The commenting procedure (hearings)
All interested persons, institutions or commercial companies can submit comments on interim steps of IQWiG reports: on the planned methods (report plan) and on interim results (preliminary report), for example, to indicate additional important studies or arguments.
Commenting procedures are also conducted for early benefit assessments of drugs pursuant to AMNOG (dossier assessments), for assessments of the potential of non-drug interventions, and for the assessment according to §137h SGB V. However, these are not conducted by IQWiG, but by the Federal Joint Committee (G-BA). The G-BA’s website provides information on the commenting procedures for early benefit assessments of drugs, for assessments of the potential and testing of non-drug interventions, and for assessments according to §137h (German Version).
Comments submitted to IQWiG must conform to certain formal requirements in order to be considered.
Summary of the most important requirements:
- Deadlines: The deadline for comments is at least 4 weeks after publication of the report plan or preliminary report. The exact deadlines are published on the relevant project webpages of the reports. In addition, current commenting procedures are listed in an overview.
- Submission of comments: comments must be submitted in writing. In order to meet the deadline, the punctual receipt of the comment per e-mail by the Institute is sufficient. If a comment is sent by e-mail in advance, then the form for submission of written comments must be submitted in its original version within 5 working days after the deadline. After receipt of the comment by e-mail or post the Institute will confirm this.
- Debate: If questions arise in the written comments, the Institute can optionally hold an oral debate. Only those persons are allowed to participate who submitted a written comment and disclosed potential conflicts of interest prior to the debate.
The detailed requirements are outlined in the relevant guidelines for comments. These are published together with all other required documents for submission of comments on the webpages of the relevant projects.