Verordnung (EU) 2021/2282 Artikel 7 (1) der Verordnung (EU) 2021/2282 spezifiziert, wann eine Gesundheitstechnologie einer Gemeinsamen Klinischen Bewertung (Joint Clinical Assessment, JCA) unterzogen werden muss. Dabei spezifiziert Absatz 1a, dass der Zeitpunkt der initialen Marktzulassung entscheidend ist. Nur wenn diese nach den in Artikel 7 (2) genannten Fristen (Onkologika und ATMPs: 12. Januar 2025,
Have a look at our latest update of German price negotiations for drugs that went through the AMNOG benefit assessment. The mean price decrease after negotiations was 28 % for all analysed products, 23 % for orphan drugs and 30 % for non-orphan drugs. If you have any further questions or suggestions, please feel free
The German Federal Ministry of Health has published a draft law on the financial stabilization of the statutory health insurance (GKV-FinStG). The subjects of the draft are amendments to the Social Code Book V, in particular Articles § 35 a and § 130 b, which include the early benefit assessment of new active substances and
The first medicinal products used to treat oncologic diseases and ATMPs will be assessed within the framework of the Joint Clinical Assessments on the level of the European Union (EU) starting in 2025. Until then, the necessary health technology assessment (HTA) process needs to be defined and refined. Today, we were honored to present our
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