With the SHI Financial Stabilisation Act (GKV-FinStG), the framework conditions for price negotiations for medicinal products in Germany have been made more complex and have been systematically tightened by the legislator to the disadvantage of the pharmaceutical industry. On the one hand the extend of the additional benefit and on the other hand the
Overview of our services in the field of non-randomised studies and indirect comparisons Strategic consulting Systematic research Study design consulting Statistical consulting Non-randomised studies and non-adjusted indirect comparisons in benefit assessments Benefit assessments, at EU level as well as full assessments in Germany, are used to compare the efficacy and safety of a health
The Regulation (EU) 2021/2282 of the European Parliament and of the Council of 15 December 2021 on health technology assessment (HTA) and amending Directive 2011/24/EU is effective starting today, 11 January 2022. Click for more information>>> The Regulation aims to establish joint clinical assessments of health technologies in the European Union (EU) starting with oncologic
On Dec 13th, 2021, the Regulation on Health Technology Assessment (HTA) has officially been adopted. The new Regulation aims to establish a system for joint clinical assessments of health technologies in the European Union. First assessments of oncologic drugs and ATMPs start in 2025, followed by orphan drugs three years later in 2028 and medicinal
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