The EU introduces changes to the assessment of medicines: EU HTA application in evaluations will gradually start next year   

Many aspects of assessing medicines are changing from the direction of the European Union (EU) and nationally; the current year is crucial in advancing these changes. This  view became clear when Jarmo Hahl, a leading consultant at Medaffcon, interviewed Kalle Aaltonen, a Senior Specialist at the Pharmaceuticals Pricing Board (Hila), and Tuomas Oravilahti, a Chief Specialist at the Finnish Medicines Agency (Fimea).  

Pan-European clinical assessments of medicines (EU HTA, Health Technology Assessment) will gradually come into force in 2025. According to Kalle Aaltonen, the experiences of implementation in 2025 will determine the direction of developments from the perspective of Finnish authorities.  

EU HTA (Health Technology Assessment) will bring changes, but their direction is still unclear  

“We will learn from the experiences once things get underway. It is difficult to say beforehand which direction the change will ultimately go,” Aaltonen says.  

According to Aaltonen, the preparatory work for these changes makes this year particularly busy.  

“We are in a hurry to get all structures ready and approved. Key regulations are still pending approval. Representatives from all member states participate in the work,” Aaltonen says.  

Fimea is responsible for hospital medicines. According to Oravilahti, changes are also visible in these medicines.  

“In the previous straightforward world, the process went from marketing authorisation to HTA and then to procurement. This is changing so that the stages overlap,” Oravilahti notes.  

Oravilahti is also a representative of the FINOSE project from Finland. FINOSE is a project initiated by the Nordic HTA  (Health Technology Assessment) authorities, including Finland’s Fimea, Sweden’s TLV, and Norway’s NOMAn, aimed at increasing and developing cooperation in HTA evaluations and speeding up the availability of new medicines for patients. The cooperation projects cover relative effectiveness assessments and economic impact assessments. 

Each EU member state submits PICO criteria for new products to improve the HTA process  

Hahl, Aaltonen, and Oravilahti discussed PICO criteria (Patient, Intervention, Comparator, Outcomes). Each member state is expected to deliver PICO criteria for new products during the process, possibly grouped into subgroups.   

According to Aaltonen, the number of PICOs is intended to be reduced to a reasonable level. Mechanisms for reduction are to be found before 2025.  

   

In the EU, the HTA Directive has also made the concept of JCA (Joint Clinical Assessment) relevant.  It aims to harmonise the assessment methods for medicines and other health technologies among member states.  

JCA aims to provide a joint assessment report on the clinical efficacy and safety of a medicine or treatment method, which different countries can utilise in their national decision-making processes.  

This procedure is designed to promote transparency, objectivity, and uniformity in assessing medicines, which may help speed up the availability of new, effective, and safe treatments across the EU. A joint clinical assessment can reduce overlapping work and enhance the use of resources in health care.  

JCA is hoped to provide assistance for the national assessment  

According to Aaltonen, JCA does not bind the national HTA authority.  

“The hope is that it could be helpful in assessment. However, it is not yet known how practical operations will take shape. The amount of work involved will determine the intensity of participation,” says Kalle Aaltonen, a Senior Specialist at the Pharmaceuticals Pricing Board (Hila).  

According to Oravilahti, the impact of JCA reports on workload is minimal.  

“It certainly does not reduce the workload, which is already considerable. Half of my working hours are spent on various committees. Running the system takes time and resources,” notes Tuomas Oravilahti, a Chief Specialist at the Finnish Medicines Agency (Fimea).  

Oravilahti also mentions that JCA does not render FINOSE unnecessary, as FINOSE also conducts economic assessments. FINOSE utilises JCA.