Assessments of potential
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 (7) Social Code Book 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 can then decide that the method applied for is tested within the framework of clinical studies.
This “testing regulation” includes the assessment of the potential of non-drug interventions, i.e. medical interventions that are not solely dependent on the use of drugs, on the basis of the application documents submitted. The assessment of potential comprises both the potential of the testing and that of the method. It is usually conducted by IQWiG after commissioning by the .
Similar to the early benefit assessment of drugs, the time period to conduct the assessment is stipulated by law: The has to decide about the potential of an examination or treatment method within three months after receipt of the application. The assessment of potential is carried out in this period, and hence has to be completed within a few weeks.
If the , on the basis of the documents submitted and of the assessment of potential conducted by IQWiG, decides that a method has potential, IQWiG is generally commissioned to conduct a further literature search. This is done to ensure that all relevant studies are considered. IQWiG conducts this search in the form of an Addendum.
Assessments of potential and addenda on assessments of potential are part of an administrative procedure conducted by the . Their results are confidential until the ’s decision on the testing directive for a method has become officially effective. Only then will the assessments of potential be published on the IQWiG website. If the determines no potential of a method, the procedure remains confidential – and the assessment of potential is not published.
Production of assessments of potential (simplified):
- Transfer of the applicant’s documents by the : An assessment of potential starts with the transfer of the application documents to IQWiG.
- Scientific assessment of the potential: On receipt of the documents at IQWiG, the Institute will start with the assessment of the content of the application documents. Medical experts may be consulted to consider current every-day health care. The process ends with the production of the assessment of potential.
- Optional: The can commission IQWiG to conduct an updated literature search to ensure that all relevant studies are considered. This search is conducted in the form of an addendum.