Harmonisation health technology assessments, a slow roll in right direction

New regulations have marked a significant shift in how health technology assessments are conducted across the EU, but its effects will not be felt overnight. As implementation rolls out in stages national agencies must navigate local challenges. 

Euractiv discussed the changes, challenges, and effects the regulation’s applicability brings with several HTA agencies within the framework.

Since the EU’s Health Technology Assessment (HTA) regulation took effect on 12 January, the objective has been to introduce a unified framework for evaluating medicines and medical devices across member states.

The new rules aim to streamline clinical assessments, reduce duplication, and speed up decision-making on pricing and reimbursement.

Initially applying to new cancer medicines and advanced therapy medicinal products, the regulation will incrementally expand to orphan medicines in 2028, and all new medicines by 2030, with high-risk medical devices, included from 2026.

“Overall, we view these changes as a step in the right direction. Harmonising health technology assessment methodologies across Europe will enhance the efficiency and credibility of medicine and health technology evaluations,” the National Agency for Medicines and Medical Devices of Romania (ANMDMR) told Euractiv.

The Commission has opened the first request submission period for joint scientific consultations (JSCs) under the new regulation, running until 3 March.

These consultations allow health technology developers to engage with regulatory authorities on product development plans and receive guidance on the data and evidence needed for joint clinical assessments (JCAs).

Gradual tweaks, no drastic shifts

According to ANMDMR, implementing joint clinical assessments and joint scientific consultations in Romania remains a work in progress. Integrating European-level evaluations is expected to enhance consistency and transparency within the national assessment framework.

“By integrating JCAs, we aim to benefit from more robust clinical evidence and comparative analyses, reducing duplicated efforts at the national level. Additionally, JSCs will facilitate early dialogue with developers, leading to better-prepared submissions and more predictable decision-making processes,” an ANMDMR spokesperson explained.

“The upcoming changes should bring better possibilities for small countries,” the State Medicines Control Agency under the Ministry of Health of the Republic of Lithuania (VVKT) shared with Euractiv.

Too early to tell

There is a broad consensus among the national HTA agencies that it is premature to comprehensively and conclusively evaluate the new legislation.

“The new HTA regulation cannot yet be fully assessed, as its implementation will take place gradually. The key factor will be how successfully the methodologies and tools—many of which were only issued at the end of last year—are put into practice,” said David Kolář, the Executive Director of the Czech Association of Innovative Pharmaceutical Industry (AIFP).

The Lithuanian agency revealed that there are currently no changes in the HTA process, and they remain focused on national assessments, awaiting upcoming joint clinical assessments.

While the HTA regulation is in place, “No drug has been assessed so far,” the Austrian Institute for Health Technology Assessment confirmed.

How the reimbursement and time to reimbursement at the country level are affected will be seen after the joint assessments and consultation are fully up and running. 

It will not be without its challenges

Despite welcoming the legislation, countries identify the challenges they will face during the proper implementation.

“These changes present new challenges. A key aspect will be integrating European-level assessments into our existing regulatory framework while maintaining flexibility for national-specific considerations, such as budget impact and local epidemiological factors,” said ANMDMR.

ANMDMR’s representative highlighted that adapting internal processes to meet new timelines and requirements demands additional resources and expertise.

The Lithuanian VVKT shared the concern that the challenges related to joint clinical assessment connect to the shortage of experienced HTA assessors and, hence, a lack of capacity.

VVKT also underlines that it is difficult to predict the real benefit in terms of increasing access to new medicines in small markets, as the sizes of national health budgets are different across the EU member states.

Kolář remarked that from a Czech perspective: “The question arises whether the State Institute for Drug Control (SÚKL) has sufficient capacity to handle the new responsibilities. There are concerns that, given the current staffing levels, the new tasks could slow down existing processes and decision-making.”

“Strengthening SÚKL’s capacity will therefore be crucial for the smooth implementation of the regulation,” Kolář added.

Overall, a well-received change

The European Medicine Agency only plays an auxiliary role in this process. Nevertheless, “EMA welcomes the new HTA regulation and is ready to do what it takes to support the European Commission and the member states in its successful implementation”, said Emer Cooke, EMA’s Executive Director.

Despite its challenges, the national HTA agencies widely endorse and approve the regulation.

“Member States of the Beneluxa Initiative have played key roles in supporting its introduction. The Initiative will work to incorporate the joint assessments into joint work on pricing and reimbursement,” the Beneluxa Initiative, a pharmaceutical policy initiative uniting Belgium, the Netherlands, Luxembourg, Austria, and Ireland, told Euractiv.

AIFP Director Kolář is hopeful and believes that the regulation will fulfil its original purpose “to prevent duplication in the so-called clinical assessment process, during which existing data from clinical trials, literature, meta-analyses, and other sources are evaluated, while also ensuring more efficient processes.”

[Edited by Vasiliki Angouridi, Brian Maguire]