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.

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.

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© Author (s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. Published by BMJ on behalf of the European Society for Medical Oncology.

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Competing interests: The current work of AB (for MoCA and as unpaid expert for the Austrian Federal Administrative Court) informs about payers’ attitudes/concerns regarding the reimbursement of expensive medicines. However, the opinions expressed here cannot be construed as an official position of any payer organisation. LKS received relevant financial funding for activities outside the submitted work, which are speaker’s fees from Roche, Novartis, BMS and MSD. GK received relevant financial funding outside the submitted work from MSD. AL: the views expressed in this article are the personal views of the the co-author and may not be understood or quoted as being made on behalf of or reflecting the position of the European Medicines Agency or one of its committees or working parties. LM is a paid employee of Fight Bladder Cancer UK, and a volunteer board member of the World Bladder Cancer Patient Coalition. Fight Bladder Cancer UK has received financial support from BMS, Janssen, MSD and F. Hoffman-La Roche AG. The World Bladder Cancer Patient Coalition has received financial support from AstraZeneca, Bayer, F. Hoffman-La Roche AG, Janssen, Ipsen, MSD and Photocure. AR is an employee of MSD International and owns shares of MSD. MSD has supported this meeting together with Boehringer Ingelheim. NW received project grants and consulting and speaking fees from a large number of pharmaceutical companies, including MSD. CZ received honoraria from Roche, Novartis, BMS, MSD, Imugene, Ariad, Pfizer, Merrimack/Shire, Merck KGaA, Fibrogen, AstraZeneca, Tesaro, Gilead, Servier, Eli Lilly and Amgen.