As the EU’s push to harmonise clinical assessments across its 27 member states moves from the initial Health Technology Assessment (HTA) regulation in 2022 to the European Joint Clinical Assessment (JCA) process that will come into effect in January, European HTA authorities and industry leaders weigh in on the implications.
Harmonising HTA
With the aim of increasing efficiency and improving patient access, the EU set out to coordinate clinical assessments of medicines across its member states with new legislation on Joint Clinical Assessments (JCA). The new JCA, which looks to reduce the duplications arising from parallel evaluations of clinical data conducted by multiple country-specific HTA bodies, is due to come into effect for oncology products and advanced therapy medicinal products (ATMPs) in January, 2025, followed by orphan products in 2028 and all medicinal products in 2030.
“The European regulation offers a positive step towards standardizing scientific review processes across member states, while ensuring each country maintains autonomy over reimbursement decisions based on its own evaluation criteria,” says Lionel Collet, president of France’s HTA body, Haute Autorité de Santé (HAS).
“We welcome the Regulation on HTA which aims to provide a transparent and inclusive framework for quality HTA across the Union, to reduce duplication for national HTA authorities and industry and to facilitate business predictability and ultimately, to accelerate access of medicines to EU patients,” the industry group the European Federation of Pharmaceutical Industries and Associations’ (EFPIA) affirms in a statement.
However, concerns about the implementation of the new JCAs do remain for both HTA bodies and the pharma industry. “While the JCA has the potential to significantly improve the drug assessment process in the EU, its success in practice will depend on effective implementation, sufficient resourcing, and flexibility to accommodate diverse local needs and preferences,” contends the director of Strategic Planning Global Value Demonstration, Market Access & Pricing at Merck, Nikola Vesic.
Maintaining Autonomy
The results of the new JCAs will not be binding and the ability to make pricing and reimbursement decisions will remain under the sovereignty of each of the EU’s member states. “The overarching goal [of the new EU JCAs] is to foster a unified vision of health technology assessment across Europe, recognizing that health challenges transcend national borders,” Collet asserts. Nevertheless, the French regulator highlights the importance of preserving each country’s autonomy. “While advocating for a Europe-wide approach, we remain mindful of maintaining the sovereignty of national healthcare systems, allowing for flexibility tailored to each country’s unique needs and circumstances.”
“The JCA will need to be flexible enough to accommodate the diverse needs and preferences of different regions and countries,” Vesic agrees. “This may require the development of customized assessment processes and protocols to reflect local healthcare priorities and needs.”
Additional Funding Pressure
Stakeholders have also expressed concerns about the possible need for additional resources to meet the conditions of the new JCAs. “Although the evaluation criteria, currently undergoing public consultation, may delve deeper than our current practices, concerns linger about the need for increased resources and potential delays in other areas, particularly routine medication evaluations,” says Collet.
“The JCA will need to be sufficiently resourced to effectively carry out its mandate,” Vesic confirms. This may require additional funding, which could pose a challenge for countries struggling with competing healthcare priorities and budget constraints. In addition, “manufacturers may need to invest additional resources and expertise to navigate the local healthcare systems and requirements in each EU member state.”
Striking a Balance with New Pharma Regulation
Another consideration is the overlapping and/or conflicting goals of the EU Pharma Legislation and the new HTA system. “From the perspective of the European HTA Heads of Agencies Group (HAG), there is a clear recognition of the importance of this legislation,” asserts Niklas Hedberg, Chair of the Executive Board at EUnetHTA, the network of government organisations and relevant regional agencies contributing to HTA in Europe.
“Looking at the two legislations, our impression is that the HTA legislation ultimately looks for a better evidence base for HTA decisions,” he proceeds. “However, we should be mindful that the pushes for accelerated approvals and conditional approvals in the pharma legislation do not necessarily support this move towards a better evidence base.” Hedberg recognizes that “100% predictability means no flexibility and that 100% flexibility means no predictability. They are two sides of the same coin, so we all need to be mindful of where we strike the balance.”
Tight Timelines, Little Interaction
Industry stakeholders argue that short timelines and limited feedback also present unique challenges. “The overall time of the JCA procedure is split in such a way that Member States will have four and a half months (140 days) solely to develop the scope of the assessment – that is the questions (PICOs) that they want companies to answer in their submission,” the EFPIA contends. “During this time, there is no visibility for companies on the draft questions, and no opportunity for companies to engage with the assessors. It is only after this initial time period that companies will finally be informed of the scope, or the questions (PICOs) of the assessment, and are then given less than three months (90 days) to respond to these questions by putting together and submitting their submission dossier.”
Moreover, “the short timeline for JCA submission may limit the opportunity for manufacturers to receive feedback and revise their submission, which could impact the quality of the assessment,” Vesic confirms.
Challenges beyond HTA
The HTA process may contribute to reducing delays, yet there are other issues that have negative consequences on patient access. “It is essential to acknowledge that achieving pan-EU access within a short timeframe requires addressing challenges and issues beyond HTA, such as healthcare system budget scarcity, regulatory variations, stakeholder engagement, and political considerations,” Merck’s Vesic points out.
