The Implementing Act on JCA is still pending – What to do next Monday?

While uncertainty brings ambiguity regarding the mandatory activities for preparing an excellent JCA Dossier, the time for starting the process is now! The EUnetHTA21 template (Deliverable 5.1) and the German AMNOG dossier template are your best friends. Sections relevant for your product’s value story like the burden of the disease and the available therapeutic options as well as e.g., sections on evidence generation methodology based on validated PICO (Population, Intervention, Comparison, Outcome) hypotheses can already be thought through. SKC’s experienced Medical Writers can guide you through the intricacies of each section. Based on our comprehensive and successful track record of writing AMNOG dossiers (the blueprint for the JCA dossier), we ensure that your submission aligns with all formal, methodological, and strategical requirements. Don’t wait - put pen to paper (or fingers to keyboard) today.

Providing the right evidence is key for the successful outcome of any JCA and in that regard PICOs take the center stage in the process. Since time for dossier compilation after having received the final PICO scope is sparse, early assessment of the relevant European PICO schemes is of utmost value. Manufacturers can prepare themselves by understanding the nuances of each “letter”, by developing scenarios for the final scope, and by initiating activities and adaptations regarding the evidence strategy. SKC’s deep understanding of the EU HTA landscape and the fundamental guidance of the German AMNOG process, combined with a reliable and proven network to clinical experts and authorities helps you to develop a robust case for your drug. It is all about understanding and mitigating the risk.

Writing a JCA dossier can seem daunting, especially given the current combination of immense workload and tight timelines. Automation tools can streamline the process, ensuring consistency and accuracy from preparatory dossier work like performing SLRs to text generation for e.g., data table description and quality checking the final document. SKC’s cutting-edge JCA90 engine provides numerous valuable instruments to increase efficiency - helping you to make the most of the valuable preparation time and making even last minute PICO changes easily manageable.

Becoming an EU HTA expert requires more than just reading guidance documents. As interdependencies are increasing and role-related requirements are changing, a prepared and enabled team is crucial for tackling the upcoming challenges. The need for preparation is highly individual and based on the currently employed staff, the existing knowledge, and the strategic outline of the planned transformation process. SKC offers tailored programs to best prepare your team for the upcoming changes. From understanding and challenging the implications for the European launch sequence to mastering evidence generation, our individual workshops and preparation concepts combine basic theory, strategic outlooks, interactive exercises and specific deep dives to equip your staff with the knowledge they need to excel in the JCA landscape. Invest in your team’s growth now.

The EU HTA and JCA process demands organizational agility, adequate allocation of resources, effective communication routines and a high plasticity of the organizational structure. It’s pan-European nature results in completely new tasks, changes in responsibilities and additional workstreams that make restructuring and transformation of the organization itself inevitable. As especially in the first years of the legislation unexpected developments can unfold during all stages, a high degree of agility is crucial. Organizations need to understand, which adaptations of their current structures and processes are necessary to enable a smooth, formally complete and strategically successful JCA delivery. SKC has a long-lasting history in supporting our clients in comprehensive transformation and restructuring processes, which we combine with our expert knowledge in Market Access and HTA strategy. When the JCA countdown runs out, your organization will deliver.

Uncertainties are still high and despite the little time that is left, there are many activities that pharmaceutical companies can and should start right now. For SKC, navigating such new and challenging conditions together with our clients is our daily business. We have successfully supported our clients through numerous uncertain situations, including the initialization of the AMNOG in Germany. Please do not hesitate to get in touch with us. We are the market access special forces.

Sources:

• EUnetHTA 21 Deliverable D5.1
• G-BA Modulvorlagen
• Regulation (EU) 2021/2282 of the European Parliament and of the Council