The EUnetHTA Roadmap: Implications for Biotech and Pharma Manufacturers

Health Technology Assessment (HTA) plays a pivotal role in determining the value of health technologies like drugs, medical devices, and procedures. It aids decision-makers in healthcare systems by providing evidence-based data that influences the allocation of resources. With healthcare costs on the rise and innovative treatments becoming more frequent, HTA has gained increased importance in European healthcare systems. However, Europe has faced challenges in HTA consistency, as multiple countries have developed their own agencies. This has resulted in discrepancies in methodologies and assessment criteria, creating inefficiencies. 

EUnetHTA: Towards Harmonized HTA in Europe 

To address these challenges, the European Union launched the EUnetHTA initiative, which began in 2010 and concluded its initial phase in 2021. The project aimed to standardize HTA processes across member states, ensuring more consistency in health technology evaluations. The long-term goal of EUnetHTA is to foster cooperation, eliminate duplication of efforts, and streamline the sharing of findings across EU countries. EUnetHTA focuses on enhancing the value of HTA input for healthcare decision-making, particularly in countries with limited HTA experience. 

The regulation (EU) 2021/2282 has formalized the process, setting in motion a shift towards more centralized evaluations. This move to harmonize HTA across Europe promises to mitigate the challenges currently faced by Biotech and Pharma manufacturers. 

Key Objectives of the EUnetHTA Regulation 

1. Efficiency Gains: EUnetHTA aims to reduce redundant evaluations of clinical evidence conducted by national HTA bodies (such as G-BA, HAS, NICE, etc.), making the process more efficient for both healthcare authorities and pharmaceutical manufacturers. 

1. Streamlining Market Access: By consolidating the evaluation process, the regulation seeks to ease market access hurdles and facilitate faster patient access to new therapies. 

1. Cost Reduction: The pooling of resources and centralization of HTA assessments will save costs for both pharmaceutical manufacturers and EU member states, allowing for more efficient use of available resources. 

1. Enhanced Transparency: EUnetHTA’s open and accessible information-sharing processes ensure trust and accountability in the evaluation of health technologies. 

The EUnetHTA Roadmap: Phased Implementation 

The implementation of the EU HTA regulation will happen gradually over several years, starting with oncology medicines and advanced therapy medicinal products (ATMPs) in January 2025. By 2028, orphan drugs will be included, and by 2030, other products will follow  

EUnetHTA is designed to introduce Joint Clinical Assessments (JCAs) that will assess the clinical effectiveness of health technologies. These assessments will help streamline the process by consolidating clinical evaluations into a single entity. Non-clinical evaluations, including economic and organizational aspects, will continue to be carried out by national HTA bodies. 

Clinical and Non-Clinical Domains in the EUnetHTA Framework 

JCAs will focus on the clinical domains, which include: 

• Health Problem & Current Use: Identifying the health problem the technology addresses. 

• Clinical Effectiveness: Comparing the efficacy of the intervention with existing alternatives. 

• Safety: Evaluating the risk of harm posed by the intervention. 

• Technical Characteristics: Assessing the technical specifications of the health technology. 

Non-clinical domains such as economic, ethical, organizational, and social aspects will remain under national authority. 

What Does This Mean for Biotech/Pharma Manufacturers? 

The transition to the centralized EUnetHTA system presents several challenges and opportunities for Biotech and Pharma manufacturers. Key implications include: 

• Early Engagement with HTA Agencies: Manufacturers must engage early with national HTA bodies through Joint Scientific Consultations (JSCs) to align their clinical trials with PICO (Patient/Population, Intervention, Comparison, Outcome) parameters. Early engagement is crucial to resolve potential issues with clinical trial designs, especially before Phase III trials. 

• Enhanced Evidence Generation: EUnetHTA will require comprehensive evidence generation that reflects variations in treatment practices across Europe. Biotech/Pharma manufacturers must invest more resources into gathering EU-wide epidemiological data, clinical management information, and real-world evidence to meet the robust requirements of the new HTA process. 

• Strategic Planning for Timely Submission: The timeline for submitting the Joint Clinical Assessment dossier is relatively short, so manufacturers must carefully plan and train their teams to meet the requirements. Efficient preparation will help ensure a successful submission, reducing the risk of delays. 
• Market Access and Patient Access: With the new process in place, smaller markets that were previously less prioritized will benefit from accelerated access to treatments. This will ensure equitable access to new therapies across Europe, which is particularly beneficial for patients in less prioritized member states. 

Moving Forward: How EUnetHTA Can Shape the Future of Biotech/Pharma Manufacturing 

Despite the potential benefits, manufacturers must remain mindful of challenges related to the EUnetHTA process. These challenges include the increased data requirements and the transition from local HTA applications to centralized submissions. The new regulation could lead to more rigorous scrutiny of clinical evidence, potentially causing delays in market access. 

Prepare for the Transition with BioBoston Consulting 

As EUnetHTA continues to evolve, it is crucial for Biotech/Pharma manufacturers to navigate these changes strategically. BioBoston Consulting offers expert guidance in preparing for HTA submissions under the new EUnetHTA framework. From early engagement with HTA bodies to comprehensive dossier preparation and submission management, BioBoston Consulting can help you ensure your product’s success in the European market. 

Connect with BioBoston Consulting Today! 

If you are looking for expert support with the EUnetHTA process, strategic planning, evidence generation, or preparing your submission dossier, reach out to BioBoston Consulting. We can help streamline your journey through the complex landscape of HTA evaluations and market access in Europe. Get in touch today to secure your product’s successful launch and market entry!