By Svetlana Nikic, Precision Oncology Consulting
Diagnostics are the foundation of precision medicine. Yet in Europe, whether a patient accesses the right test at the right time still depends on where they live, which hospital they visit, and whether local budgets can support the technology. Even for tests that are clinically validated, CE-marked, and included in treatment guidelines, the journey to reimbursement can take two to six years, and the path looks very different across Spain, Italy, France, Germany, and the UK.
That reality was front and center in our recent webinar, “Healthcare Fragmentation in Europe: What It Means for Diagnostics & Precision Oncology.” I was joined by Benjamin Gannon, Lee-Anne Zinetti, Tommi Lehtonen, and Prithwish Pal to unpack how fragmentation affects adoption, where pharma and diagnostics alignment helps, and what best practices actually work on the ground.
Europe Does Not Have One System — It Has 27+
Two points set the stage:
- Decentralization vs. national processes. Spain and Italy are highly decentralized, with autonomous regions shaping practice and funding. France and Germany have national HTA bodies, but tests still need separate coding, tariffs, and hospital-level adoption.
- Pilot schemes are not permanent access. Programs like France’s RIHN 2.0 or Germany’s Model Project can accelerate real-world evidence and enable early use, but they do not equal permanent reimbursement.
A well-known illustration is Oncotype DX. Despite strong evidence and guideline support, its reimbursement journey in Europe happened market by market over more than a decade. Progress in Ireland and the UK came earlier through HTA and cost-effectiveness frameworks; Germany only reached nationwide listing much later; and several countries still restrict access to narrow subgroups. The lesson: in Europe, success is not a single “win” but it is a rather sequence of localized wins requiring tailored evidence, coding, and pricing strategies.
Why Fragmentation Matters: Access, Timelines, and Uptake
Fragmentation slows implementation. Each country (and sometimes each region) demands a slightly different combination of analytical validity, clinical validity, clinical utility, and health-economic impact. This creates uneven timelines, parallel submissions, and duplicated effort for manufacturers, especially challenging for small, innovative companies with limited resources.
From the startup perspective, our panelists underscored the practical barriers: limited resources to run multiple market-specific evidence programs; the need to choose lighthouse centers and priority countries; and the very real operational details (from lab partnerships to logistics) that can make or break early adoption. Startups must be laser-focused on markets and partnerships that de-risk the first few reimbursed use cases.
Pharma & Diagnostics Alignment: When Therapy Is Reimbursed but Testing Is Not
A recurring challenge is the disconnect between reimbursed therapies and unreimbursed (or under-funded) companion diagnostics. During our panel discussion, we described how this mismatch stalls entire care pathways: targeted therapies depend on accurate stratification, but without sustainable funding for testing, eligible patients are missed or treatment is delayed.
How pharma steps in varies by portfolio and market:
- Funding or supporting companion diagnostics in pivotal trials and label expansions.
- Seeding testing infrastructure (e.g., establishing hub labs or supporting quality programs) to accelerate readiness.
- Aligning value propositions, by pairing therapy outcomes with diagnostic utility and budget impact to help payers see the end-to-end value.
What helps most? Early, joint planning among diagnostic developers, pharma partners, and clinical sites, so evidence packages and access pathways are cohesive, not an afterthought.
Evidence That Moves European Payers
The diagnostics manufacturers must consider the evidence mix, which should ideally reflect payer priorities in each country, but some common patterns remain:
- Clinical validity is essential starting point.
- Clinical utility (how the test changes decisions and outcomes) moves the needle.
- Health-economic evidence (cost offsets, avoided ineffective therapies, downstream savings) closes the loop.
Real-world evidence (RWE) is becoming essential, especially when payers want to see how tests perform outside academic centers. That’s where registries, pilot programs (e.g., RIHN 2.0, Model Projects), and structured RWE protocols can turn early access into durable coverage.
EU HTA Regulation: Helpful for Drugs, Unclear for Diagnostics (So Far)
The EU HTA Regulation begins with joint clinical assessments for oncology drugs and Advanced Therapy Medicinal Products (ATMPs). For diagnostics, the panel’s consensus was pragmatic: it’s too early to expect a harmonized EU-level process to replace the country-by-country reality. Diagnostics are likely to remain nationally evaluated for the near term, meaning early dialogues with local HTA bodies, payers, and clinical champions will still make the difference.
That said, there’s momentum around joint scientific consultations and more structured approaches to multi-country evidence, useful stepping stones even if formal HTA for diagnostics remains local.
What Is Working: A Practical Playbook
Across experiences from the panel, several best practices stood out:
- Sequence markets intentionally. Start where your evidence and clinical champions are strongest. Build 2 – 3 lighthouse sites and use those results to unlock the next countries.
- Build a global evidence package and adapt it locally. Develop one comprehensive dossier covering analytical validity, clinical utility, and health-economic outcomes, but customize key inputs such as comparators, resource use, and cost assumptions, to match each country’s HTA framework
- Engage early with HTA and payers. Do not wait until the study is done. Ask local stakeholder early, what outcomes and endpoints will be persuasive before you lock your protocol.
- Use pilots and RWE as bridges. Programs like RIHN 2.0 or Model Project can generate the real-world utility data that many payers now require.
- Align with pharma where it helps. Co-planning companion diagnostics and access strategies with therapy sponsors can accelerate coding, contracting, and adoption pathways.
- Invest in implementation details. Coding, tariffs, lab capacity, turnaround time (TAT), and reporting workflows often determine real-world uptake more than the paper dossier.
- Think beyond academic centers. Community hospitals manage most patients. Build scalable logistics, training, and reporting so access does not stop at a few centers of excellence.
Our panelists also added that a crucial layer from an operational angle: test readiness (assay robustness, quality systems, and consistent TAT) plus clear coding and contracting are what turn clinical enthusiasm into routine use. For many labs and hospitals, predictable operations matter as much as the clinical paper.
For Startups: Where to Lean In
- Pick your battles. Two or three well-chosen markets beats a scattered approach across ten.
- Partner for credibility and reach. Use collaborations (pharma, reference labs, academic centers) to anchor early evidence and distribution.
- Prototype reimbursement. Work with payers on small, measurable implementations to prove utility and build the case for broader coverage.
- Narrative plus numbers. Pair the clinical story with a clean budget-impact narrative: “Right patient, earlier, fewer ineffective treatments, lower total cost of care.”
Looking Ahead: What Would Move the Needle Most?
We closed by asking each speaker: If you could change one thing tomorrow to improve access to innovative diagnostics, what would it be? The themes converged:
- Clearer, more consistent HTA criteria for diagnostics (what counts as sufficient utility and economic value).
- Unified funding pathways for precision oncology testing, aligned with therapy access.
- Earlier, structured payer dialogue so study designs answer the right questions the first time.
- Better alignment of diagnostics and therapy timelines, so access to testing does not lag drug reimbursement.
In Summary
Europe’s challenge is not a lack of innovation, it is the pathway to access. The solution is not a single policy lever; it is a repeatable playbook: plan evidence with payers, align with pharma where it accelerates, prove value in real settings, and scale beyond centers of excellence. Do that well, and innovative diagnostics will reach more patients, faster.
