Achieving equal and timely access to innovative anticancer drugs in the European Union (EU): summary of a multidisciplinary CECOG-driven roundtable discussion with a focus on Eastern and South-Eastern EU countries. Issue 6 (13th November 2019)

• Record Type: Journal Article
• Authors: Wilking, Nils; Bucsics, Anna; Kandolf Sekulovic, Lidlija; Kobelt, Gisela; Laslop, Andrea; Makaroff, Lydia; Roediger, Alexander; Zielinski, Christoph
• Is Part Of: ESMO open. Volume 4:Issue 6(2019)
• Publication Date: 2019-11-13
• Subjects: cancer drugs -- drug access -- regulatory approval -- early access to medicines -- study design -- benefit-risk assessment -- cancer care; Cancer -- Periodicals; 616.994005
• DOI: 10.1136/esmoopen-2019-000550
• Languages: English
• ISSNs: 2059-7029

Abstract

Abstract : The Central European Cooperative Oncology Group (CECOG) and 'ESMO Open—Cancer Horizons' roundtable discussion brought together stakeholders from several European Union (EU) countries involved in drug development, drug authorisation and reimbursement or otherwise affected by delayed and unequal access to innovative anticancer drugs. The approval process of drugs is well established and access delays can be caused directly or indirectly by national or regional decision-making processes on reimbursement. The two key aspects for those involved in reimbursement decisions are first the level of evidence required to decide and second pricing, which can be challenging for some innovative oncology compounds, especially in Eastern and South-Eastern European countries. Other important factors include: available healthcare budget; the structure and sophistication of healthcare authorities and health technology assessment processes; societal context and political will. From the point of view of the pharmaceutical industry, better alignment between stakeholders in the process and adaptive pathway initiatives is desirable. Key aspects for patients are improved access to clinical trials, preapproval availability and reports on real-world evidence. Restricted access limits oncologists' daily work in Eastern and South-Eastern EU countries. The roundtable discussion suggested considering the sequencing of regulatory approval and reimbursement decisions together with more flexible contracting as a possible way forward. The panel concluded that early and regular dialogue between all stakeholders including regulators, payers, patient stakeholders and industry is required to improve the situation.