Svetlana Nikic, Founder of Precision Oncology Consulting, shared a post on LinkedIn:
“When strong evidence stalls: the EU access gap for novel diagnostics.
Across Europe, market access fails not for lack of science but because country pathways, coding, and budget rules are misaligned with how value is demonstrated in practice. Precision Oncology Consulting European Insights distil what actually works to shorten time-to-access and avoid dead ends, by aligning evidence to payer priorities, selecting the right early-entry lever, and planning scale from day one. I’ve been working on expanding my network of local Dx Market Access experts so I am now able to support you with the implementation of Market Access strategies across EU.
Download: Navigating European Healthcare System and Reimbursement Insights.
Join on 25 November, at 17:00–18:00 CET for a webinar on ‘Bridging Evidence and Access: How WGS Can Shape Future Cancer Care‘
Fresh updates I’m tracking (and will be incorporated into next edition of the insights):
May 2025 – United Kingdom: national roll-out of ‘blood-first’ ctDNA liquid biopsy for lung cancer patients (expanding testing in advanced breast cancer) across NHS England. An independent health economic assessment of the pilot estimated the test could save the NHS up to £11 million per year in lung cancer care. Access the article.
Oct 2025 – France: positive evaluation by French National Authority for Health for targeted NGS on circulating tumour DNA in advanced NSCLC – steps toward routine reimbursement under NABM/CCAM. Access the article.
Oct 2025 – Germany (the Federal Joint Committee (Gemeinsamer Bundesausschuss (G-BA)) has expanded access to biomarker testing (specifically Oncotype Dx by Exact Sciences) to guide adjuvant chemotherapy now covered by Statutory Health Insurance, for early breast cancer with 1–3 positive nodes. For patients without lymph-node involvement, the other three tests remain reimbursable (EndoPredict, MammaPrint, Prosigna).
Oct 2025 – Italy: announced a significant increase budget spend for NGS ESCAT Tier 1 alterations, from €5M to €38M to harmonise access to testing and coding. Access the article.“
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