Joint Clinical Assessment is the procedure under the EU Health Technology Assessment Regulation in which the clinical evidence part of certain new health technologies is assessed jointly at the European level. Its result is a scientific report on the relative clinical effects in relation to the questions posed by the participating Member States. The report does not create a uniform reimbursement decision for Europe.<\/p>\n
The focus is on the clinical dimension of a technology: Which patient-relevant results do the submitted studies show, with which comparator therapies are they compared, and which uncertainties limit their significance? The assessment is organized by the Member States within the framework of the HTA Coordination Group. For medicinal products, the EU HTA Regulation, implementing acts, and methodological guidelines regulate how manufacturer information is requested, assessed, and consolidated in the report.<\/p>\n
In this context, ‘joint’ does not mean that all national HTA bodies ask the same healthcare question. Member States submit their intended clinical questions so that the assessment can take into account relevant populations, interventions, comparators, and endpoints. The published report bundles the clinical analysis; its subsequent use takes place in the respective national procedure. Thus, the Joint Clinical Assessment concretizes the existing umbrella term ‘health technology assessment’.<\/p>\n
Regulation (EU) 2021\/2282 has applied since January 12, 2025, according to its Article 36(2), but its scope for medicinal products is being expanded gradually according to Article 7(2). Since January 12, 2025, it has covered medicinal products with new active substances whose therapeutic indication is the treatment of cancer, as well as advanced therapy medicinal products under Regulation (EC) No 1394\/2007. From January 13, 2028, orphan medicinal products under Regulation (EC) No 141\/2000 will be added, and from January 13, 2030, the remaining medicinal products within the scope\u2014namely those to be centrally assessed under Article 3 of Regulation (EC) No 726\/2004\u2014will follow.<\/p>\n
The procedure begins with an announcement and the appointment of assessors and co-assessors from Member States. The health technology developer submits a dossier, answers queries, and can comment on a draft report. The assessment is not based on the marketing authorization decision, but on the specified clinical questions and the evidence suitable for them. After the technical review, the report is adopted and published according to the procedure of the Regulation.<\/p>\n
For study planning, the fit between pivotal studies and multiple European healthcare contexts thus gains importance. Subgroups, comparators, and patient-relevant endpoints must be comprehensible not only for a regulatory authority but also for the questions submitted in the procedure. Subsequent supplementation of data cannot always close the gap between a narrow marketing authorization population and the clinical assessment questions.<\/p>\n
The Joint Clinical Assessment replaces neither a national decision on added benefit nor the setting or negotiation of a reimbursement amount. In Germany, the early benefit assessment according to Section 35a SGB V, with its appropriate comparator therapy, remains a separate procedure. National bodies may continue to assess non-clinical criteria, such as economic or organizational aspects, according to their own law alongside the joint clinical report.<\/p>\n
Similarly, the procedure is not to be equated with the benefit-risk assessment of a marketing authorization. A marketing authorization answers whether quality, safety, and efficacy support a positive benefit-risk ratio for a specific area of application. In contrast, the Joint Clinical Assessment considers comparative clinical effects for HTA questions and does not decide whether a product may be placed on the market.<\/p>\n
The European report also does not replace a clinical guideline. It does not formulate a therapy recommendation and does not mandate the care practice of a Member State. Its task is narrower: it transparently records which clinical data are available for a previously described assessment question and how these data were methodologically evaluated. National bodies can draw different conclusions from this if their populations, comparators, or additional criteria deviate from one another.<\/p>\n
For developers, a distinction must also be made between a joint clinical assessment and joint scientific consultation. Consultation can provide early advice on evidence generation. The assessment takes place later on the basis of the submitted dossier and results in a report. A favorable consultation discussion therefore guarantees neither the selection of specific PICO questions nor a specific conclusion in the assessment report.<\/p>\n
A European assessment can therefore make the same clinical data set usable in several national procedures without centralizing national competencies. The decisive factor is the documented compatibility of the report with the respective national question.<\/p>\n
Study teams must recognize early on whether the chosen control arms and endpoints cover the subsequent European assessment questions. Relevant work arises during evidence mapping, the consistent presentation of the protocol, analysis populations, and results, as well as in responding to information requests. Data packages in which different Member States consider different standard therapies or different subgroups as relevant for decision-making are particularly demanding.<\/p>\n
Full-service CROs like Mediconomics support the translation of the development program into a structured EU HTA dossier, the preparation of study documents, and the tracking of queries in the assessment process. This includes medical writing for clinical evidence presentations, biostatistics for the transparent analysis of subgroups, and project management for coordinated versions of the submitted documents.<\/p>\n
Does a joint clinical report immediately count as a reimbursement commitment in Germany?<\/strong><\/p>\n No. The report can be taken into account in the German procedure, but it replaces neither the resolution of the Federal Joint Committee (G-BA) nor the subsequent price agreement.<\/p>\n Does the Joint Clinical Assessment also evaluate the price of a medicinal product?<\/strong><\/p>\n No. The subject is the scientific analysis of clinical evidence; pricing and other non-clinical assessment aspects remain the responsibility of the Member States.<\/p>\n Is a European Joint Clinical Assessment a marketing authorization?<\/strong><\/p>\n No. It is an HTA procedure and not a decision by regulatory authorities regarding the quality, safety, and efficacy of a medicinal product.<\/p>\n Joint Clinical Assessment is the procedure under the EU Health Technology Assessment Regulation in which the clinical evidence part of certain new health technologies is assessed jointly at the European level. Its result is a scientific report on the relative clinical effects in relation to the questions posed by the participating Member States. The report […]<\/p>\n","protected":false},"author":10,"featured_media":0,"parent":0,"template":"","meta":{"_acf_changed":false,"site-sidebar-layout":"default","site-content-layout":"","ast-site-content-layout":"default","site-content-style":"default","site-sidebar-style":"default","ast-global-header-display":"","ast-banner-title-visibility":"","ast-main-header-display":"","ast-hfb-above-header-display":"","ast-hfb-below-header-display":"","ast-hfb-mobile-header-display":"","site-post-title":"","ast-breadcrumbs-content":"","ast-featured-img":"","footer-sml-layout":"","ast-disable-related-posts":"","theme-transparent-header-meta":"","adv-header-id-meta":"","stick-header-meta":"","header-above-stick-meta":"","header-main-stick-meta":"","header-below-stick-meta":"","astra-migrate-meta-layouts":"default","ast-page-background-enabled":"default","ast-page-background-meta":{"desktop":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"ast-content-background-meta":{"desktop":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"tablet":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""},"mobile":{"background-color":"var(--ast-global-color-5)","background-image":"","background-repeat":"repeat","background-position":"center center","background-size":"auto","background-attachment":"scroll","background-type":"","background-media":"","overlay-type":"","overlay-color":"","overlay-opacity":"","overlay-gradient":""}},"footnotes":""},"glossary-cat":[28],"class_list":["post-8176","glossary","type-glossary","status-publish","hentry","glossary-cat-market-access-heor"],"acf":[],"related_terms":"","external_url":"","internal_reference_id":"","_links":{"self":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8176","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary"}],"about":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/types\/glossary"}],"author":[{"embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/users\/10"}],"version-history":[{"count":0,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary\/8176\/revisions"}],"wp:attachment":[{"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/media?parent=8176"}],"wp:term":[{"taxonomy":"glossary-cat","embeddable":true,"href":"https:\/\/mediconomics.com\/en\/wp-json\/wp\/v2\/glossary-cat?post=8176"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}Regulatory references<\/h2>\n
\n