The EU Regulation on Health Technology Assessment entered into force in January 2022, applicable for oncology and ATMP products as of 2025, orphan drugs by 2028, and to all drugs by 2030. Therefore, there is an urgent need for pharmaceutical and MedTech companies to rethink the way they have historically organised themselves internally and prepared for country specific HTA submissions. But how can you adapt in a timely manner? Our point of view is based on discussions with industry experts who underwent the Joint Action 3 on a voluntary basis, regular questions from the industry, our observations during external events, and our research on the HTA Regulation.

Will all industry players be impacted by this?

Yes. Global and regional teams need to introduce new activities and adapt their current ways of working,  while we anticipate a potential opportunity for synergies and reduction of duplication at local level.
Global and regional teams will face a need to address new strategic decisions as well as intensify cross-functional collaboration with local teams. Some activities will need to be executed earlier and capacity challenges will need to be addressed due to an increased workload at peak times. In addition, existing collaboration platforms and tools can be reconsidered to foster tighter collaboration as of the early development stages across functions and countries.

Are all countries going to be impacted in the same way?

Not really. By categorising countries into archetypes, we can identify the expected reaction of HTA bodies to the new HTA Regulation and anticipate the level of disruption and opportunities for process efficiency for pharmaceutical companies at affiliate level. In the EU, four archetypes were identified, ranging from countries with mature local HTA (safeguards and timesavers) to limited mature local HTA (discoverers and backbenchers). Additionally, countries beyond the EU (observers) which will not be impacted by the regulation can access the published JCA report and potentially refer to it or its content when going through HTA. Timesaver and discoverer countries are expected to benefit from higher potential to fasten the submission process with the HTA Regulation, even though this implies a higher level of disruption of local HTA dossier submission processes.

Are you ready from an organisational perspective?

Probably not. So far, most players we have engaged with have taken preliminary steps but none have wholeheartedly analysed the impact front to back and made adequate changes.

But concretely, what do you need to do? To clarify where you are in this journey, here is a snapshot of some of the key questions access leaders need to ask themselves to evaluate their organisational readiness:

• Are the global and regional access teams aware about the changes introduced by the new HTA Regulation?
• Have you already onboarded cross-functional teams, such as Medical Affairs, Regulatory, Clinical teams?
• Have you reviewed your pipeline and analysed which assets will be impacted first?
• Have you set the priorities in terms of critical actions you need to act upon now to be ready for your upcoming launches?
• Have you already aligned cross-functionally to define how to adapt your current ways of working in terms of activities and processes?
• Have you already defined the appropriate governance mechanisms and roles and responsibilities cross-functionally in order to successfully deliver JCA submissions?
• Do you have a change management plan in place to ensure a smooth internal transition?
• ...

Conclusion

The new HTA Regulation will introduce changes along the end-to-end asset development stages and impact all cross-functional teams. Many pre-launch preparation activities should already start now, such as introducing new strategic decisions, adapting the way teams collaborate cross-functionally and how local teams are being involved. However, not all countries will be impacted in the same way; it will depend on the level of disruption and opportunities for process efficiency. Keeping in mind that many uncertainties remain, plan ahead but stay agile to quickly change plans when needed and successfully adapt to the new HTA Regulation.