Overcoming the HTA Hurdle in Germany: Key Considerations for a Manufacturer’s Pricing and Market Access Strategy

In 2011, we saw the introduction of an evidence-based pricing approach to new branded pharmaceuticals in Germany. The process arose from the Act of the Reform of the Market for Medicinal Products (AMNOG) and all new drugs must undergo clinical benefit assessment by the Federal Joint Committee (GBA) followed by price negotiation with the German sick fund (GKV-SV) heads depending on whether additional benefit has been demonstrated. A review of the final GBA assessments published to date was undertaken and the aim was to evaluate the implications for manufacturers considering Germany as a launch country. The GBA and IQWIG websites were searched for AMNOG evaluations performed between January 2011 to May 2013. Where appropriate the approach taken in the GBA assessment was compared with that of other HTA groups in Europe. The most important consideration for a manufacturer is choosing the right comparator in their submission, the core evidence document in this process. A number of drugs have been compared to the wrong treatment and subsequently were found to have no additional benefit. Some submissions chose the appropriate comparator but only for certain subgroups, leading to a reduced overall benefit for the new drug. Like most HTA groups, the preference is for mortality, morbidity and side effects evidence from head-to-head trials, however GBA appear to give little consideration to quality of life evidence. The review also revealed that GBA make decisions that are independent of other HTA bodies and sometimes reject recommendations of its own evidence review group, IQWIG. Early engagement with GBA to agree an appropriate comparator, patient population and clinical outcome measures is very important to improve chances of a positive assessment. However, the requirements of the GBA process should be balanced with those of other key markets as part of the drug’s global PRA strategy.