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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.

Objective: Biosimilar policies with a focus on uptake have received a lot of attention at national and regional level in the last few years. It is now 10 years since the fi rst biosimilar was approved in the European Union, but do policies in the Member States take the differences between biological medicines and small-molecule generics into account? To map the policy landscape in Europe, European Biopharmaceutical Enterprises (EBE) has conducted a second round of its descriptive survey of pricing and reimbursement policies for off -patent biologicals. Methods: The EBE survey was conducted among national pharmaceutical trade associations in 32 countries, the 28 EU Member States plus Norway, Serbia, Switzerland and Turkey. The questionnaire was a revised version of the previous survey of 2014 and was developed by the EBE Biosimilars Working Group. It contained 44 questions about eight policy areas: Availability of biological medicines, Tendering, Health Technology Assessment, International Nonproprietary Name prescribing, Internal Reference Pricing, Substitution, Interchangeability and Quotas. Results: Responses were received from all national trade associations contacted. According to the responses, the majority of the 32 countries surveyed have specifi c policies for off -patent biologicals in place and therefore take account of the specifi cities of biologicals. Nevertheless, variations exist and refl ect the responsibilities in healthcare policy-making in Europe. In the majority of countries, treatment decisions remain in the hands of physicians. Compared to the fi rst EBE survey, shifts have been seen in the areas of substitution and interchangeability. Conclusion: The second EBE survey on biological medicines policies indicates that nearly all jurisdictions have policies in place that refl ect the diff erent nature of biological medicines. However, policies and their implementation vary among diff erent jurisdictions.

Background: Health literacy is increasingly being recognized as a widespread public health challenge in Europe. This commentary explores the importance of health literacy amongst cancer patients (ie, cancer literacy) and examines how cancer literacy can be improved through the practical application of health literacy principles within the context of providing timely, patient-centered, value-based care in Europe. Main body: Despite implementation of evidence-based cancer prevention programs and increased cancer survival rates, low cancer literacy may impact the personal capacity to manage risks and adversely impact behavior and outcomes. Cancer literacy poses a unique set of challenges compared to other types of health literacy, as patient decisions regarding screening, treatment, and side effect management are often complex, and timely decisionmaking is more critical. Accordingly, European health policies increasingly recognize the importance of health literacy. The European Patients Forum, European Cancer Patient Coalition, and the Association of European Cancer Leagues supported a joint statement, "Europe Let's Do More for Health," which emphasizes the need to empower citizens and patients by addressing health literacy, self-management, and shared decision-making. Implementation of comprehensive programs and strategies will be important to improve health literacy. Cancer literacy can be improved through application of health literacy principles in the communication and cooperation with professionals, patients and caregivers for providing timely, patient-centered, value-based care. Recommendations are made for further action to improve cancer literacy in Europe through coordinated efforts among providers, organizations, patients, and research. A policy paper developed by the European Joint Action on Cancer Control provides practical recommendations that Member States can take to reduce social inequalities in cancer care and defines focus areas that are closely connected with the need to improve cancer literacy. Conclusion: Improved personal cancer literacy combined with health literate organizations and systems can potentially improve the quality of care and health outcomes among patients with cancer. National Cancer Control Plans and Europe's Beating Cancer Plan can strengthen cancer literacy.

Background: In recent years, innovation in oncology has created new challenges for pricing and reimbursement systems. Oncology medicines with multiple indications face a number of access challenges: (1) the number of assessments and administrative burden; (2) aligning price to different values of the same product; (3) managing clinical uncertainty at time of launch; and (4) managing budget uncertainty. These challenges impact a range of stakeholders and can result in delayed patient access to life-saving treatments. Consequently, countries have taken steps to facilitate patient access. Methods: Drawing on the experience across Europe we have reviewed different mechanisms countries have adopted that address these challenges. These include approaches aimed directly at the issue, multi-year-multi-indication (MYMI) agreements (BE, NL), and other approaches to manage access: flexible access agreements for new indications with clinical uncertainty (UK); development of a new agreement for each new indication (IT); and immediate access for new indications and bundled assessments (DE). Results: MYMI agreements are valuable where existing rules mean that every indication faces the same upfront evaluation process that delays patient access. They are also useful in managing budget impact and uncertainty. Other approaches that adopt an indication-specific approach helps manage clinical uncertainty at the time of launch and realise different values for the same product. They can help align price to value, even though indication-based pricing does not exist. Bundled assessments reduce the administrative burden for stakeholders, and the benefits of immediate reimbursement is that patient access is not delayed. Conclusion: The challenges for medicines with multiple indications impact a range of stakeholders and can result in delayed patient access to life-saving treatments. MYMI agreements have created a more pragmatic approach to HTA for medicines with multiple indications to ensure both fast and broad patient access. Continued innovation in oncology will require further innovative approaches in pricing and reimbursement. It is important that policymakers, payers and manufacturers engage in early discussions and are willing to find new solutions to help accelerate patient access to innovative therapies.