Frequently asked questions (FAQs): external experts

You register in the database if you wish to contribute your expertise to the following areas of work at IQWiG:

• dossier assessments of drugs (acc. to AMNOG, §35a SGB V),
• assessments of the potential of non-drug interventions (testing regulation acc. to §137e SGB V),
• assessments of examination and treatment methods using high-risk medical devices (acc. to §137h SGB V)
• production of easily-understandable health information

Due to the short processing time for dossier assessments, §137h assessments and assessments of potential, we often search for experts for special questions at very short notice. Therefore, we need a pool of experts that is as large and versatile as possible. By entering your data into the expert database, you can supplement this pool with your expertise.

No. With your entry in IQWiG's expert database, you have indicated your interest in certain areas of work and provided us with your profile.

IQWiG commissions experts through tendering procedures. If we need special expertise for dossier assessments, §137h assessments, assessments of potential or health information, we use the expert database as a pool for the award of a commission.

As the award of a commission depends on our current commissions, we cannot predict when you may be contacted by us.

For more information on the selection procedure, please see the answer to the question: "How are experts selected from the database? “

35a of the German Social Code, Book V (SGB V) was created by the Act on the Reorganization of the Pharmaceutical Market (AMNOG). It stipulates that a new drug that is launched on the market in Germany is in principle subject to an early benefit assessment. To this end, manufacturers must submit a dossier at the time of market entry, on the basis of which the added benefit of the new drug versus standard treatment, the number of patients who are eligible for treatment with the drug of interest, and the associated costs are assessed.

The Federal Joint Committee (G-BA), which usually commissions IQWiG to carry out the scientific assessment of the dossier, manages the associated procedure of early benefit assessment. This dossier assessment at IQWiG must be completed within three months of receipt of the manufacturer's dossier.

Orphan drugs are a special case. These are drugs approved to treat a rare disease under Regulation (EC) No 141/2000 of 16 December 1999 on orphan drugs by the European Parliament and Commission (OJ L 18, 22.1.2000, p. 1). For these drugs, the added medical benefit is deemed to be demonstrated by the marketing authorization. In the case of orphan drugs, IQWiG therefore only evaluates the number of patients eligible for treatment with the drug of interest and the associated costs. This procedure applies to all orphan drugs below the 30 million euro turnover threshold. More information is available on the G-BA website. We also involve experts in dossier assessments of orphan drugs.

The assessment of the potential of examination and treatment methods applies to non-drug interventions, that is, medical interventions used without drugs or in combination with drugs. These include medical devices.

The testing regulation, which was introduced with the Statutory Health Insurance (SHI) – Health Care Structure Act, provides the option to apply for the testing of a new examination or treatment method according to §137e SGB V within the framework of a clinical study. Manufacturers or providers of a medical device used in a new examination or treatment method can submit such applications. The Federal Joint Committee (G-BA) then decides on whether to test the method applied for within the framework of clinical studies.

This requires the applicant (manufacturer or provider) to provide documentation demonstrating the potential of the method in question. These documents will be scientifically evaluated as part of the procedure. The G-BA can commission IQWiG with this assessment of potential, which must be prepared within a short time: The G-BA must take a decision on the existence of potential within three months of receiving the application documents. Assessments of potential are part of an administrative procedure conducted by the G-BA; the topics and contents are confidential.

More information is available on the G-BA website.

The SHI Act to Promote Health Care (GKV-VSG) stipulates that certain examination and treatment methods using medical devices that are performed in hospitals are subject to an assessment by the G-BA. This applies to those medical device methods to which the following conditions apply: a hospital submits an enquiry according to §6 (2) of the Hospital Fee Act ("NUB enquiry*") for the first time, the method is mainly based on a high-risk medical device, and the method has a new theoretical-scientific concept.

The G-BA conducts its assessment based on documents submitted by hospitals and, where appropriate, by the manufacturers of medical devices concerned. On the basis of these documents, the G-BA must decide within three months whether the method shows (or does not show) benefit or harm. To do this, it can commission IQWiG to conduct the scientific assessment of the documents, which must be prepared within a short period of time due to the legally prescribed deadlines.

More information is available on the G-BA website (german Version).

The selection procedure for dossier assessments, assessments of potential, and §137h assessments includes the following steps:

1. IQWiG searches in the expert database for interested experts who have indicated the relevant subject area as their area of interest.
2. The most suitable then receive a request from IQWiG by e-mail. For information on how to proceed, see >> Question 10.
3. In the further procedure, the following criteria are used for selection, depending on the type of commission:
   • degree in medicine, specialist (physician) qualification, additional continuing education, specialization (according to the continuing education and training regulations of the German Medical Association)
   • clinical work experience, qualifications
   • scientific publications
   • provision of German-language advice

Health information:

The selection procedure for health information includes the following steps:

1. IQWiG searches the expert database for interested experts who have indicated the respective subject area as their area of interest.
2. From the interested experts, those experts are selected who have a degree in medicine or nursing science or who are trained health care professionals (midwife, physiotherapist, etc.), several years of practical clinical experience (specialist medical qualification) or several years of other relevant professional experience.
3. The most suitable candidate is selected based on the length of clinical/professional experience.
4. This person will then receive a request from IQWiG by e-mail. For information on further progress, see >> Question 10.

At the beginning of a project, experts will receive a questionnaire with about five questions. The answers should give an overview of the medical context in which the drug of interest will be used. A further aim is to identify relevant issues to be taken into account in the assessment at an early stage.

Feedback from the experts are taken into account in the assessment. The responsibility for the assessment and for the assessment result lies exclusively with IQWiG.

The questions usually relate to the following topics:

• disease and consequences of disease
• treatment goals
• patients in German clinical practice
• treatment options (drug and non-drug)
• need for treatment beyond the existing treatment options
• state of current clinical practice (e.g. as described in clinical practice guidelines)

These questions should be answered in the usual scientific manner; statements should be supported by references to sources. If further questions arise in the further course of the project, IQWiG consults the experts as necessary. These could be questions on the following topics, for example:

• operationalization of outcomes
• patient groups (e.g. data on incidence and prevalence)
• evaluation of adverse effects
• relevance of aspects of the study design for clinical practice (e.g. patient population)
• relevance of the treatment regimen investigated in the studies for clinical practice
• specific cost aspects

A contract is concluded with the experts before the start of the collaboration.

The type of involvement is to be understood in the sense of an advisory function, with regard to medical-scientific questions. Due to the tight time frames of the assessments according to §137h SGB V and the assessments of potential, questions sometimes need to be answered within short deadlines (e.g. within 2 days). Questions are asked by the responsible project manager by telephone or e-mail and usually relate to the following topics:

• method to be assessed
• medical context
• comparator intervention
• key points and feasibility of a possible testing study
• presentation of clinical aspects in the IQWiG report

Feedback from the experts is taken into account in the assessment. The responsibility for the assessment according to §137h SGB V or for the assessment of potential, as well as for the respective assessment result lies exclusively with IQWiG.

A contract is concluded with the experts before the start of the collaboration. The contract period ends with the G-BA‘s assessment decision. This results in a contract period of up to 18 weeks for assessments according to §137h, and of about 20 weeks for assessments of potential.

The task of the experts in the production of health information is the medical-scientific assessment of the texts prepared by the Health Information Department. The following points in particular should be evaluated:

1. Is the information presented correct?
2. Are the various aspects and symptoms of the disease adequately weighted?
3. Are the impact of the disease and possible restrictions in relation to daily life and the patient`s environment (partner, relatives, workplace, etc.) accurately described?
4. Are there any gender or age-specific differences with regard to the disease (incidence, prevalence, prognosis, etc.) and are they sufficiently addressed in the text?
5. Are the effects and adverse effects of the treatments of interest adequately presented?
6. Can the health information be applied to the German health care system? For example, are treatments mentioned that are not common in Germany, or are important treatment options missing?

A contract is concluded with the experts before the start of the collaboration.

To give an idea of what involvement in a dossier assessment looks like in practice, the following sample questionnaire is available online on the IQWiG website:

Questionnaire with general questions on the medical context for external experts (SAMPLE; german version)

The time frame of the G-BA for dossier assessments (AMNOG) is very tight. Therefore, the external expert must also answer the medical/scientific questions at very short notice.

Example of the schedule:

• Day 0: Sending of the documents to (up to five) interested parties.
• Working day 5: Receipt by IQWiG of the forms for disclosing relationships and other documents from interested parties (declarations on interest and availability, further publications by the external experts on the topic, etc.).
• Working day 7: The selection procedure at IQWiG is completed: The selected expert receives the contract signed by IQWiG and the questionnaire. The other interested experts receive a rejection.
  n
• Working day 12: Receipt of the completed questionnaire and signed contract by IQWiG

If, in exceptional cases, further questions arise in the course of the project, IQWiG will then consult the experts as necessary. The project period is 12 to 14 weeks. The expert must be available for questions during this period.

Please enter the following information in your expert profile:

• your contact data
• degree in medicine/dentistry or nursing or training in another health care profession
• information on relevant work experience – for physicians, usually specialist (physician) qualification, if appropriate, additional continuing education as well as specific training according to the continuing education and training regulations of the German Medical Association, clinical experience (one or more specialist areas) and current position as well as any other relevant qualifications
• confirmation that advice can be provided in German
• publication list with scientific articles published in relevant scientific journals
  
  Please note that only the first 10 articles will be considered in the selection process. In addition, the articles must be clearly named; a reference only to databases (e.g. PubMed) is not sufficient. Please also note that all authors should be named. In particular, your collaboration as a (co-)author should be clearly visible.
• specialist areas where you would like to work as an external expert
  Register in the expert database now

You can update your expert profile at any time or object to further use of the data in the future by deleting the profile. Please make sure that both your contact details and the information on your professional qualifications are up to date. This is the only way we can consider you in the selection process of a project.

The information you enter in the database is confidential. You can find more information in our Data protection declaration.

IQWiG also involves external experts in the writing of texts and the review of benefit assessments of drugs and non-drug interventions, in the definition of standards of care for guideline synopses, and in the production of HTA reports within the framework of “ThemenCheck Medizin”. These experts are not regularly selected from the expert database, but are searched anew for each project and either specifically requested to submit a bid within the framework of a tendering procedure or made aware of this possibility by means of an announcement on the IQWiG homepage.

You can use the IQWiG info service (only in german) to receive information on new calls for tender by e-mail.

Information about you or your task will only be published if you have actually worked on a project as an expert.

In our assessments (reports, dossier assessments, assessments of potential, rapid reports, HTA reports within the framework of the ThemenCheck Medizin), the following information is published for reasons of transparency:

• name and, if applicable, affiliation of experts involved in a project
• information provided
• tabularized summary of disclosure of relationships (without details)

Note: assessments of potential are only published in the following cases:

• if the G-BA decides on a testing regulation for the method and this regulation becomes effective,
• if the G-BA suspends consultations on a testing regulation because of studies already in progress, or
• if it initiates a Procedure for the Assessment of Methods for the method.

If you have contributed to IQWiG’s health information, no personal information will be published.

Independently produced assessments are an important basis of IQWiG's work and for the decisions of the G-BA. Experts who work for IQWiG are therefore obliged to disclose relationships, especially with industry (see §139b (3) sentence 2 of SGB V).

You can find more details in our information on disclosing relationships.