The EU Health Technology Assessment Regulation (HTAR)
Successfully navigate the changing European HTA landscape
The European Union’s new regulation 2021/2282 on health technology assessment (HTA) is intended to make innovative health technologies more widely available to EU patients, reduce duplication of efforts by national HTA bodies and ensure resource efficiency. Initial implementation began in January 2025 for cancer treatments and advanced therapy medicinal products (ATMPs), with full implementation for all therapeutic areas to be finalized in 2030.
The regulation changes represent a monumental shift in the process for bringing medical innovations to the EU market, and these changes are already spurring the development of a new EU HTA and market access ecosystem. Questions continue to emerge as pharmaceutical and technology developers strive to adequately prepare.
Collaborative operating models are imperative
With the changing dynamics of the EU HTA process, drug developers must evolve how they work. Your future success in receiving market access is dependent on:
- Enhancing cross-functional collaboration and cooperation
- Involving market access teams in early clinical program decision-making
- Ensuring the needs of all stakeholders are met with an integrated evidence plan
Five strategic considerations for HTA and market access success
Integrated Scientific Advice
Optimizing your evidence generation plans and developing robust evidence that is relevant to all stakeholders can be achieved with integrated scientific advice (ISA), a multi-stakeholder process that brings together regulatory and HTA advice. In the new EU HTA construct, there are many factors to be considered before engaging in ISA to ensure you get the most benefit out of your interactions and feedback. Move your programs forward with speed and agility by ensuring alignment on evidence needs, identifying challenges, and seeking regulatory guidance.
Joint Clinical Assessment and PICO scoping
Clarifying your goals and understanding how different scenarios could affect your joint clinical assessment (JCA) scoping is critical in developing a successful population, intervention, comparator and outcomes (PICO) strategy. As part of the HTA process, JCAs use clinical effectiveness and safety data to complete a comparative analysis with other health technologies or existing products. A scoping process is conducted prior to dossier submission to define the PICO, enabling the research question and assessment scope for the dossier to be identified. There are different questions and new decisions under the HTAR that need to be considered to support successful PICO scoping.
Early real-world evidence and health economic modeling
Staying ahead of global payer and HTA demands and generating the right evidence to guide your decision-making across the development process allows you to move your product forward effectively. Integrating health economic modeling studies early can inform your clinical development plan, while its use in later phases can inform pricing and reimbursement decisions. While the JCA process considers clinical data, the larger HTA appraisals, country-specific pricing and reimbursement decisions consider the larger product value story supported by real-world evidence (RWE), allowing you to demonstrate your product’s value and optimize reimbursement with real-world insights.
Local pricing and reimbursement and market access
Developing a local pricing and reimbursement strategy alongside your global HTA submission is necessary to avoid delays in market access at a country level. While the EU HTA process is consolidated, each country still can assess new products to determine pricing and reimbursement status. It is critically important to understand local landscapes and any additional data that may be required by specific countries to best position your product for accessibility.
JCA report impact
Monitoring and understanding the impact of the JCA report on decision-makers, and, ultimately, your product needs to be a foundational part of your overall planning. Without these insights, steps may be overlooked that could delay decision-making, or worse, result in unfavorable decisions.
Partnering for success
Having a global partner with an in-depth understanding of the new regulation and its complex nuances can make a significant impact on successful market access. The right partner will provide you with health economics and market access expertise to enable you to navigate this major change to the EU market access landscape and address how to:
- Determine the need to identify a new evidence strategy considering the new regulation
- Learn how to equip your organization to robustly prepare for this major change
- Implement the optimal integrated scientific advice strategy with regulatory and HTA bodies for your asset amid this major change
- Understand the value of joint scientific consultation (JSC), determining if it is necessary for your product, and if so, when and how to initiate and implement it
- Understand which considerations will be given to RWE in the evaluation process
- Handle the challenge of member states being allowed an unlimited number of PICO elements
- Interpret the role of patients and health care professionals in JCAs
Moving forward in uncertain regulatory times
With the first implementation of the new HTAR, the full impact on pharmaceutical and technology developers remains to be seen. Our experts have unparalleled experience with HTA submissions and JSCs. For many years, we have actively collaborated with companies to prepare strategies and evidence plans to ensure pharmaceutical and technology developers are ready for new processes. Whether you have one asset or a full portfolio, we are positioned to navigate the changes ahead, together.
We closely track all HTA guidance documents, comments from public consultations, and the initial JCA reports to glean insights that can influence your plan. Gain valuable knowledge to drive critical decisions needed to successfully move your product forward through planning, early engagement and ongoing communication with HTA bodies.
Related resources regarding the EU HTA Regulation
