Experts from SmartStep Consulting regularly publish articles here on current, relevant topics from the healthcare, pharmaceutical and medical technology sectors. Here you can find an overview of all published blogposts.
The number „15“ in the German HTA system – the “fixed threshold” as a fixed solution?
This blog post provides a brief overview of the current discourse regarding the presentation of clinically relevant outcomes in the early benefit assessment.
3rd-year DiGA: factors influencing the reimbursement amount
This blog post addresses which factors influencing the reimbursement amount have been most significant in previous arbitration board decisions.
The systematic literature search – an indispensable tool in the context of benefit assessment
This blogpost addresses the relevance of a systematic literature search in the context of the AMNOG according to § 35a SGB V.
If a third party must decide: The reimbursement amount set by the Arbitration Board
Our latest blog post looks at how the Arbitration Board makes decisions and also provides an overview of decisions made in 2022.
Does the assessment based on new scientific findings always lead to an additional benefit?
The quality of newly generated study data is a decisive factor after resubmission due to new scientific findings as well. Our latest blog post highlights the aspects of reassessment based on new scientific evidence according to chapter 5 section 13 of the German Social Code Book Five (SGB V).
Re-evaluation of clinical trials for the German AMNOG process
This blogpost provides an overview of the re-evaluation of clinical trials in the context of the German AMNOG process and addresses the relevance of full HTA process support from a single source.
What has happened since the DiGA fast track began? An overview of the status quo
This blog post provides a brief overview of the status quo of DiGA fast track since the DVG went into effect in December 2019.
The long road to EU-HTA: An overview of developments and challenges
This article provides a brief overview of the key challenges facing European stakeholders, looks at the upcoming development steps of the project, and asks how manufacturers of medicines, medical devices, and other new health technologies can best prepare for an upcoming EU HTA process.
“Apps on prescription” : Digital Health Applications (DiGAs) – Path to reimbursement
In this blogpost, SmartStep Consulting provides an overview and field report on “apps on prescription” – e-health as a future model in healthcare.