needs of the population.
- Supporting research and innovation in healthcare.
7. German Network for Health Technology Assessment (DAHTA)
Role: DAHTA is a network that promotes and coordinates HTA activities in Germany.
Responsibilities:
- Facilitating collaboration among HTA researchers and institutions.
- Disseminating HTA findings to policymakers, healthcare providers, and the public.
- Supporting the development of HTA methodologies and standards.
8. Patient and Consumer Organizations
Role: Represent the interests of patients and consumers in the healthcare system.
Responsibilities:
- Providing input and feedback on HTA processes and decisions.
- Ensuring that patient perspectives are considered in the assessment and decision-making process.
- Participating in public consultations and G-BA deliberations.
But how do the different institutions interact together during the assessment of heath technologies?
Here’s an overview of the HTA process in Germany:
1. Initiation and Scoping
Topic Selection: The HTA Board of Trustees (composed of insurance companies, hospitals, and physicians, complemented by representatives of nursing, patients, or consumers, as well as observer representatives from the IQWiG and the industry) sets priorities and determines the topics for future reports in a multilevel procedure. The G-BA plays a crucial role in selecting and prioritizing topics for assessment.
Scoping: The specific research questions and the scope of the assessment is defined. This involves identifying the health technology to be assessed, the patient population, comparators, and relevant outcomes.
2. Assessment by IQWiG
Commissioning of IQWiG: The G-BA commissions IQWiG to conduct the assessment. IQWiG is responsible for the scientific evaluation of the medical benefits, quality, and efficiency of healthcare services.
Literature Review and Data Analysis: IQWiG conducts a systematic review of existing literature and, where applicable, analyzes data from clinical studies, registries, and real-world evidence. They assess the clinical effectiveness, safety, and cost-effectiveness of the technology.
Stakeholder Involvement: During the assessment, stakeholders, including manufacturers, healthcare professionals, and patient representatives, may provide input and evidence. Public consultations are often held to gather broader feedback.
3. Report Preparation and Publication
Draft Report: IQWiG prepares a draft report based on its findings. The draft report is shared with stakeholders for comments and feedback.
Final Report: After considering stakeholder feedback, IQWiG finalizes the report. The final report includes recommendations on the use of the technology, based on the evidence gathered.
Publication: The final report is published on IQWiG’s website, ensuring transparency and accessibility.
4. Decision-Making by the G-BA
G-BA Review: The G-BA reviews IQWiG’s final report and considers additional stakeholder input. The G-BA conducts its own deliberations, which may include hearings with stakeholders.
Decision-Making: Based on the evidence and deliberations, the G-BA makes a decision regarding the inclusion of the health technology in the statutory health insurance (SHI) benefits catalog. Decisions can range from full inclusion, conditional inclusion, or exclusion from reimbursement.
Implementation: If the technology is approved, the G-BA’s decision is implemented within the SHI system. This may involve setting reimbursement prices and conditions for use.
5. Post-Assessment and Monitoring
Real-World Evidence (RWE) Collection: Continuous monitoring of the technology’s performance in real-world settings may be required. RWE helps in evaluating the long-term effectiveness and safety of the technology.
Re-Evaluation: Periodic re-evaluations of the technology may be conducted to ensure it remains beneficial and cost-effective. New evidence or changes in clinical practice can trigger re-assessment.
In conclusion, the HTA process in Germany is rigorous and well structured process involving multiple steps to ensure that health technologies are thoroughly evaluated for their clinical and economic impact. The collaboration between IQWiG and the G-BA, along with stakeholder involvement, ensures that decisions are based on robust evidence and reflect the needs and perspectives of various parties within the healthcare system. This comprehensive approach helps maintain high standards of care and ensures the efficient allocation of healthcare resources.
References & Websites:
G-BA: https://www.g-ba.de/
IQWiG: https://www.iqwig.de/
BfArM: https://www.bundesgesundheitsministerium.de/
PEI: https://www.pei.de/DE/home/home-node.html
SHIs: https://www.health-insurance.de/statutory-health-insurance/list/
BMG: https://www.bundesgesundheitsministerium.de/
DAHTA: https://www.bfarm.de/DE/Das-BfArM/Aufgaben/HTA/Datenbankinformation/_node.html
Health Technology Assessment:
https://www.bundesaerztekammer.de/themen/aerzte/qualitaetssicherung/health-technology-assessment