{"id":172588,"date":"2025-11-10T05:10:10","date_gmt":"2025-11-10T05:10:10","guid":{"rendered":"https:\/\/www.europesays.com\/ie\/172588\/"},"modified":"2025-11-10T05:10:10","modified_gmt":"2025-11-10T05:10:10","slug":"eu-reform-aims-to-fast-track-cancer-drug-access","status":"publish","type":"post","link":"https:\/\/www.europesays.com\/ie\/172588\/","title":{"rendered":"EU Reform Aims to Fast-Track Cancer Drug Access"},"content":{"rendered":"

At the European Society for Medical Oncology (ESMO) Annual Meeting 2025<\/a>, held recently in Berlin, experts presented an early evaluation of the European Health Technology Assessment (HTA) Regulation, which took effect on January 12, 2025. For the first time, the regulation formally includes clinicians and patients in joint evaluations of new medicines \u2014 aiming to accelerate and harmonize access to innovative treatments across EU member states.<\/p>\n

Shared Framework for Europe<\/p>\n

Maya Matthews, MSc, head of the HTA Unit at the European Commission, discussed the reform\u2019s impact during a session on the future of health technology evaluation. \u201cWe are a new player on the scene,\u201d Matthews said. \u201cThe regulation has been in force for only 10 months, but it already represents a fundamental shift in how Europe assesses medicines.\u201d<\/p>\n

The EU\u2019s new framework introduces Joint Clinical Assessments (JCAs), which will involve HTA agencies from all member states. Unlike before \u2014 when each country conducted its own evaluations \u2014 the process will now run in parallel with the European Medicines Agency (EMA) authorisation, aiming to publish a relative effectiveness report within a month of market approval.<\/p>\n

\u201cThe idea is simple but powerful: data are global, decisions remain local,\u201d Matthews explained. \u201cWe are pooling clinical evidence so that all member states can access high-quality data when making national pricing and reimbursement decisions.\u201d<\/p>\n

Implementation will follow a phased approach. During the first 3 years, all new oncology therapies and advanced therapy medicinal products will undergo joint assessment. Starting in 2028, the process will extend to orphan drugs for rare diseases, and by 2030, it will cover all centrally authorized medicines. High-risk medical devices are expected to join the system in 2026.<\/p>\n

Patients and Clinicians at the Table<\/p>\n

The process for selecting experts is designed to be rigorous yet inclusive. Once a new product is identified for evaluation, the European Commission consults the HTA Stakeholder Network \u2014 a group of 71 organisations (36% representing patients and 29% healthcare professionals) \u2014 to nominate appropriate experts. Candidates must submit a CV and declaration of interests, which are carefully reviewed before appointment.<\/p>\n

Monica Racovita, policy manager at Myeloma Patients Europe, explained what \u201cmeaningful\u201d patient involvement in HTA means. \u201cIt\u2019s not about passive participation,\u201d she said. \u201cIt\u2019s about being true partners in decision-making. Patients bring unique knowledge, perspectives, and experiences that can inform HTA recommendations and improve their quality.\u201d<\/p>\n

Racovita outlined three levels of patient expertise: individuals with firsthand experience of a disease; representatives of patient organisations who understand community-wide needs; and patient experts with technical knowledge of research, development, and regulation. \u201cIdeally, we need people who combine personal experience of illness with an understanding of the regulatory environment,\u201d she said.<\/p>\n

Patient participation can take place at multiple stages \u2014 from clinical trial design and defining the scope of assessments to submitting evidence, serving as expert reviewers on HTA committees, and commenting on draft reports.<\/p>\n

Challenges of Implementation<\/p>\n

Beate Wieseler, PhD, head of the Drug Assessment Department at IQWiG (Germany\u2019s Institute for Quality and Efficiency in Health Care), offered a pragmatic perspective on the challenges ahead, drawing from Germany\u2019s extensive experience in evaluating medicines.<\/p>\n

\u201cThe central question is: How do we define the goals of the assessment?\u201d she asked. The process begins with establishing the PICO framework \u2014 Population, Intervention, Comparator, Outcome \u2014 which determines the key clinical questions the evaluation must answer.<\/p>\n

Wieseler noted that differences among EU countries in access to and use of oncology drugs could complicate the development of a common PICO. \u201cAcross Europe, we see substantial variability: some countries reimburse 90% of new oncology indications, others less than 50%. The time from EMA approval to reimbursement ranges from a few months to more than 3 years,\u201d she said.<\/p>\n

She cited durvalumab for hepatocellular carcinoma as an example. Some member states compare it with atezolizumab\/bevacizumab or sorafenib, while others include transarterial chemoembolisation as an additional comparator. \u201cThese differences stem from structural variations in national health systems,\u201d Wieseler explained. \u201cThe availability of a JCA report will address only some of these disparities.\u201d<\/p>\n

Still, she emphasized that member states must define the scope of each JCA to ensure its relevance. \u201cTo inform national decisions, the JCA report must address questions that matter within different national contexts. The regulation ensures this by requiring that these priorities be defined by the member states themselves,\u201d she said.<\/p>\n

Barriers to Patient Participation<\/p>\n

Despite the momentum surrounding the new regulation, several challenges remain. Racovita highlighted that strict conflict-of-interest rules could unintentionally exclude some of the most knowledgeable patients \u2014 those who have previously collaborated with industry or taken part in clinical trials. \u201cAny prior involvement with industry raises concerns, which removes some of the most qualified patient experts from the process,\u201d she said.<\/p>\n

Tight feedback deadlines \u2014 often as short as 1 week \u2014 make it difficult for patients to provide meaningful input. The use of English as the sole working language also limits participation from non-English-speaking countries. In addition, early-stage patient involvement remains optional, missing key opportunities to influence the formulation of clinical questions from the outset.<\/p>\n

Another unresolved issue is how to systematically integrate patient input into evaluations. Wieseler underscored the importance of patient-reported outcomes (PROs): \u201cWe already have a well-established methodology for involving patients \u2014 the PROs. They allow us to gather robust data on health-related quality of life and symptoms directly from patients. If PROs are collected in well-designed trials, they are the best way to bring the patient\u2019s voice into evaluation.\u201d<\/p>\n

Racovita agreed, adding, \u201cPROs are the best tools we have \u2014 if they are well designed, standardized, and transparently reported. The problem is that PRO data are often missing or difficult to find in clinical trial reports.\u201d<\/p>\n

Looking Ahead<\/p>\n

The first JCAs began in March 2025, with the list of evaluated products regularly updated on the EU\u2019s dedicated HTA website. The first Joint Scientific Consultations (JSCs) \u2014 which offer early regulatory and development guidance for drug developers \u2014 have also produced their initial reports.<\/p>\n

\u201cWe\u2019re learning from the early JCA and JSC experiences,\u201d said Matthews. \u201cThe goal now is to raise awareness of the HTA regulation among companies, patients, and clinicians, and to build capacity through education and training.\u201d<\/p>\n

Patient expectations are high. \u201cWe hope that better use of time, effort, and resources will lead to faster inclusion of innovative therapies in reimbursement schemes \u2014 and thus faster access for patients,\u201d Racovita said. \u201cAnd we hope that the mandatory involvement of patients in European HTA will inspire similar participation at the national level.\u201d<\/p>\n

Examples from France, where patient representatives at the Haute Autorit\u00e9 de Sant\u00e9 have voting rights, and from the UK, where NICE has required patient experts in drug assessments since 2013, demonstrate that such integration is feasible.<\/p>\n

The overarching challenge, as highlighted during the ESMO session, will be balancing scientific rigor, inclusivity, and timeliness \u2014 ensuring that the voices of patients and clinicians genuinely inform better decisions on access to innovative therapies for all European citizens.<\/p>\n

This story was translated from Univadis Italy<\/a>, part of the Medscape Professional Network.\u00a0<\/p>\n","protected":false},"excerpt":{"rendered":"At the European Society for Medical Oncology (ESMO) Annual Meeting 2025, held recently in Berlin, experts presented an…\n","protected":false},"author":2,"featured_media":172589,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[275],"tags":[110,13007,10722,10724,10723,10726,18,1015,11563,135,475,3953,98502,98501,19419,3954,474,98503,19,17,13006,13008,98500,10725,3911],"class_list":{"0":"post-172588","1":"post","2":"type-post","3":"status-publish","4":"format-standard","5":"has-post-thumbnail","7":"category-healthcare","8":"tag-cancer","9":"tag-carcinoma","10":"tag-clinical-research","11":"tag-clinical-studies","12":"tag-clinical-trials","13":"tag-double-blind-study","14":"tag-eire","15":"tag-europe","16":"tag-european","17":"tag-health","18":"tag-health-care","19":"tag-health-care-access","20":"tag-health-care-reform","21":"tag-health-care-services","22":"tag-health-services","23":"tag-health-services-accessibility","24":"tag-healthcare","25":"tag-healthcare-reform","26":"tag-ie","27":"tag-ireland","28":"tag-malignant-neoplasia","29":"tag-malignant-neoplasm","30":"tag-orphan-drugs","31":"tag-pre-clinical-trial","32":"tag-revenue-and-practice-management-practice-management-revenue"},"share_on_mastodon":{"url":"https:\/\/pubeurope.com\/@ie\/115523683771827382","error":""},"_links":{"self":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/172588","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/comments?post=172588"}],"version-history":[{"count":0,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/posts\/172588\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media\/172589"}],"wp:attachment":[{"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/media?parent=172588"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/categories?post=172588"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.europesays.com\/ie\/wp-json\/wp\/v2\/tags?post=172588"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}