Patient Involvement Under EU HTA: What JSC and JCA Mean for Pharma, Biotech, and Medtech Companies

Health technology assessment (HTA) is one of the most widely used methods in healthcare systems to inform decisions on whether to include new health interventions. Until recently, HTA has largely been a nationally driven process. The criteria used for decision-making therefore differ across countries, including how patient involvement is approached. Some national HTA systems have well-established mechanisms to capture patient perspectives and place high value on patient experience data, while others rely on limited or more informal involvement. As a result, patient involvement in HTA has been shaped by local practices, with varying relevance by country, and it has often been introduced relatively late in the process.

With the introduction of Joint Scientific Consultation (JSC) and Joint Clinical Assessment (JCA) under EU HTA Regulation, key phases of HTA will now take place at the EU level, bringing a more structured approach to how evidence is reviewed across Member States.

For health technologies that fall under JCA, patient involvement can no longer be viewed as a purely national activity. Companies should plan when and how patient input will be used across EU joint work, while still recognizing that part of the HTA process will remain in the hands of Member States.

This article outlines where patient involvement fits within JSC and JCA, what will continue to happen at the national level, and how companies developing health technologies can prepare for a more coordinated approach to patient engagement under EU HTA.

Two EU-level Routes for Patient Involvement

Under the new EU HTA Regulation, patient participation occurs at the EU level through two main routes, each serving a different purpose.

• The first route: Patient organizations that are members of the Stakeholder Network can contribute to horizontal and strategic issues. Their involvement supports the work of the Coordination Group and its subgroups on topics that extend beyond specific therapeutic areas or individual products.
• The second route: Direct involvement via external experts, such as patients, can provide patient input into defined pieces of joint work.

Where Patient Input Fits in JSC

JSC is an early scientific dialogue on study design to meet evidence requirements for the JCA and is intended to support evidence generation for technologies likely to undergo JCA. It applies to health technologies that are likely to be subject to JCA and occurs while clinical studies are still in the planning stage. This makes JSC an important opportunity to consider patient input before evidence-generation plans are finalized.

According to the procedural framework, patient involvement in JSC may occur through:

• Input during drafting of the JSC report
• Contributions to the definition of questions and topics to be addressed during the consultation meeting phase
• Participation in meetings with the health technology developer for review and validation of the JSC report prior to its finalization

From our experience supporting HTA evidence planning, a common challenge is that patient input is often introduced after key design decisions have already been made. At that stage, adjusting important elements of study design becomes difficult without added cost or delays.

As early as the clinical study design phase, patient perspectives can help inform key research questions, support the selection of relevant outcomes, and highlight what matters in day-to-day disease management. They can also surface feasibility constraints that may not be obvious from a purely clinical standpoint. Integrating this input earlier supports evidence plans that are both scientifically robust and better aligned with real-world relevance while reducing the risk of late-stage protocol changes. In parallel, JSC may involve coordinated interactions with the European Medicines Agency scientific advice, helping ensure that clinical development plans meet both regulatory and HTA expectations.

How Patient Input Strengthens JCA

JCA represents the comparative analysis of clinical evidence at a pan-European level. It does not include economic evaluations or produce value judgments, which take place at a national level.

According to the procedural framework, patient involvement can play a role in scoping activities and what is assessed, including:

• Development of the PICO framework (Population, Intervention, Comparator, Outcomes) during scoping
• Drafting of the JCA report and summary
• Participation in meetings for review and validation of the JCA prior to finalization

Scoping is one of the most important points of influence. The scoping stage in JCA is where the framework of the assessment is established, which is similar to how JSC provides an opportunity to reflect on evidence generation when planning clinical studies. The definition of the PICO framework sets the boundaries of the assessment, and patient input can help ensure that the assessment considers outcomes and aspects of disease burden that reflect lived experience, not just clinical or technical priorities.

In addition, during the assessment itself, even when assessments remain strongly clinical, patient input can be collected to complement the clinical data and support value communication for the health technology under evaluation, so that the overall narrative is clear beyond a purely technical audience. This can take the form of patient experience data collected through quantitative or qualitative methods. For health technology developers, this can strengthen the evidence package by adding context on disease burden, treatment experience, unmet need, and outcomes that matter to patients.

Which HTA Processes Still Happen Locally

EU HTA Regulation introduces harmonized clinical assessments through JCA, including scoping and the assessment itself, while countries may still request additional or complementary evidence.

However, economic evaluations, appraisal (including wider consideration of evidence in the local context and value judgments), and pricing and reimbursement decisions remain at Member State level. The points where value judgments are made, where trade-offs are discussed, and where decisions are taken will continue to sit within national HTA processes. At the national level, patients may contribute through testimonies, written submissions, or, in some systems, participation in appraisal committees.

This distinction is critical when companies think about building a patient engagement strategy. Focusing only on EU-level engagement risks missing how patient-related evidence will ultimately be interpreted locally. At the same time, relying solely on national approaches may leave gaps in how patient perspectives are reflected in the joint clinical foundation.

Conclusion

As EU HTA evolves, patient involvement will need to become more structured, earlier, and better coordinated across EU and national processes. For pharma, biotech, and medtech companies, this means identifying where patient input can meaningfully inform evidence generation, JSC preparation, JCA scoping, and national appraisal strategy.

It also means designing engagement in a way that is transparent and robust. Conflict-of-interest management is becoming more visible at the EU level, and certain advisory relationships with developers may restrict participation in the JCA process. Processes for collecting disclosures, assessing potential conflicts, and documenting how patient input is used should be defined in advance, rather than addressed reactively when timelines are already tight.

Ultimately, patient engagement under EU HTA should not be treated as a standalone activity or a late-stage input. It can help companies build evidence packages that are clinically robust, patient-relevant, and aligned with both EU-level assessment and national decision-making when integrated into evidence planning, value communication, and access strategy from the outset.