On March 15 2018, the Federal Joint Committee (G-BA) reviewed and updated its benefit submission dossier template, subject to pending approval by the Federal Ministry of Health.
The new dossier template will be compulsory from January 2019 onwards. Until then, the old template (as of April 2013) or the new template may be used.
The main changes to the dossier are in Appendix II, a brief summary of which is:
- Though differentiation to the mode of action of other drugs is no longer required, the cost of the drug must be presented even if the drug is distributed via a pharmacy-independent channel
- Compulsory searches for study results must be performed from the AMIS, EMA and G-BA databases
- Time-to-event analyses (or a similar mechanism) must be performed for every endpoint. This includes specific adverse events, the presentation for which has been amended to now include mandatory System Organ Class (SOC) and Preferred Time (PT). Endpoints assessed with scales must be analysed and must include the complete study duration
- All individual patient data must be presented completely and not be amended in any way (e.g. blackened out)
Until 16 March, drugs that were used exclusively in hospital, or that are applied within the outpatient setting where sales do not exceed a total of one million euros, could be exempted from the benefit assessment. Since then, regardless of whether or not the drugs are used primarily in hospital or outpatient settings, companies will still have to prove that total sales of the drug does not exceed one million euros.