Frequently Asked Questions (FAQ) about ECGP
EUCOPE with Exact Sciences, Guardant Health, Illumina, MSD and Novartis, launched the European Coalition for Access to Comprehensive Genomic Profiling (ECGP) in May 2023. Below are some frequently asked questions (FAQ) about the partnership and our efforts to improve cancer care through increased routine clinical access and reimbursement of Comprehensive Genomic Profiling (CGP)
Frequently Asked Questions (FAQ)
- 1. What is the European Coalition for Access to Comprehensive Genomic Profiling (ECGP)?
ECGP is a multi-stakeholder coalition created under the auspices of EUCOPE, the European Confederation of Pharmaceutical Entrepreneurs. Our commitment is to lead and engage in partnerships spanning across the entire medicine lifecycle to find actionable solutions that benefit our members, the patients they serve, and healthcare systems overall. The European coalition is modelled on a similar collaborative coalition that has been set-up in the U.S., called Access to Comprehensive Genomic Profiling (ACGP). We believe that ECGP, as a multi-stakeholder coalition, will address an important access gap for European cancer patients and help complete the picture on personalised medicine by opening the door to biomarker testing.
- 2. What is Comprehensive Genomic Profiling (CGP)?
CGP is a method of testing tumours that utilises next-generation sequencing (NGS) to detect the main classes of genomic alterations and signatures in the full exonic region of genes known to drive cancer growth and identify patient eligibility for clinical trials, targeted therapies, and immunotherapies.
- 3. Who are the founding companies of ECGP?
The founding companies of ECGP are Exact Sciences, Guardant Health, Illumina, MSD and Novartis.
- 4. Why has ECGP been created?
Clinical practice is rapidly evolving with increased uptake of precision medicine and the ability to conduct large-scale, high-quality genetic and genomic profiling of patients. The health benefits of genomics and advanced genomic testing – including CGP – are significant. CGP enables targeted therapeutic interventions based on an unprecedented understanding of the underlying molecular characteristics of patients, hence improving disease outcome. However, its adoption in clinic and healthcare systems is mixed, and the rate of uptake in Europe is falling behind other regions globally. While important progress has been made in making genomic tests based on single biomarkers or a limited number of genes available to patients in Europe – access to more comprehensive tests like CGP is much more limited
- 5. What does ECGP want to achieve?
ECGP is a partnership to improve cancer care through increased routine clinical access and reimbursement of CGP. It aims to develop and communicate detailed, evidence-based educational materials on the clinical and economic utility of CGP to Payers and decision-makers, based on multi-stakeholder and multi-disciplinary perspectives. ECGP may also release recommendations for increased access to CGP that will contribute to increasing awareness, building a framework for reimbursement evaluations and drive prioritisation of preparing healthcare systems in terms of capacity and capability in reimbursing and adopting CGP for cancer patients.
ECPG will achieve its goals by:
- Gathering case studies from European countries on the use of CGP, and benchmarking between markets with the aim to share best practices between countries.
- Leading multi-stakeholder discussions about the value of CGP and the challenges posed by the regulatory, healthcare systems, HTA bodies and payers on its uptake and reimbursement.
- Making proposals and facilitating advanced in policy and decision-making (regulators, HTA bodies, Payers, patients, clinicians, laboratories, industry and other relevant stakeholders) through the organisation of events, bringing together the different perspectives and ensuring that patients’ voices are heard.
- 6. Who is the ECGP targeted at?
ECGP is aimed at decision-makers and payers at the Member State level who are involved in funding and reimbursement decisions that decide patients’ access to genomic sequencing.
- 7. Who can participate in ECGP?
ECGP is a multi-stakeholder partnership. It is in principle open to engagement with any individual or organisation that expresses an interest in raising awareness, fostering effective dialogue and providing evidence-based policy recommendations around genomic sequencing and personalised medicine uptake at above-country and (relevant) national level. Industry members of ECGP include advanced diagnostic companies that developed CGP assays and pharmaceutical companies that develop targeted therapeutics that rely on genomic testing for identifying patients for clinical trials, target therapies and immunotherapies.
- 8. Who are the stakeholders participating in ECGP?
ECGP strives for an equal representation from the key stakeholders, including patients, clinicians, and pathologists and a balanced representation of advanced diagnostic and pharmaceutical companies in its membership.
- 9. How does ECGP work?
ECGP is a joint working initiative of all participants, overseen by the Steering Group. The Steering Group is made up of the different stakeholders who are members of ECGP, and reviews and approves the annual work programme and the joint work of the Coalition.
ECGP also aims to establish a network of chapters at the country level, in order to implement its goals. The Steering Group will be involved in the creation, designation and strategic oversight of the National Spokes.
EUCOPE’s Member companies in ECGP provide the financial support to the Coalition, by engaging and providing funding in the form of an annual membership fee to an independent third-party secretariat.
- 10. How does ECGP contribute to Europe’s Beating Cancer plan and EU’s Mission on Cancer
In alignment with flagship initiatives of Europe’s Beating Cancer Plan and recommendations of the EU Mission on Cancer, EUCOPE advocates for sound public policy that supports innovation, while fostering a community built on a shared purpose: improving and saving the lives of European patients through innovative therapies and medical technology, contributing to the vision of the Cancer Mission of improving the lives of more than 3 million people by 2030.
Adoption of CGP is a necessary step towards the successful delivery of personalised medicine, which as recognised in Europe’s Beating Cancer Plan, brings value to patients, healthcare systems and societies. The overall adoption of advanced diagnostics in the clinic and healthcare systems is still limited in scale however, due to their value not being sufficiently recognised, the lack of pathways for appraisal that are time-bound and fit-for-purpose and lack of essential clinical supporting infrastructure in Europe.
ECGP aims to ensure that the political commitment of Europe’s Beating Cancer Plan and EU’s Cancer Mission to “leave no stone unturned to take action against cancer” is met at the Member State level, where decisions on funding and reimbursement are made. The European Parliament has called on EU Member States to increase access to genomic testing by earmarking financing and creating clear pathways for fast and efficient reimbursement and to facilitate equal and rapid access to advanced diagnostics alongside personalised therapies.