EU's New Health Technology Assessment Regulation to Streamline Market Access for Innovative Therapies

Key Insights

• The European Health Technology Assessment Regulation (HTAR), introduced in 2021, mandates Joint Clinical Assessments (JCAs) for specific medicinal products, starting with cancer treatments and ATMPs in 2025.
• Companies filing Market Authorization Applications (MAA) with the EMA must prepare a JCA dossier within 100 days, adhering to frameworks set by EU state assessors.
• The HTAR introduces Joint Scientific Consultations (JSCs) to allow companies to gain feedback on clinical development plans, aligning with JCA expectations and facilitating faster market entry.

The European Union's Health Technology Assessment Regulation (HTAR), established in 2021, is set to transform the landscape of pharmaceutical market access. Beginning in 2025, the regulation mandates Joint Clinical Assessments (JCAs) for specific medicinal products and therapies, initially focusing on cancer treatments and Advanced Therapy Medicinal Products (ATMPs). This initiative aims to harmonize clinical assessments across EU member states, streamlining the introduction of innovative therapies and ensuring quicker patient access.

Joint Clinical Assessment (JCA) Process

Following the submission of a Market Authorization Application (MAA) to the EMA, companies will be required to compile a JCA dossier within a strict 100-day timeframe. This dossier must adhere to specific frameworks, including the PICO (Population, Intervention, Comparator, Outcome) model, as defined by assessors from various EU member states. The extensive data requirements, encompassing clinical, safety, and epidemiological information, may pose challenges for companies, potentially straining resources and extending preparation times.

Joint Scientific Consultations (JSCs)

The HTAR also introduces Joint Scientific Consultations (JSCs), providing companies with the opportunity to receive feedback from HTA bodies and the EMA regarding their clinical development plans. This collaborative approach aims to ensure alignment with JCA expectations, fostering a more efficient and consistent pathway for health technologies to enter the European market. ProPharma suggests a structured approach to tackle HTAR requirements, involving training, technology-specific scoping studies, PICO workshops, and comprehensive JCA dossier planning.

Preparing for Implementation

While the HTAR is designed to accelerate and standardize European market entry for health technologies, companies must proactively prepare to navigate its complex requirements and tight deadlines. Early preparation is essential to ensure compliance and maximize the benefits of this evolving regulatory framework.