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EU HTA

EU HTA

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IMPLEMENTATION DATE

12th January 2025

Introduction

A Health Technology Assessment (HTA, benefit assessment of health technologies) is a central part of market access for innovative products as it provides the basis for successful patient access and reimbursement. Until 2025, HTA procedures across Europe have been carried out independently at national level. With Regulation (EU) 2021/2282 coming into force, the national clinical parts of the HTAs will now be gradually amended by a Joint Clinical Assessment (JCA) at European level, starting from 2025. The decision on the additional benefit and reimbursement remains the responsibility of the respective member states at national level. Oncology drugs and advanced therapy medicinal products (ATMPs) have to undergo the EU HTA process from 12 January 2025. Orphan medicinal products (OMPs) will follow from 2028 until all other medicinal products authorised by the European Medicines Agency (EMA) are finally assessed in the EU HTA process in 2030.

The Challenge

Addressing the challenges of the EU HTA 

The main objectives of the EU HTA regulation appear convincing: harmonise HTAs and thereby improve access to innovative therapies in Europe and reduce the administrative burden for companies and HTA authorities. However, in order to achieve a fair price through an HTA process, it needs to consider numerous aspects that can differ fundamentally within the EU, such as the available therapies, the current standard of care and the respective costs.

The European Commission’s solution and now central feature of the EU regulation is the JCA of new medicines at European level. While JCAs streamline clinical evaluations across the EU, individual Member States still retain authority over decisions regarding economic, social, and other aspects of health technology assessments, including pricing and reimbursement. This approach substantially increases complexity: The EU JCA dossier must simultaneously address all member states’ evidence requirements and associated individual specificities (#PICOs) and is now to be compiled in parallel with the regulatory EMA marketing authorisation application (MAA) (see figure). 

The new EU HTA setup brings several strategic and operational questions for manufacturers:  

How can I successfully prevent surprises in the PICO scope?

Are my evidence gaps critical for pricing? Can I close the gaps? And if yes, should I?

Which methodological requirements apply? How can I best position myself if I cannot – or do not want to – fulfil them?

It is all about pricing: How can I optimally prepare for the national negotiation tables even though my JCA preparations start many years earlier?

How can I handle the 100 days? How can I mitigate the risk of a high misplaced investment in my preparations? What is the optimal balance of proactive preparation and reactive navigation during the EU HTA process?

What are the key interfaces, and how can I set up the perfect strategic and operational workforce?

How can I effectively and efficiently ensure an optimally and continuously aligned cross-functional team setup?

How can I efficiently coordinate the procedures at European and national level? How can I reduce the supposed complexity and general multifunctionality?

How can I benefit from current tech/AI developments?

The Solution

Smart European market access strategy and operational excellence

Our team at the MAP Group are both your experienced strategic partners and your reliable and committed operational workforce. We see the EU HTA process as a strategic hurdle to build the best possible basis for the downstream national negotiation processes – in the most efficient and smart manner. We have accompanied the development of the EU HTA / JCA process from the very beginning as one of the most active opinion leaders, and have been supporting our clients with strategic advice on organisational and operational implications and their hands-on implementation along the way.

Our joint aim is to provide patient access for as many patients as possible while maximising pricing potential.

Leveraging an international network for European excellence 

The MAP Group is Europe’s largest independent specialist pharmaceutical and biotechnology management consultancy. As well as established operations in Germany, the UK, Ireland and Benelux, the MAP Group has strong strategic and operational partnerships in Europe and worldwide.  

We work with national market access agencies to incorporate further local HTA and pricing expertise into the overall European strategy as required.

In addition, we utilise a clinical network spanning all European member states in order to validate our hypotheses through clinical experience, e.g. on relevant PICOs.

We also work with other functional experts as required, such as research analysts in market and payer research, or HTA biostatisticians in relation to evidence strategy.

We are an active member in European associations and stakeholder groups such as the EUCOPE and EuropaBio networks and are in frequent dialogue with the pharmaceutical industry.

Experts for European market access

The MAP Group has participated in over 400 HTAs in the UK and key European markets, including the rigorous German and Benelux assessments. Since the beginning of the AMNOG law in Germany, we have successfully supported our clients strategically and operationally in the German benefit assessment and price negotiation process. Due to the central influence of the Gemeinsamer Bundesausschuss (G-BA) and Institute for Quality and Efficiency in Health Care (IQWiG) as well as the generally high quality standards and requirements, the German procedure has now become the blueprint for EU HTA. With our extensive experience in the local European HTAs and long-standing interactions based on mutual trust with the involved authorities, we are the perfect partner to successfully guide our clients through the European HTA process. Especially at the beginning of the implementation of the new EU HTA framework, it is important to draw on our extensive experience in the German AMNOG and other local HTA processes in order to anticipate adjustments and implications and reduce uncertainties. 

Agile working methods and active handling of innovations and uncertainties 

In today’s world, VUCA – volatility, uncertainty, complexity, ambiguity – is a key challenge in strategy development and implementation. A further European level now reinforces this. The MAP Group utilises an agile way of working to respond flexibly to unpredictable obstacles and changing circumstances. We are certain that the agile way of working results in significant efficiencies, thanks to the high level of responsiveness and constant flow of information in market access, especially now when it comes to EU HTA.

Our Approach

As your strategic and operational full-service partner for patient access in Europe, we guide you through your European market access journey.

"EU HTA Readiness Workshop" – our joint start

In our established EU HTA readiness workshop, we jointly analyse and discuss the general requirements and success factors of the new process and, based on this, collectively evaluate the specific strategic implications, for example for your portfolio and corporate structure. The workshop may also include an active self-assessment and a specific evaluation for the respective functions in the company. This approach has proven its worth in creating the necessary awareness as well as initiating sustainable tactical measures as part of the overall European orientation.

PICO simulation and evidence generation strategy – smart preparation to reduce uncertainty and mitigate the risks

PICO schemes (P=Population, I=Intervention, C=Comparator, O=Outcome) define the scientific questions of clinical evaluation that need to be answered through statistical analyses of study data in the JCA dossier. There can be fundamental differences between the member states regarding the requested evidence. Depending on the indication to be assessed, there may be substantial differences in the standard of care within the EU, which means that the pharmaceutical company could have to address numerous PICOs with its study data. However, the requested PICO schemes are only shared with the pharmaceutical company 100 days before the JCA dossier has to be submitted.

We support our clients in both operational assessments / simulations and strategic interpretations for concrete advice. Due to the short timeframe for preparing the European dossier, a key success factor is defining valid hypotheses for the final PICOs requested and strategically evaluating these for their respective implications, for example for national pricing negotiations. In a gap analysis, the evidence package is formally and strategically analysed against the expected requirements and appropriate options for closing the gaps are derived. In this way, effort and benefit can be optimally balanced, e.g. in view of further evidence generation. It is all about the strategic optimum for the national downstream processes.

JSC, Scientific Advice and National Early HTA advice – asking the right questions and substantiating our story

Early HTA advice is a key component of every successful market access strategy. With the EU HTA process, the HTAR also brings the option of the Joint Scientific Consultation (JSC) with the HTA bodies, which can optionally be requested in parallel with EMA scientific advice. Similar to national HTA advice meetings, these opportunities for interaction with the respective authorities can provide valuable strategic and operational information on the optimal design of pivotal studies, the anticipated PICO schemes and the course of the HTA process(es).

With significant experience of the previous EUnetHTA 21 advice process, national HTA consultations and EMA scientific advice applications, the MAP Group is the ideal partner for Health Technology Developers (HTDs) in the JSC process.

Together we will assess which early HTA advice strategy is optimal for your specific situation. We develop a strategically sound and comprehensive briefing package, including e.g. initial PICO scope suggestions and other tactical elements for successful market access down the road. Where JSC is carried out in parallel with scientific advice we prepare and submit the briefing package to the EMA, asking the relevant questions and clearly presenting the data to ensure that the advice received is of maximum benefit to the product development. In addition, we support with the execution of the actual meetings to maximise the engagement with the authorities. Finally, we will re-iterate our EU market access strategy based on the outcome of the meeting to pave the way for the next milestones on our joint journey.

Developing and implementing an anticipated EU HTA strategy 

Once potential risks, opportunities and approaches have been identified, the next step is to address these action points by developing and implementing an EU HTA strategy. This strategy incorporates the national price negotiations of the individual member states right from the start. We always start with the goal in mind: how can we successfully achieve the desired level of reimbursement while making the medicine available to as many patients as possible?  

Together, we develop a roadmap for the implementation of concrete steps within the identified areas, to improve the chances of success before and during EU HTA. We provide both strategic support in the creation of scenarios and operational support in the implementation of tactical measures. We accompany you through all steps of the EU HTA process as an approachable and reliable partner at eye level. 

Creating a strategically complete and target-oriented JCA dossier

The European dossier requires the collation of large volumes of data within tight timeframes, so maintaining focus is crucial whilst considering the vast amounts of information to be processed.. This poses not only methodological but also technical challenges that need to be solved. We have developed a modular and AI-supported process to substantially enhance dossier writing efficiency and Quality Control (QC). This is of particular importance to meet the special timeframe of finalising the JCA dossier in 100 days. Our innovative approach is based on the statistical calculation of PICO datasets, their orchestration and semi-automated textualisation and interpretation in accordance with the qualitative requirements of the JCA. Our tools are already established in the German HTA process, and have demonstrated their effectiveness in a real-world scenario. With this experience from numerous German HTA dossier projects, we are the ideal partner for the implementation of the European dossier.

The Delta dossier – using local expertise to complete the package 

The JCA dossier contains all necessary information for a European clinical assessment. Yet to achieve successful market access, it requires both a smart European and national strategy: at national level, additional requirements often apply, for example with regards to cost-effectiveness of the new therapy. These aspects will also be provided in a national dossier. As the interface between the European and national pricing strategy and as a decisive opportunity to anchor the national value story, the “delta” dossier is of considerable tactical importance. We support our clients both in providing advice and in preparing the necessary documents in accordance with the national requirements.

Harmonising European assessment and national negotiations optimally

To achieve the optimal strategic alignment for national benefit assessment and price negotiation, we develop our EU market access strategies with a holistic approach, aiming for the best position at the negotiation table, i.e., far beyond the JCA process per se. Having provided strategic and / or operational support to more than 200 clients in 20 markets, we know that our highly strategic approach is the essential piece of our joint success story.

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