ABOUT ECGP

The European Coalition for Access to Comprehensive Genomic Profiling (ECGP) is a multi-stakeholder coalition involving key stakeholders, including patients, clinicians, pathologists and representatives from advanced diagnostic and pharmaceutical companies. ECGP identifies and shares best practices and develops evidence-based policy recommendations on the clinical and economic utility of CGP for payers and other decision-makers, based on multi-stakeholder and multi-disciplinary perspectives.

Access to comprehensive genomic profiling in Europe is limited, with European cancer patients not having access to potentially life-changing targeted cancer treatments because current funding and reimbursement frameworks do not allow for routine testing for all relevant cancer mutations.

In alignment with flagship initiatives of Europe’s Beating Cancer Plan and recommendations of the EU Mission on Cancer, ECGP 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 three million people by 2030.

Adoption of Comprehensive Genomic Profiling is limited in Europe

Significant advances have been made in both genomic testing and the development of targeted therapies and immunotherapies for cancer patients over the last decade based on our increased understanding of cancer and the impact of the individual genomic makeup of each patient’s tumour. We now know that a variety of genomic alterations in a broad number of genes can drive cancer growth. CGP can accurately detect these relevant genomic alterations across a large number of genes compared to standard diagnostic tests which are narrow in scope and therefore potentially miss clinically relevant mutations.

We have the ambition to deliver the right treatment to the right patient at the right time – with widespread adoption of personalised medicine, the potential is enormous to derive significant benefit to patients and to healthcare systems alongside more targeted and efficient use of resources. Today, this rapid technological advancement is not fully adopted in clinical practice due to access for patients to comprehensive genomic profiling remaining limited. 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 limited1.

Unlocking access to precision oncology through funding and reimbursement of CGP

Adoption of CGP is a necessary step towards the 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 the lack of essential clinical supporting infrastructure in Europe2.

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 facilitating equal and rapid access to advanced diagnostics alongside personalised therapies3.

ECGP’s objectives

ECGP’s objective is to support wider CGP coverage and reimbursement in view of the development of personalised medicine.

ECGP’s policy recommendations

Comprehensive Genomic Profiling (CGP) enables the selection of appropriate treatment options for patients when available, thereby avoiding the use of less suitable treatments.
  • Engagement programmes: Engage with policymakers about the true value of CGP compared to other diagnostics techniques, including hotspot panels, in collaboration with medical soceities and patient advocacy groups.
  • Awareness campaigns: Develop and launch public awareness campaigns to inform patients and the general public about the availability and benefits of CGP, in collaboration with patient advocacy groups.
  • Information campaigns: Develop and launch information campaigns to inform healthcare practitioners on how to utilise CGP and understand the clinical data report, in collaboration with medical societies.
Swift adoption of CGP requires clear funding and reimbursement pathways, both of which are currently lacking.
  • Assessment framework: Develop standardized assessment frameworks for CGP across Europe in line with HTA standards, with clear and transparent evaluation criteria that focus on the timely evaluation of the benefits of CGP in indications where this is not established yet.
  • Flexible reimbursement methods: For indications where current evidence is sufficient e.g., cancer of unknown primary (CUP) and non-small cell lung cancer (NSCLC), evaluate the use of CGP in clinical practice for coverage in public health insurance.
  • Funding: For indications where more evidence is needed, allocate EU and national funds to support CGP utilisation in pilot programmes and studies for gathering evidence. Funding can be facilitated through innovative solutions such as co-financing with research funding for temporary coverage. This approach aims to kick-start the use of GCP which enables data collection without promising full funding. The collected evidence can then be used for a thorough evaluation to support long-term reimbursement.
Optimal implementation of CGP requires inclusion in guidelines, enhanced (data) infrastructure, sufficient qualified professionals and fair procurement policies.
  • Guidelines: Advocate for the inclusion of CGP in national treatment guidelines of medical societies and install Molecular Tumour Boards (MTBs).
  • Infrastructure and data integration: Invest in enhancing existing infrastructures and support the European Health Data Space to facilitate CGP data integration into clinical workflows.
  • Data standards: Develop and implement standardized protocols for CGP data collection across EU member states, for effective cross-country comparison.
  • People: Attract and retain professionals in the genomic health sector, initiate training development by In Vitro Diagnostics (IVD) providers and professional societies, and evolve reporting and analytics tools to ensure they are easy to use.
  • Procurement policies: Develop fair and transparent procurement policies that foster long-term competition among IVD suppliers and laboratories, prioritizing quality and value for money.
Cancer care outcomes can improve rapidly through enhanced collaboration among policymakers, industry, healthcare professionals, and patient advocacy groups, with CGP as a key enabler.
  • Policy forums and joint initiatives: Establish regular policy forums and launch joint initiatives that bring together policymakers, industry leaders, healthcare professionals, and patient advocacy groups to discuss and develop CGP strategies.
  • Performance metrics and funding mechanisms: Enhance pan-European policy frameworks with improved metrics for implementation, linking financial resources and operational strength to project acceleration in personalized cancer care.
  • Collaborative networks: Establish collaborative networks (between academia, industry, suppliers) at national and regional levels to collaboratively work on implementation of CGP in clinical practice, facilitate knowledge sharing and rapid dissemination of best practices.
  • Inclusive design: Involve all relevant stakeholders (e.g. policy-makers, payers, HTA agencies, industry stakeholders, healthcare professionals and societies, patient organisations and patients) in designing and implementing optimal care pathways.
Frequently asked questions (FAQ) about ECGP

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).

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.

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.

Who are the companies supporting ECGP?

The companies supporting ECGP are Amgen, Exact Sciences, Guardant, Illumina, Labcorp, Menarini Stemline, MSD and Novartis.

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.

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.

ECGP will achieve its goal 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.
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.

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.

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.

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.

How does ECGP contribute to Europe’s Beating Cancer plan and EU’s Mission on Cancer?

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.

  1. Normanno et al (2022): “Access and quality of biomarker testing for precision oncology in Europe” European Journal of Cancer. 176:70-77. ↩︎
  2. EUCOPE (2021): Developing an Advanced Diagnostics Ecosystem in Europe: A Proposal for Change. https://www.eucope.org/wp-content/uploads/2021/03/eucope-advanced-diagnostics-white-paper.pdf ↩︎
  3. European Parliament (2022): European Parliament resolution of 16 February 2022 on strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy. 2020/2267(INI) https://www.europarl.europa.eu/doceo/document/TA-9-2022-0038_EN.html ↩︎