Catering to the healthcare needs of the nearly 450 million people in the European Union (EU) is an enormous feat. However, the EU’s new Health Technology Assessment Regulation (HTAR) adopted on January 11, 2022, aims to streamline the process by addressing some of the longstanding challenges facing EU healthcare. The HTAR framework comes into effect in January 2025, and is expected to significantly impact the healthcare landscape. For life science companies, the race to the implementation date is on to understand the requirements of the new legislation and how it applies to their operations. 
 

Key Aspects of the HTAR

The purpose of the HTAR is to improve and accelerate patients’ access to new health technologies in the EU. Countries across the region currently duplicate many of the same evaluations of medicines, diagnostic tests and high-risk medical devices before they become available to patients. This causes unnecessarily high costs and delays in patient access to treatments. By using joint clinical assessments (JCAs) and sharing information about evaluations between participants, countries can eliminate much of the time and cost involved. However, the process requires mandatory collaboration between countries, which gives rise to additional challenges. 
 

Primary Stakeholder Concerns

While European countries can expect to benefit from shared resources and expertise, concerns exist about how patients, clinicians and other stakeholders will be involved. The main concerns include the language and processes required, such as:

1.     Documentation Complexity

The language and requirements for JCA submissions can be convoluted and demanding, making it challenging for stakeholders to understand and comply with the regulations.

2.     Faster Timelines

The shorter timeframes for developing robust evidence and producing comprehensive submissions add pressure and complexity to the process. Stakeholders may find it challenging to meet these tight deadlines.

3.     Lack of Input During Drafting Process

Some stakeholders have expressed concerns about the lack of input and communication during the drafting of guidelines and regulations. This deficit could lead to misunderstandings and difficulties in implementation.

4.     Inconsistency Among Components

There may not be enough cohesion among different components of the regulations, such as Joint Scientific Consultations (JSCs) and JCAs. This inconsistency is likely to create confusion and uncertainty for stakeholders.

5.     Limited Resources for Involvement

While the regulations appear to encourage the involvement of patients, clinicians and other stakeholders, questions remain about how to gather input, especially considering the limited resources available.

6.     Analytical Intricacy

The process for JCAs is triggered shortly after regulatory filing, leading to analytical complexities. The recommendation for scoping processes might be more of a combination of country-specific requirements, rather than a streamlining of the evidence requirements.

7.     Lack of Communication with Sponsors

Under the HTAR, there is a concern about the lack of communication with sponsors during the JCA process. This makes it difficult to create alignment and understanding between involved parties.
 
These regulations represent a major change in how health technologies are viewed within the EU, with the intent of bringing a more unified, transparent and efficient approach. However, the concerns listed indicate a high need for clear communication, well-defined processes and careful consideration of various stakeholders’ capabilities when implementing the HTAR.
 

Heading Towards 2025

As the first implementation deadline scheduled for 2025 approaches, the healthcare industry must take steps to prepare for execution and compliance. Here is how these can be achieved.

1.     Advance Planning

Planning well ahead of time is essential to ensure the availability of robust comparative evidence for JCAs, as is a clear understanding of payer-relevant populations and comparators in each market. Early engagement with local clinicians, patients and affiliates, combined with thorough market evaluations, will enable companies to gather insights and understand the unique needs and challenges of different markets.

2.     Evidence Gathering

Companies must begin early to prepare generating evidence that accounts for all these factors. Pharmaceutical organizations should start mapping out their processes and governance. Healthcare organizations must align their operating models with the EU JCA process, and project sponsors must begin embedding dialogues such as JSCs into their processes without delay.

3.     Relationship Building

Relationships are critical to ease the pathway to successful implementation. For example, close collaboration between departments like Health Economics and Outcomes Research (HEOR), market access, biostatistics, regulatory and clinical development will be vital. Engaging with HTA bodies, Coordination Groups (CG) and national decision-makers will foster cooperation and understanding.

4.     Technology Deployment

Companies will be required to invest capital in tools and technologies that facilitate compliance with the new regulations, including data management and analytics.

5.     Development Monitoring

The EU HTAR will likely evolve between now and 2025, as well as during and after implementation, so continuous monitoring of changes and adapting strategies accordingly will be essential. Companies must ensure they remain informed about updates released by EUnetHTA 21 and implementation acts from the European Community.
 
By focusing on these areas, the industry can navigate the complexities of the new regulations and position itself for success as the 2025 deadline approaches. The emphasis should be on collaboration, transparency, adaptability and a proactive approach to understanding and meeting the unique requirements of the EU HTAR.
 

Transforming the EU Landscape 

The adoption of the EU HTAR in 2021 marked a transformative moment in the European healthcare landscape by establishing the framework for shared evaluations to enhance patient care across the continent. While the process has complexities and challenges it presents an opportunity for industry stakeholders to collaborate, innovate and adapt to new internal processes. By embracing the principles of unity, clarity and efficiency, EU HTAR implementation will help shape a system that better supports EU citizens.

---

Anke van Engen, Senior Principal, EMEA Value & Payer Evidence, IQVIA
Anke leads IQVIA’s EMEA Payer Evidence Solutions practice, working with clients to develop and execute payer evidence generation strategies and communicate a compelling payer value story. She is experienced in high quality consultancy and is dedicated to helping life sciences companies maximize the commercial success of products through integrated market access strategies. With over 20 years of global HEOR and PMA experience, Anke has a proven track record of enabling companies to achieve greater commercial successes. 
 
Edel Falla, Principal, EMEA Real World Methods & Evidence Generation, IQVIA
Edel leads IQVIA’s HEOR evidence generation and reimbursement submission programs across the European region and works with clients to develop and deliver HTA strategy, optimizing HTA outcomes. She is a Health Economist with a background as a Clinical Pharmacist with +15 years’ experience.