Photo story: A dossier assessment is produced
To illustrate the production of a dossier assessment and to show the people behind IQWiG's reports:
This was the idea behind our first photo story, which we prepared in 2019 and posted on our Twitter account in early 2020.
The disease and the drug of this exemplary assessment within the context of early benefit assessments according to the German Act on the Reform of the Market for Medicinal Products (AMNOG) are fictitious. However, the processes are presented as realistically as possible. The participants really work in the respective departments and units – and use their real names!
With "chronic cough", we chose a widespread disease that can be well illustrated and that is not as fear-evoking as cancer. The story described here can also be accessed as a Twitter thread.
Thread: How is a dossier assessment conducted? This is what we will show here in real time over the next 13 weeks for a fictitious new drug. Project Manager Vanessa will lead through the #IQWiGfotostory. #WhyWeDoResearch Infografik: Was sind Dossierbewertungen?
Today, a new commission was received from the Federal Joint Committee (G-BA) with the question: Does the new "HustenWeg" show added benefit in chronic coughs? The Department Head decides: Vanessa will be project manager, Katrin supervisor. #IQWiGphotostory www.g-ba.de/bewertungsverfahren/nutzenbewertung/
The clock is ticking: Everything has to be ready in 3 months. Quickly form a team, prepare a schedule and print out the manufacturer dossier on which the assessment is based. Module 5 of the dossier (see figure) is confidential. #IQWiGfotostory www.g-ba.de/themen/arzneimittel/arzneimittel-richtlinie-anlagen/nutzenbewertung-35a/faqs/
According to the 4-eyes principle, Susanne and Gini select 5 external experts from our database who are particularly familiar with chronic cough. At the same time, they look for affected patients to answer our questions about their disease. #IQWiGfotostory FAQs for external experts
Information specialist Marco checks whether the manufacturer has reported all relevant studies and publications. The procedure for dossier assessments is described in our methods paper (Sections 2.1.3 and 3.3.3). #IQWiGfotostory General Methods
Week 4: Based on the literature, the external expert confirms our opinion that the patients were correctly pre-treated. We determine the endpoints for the assessment. Unfortunately, the data on quality of life are rather incomplete. #IQWiGfotostory infographic: patient-relevant endpoints
Week 7: A patient with a chronic cough participates in the assessment via the German Federal Working Group of Self-Help Organizations. The patient questionnaire that he fills in tells us which endpoints are particularly important for him. #IQWiGfotostory Contributing the patients' perspective
Week 13: Jochen from the Technical Editing Unit checks the report format and produces a PDF. Susanne writes the health information for "HustenWeg". Andrea discusses the press release with the Institute’s Management. #IQWiGfotostory
Volker sends the report to the contracting agency (Federal Committee = G-BA). Nelli and Johannes publish it on our website. From now on, comments can be submitted. In 3 months, the G-BA will decide on the added benefit of "HustenWeg". #IQWiGfotostory
Finished! But Vanessa hardly has time to take a deep breath; the next assessment is coming up. #IQWiGfotostory