The European Coalition for Access to Comprehensive Genomic Profiling (ECGP) is a new initiative made up of industry association the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), molecular diagnostics firms Exact Sciences and Guardant Health, sequencing platform provider Illumina, and drugmakers MSD and Novartis. Here, the coalition lays out its aims for improving the access and reimbursement of comprehensive genomic profiling in Europe.

 

Precision oncology, defined as the right treatment for the right patient at the right time, is a paradigm shift in the traditional one-size-fits-all approach to therapies, a radical change in how we approach patient care. Instead of treating cancer based on the location or origin of the tumour in the body, treatments specifically target molecular or genomic alterations in the tumour, sometimes even regardless of the location of the tumour itself.

In light of this new approach towards personalised patient care, molecular diagnostics have played an increasing role in guiding physician decisions toward timely, accurate diagnosis and selection of optimal targeted therapeutic and/or immunotherapeutic approaches for the management of patients with cancer. These approaches may be considered upfront or may be considered after the patient has already undergone several lines of treatment, when oftentimes standard combinations of chemotherapy agents and radiotherapy may not be suitable.

Targeted treatments require testing multiple gene mutations (e.g., EGFR, BRAF, KRAS), fusions (e.g., ALK, ROS1, NTRK1-3), and/or emerging complex biomarkers, so-called “mutational signatures”, such as Tumour Mutational Burden (TMB), Microsatellite Instability (MSI) and Homologous Recombination Deficiency (HRD). Various existing molecular approaches to identifying genetic variants and biomarkers in cancer include iterative single-gene testing using immunohistochemistry (IHC), Polymerase Chain Reaction (PCR) and Fluorescence In Situ Hybridisation (FISH); Hotspot panel testing approaches (+FISH and other approaches for some biomarkers that are not captured in small panels); and Next-Generation Sequencing (NGS)-based Comprehensive Genomic Profiling (CGP).

The benefits of precision medicine-based treatment approaches have been demonstrated in numerous clinical studies and meta-analyses and are supported by clinical practice guidelines. Precision oncology puts patients first, deploying tailored diagnostics and treatments, enabling timely interventions, and providing options when standard of care no longer helps.

 

Demonstrating the Value of Personalised Medicine

The future promise of precision oncology is to bring even greater value considering the demographic trends and the pressures on healthcare systems. By detecting diseases earlier, efficiently improving diagnosis accuracy and tailoring treatment plans for patients, precision oncology has cost-saving potential for the health system, improving patient outcomes while also reducing unnecessary treatment side effects.

Several publications demonstrate the value of precision oncology for patients, healthcare systems and societies:

  • An EU-funded project recently demonstrated the benefits of prescribing targeted treatments to patients based on their genetic information. In this groundbreaking research looking at clinical practices across Europe, the power of using personalised approaches to select and correctly apply pharmaceuticals to patients is demonstrated.
  • Another study focused on Non-Small Cell Lung Cancer (NSCLC) demonstrated that the broad use of biomarker testing and precision medicine in oncology leads to more efficient treatment assignment and improves health outcomes for patients globally, in particular prolonged progression-free disease and overall survival(1).

Whilst the benefits of precision oncology have been demonstrated, its routine implementation in clinical practice is lacking. To address access challenges and realise the promise of precision oncology, we need policies to facilitate appropriate infrastructure for testing, enable timely and adequate funding of molecular diagnostics and targeted treatments for cancer patients today, and lay the groundwork for a resilient health system that prevents, diagnoses, and treats cancers earlier, efficiently and sustainably.

We need to re-think the relationship between testing and treatment.

 

The Adoption of Comprehensive Genomic Profiling is limited in Europe

There is currently policy momentum in Europe (Europe’s Beating Cancer Plan;  EU Mission: Cancer) and there are several initiatives aiming at enabling uptake of precision oncology. For example, there are important EU-wide initiatives focusing on genomics infrastructure and capacity building, on developing databases bridging genomic data with clinical insights, and, overall, on building increased understanding of the underlying technologies (2;3;4;5;6). Several projects funded by the European Commission drive an important cultural shift in national healthcare systems, underlining the potential cost-effectiveness of applying genomics in diagnostics, prevention, and treatment. (7; 8).

Academic-driven groups tend to focus their efforts on awareness raising, strengthening the knowledge base, and gathering evidence to support patient access to precision oncology. Their activities tackle operational challenges, ranging from e.g., capacity building and quality control in the laboratory, to establishing tumour boards, and facilitating access to clinical trials (10). So, with all of these positive developments, is there a ‘white space’ for a new coalition? We think so, and with the European Coalition for Access to CGP, our ambition is to deliver the right treatment to the right patient at the right time.

While progress has been made in making molecular 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 (10).

 

ECGP: The European Coalition for Access to Comprehensive Genomic Profiling    

For this reason, EUCOPE – the European Confederation of Pharmaceutical Entrepreneurs along with Exact Sciences, Guardant Health, Illumina, MSD and Novartis, launched the European Coalition for Access to Comprehensive Genomic Profiling (ECGP), to improve cancer care through increased routine clinical access and reimbursement of CGP.

The objective of the coalition is to create multi-stakeholder outputs, raise awareness on the role of CGP, promote the exchange of best practices to foster the use of CGP in clinical practice, gather clinical, economic, and operational evidence to evolve funding and Pricing & Reimbursement frameworks leading to wider CGP adoption.

This structure of the Coalition is unique in the precision oncology space: a Steering Group-led initiative with equal leadership amongst stakeholders representing all relevant constituents (clinicians, pathologists, patients, former payers, health economists and both pharmaceutical and diagnostic companies) with a hub & spoke model which will mean that work to impact the national level access landscape can happen in tandem with pan-European thought-leadership and strategic guidance, linking to policy and political priorities.

Given that not all healthcare systems have the same level of maturity when implementing precision oncology, there is, in ECGP, the opportunity to share experiences and to find a true ‘European’ solution to the barriers to CGP access, via representation of Member States to unlock CGP coverage at the national level and facilitate its adoption in the clinical setting.

Multifaceted issues require a multistakeholder approach to be tackled: ECGP is uniquely positioned to do that, leveraging regional and national expertise for multi-stakeholder consensus-driven solutions to CGP value recognition challenges.

In the coming months, ECGP will be inviting interested stakeholders to become involved, to co-create solutions and progress the adoption of CGP in Member States. If you would like more information or are interested in joining ECGP, please contact: Matias Olsen (olsen@eucope.org)

 

References

  1. Hofmarcher T, Malmberg C and Lindgren P (2023) A global analysis of the value of precision medicine in oncology – The case of non-small cell lung cancer. Med. 10:1119506. doi: 10.3389/fmed.2023.1119506
  2. European ‘1+ Million Genomes’ Initiative | Shaping Europe’s digital future (europa.eu)
  3. Beyond One Million Genomes (B1MG) project (b1mg-project.eu)
  4. How the project is organised | Beyond 1 Million Genomes (B1MG) (b1mg-project.eu)
  5. ICPerMed ‘Family’ – Related Initiatives and ERA-Nets – ICPerMed
  6. HEcoPerMed – Health Economic Models for Personalised Medicine
  7. Project – Can.Heal (canheal.eu)
  8. https://www.matrix-fkb.no/en/pcm4eu/home
  9. Translational Research & Personlised Medicine Working Group (esmo.org)
  10. Normanno N et all (2022) Access and quality of biomarker testing for precision oncology in Europe. Elsevier Ltd https://doi.org/10.1016/j.ejca.2022.09.005