Frequently asked questions (FAQs): external experts
Here you will find the answers to various questions on the database of external experts.
List of frequently asked questions
What are my data in the database used for?
You register in the database if you would like to participate in the following fields of work at IQWiG with your expert knowledge:
- in the early benefit assessment of drugs according to AMNOG
- in the assessment of the potential of non-drug interventions according to GKV-VStG
- in the production of easily understandable health information
Due to the short time frame of the early benefit assessments and assessments of potential, IQWiG often searches for external experts for specific questions at very short notice. A large and varied pool of experts is helpful for this purpose. Your entry in the database of external experts complements this pool with your expertise.
Will I automatically be an external expert for the next project if I register?
No. With your registration in the IQWiG database of external experts you have first indicated your interest in certain fields of work and have provided us with your profile.
External experts for IQWiG are commissioned in award procedures. If we need special expert knowledge for early benefit assessments, assessments of potential, or health information, we use the database of external experts as an expert pool for awarding the commission.
As the award of a commission depends on current commissions, we cannot predict when you might be approached by us.
You can find out more about the selection procedure in the answer to the question How are experts chosen from the database?
What does "early benefit assessment of drugs according to AMNOG" mean?
The Act on the Reform of the Market for Medicinal Products (AMNOG) stipulates that a new drug entering the market in Germany in principle has to undergo an early benefit assessment. For this assessment, manufacturers have to submit a dossier at market entry, which forms the basis to assess the added benefit of the new drug in comparison with the current standard therapy.
The Federal Joint Committee (G-BA) supervises the procedure of the early benefit assessment and usually commissions IQWiG with the scientific assessment of the dossier. This dossier assessment has to be completed within three months after receipt of the manufacturer's dossier.
You can find out more about this on the G-BA's website.
What does "assessment of the potential of non-drug interventions according to GKV-VStG" mean?
The assessment of the potential of examination and treatment methods concerns non-drug interventions and hence medical interventions that are not solely dependent on the use of drugs. This includes medical devices.
The Structure of Health Care Act of the Statutory Health Insurance (GKV-VStG) offers the opportunity to apply for the testing of a new examination or treatment method according to §137e Social Code Book (SGB) V within the framework of a clinical study. These applications can be made by manufacturers of a medical device that is relevant for a new examination or treatment method, or by providers of such methods. The G-BA can then decide that the method applied for is tested within the framework of clinical studies.
A precondition for this is that the applicant (manufacturer or provider) submits documents presenting the potential of the particular method. These documents are evaluated scientifically within the procedure. The G-BA can commission IQWiG with this assessment of potential, which has to be conducted within a short period of time: The G-BA has to make a decision about the presence of a potential within three months after submission of the application documents. Assessments of potential are part of an administrative procedure conducted by the G-BA. The topics and contents of this procedure are confidential.
You can find out more about this on the G-BA's Website.
What does “assessments according to §137h SGB V on treatment and examination methods with high-risk class medical devices” mean?
The Act to Strengthen the Provision of Health Care (GKV-VSG) mandates that certain examination and treatment methods with medical devices used in the hospital setting are subject to an assessment by the G-BA. This applies to medical device methods for which the following preconditions are met: A hospital submits the first application according to §6 (2) Hospital Reimbursement Act (“NUB application”), the method is largely based on a high-risk class medical device, and the method is based on a new theoretical-scientific concept.
The G-BA conducts its assessment on the basis of documents transferred by hospitals and, if applicable, medical device manufacturers concerned. On the basis of the documents submitted, the G-BA has to decide within three months whether the method shows a benefit, potential, or neither benefit nor potential. For this purpose, it can commission IQWiG with the scientific assessment of the documents, which has to be produced in a short period of time due to the statutory deadlines.
You can find out more about this on the G-BA’s Website (german Version).
How are external experts chosen from the database?
Early benefit assessments (AMNOG) / assessments of potential (GKV-VStG):
The selection procedure for early benefit assessments and assessments of potential includes the following steps:
- IQWiG searches the database of external experts to find interested persons who have entered the specialty in question.
- Then those experts are chosen from the list who hold a university degree in medicine, have relevant professional experience (usually qualification as a medical specialist and clinical experience), have authored relevant scientific publications, and are able to conduct the consultation in German. Interested persons who fulfil these criteria are generally suitable as external experts.
- If more than five suitable external experts are identified, five of them are chosen on the basis of the length of their professional experience (usually after having obtained a qualification as a medical specialist in the speciality relevant to the commission) and of the quality of the publications cited.
- Up to five of these external experts will then receive a request from IQWiG by e-mail.
The selection procedure for health information includes the following steps:
- IQWiG searches the database of external experts to find interested persons who have entered the specialty in question.
- From the interested persons, those are chosen who hold a university degree in medicine or nursing science or, alternatively, have had job training in a health profession (midwife, physiotherapist, etc.), have several years of practical clinical experience (qualification as a medical specialist) or several years of relevant professional experience.
- If more than three suitable external experts are identified for the specific questions, three of them are chosen on the basis of the length of their clinical or professional experience.
- Up to three of these external experts will then receive a request from IQWiG by e-mail.
What responsibilities do I have as an external expert in the early benefit assessment and the assessment of potential?
At the start of a project, the external experts receive a questionnaire containing about five questions. The answers should provide an overview of the medical context in which the drug or the intervention under assessment is to be used. Moreover, relevant aspects to be considered when assessing the drug or non-drug intervention should be identified at an early stage.
The responsibility for the assessment and its results lies solely with IQWiG.
The questions will usually concern the following topics:
- clinical picture and consequences of the disease
- treatment goals
- patients in the every-day German health care setting
- (drug and non-drug) treatment options
- treatment needs beyond the available treatment options
- current state of medical practice (in guidelines, if applicable)
These questions should be answered following the usual scientific approach and statements should be fully referenced. If further questions arise during the course of the project, IQWiG will consult the external experts as required. These consultations can include questions on the following topics, for example:
- operationalization of outcomes
- patient groups
- classification of side effects
- relevance of aspects of study design for every-day health care (e.g. patient population included) (early benefit assessment)
- relevance of the therapeutic regimens tested in the studies for medical practice (early benefit assessment)
A contract will be concluded with the external experts before the start of the collaboration.
What responsibilities do I have as an external expert in the production of health information?
In the production of health information, external experts have the task of performing a medical and professional review of the texts produced in the Department of Health Information. These are the main aspects to be reviewed:
- Are the facts described correct?
- Are the different aspects and symptoms of the disease appropriately weighted?
- Are the impact of the disease and possible impediments regarding daily life and the environment of the patient (partner, family, workplace, etc.) described appropriately?
- Are there sex- or age-specific differences regarding the disease (incidence, prevalence, prognosis, etc.) and are they sufficiently addressed in the text?
- Are effects and side effects of the treatments mentioned described appropriately?
- Can the health information be transferred to the German health care system? For example, are treatments mentioned that are not commonly used in Germany, or have important treatment options been omitted?
What does a questionnaire for the early benefit assessment of drugs or the assessment of the potential of non-drug interventions look like?
In order for you to obtain an idea about what the participation in an early benefit assessment or an assessment of potential specifically involves, the IQWiG website provides the following online sample questionnaires (in German):
Early benefit assessment of drugs (according to AMNOG): Questionnaire with general questions on the medical context for external experts (SAMPLE, German version)
Assessment of the potential of non-drug interventions (testing regulation according to VStG): Questionnaire with general questions on the medical context for external experts within the framework of the assessment of potential (SAMPLE, German version)
What is the process of participation in early benefit assessments and assessments of potential?
The G-BA's time frame for the early benefit assessment of drugs (AMNOG) and the assessment of the potential of examination and treatment methods (GKV-VStG) is very narrow. Hence the external experts have to answer the medical and scientific questions at very short notice.
Example of the time flow:
Day 0: Transmission of the documents to (up to five) interested persons.
Working day 5: Receipt by IQWiG of the forms on the conflicts of interest and other documents from the interested persons (declarations on interest and availability, draft contract, etc.).
Working day 7: The selection procedure at IQWiG is completed: The external experts receive the contract and the questionnaire. The remaining interested persons receive a letter of rejection.
Working day 12: Receipt by IQWiG of the filled-in questionnaire and of the signed contract from the external experts.
Optional: If, in exceptional cases, further questions arise during the course of the project, IQWiG will contact the external experts as required.
What information do I enter into the database of external experts?
Please enter the following information into your expert profile:
- university degree in medicine
- information on relevant professional experience, usually qualification as a medical specialist and clinical experience (also in several specialties)
- confirmation that you are able to conduct the consultation in German
- list of publications of scientific articles that have been published in relevant specialist journals
Please note that only the first 10 articles will be considered in the selection procedure. It is also necessary to precisely cite the articles; merely referring to databases (e.g. Pubmed) is insufficient. Please note that all authors should be named. In particular, your collaboration as (co-)author should be clear.
You can update your expert profile at any time or withdraw your permission for future use of your data by deleting the profile. The information you save in the database is confidential. You can find out more about this in our data protection regulations.
How can I become external expert in other assessments of IQWiG?
IQWiG also involves external experts in more extensive benefit assessments of drugs and non-drug interventions, in cost-benefit assessments and descriptions of the quality of health care (guidelines, DMPs). These external experts are not regularly chosen from the database of external experts, but are newly searched for each project. In an award procedure, IQWiG then either invites them directly to submit a quote or it publishes the announcement on its homepage.
What personal information is published in an assessment?
Generally, personal information or information on your assignment is only published if you have in fact collaborated in a project as an external expert.
The following information is published in our assessments (reports, dossier assessments, assessments of potential, rapid reports) to ensure transparency:
- names of the external experts who have collaborated in the respective project
- tasks carried out
- table summarizing the disclosure of conflicts of interest (without details)
Note: Assessments of potential are generally only published if the G-BA decides on a testing directive for the method and this becomes effective.
If you have collaborated in an IQWiG health information product, no personal information is published.
What does "conflict of interest" mean?
Professionally-independent assessments are an important principle in IQWiG's work, and in the decisions of the Federal Joint Committee (G-BA). External experts working for IQWiG are therefore obliged to disclose contacts (particularly with industry).
You can find more about this in our information on conflicts of interest.