Spain Joins First EU Joint Clinical Assessment Under New Health Technology Regulation

It will soon be a year since the European regulation on health technology assessment came into force, aiming to harmonize the scientific evaluation of medicines, technologies, and medical devices and accelerate their access through the creation of Joint Clinical Assessments (JCAs) and Joint Scientific Consultations (JSCs).

The Spanish Agency for Medicines and Health Products (AEMPS) has participated for the first time as a co-assessment body in one of the Joint Clinical Assessments

These assessments have been underway since January 12 of this year, and there are already 12 joint clinical evaluations studying marketing authorization applications for new cancer treatments and advanced therapy medicinal products. The Spanish Agency for Medicines and Health Products (AEMPS) considers its participation a “decisive step” in its European involvement in the evaluation processes.

As a co-evaluation organization, the Spanish Agency for Medicines and Health Products (AEMPS) will have to participate actively in the preparation of the report that the Clinical Research Centres (CRCs) must issue. In this case, they are analyzing the drug ensartinib for the treatment of advanced non-small cell lung cancer (NSCLC) that is positive for anaplastic lymphoma kinase (ALK) in adult patients.

The Spanish Agency for Medicines and Health Products (AEMPS) is participating as a co-evaluator of the drug ensartinib for the treatment of advanced ALK-positive non-small cell lung cancer.

The health agency emphasizes that this assessment and its participation will allow for the integration of “sound scientific criteria” and accelerate the availability of a harmonized technical report for all member states. With this, they aim to reduce disparities and “strengthen the added value” of the European process.

In a statement, the Spanish Agency for Medicines and Health Products (AEMPS) explains that its role also allows it to convey Spain’s needs in defining the scope of evaluation (PICOs) established at the start of each new randomized controlled trial (RCT). They clarify that this coordinated work in the initial stages is key to ensuring, in the long term, a reduction in duplication between European and national evaluations, alignment of expectations, and easier implementation of the results in Spain.

For now, Joint Clinical Assessments are only being conducted on drug innovations for cancer treatment and advanced therapies. From 2028, they will be expanded to orphan drugs, and by 2030 to all new medicines. Starting next January, some high-risk medical devices will also be assessed.

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(Featured image by Louis Reed via Unsplash)

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First published in iSanidad. A third-party contributor translated and adapted the article from the original. In case of discrepancy, the original will prevail.

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