EU HTA: European Health Technology Assessment (JCA)

In our Fit for EU HTA mastery workshop, we jointly analyze and discuss the general requirements and success factors of the new process and, based on this, collectively evaluate the specific strategic implications, for example for your portfolio and corporate structure. The workshop also includes an active self-assessment and a specific evaluation for the respective functions in the company. This approach has proven its worth in creating the necessary awareness as well as initiating sustainable tactical measures as part of the overall European orientation.

PICO schemes (P=Population, I=Intervention, C=Comparator, O=Outcome) define the scientific questions of clinical evaluation that need to be answered with the help of statistical analyses of study data in the JCA dossier. There can be fundamental differences between the member states in this respect. Depending on the indication to be assessed, there may be substantial differences in the standard of care within the EU, which means that the pharmaceutical company must provide several and possibly numerous PICOs with its study data. However, the requested PICO schemes are only made known to the pharmaceutical company 100 days before the JCA dossier is submitted (as of Feb 2024).  

Due to the short timeframe for preparing the European dossier, a key success factor is defining valid hypotheses for the final PICOs requested and strategically evaluating these for their respective implications, for example for national price negotiations. In a gap analysis, the evidence package is formally and strategically analyzed with regard to the expected requirements and appropriate options for closing the gaps are derived. In this way, effort and benefit can be optimally balanced, for example with regard to the generation of further evidence. 

Once potential risks, opportunities and fields of action have been identified for specific products and clients, the next step is to address these fields of action in the form of developing and implementing an EU HTA strategy. This strategy incorporates the national price negotiations of the individual member states right from the start. We always start with the goal in mind: how can we successfully achieve the desired level of reimbursement while making the medicine available to as many patients as possible.  

Together with our clients, we develop a roadmap in a strategy workshop for the implementation of concrete steps within the identified fields of action to improve the chances of success before and during EU HTA. We provide both strategic support in the creation of scenarios and operational support in the actual implementation of tactical measures. We accompany you through the EU HTA process as an approachable and reliable partner at eye level. 

The European dossier requires the collation of large volumes of data within tight timeframes. This poses not only methodological but also technical challenges that need to be solved. SKC has developed a modular and AI-supported process ("JCA100") to meet the special requirements of creating the JCA dossier in 100 days. This innovative approach is based on the statistical calculation of PICO datasets, their orchestration and semi-automated textualization in accordance with the qualitative requirements of the JCA. 

With its experience from numerous AMNOG dossier projects, SKC is the ideal partner for the implementation of the European dossier. Based on our extensive experience in dealing with the methodological requirements of the German authorities, which are high by international standards, we create an evidence presentation that meets the requirement criteria in conjunction with a value story tailored to the product.

The JCA dossier contains all necessary information for a European clinical assessment. At national level, additional or specific requirements often apply, for example with regard to the costs of the comparator therapies or the cost-effectiveness of the new therapy. These aspects will also be provided in a national dossier. As the interface between the European and national pricing strategy and as a decisive opportunity to anchor the national value story, the "delta" dossier is of considerable tactical importance. We support our clients both in providing advice and in preparing the necessary documents

To achieve the optimal strategic alignment for national benefit assessment and price negotiation, the strategy needs to be thought beyond the JCA. The joint clinical assessment based on multiple PICO schemes can create risks and opportunities that the pharmaceutical company should strategically consider for successful national HTA procedures. We analyze the implications of the JCA report for national assessment procedures and subsequent price negotiations for optimal preparation. Having provided strategic or operational support or managed more than 80 price negotiations in Germany, we know that early strategy development is crucial for the basis of national price negotiations and thus for successful market access.