The transition toward European joint clinical assessments of health technologies is just around the corner.
Health technology assessments—which provide policymakers with evidence about the clinical, economic, social and ethical issues related to the use of medicinal products and medical technology—have traditionally been conducted at the national level. The European Union Health Technology Assessment Regulation 2021/2282 will streamline this process by conducting a joint clinical assessment (JCA). The JCA is intended to decrease the time it takes to get medications to the patients who need them and to aid reimbursement in markets with minimal to no pricing and reimbursement infrastructure.
EU Joint Clinical Assessment Timeline
Regulation (EU) 2021/2282 was adopted December 15, 2021. Since January 2023, it has been used to assess all oncology drugs and advanced therapy medicinal products, and beginning in 2028, it will cover orphan drugs as well. By 2030, all new medicines and certain high-risk medical devices could be subject to joint clinical assessments.
A coordination group within the European Network for Health Technology Assessment (EUnetHTA) consortium will perform joint clinical assessments. This group has conducted a number of pilot JCAs since 2019; their experience will certainly inform joint clinical assessments moving forward.
EU member states still have time to voice their concerns and suggestions, which may be considered as the consortium further develops JCA plans and methodologies.
JCA and National HTA Similarities and Differences
Like national health technology assessments, JCAs are intended to provide policymakers evidence-based information related to the use of medicines and medical technology. But while some countries also use the data gathered during HTAs to determine reimbursement and pricing, the EU JCAs will focus only on clinical data. The economic assessment of products will remain at the individual country level.
An OPEN Health analysis that compared pilot JCAs with national health technology assessments found that joint clinical assessments considered a wider scope of clinical trials and product comparators than some national assessments. There was also variety in the use of safety endpoints considered by the JCA; however, there appeared to be a good level of agreement in the use of efficacy endpoints by both the JCA and national assessments.
It’s important to note that the summary reports provided by the assessors of JCA will not have a legally binding effect. Countries are welcome to draw their own conclusions on the clinical value of new medicines—and may request further evidence as part of their decision-making process.
The new process will likely guarantee fairness in determining the true value and pricing of new technologies, but reimbursement decisions will ultimately rest at the national level.
Methodological and Process Challenges
Determining appropriate comparators is a challenge in joint assessments. Currently, standards of care may vary market to market, so it’s historically made sense to compare new products to their local comparators. Identifying pan-European comparators may stir up disagreement and miss relevant comparators in specific markets.
Methodological challenges also remain. The consortium that will conduct the joint clinical assessments must decide how to conduct an acceptable joint assessment if head-to-head clinical trials aren’t available. Will an indirect treatment comparison suffice? What forms of evidence will be deemed acceptable, particularly for treatments for rare diseases?
There is no clear guidance—or consensus—on how joint clinical assessments will be implemented. That may hinder the full adoption of regulation (EU) 2021/2282. Between now and 2025, the decision-makers will need to establish a quick and standardized procedure to ensure the assessments are transparent and effective, with minimal administrative burden, for optimal adoption.
How Industry Can Prepare for Joint Clinical Assessments
Prioritizing early scientific advice as a key part of strategy is one way companies can minimize the risk of surprise negative outcomes. And while no one yet seems to know exactly which data will be required for joint clinical assessments, it’s smart to build a strong rationale for trial design, develop robust justification for the use of surrogate endpoints and include patient-relevant outcomes. Industry leaders should also work with industry groups such as EUCOPE and EFPIA to convey their concerns and understand how the EU JCAs and national assessments will fit together.
At OPEN Health, we believe that effective evidence generation and communication is increasingly important in driving healthcare decision-making. Our multidisciplinary teams have a deep knowledge of global market access challenges and apply the highest scientific standards to our research to communicate a product’s value. We have experience with joint clinical assessments and can help pharmaceutical companies efficiently navigate the challenges and opportunities that relate to evolving discussions around and the likely implementation of EU HTA.
