Countdown to the Joint Clinical Assessment: Revolutionizing the European market landscape

After years of debate, the EU-wide health technology assessment also known as the Joint Clinical Assessment (JCA) goes into effect in January 2025 for oncology medicines and advanced therapy medicinal products (ATMP). The JCA will expand to all medicinal products, in vitro diagnostics and certain medical devices by 2030. Through the JCA, the European Commission aims to harmonize processes and evidence requirements, establish predictability, avoid duplication of dossier development for manufacturers and accelerate patient access across its member states through a single clinical assessment occurring in parallel with the European Medicines Agency (EMA) marketing authorization process. The EU health technology assessment (HTA) regulation, including JCA, represents the most significant change in the European healthcare landscape in recent years. Critically, pricing and reimbursement decision-making remain the responsibility of individual member states.

In addition to the JCA, the European Commission also published a draft of the EU pharmaceutical legislation with a sweeping set of proposals likely to affect numerous aspects of how pharmaceuticals are regulated in Europe, including intellectual property rights and incentives. While the final details remain unclear, the revised EU pharmaceutical legislation will certainly pose additional challenges for the industry.

In a ZS-led webinar, we sat down with GSK’s Indranil Bagchi, Roche’s Vanessa Schaub and Ipsen’s Lisa Marsden to discuss how these significant pieces of legislation may play out for the industry and how best to prepare. During our discussion, it became clear that JCA success relies on the extent to which the JCA assessments are adopted by individual member states into national decision-making processes. It’s apparent the industry must work to overcome challenges as they arise to ensure we continue to fund innovation and improve access to medicines for all patients in Europe. 

The regulation does not establish a new EU agency. Instead, it operates under the governance of member states. Although JCA is nonbinding, member states are expected to give it due consideration as part of their decision-making processes. Access decisions, however, will continue to be determined locally, based on factors such as population, budgets, healthcare priorities, reimbursement levels and pricing. At ZS, we anticipate a substantial amount of local decision-making will persist, especially in more established HTA markets such as Germany and France, driven by circumstances within each market. Our panel discussed possible implications if local bodies do not utilize JCA results—from duplication of effort to increased administrative burden that could increase timelines for patient access.

“As JCA is not mandated at the national level, the risk is that it becomes an additional administrative layer. We need more details. The devil is in the details.” —Indranil Bagchi, GSK

The PICO framework is garnering significant attention as part of JCA discussions. Our panelists discussed how the industry engages with payer organizations such as the Federal Joint Committee and the French National Authority for Health, to understand their requirements for subgroups, comparators and outcomes. This enables strategic decision-making on resource allocation. However, JCA’s introduction brings forth a fresh challenge as 27 member states contribute their perspectives on PICOs, all with likely different standards of care and thus, different suggested comparators. With multiple PICOs and limited resources, careful selection and prioritization of PICOs will become necessary while operating blind regarding the specific demands of each market. As such, the industry will continue to engage in dialogue with key markets such as Germany and France, leading to some initial duplication and adding stress to both industry and healthcare systems.

“Looking at our portfolio, we have an asset that will be subject to JCA and where you could potentially see 14 to 18 PICOs. This requires us to make a choice as a company as to which we should prioritize, not knowing who is asking, that is uncomfortable in the context of limited resources.” —Lisa Marsden, Ipsen

According to ZS payer research, payers expect JCA implementation to positively impact the efficiency of reimbursement decision-making at the national level. They also acknowledge early-stage challenges like dossier duplication, especially in established HTA markets such as Germany and France. 

Our panelists discussed how preparing for JCA implementation requires a substantial operational shift. Within the industry, trade-off decisions are a daily occurrence, and it’s easy today for global teams to delegate responsibility to affiliates to solve market-specific challenges such as evidence requirements. However, JCA demands global internal alignment, as the first dossier to go out will likely be from the global team compared with today when individual G-BA, TC or NICE dossiers are submitted first by the affiliate teams. This shift is operationally significant and of utmost strategic and technical importance.

While binding regulations would simplify matters, the challenge is that local assessment requirements that have not been addressed at the pan-EU level will still need to be addressed alongside the global dossier. This expertise sits primarily in affiliates who live and breathe their system and best understand their local payers and health system stakeholders. This transition necessitates reevaluating the interface between global and local functions and operationalizing a new framework. Collaboration is essential and will enable affiliates to leverage the JCA report for successful national negotiations for pricing and reimbursement.

During the webinar, we also took a pulse check on the perception of industry readiness versus the health system for JCA implementation. Despite the inherent bias on the side of industry, it became clear that neither stakeholder is adequately prepared for the impending implementation in less than two years.

At ZS, we believe that enhanced collaboration between clinical, commercial and regulatory functions is critical to ensure success given the landscape shifts and challenges. While regulatory approval remains pivotal, incorporating value and relative affordability into the clinical program development process is equally important. With the advent of the JCA legislations, patient access to innovation relies on achieving success in both categories. While this collaboration has made great strides in recent years, we’re not quite there yet. For us to truly be prepared for the implications of JCA, there has not been a better time to foster this step change. We require a much closer collaboration between R&D and clinical and commercial functions, and a reevaluation of incentives for both. Successfully navigating this model necessitates access and pricing functions being a strategic thought partner in decision-making from the pre-clinical stage through go-no-go launch milestones.

“Quality, safety and efficacy are, of course, critically important, but so are value and affordability. JCA highlights this importance as we put clinical profiles together and should lead to closer collaboration of these functions in the long term.” —Indranil Bagchi, GSK

The panel discussed the challenges of integrating new processes alongside existing ones that must continue to meet patient needs. A seamless transition requires meticulous resource management. In addition, scanning portfolios and identifying priorities for 2025 is critical, as is leveraging opportunities such as joint scientific consultations, where available.

Ultimately, what matters the most is that the EU is creating the largest global HTA block, and we need to embrace the JCA as a new and critically important stakeholder. It requires a mindset shift internally in terms of the need to work diligently to build capacity, resources and adjust our processes. However, we also must consider how we position ourselves externally. It’s important that we call out concerns regarding aspects that may hinder patient access such as capacity constraints within JSC and perhaps the lack of scientific judgement in PICO selection. More importantly, we must position our industry differently with JCA considered as a key customer.

“Today, nobody questions the importance of the EMA. I envisage a future in which the EU HTA authorities will be as important a customer as the EMA.” —Vanessa Schaub, Roche

In preparing ourselves to be ready for the JCA, we discussed not only the challenges it brings for Europe but also the opportunity.

If successful, the JCA could bring about the improved speed and breadth of access we want in Europe. By publishing the JCA report within 30 days post-EMA recommendation, pricing and reimbursement decisions at the national level can be expedited. This may be especially beneficial for smaller countries with limited resources and less established HTA processes. However, healthcare systems already struggling to review existing dossiers will need to ensure adequate resource allocation for these advantages to be realized.

Our panel discussed a pivotal element of JCA, the introduction of joint scientific consultations (JSC). These consultations aim to provide the industry with greater predictability with evidence generation and better insight into where and when to invest. This enhanced level of clarity will allow companies to align their development strategies with the expectations of regulators and other stakeholders, thereby mitigating risks and significantly increasing their chances of success.

“JSC provides a good basis and a starting point to discuss PICOs early on to avoid the challenges that might arise as part of JCA dossier development and submission.” —Vanessa Schaub, Roche

Notably, with the population of Europe exceeding 450 million people, the JCA represents a potential shift in the overall attractiveness of Europe from an industry perspective. It offers hope for a more harmonized assessment approach, providing a unique opportunity to amplify the EU’s voice internally within companies when making pivotal investments decisions in R&D, including around evidence generation and clinical trial design.

“We are all aligned on the visionary piece of JCA in improving the speed and breadth of access, but what is important to consider as well, is the opportunity to elevate the voice of Europe internally within our organizations.” —Vanessa Schaub, Roche

Regardless of the skepticism and ongoing uncertainties, the reality is that the clock is ticking on JCA implementation. While the industry should continue to seek clarity on the processes and methodology to be employed, we encourage all stakeholders to seize the opportunity this change presents, both for the benefit of the industry and the EU healthcare ecosystem.