What the Dutch Pluvicto judgment reveals about national pricing power, hospital-compounded comparators and the limits of European reimbursement precedent A European marketing authorisation can open a common regulatory route, but …
Odelle Technology
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What a Dutch population study of MammaPrint and Oncotype DX reveals about access, adoption and chemotherapy decisions A short evidence blog from Odelle Technology 9% → 25% → 37% Use …
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How innovators can enter RIGA, build a credible regional proposition,and move from product evidence to system-level adoption The next market-access question is not simply whether a technology can be reimbursed. …
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What to partner with, when to approach pharmaceutical companies and how to turn an app into a strategic treatment asset A medicine does not create value when it leaves the …
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Why early HTA, health-economic modelling and payer dialogue should begin before the pivotal trial is finalised A medical device, diagnostic or digital-health technology can be safe, technically successful and supported …
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An evidence-informed guide to patient-pathway value, reimbursement, strategic fit and acquisition readiness Most healthcare-app founders believe they are building a product. A future buyer may be looking for something entirely …
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Germany gives pharmaceutical companies unusually rapid access to a major European market. A newly authorised medicine can generally enter reimbursed use while its comparative benefit and long-term reimbursement amount are …
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Receiving FDA clearance or approval is one of the defining moments in a medical technology company’s life. It is also the point at which many companies discover that regulatory success …
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UK RWE can support EU market access, but only when clinical, economic and payer evidence is translated for local HTA decisions. The UK remains one of the strongest environments in …
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Biotechnology sponsors entering Europe are facing a quieter but more important access shift than many realise. It is easy to describe this shift as procedural. The European Union has introduced …