The HTA Revolution Will Not Be Televised: A Quiet Regime Change in European Market Access 

Amid frantic discussion about potential EU-U.S. tariffs in the pharmaceutical sector, a potentially revolutionary reform for patient access to novel therapies in Europe is passing almost unnoticed in public debate. The EU Health Technology Assessment (HTA) Regulation came into effect in January 2025, and the first two therapies to undergo Joint Clinical Assessment (JCA) were announced in April. These reforms come amid pressure on health budgets and the accompanying trend towards stricter value assessment of innovative medicines. Combined with cost-containment measures in many European countries, and downward pressure on U.S. pricing, medicine developers have a myriad of challenges to respond to.  

The JCA, in particular, will radically change the way pharmaceutical companies plan their launches. Member States will start deciding what evidence they want to see as soon as a marketing authorisation application is submitted, and the final JCA will be available within 30 days of the authorisation decision. This timeline requires the developer to carefully manage stakeholder engagement and health economic modelling decisions. Additionally, advocacy considerations and policy issues will need to be integrated throughout the process to prepare for these accelerated timelines, with a cross-functional team structure involving of local and global public affairs, patient engagement, market access and medical affairs staff.  

Asset-specific Challenges

Failure to address public affairs and government affairs early on could put pharmaceutical companies at a disadvantage when the JCA starts, due to tight regulations on conflict of interest. Recruiting health care professionals and/or patient advocates to take part in an ad board, for example, may exclude their input from the EU HTA process due to perceived connections to the developer. This risk is particularly acute for the rare disease community, given the inherently limited number of experts in low-prevalence conditions.  

Smaller and medium enterprises will find this particularly difficult. It is far from the only challenge they face, and they do not have the same capacity to adapt to demand for data on a wider range of populations, interventions, comparators and outcomes (PICOs) stemming from consolidation of Member States’ preferences under the JCA. The choice facing them, therefore, may be whether to invest scarce resources in further evidence generation or to accept reduced revenues through lower-than-anticipated pricing, narrower indications or limited uptake by physicians. 

As if that was not enough, traditional assumptions about launch sequence planning may not hold once the EU JCA is fully up and running—presenting additional strategic questions for developers. As more resource-constrained EU Member States may benefit from the EU JCA process to accelerate their own reimbursement procedures relative to larger countries, the reference pricing landscape can easily become more complicated.  

National Decisions

If we look beyond these context-specific decisions that are likely to affect individual assets, one big question is whether we will see a trend in the coming years of European HTA systems moving towards a narrow definition (akin to the German Federal Joint Committee (G-BA) system) of additional benefit provided over the current standard of care. 

Germany’s leading role in the EU HTA legislative process has also arguably resulted in the potential for dissemination of its HTA methods to other European markets, although Member States have reserved the right to ask for additional information at national level as a safeguard. As such, EU Member States may not have a consistent answer to the question of how they plan to use JCA reports, instead taking a case-by-case approach—engendering further confusion for developers. Member States still control pricing and reimbursement, and there is no guarantee they will simply accept the JCA report alone.  

Overall, the risk that payers request more information on the national level is a crucial aspect of the procedure. As long as willingness and ability to pay remain national, the impact of the JCA may turn out to be limited. However, at the very least the JCAs could help EU Member States anticipate their needs earlier and therefore also influence national health system planning for highly innovative technologies.  

The only certainty is that the EU HTA reforms are, at least in part, motivated by financial considerations. Even prior to recent geopolitical turmoil, countries were seeking to tighten their belts on medicine expenditure. As defence and security spending increases, the political motivation to improve access to medicines at reduced cost will only intensify over time—making timely attention to public affairs and market access even more important.