CGP Evidence Playbook

Comprehensive Genomic Profiling (CGP) in European Precision Oncology

Comprehensive Genomic Profiling (CGP) has become an important enabler of precision oncology, allowing clinicians to move beyond single biomarkers and small gene panels towards broader genomic testing capable of detecting multiple classes of genomic alterations and signatures in a single test.

However, demonstrating analytical performance alone is not enough to achieve widespread clinical adoption. Across Europe, successful access to CGP increasingly depends on robust evidence demonstrating clinical utility, economic value, healthcare system impact and relevance to Health Technology Assessment (HTA) and reimbursement decisions.

The CGP Evidence Playbook provides diagnostic manufacturers, biotechnology companies, pharmaceutical organisations and market access teams with a practical framework for understanding the evidence required to support Comprehensive Genomic Profiling adoption and reimbursement in Europe.

The Playbook connects the global evidence base for CGP with the expectations of European payers and healthcare decision-makers, helping organisations translate scientific evidence into effective evidence generation and market access strategies.

Key Insights

Why CGP Evidence Generation Matters

Comprehensive Genomic Profiling can provide a broader molecular characterisation of cancer than more limited genomic testing approaches, helping identify actionable genomic alterations and potential treatment opportunities.

Yet the availability of the technology does not automatically translate into reimbursement or routine clinical implementation. European payers and healthcare decision-makers need to understand whether CGP generates meaningful value within real healthcare pathways.

For organisations developing or commercialising CGP solutions, evidence generation therefore needs to address several interconnected dimensions:

• Analytical validity and test performance
• Clinical validity of identified genomic alterations
• Clinical utility and impact on treatment decisions
• Patient outcomes and access to matched therapies
• Cost-effectiveness and budget impact
• Healthcare resource utilisation
• HTA and reimbursement requirements
• Real-world evidence generation
• Operational feasibility and healthcare system implementation

A coordinated CGP evidence strategy can help bridge the gap between scientific innovation, payer expectations, reimbursement and sustainable clinical adoption.

What Evidence Do European Payers Need for CGP?

Regulatory evidence and payer evidence answer different questions. While regulatory assessment focuses strongly on whether a diagnostic performs as intended, payers and HTA bodies need to understand whether introducing CGP creates meaningful clinical and economic value for patients and healthcare systems.

A comprehensive CGP market access strategy should therefore consider four fundamental evidence areas:

• Analytical Validity – Evidence of sensitivity, specificity, reproducibility and analytical performance.
• Clinical Validity – Evidence demonstrating the relationship between genomic findings and clinically relevant disease characteristics or treatment response.
• Clinical Utility – Evidence showing whether CGP-guided decisions influence treatment selection, patient management and health outcomes.
• Economic Value – Evidence addressing cost-effectiveness, budget impact and healthcare resource utilisation compared with existing diagnostic pathways.

What the CGP Evidence Playbook Covers

The CGP Evidence Playbook provides a structured analysis of the evidence required to support the adoption, reimbursement and implementation of Comprehensive Genomic Profiling, translating the global CGP evidence base into a practical European market access perspective.

• Clinical Utility of CGP – Analysis of diagnostic yield, analytical characteristics, clinical evidence and the ability of genomic findings to influence treatment decisions.
• Economic Value of CGP – Assessment of cost-effectiveness, budget impact, diagnostic pathway costs, resource utilisation and the broader economic implications of CGP implementation.
• European HTA & Reimbursement – Analysis of payer expectations, reimbursement considerations and evidence requirements affecting CGP access in European healthcare systems.
• CGP Implementation – Consideration of the operational requirements and healthcare resources needed to integrate Comprehensive Genomic Profiling into routine clinical practice.
• Evidence Gaps & Strategic Recommendations – Identification of evidence challenges and strategic considerations for organisations developing CGP evidence and market access strategies.
• Practical Tools & Templates – Action-oriented resources designed to support evidence readiness, payer engagement and reimbursement planning.

What You Will Get in the CGP Evidence Playbook

Clinical Utility of Comprehensive Genomic Profiling

The clinical value of Comprehensive Genomic Profiling extends beyond its ability to identify genomic alterations. For healthcare decision-makers, the critical question is whether the information generated by CGP translates into meaningful changes in clinical management and patient outcomes.

The CGP Evidence Playbook examines clinical utility from several perspectives:

• Diagnostic Yield – The ability of broader genomic profiling to identify clinically relevant alterations compared with more limited testing approaches.
• Treatment Matching – How genomic findings can help identify potential targeted treatment and clinical trial opportunities.
• Clinical Decision-Making – Evidence demonstrating whether CGP results influence treatment selection and patient management.
• Patient Outcomes – Assessment of evidence linking CGP-guided treatment strategies with clinically meaningful outcomes.
• Real-World Evidence – Understanding how CGP performs when integrated into routine oncology pathways outside controlled clinical studies.

Economic Value of Comprehensive Genomic Profiling

Demonstrating clinical utility is only part of the evidence required for CGP reimbursement. Payers also need to evaluate whether the diagnostic strategy provides sustainable economic value within the healthcare system.

The Playbook examines several key areas of health economic evaluation:

• Cost-Effectiveness Analysis – Assessment of the relationship between the additional costs and health outcomes associated with CGP implementation.
• Budget Impact Analysis – Evaluation of the financial implications of introducing CGP across eligible patient populations and different adoption scenarios.
• Cost-Consequence Analysis – Comparison of diagnostic yield and clinical benefits with total pathway costs, including potential reductions in re-biopsy and diagnostic delays.
• Microcosting – Analysis of per-sample implementation costs, including consumables, personnel, equipment and multidisciplinary review.
• Healthcare Resource Utilisation – Assessment of how CGP may influence diagnostic procedures, hospital resource use, multidisciplinary workload and clinical trial enrolment.

When effectively integrated into healthcare pathways, CGP may create economic value by supporting more informed treatment selection, enabling clinical trial access and improving the efficiency of healthcare resource utilisation.

CGP HTA and Reimbursement in Europe

There is no single reimbursement pathway for Comprehensive Genomic Profiling across Europe. Healthcare systems differ in how diagnostic technologies are assessed, funded and implemented, and evidence that supports access in one market may not automatically satisfy decision-makers in another.

The CGP Evidence Playbook helps organisations understand how global clinical and economic evidence may be interpreted within European reimbursement environments and why country-specific evidence and market access strategies remain important.

For CGP developers and precision oncology stakeholders, this means anticipating differences in:

• HTA and evidence assessment processes
• Payer evidence expectations
• National and regional funding mechanisms
• Clinical implementation pathways
• Healthcare infrastructure and genomic testing capacity
• Acceptance and use of real-world evidence

A successful European CGP market access strategy therefore needs to combine a strong global evidence base with locally relevant evidence and market-specific reimbursement planning.

Practical Tools for CGP Market Access Teams

The CGP Evidence Playbook goes beyond evidence review by providing practical tools designed to help organisations assess evidence readiness, anticipate payer requirements and structure reimbursement strategies.

Who Should Read the CGP Evidence Playbook?

• Diagnostic manufacturers developing or commercialising Comprehensive Genomic Profiling assays
• Biotechnology companies working in genomic diagnostics and precision oncology
• Pharmaceutical companies involved in biomarker-driven and targeted therapies
• Market access and reimbursement teams
• Health Economics and Outcomes Research (HEOR) professionals
• Medical Affairs and evidence generation teams
• Clinical development and precision medicine teams
• Healthcare strategy and commercial planning teams

What You Will Gain

The CGP Evidence Playbook equips organisations with a practical understanding of how clinical evidence, economic value, payer expectations and healthcare system requirements interact when developing a European market access strategy for Comprehensive Genomic Profiling.

• Understanding of what strong CGP evidence looks like from a payer and HTA perspective
• Insights into the clinical utility evidence supporting Comprehensive Genomic Profiling
• Understanding of CGP cost-effectiveness, budget impact and healthcare resource utilisation
• Perspectives on European HTA and reimbursement requirements
• Understanding of how global CGP evidence may translate into local European decision-making
• Identification of potential evidence gaps and payer objections
• Practical guidance for evidence generation and reimbursement planning

Inside the CGP Evidence Playbook

The 58-page CGP Evidence Playbook combines clinical evidence, health economics, European HTA and reimbursement perspectives with practical tools designed to support CGP evidence and market access strategies.

Frequently Asked Questions About Comprehensive Genomic Profiling