A marketing authorization lets you sell a medicine. Reimbursement is what lets patients actually receive it. In Greece, the two are separate processes — and the second is where many products stall.
Once EOF has authorized a product, the sponsor must secure inclusion on the reimbursement list so that the cost is covered by the national health system. This is managed through a health technology assessment (HTA) process and the reimbursement authorities, including EOPYY.
What the assessment looks at
The reimbursement dossier is fundamentally an argument about value. Assessors weigh clinical benefit against cost, compared with the therapies already available. A strong submission typically includes:
- A clear description of the disease, its burden, and the eligible patient population in Greece.
- Evidence of clinical efficacy and safety versus relevant comparators.
- An economic analysis — often a cost-minimization, cost-effectiveness, or budget-impact model.
The role of economic modelling
Where a new product is clinically equivalent to existing options — as is often the case with biosimilars — a cost-minimization analysis can be the most persuasive tool, demonstrating equivalent outcomes at a lower cost to the payer. For products offering additional benefit, cost-effectiveness and budget-impact models show that value is proportionate and affordable within the system.
Build the value story early
The most common mistake is treating reimbursement as a step that begins after approval. In reality, the evidence that supports a strong value dossier — comparative data, local epidemiology, and a credible economic model — is best planned well before submission. Early payer-evidence planning turns a marketing authorization into genuine, timely patient access.
How PQRA helps
PQRA builds HTA and reimbursement dossiers for the Greek market, from local epidemiology and comparator analysis to fully documented cost-minimization and budget-impact models. We help sponsors move from approval to access with a defensible, payer-ready value story.
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