Roche Diagnostics has reached a major milestone as the World Health Organisation (WHO) has granted pre-qualification to its cobas® HPV test for use on the cobas 5800, 6800, and 8800 systems, including for…
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The structure of roles and responsibilities under the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) brings together a blend of EU-level regulation and local oversight. This balance ensures that while…
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The NHS Work Programme plays a vital role in ensuring patients across the UK gain access to innovative and effective treatments. Through a rigorous evaluation process, the Clinical Priorities Advisory…
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Regulatory Pathway for Companion Diagnostics in France In France, companion diagnostics (CDx) are subject to a thorough regulatory and reimbursement process, primarily led by the Haute Autorité de Santé (HAS).…
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Companion diagnostic (CDx) is evaluated and listed in the EBM (Einheitlicher Bewertungsmaßstab) catalogue in Germany, let’s enrich the discussion around each step, focusing on specific mechanisms, scientific rationale, and real-world examples. Here’s a…
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Evidence Requirements for Medical Device Reimbursement in France: An Analysis of the LPPR 2024 Guidelines
The French healthcare system is well-regarded for its extensive coverage and robust framework for evaluating and reimbursing medical devices. At the heart of this system is the Liste des Produits…
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Denmark has made a significant breakthrough by becoming the first Scandinavian country to approve the routine use of Hemgenix (etranacogene dezaparvovec) for treating haemophilia B. This approval is the result…
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The New Framework Agreement for Medical Devices and Medicines in France: Detailed Impact Analysis
On July 2, 2024, a significant framework agreement was signed between the Economic Committee for Health Products (Comité Économique des Produits de Santé, CEPS) and various industry organisations, including Snitem,…
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Submitting a proposal for a new procedure code in the Common Classification of Medical Procedures (CCAM) in France is essential for accurately reflecting medical advancements and ensuring proper reimbursement. This…
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Enhancing Economic Evaluations by Integrating Adverse Events: A Call for Standardization and Improved Practices
In the evolving landscape of health technology assessment (HTA), the inclusion of adverse events (AEs) in economic evaluations remains a critical yet underdeveloped area. Despite the rigorous benefit-risk assessments conducted…