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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.

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.

SUBMITTER: Wilking N

PROVIDER: S-EPMC6863652 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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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.

Wilking Nils N Bucsics Anna A Kandolf Sekulovic Lidlija L Kobelt Gisela G Laslop Andrea A Makaroff Lydia L Roediger Alexander A Zielinski Christoph C

ESMO open 20191113 6

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 reimburs ...[more]

PMID: 31798977

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Project description:ContextCancer and its treatments cause fatigue in up to 90% of men with advanced prostate cancer. As men with prostate cancer are surviving longer, cancer-related fatigue is becoming increasingly important for clinicians to understand and proactively manage.ObjectiveThe aim of this work is to identify knowledge gaps that may support healthcare professionals to recommend personalised fatigue management strategies.Evidence acquisitionThis manuscript is based on a roundtable discussion held during the European Association of Urology 2022 Annual Symposium, combined with a review of the literature. Five core themes were generated from the roundtable: (1) meaning of fatigue in prostate cancer patients, (2) impact of fatigue, (3) association between fatigue and treatment selection, (4) benefits of managing fatigue, and (5) barriers to exercise.Evidence synthesisCancer-related fatigue has complex underlying aetiology and is a subjective experience that may be under-reported. Some studies have shown that techniques such as education, cognitive behavioural therapy, guided imagery, and progressive muscle relaxation can result in clinically meaningful improvements in fatigue. However, the largest body of evidence, and a theme echoed in the roundtable discussions, was the benefit of exercise on fatigue. Despite the benefits of exercise, for some men, objective barriers to exercise exist and knowledge of benefits does not automatically translate into implementation and adherence.ConclusionsUnderstanding the specific health needs of individual patients and their desired health outcomes is essential to identify personalised strategies for minimising fatigue. As an outcome of the roundtable meeting, we developed a quick reference guide for healthcare providers. A high-resolution copy can be downloaded from https://patients.uroweb.org/library/fatigue-in-prostate-cancer-patients-guide/.Patient summaryThis article is based on dialogue between a group of specialists, patients, and caregivers, which took place at a roundtable meeting during the European Association of Urology 2022 Annual Symposium. The group discussed how healthcare providers can best support their patients who experience fatigue. The group subsequently developed a guide to help healthcare providers during appointments.

Dataset Information

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.

Publications

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.

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