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.

IQWiG staff member Vanessa is standing on a bridge, smiling into the camera. In the background is a high-rise building with a glass facade.

An entrance to an underground car park leads downwards between trees. In the background is a skyscraper with a glass facade.

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?

A woman is sitting at a desk, and turns towards the camera and smiles. She has medium-length hair and is wearing a black top. There is a computer keyboard and screen on the desk. Also on the desk are a cup of tea, a writing pad, a jar of pens, a stapler and a puncher. To the left of the woman is a window.

A man and a woman are sitting opposite each other at a table. They are studying a document lying between them. The man has short hair, a beard and a blue shirt. The woman has medium-length hair and is wearing a black top. There are two other single documents and two stacks of documents on the table. Behind them, on the left, is a cinema with a dome and, on the right, Cologne Cathedral.

Two women are smiling at the camera. The woman on the left has short hair and is wearing glasses. The woman on the right has long hair. Cologne Cathedral can be seen through the window behind them.

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/

Two women are facing each other. There is a magnetic board between them. A project protocol is drawn on it. The woman on the right has short hair, and is wearing glasses and a light brown corduroy jacket. The woman on the left has long hair, and is wearing a dark blue top and a checked skirt.

A woman is taking a stack of documents out of a printer and is smiling at the camera. She has long hair and is wearing a black top, blue jeans and white trainers.

Screen showing an email in which Vanessa asks the department heads to nominate the project group members for the assessment of the new drug, the cough medicine “HustenWeg” (translation: cough gone).

Pyramid-shaped diagram of the structure of the dossier that manufacturers prepare for the dossier assessment. The top four modules are publicly available and include general information on the drug, the therapeutic indication, the appropriate comparator therapy, the number of patients who could benefit from the new drug, and the cost of treatment. The bottom module 5 is confidential. It includes the marketing authorization documents and the assessment report of the regulatory authority.

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/

Two women are sitting opposite each other at their desks. They are working on their computers, looking intently at their screens. The woman on the left has medium-length hair, and is wearing glasses and a red top. The woman on the right has long hair and is wearing a checked top. A laptop, computer keyboard, screens, writing utensils, a telephone and documents are on both desks. There is a window in the background. Through it, you can see the facade of the building opposite.

An IQWiG flyer is on a table. It is used to recruit external experts. On the front, it says in large letters, “We are looking for you!”

Screen showing a page on the IQWiG website aimed at external experts. The heading reads: “Taking part in IQWiG's work.”

Screen showing the cover page of a questionnaire in which patients or patient organizations describe a disease and its treatment.

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

A woman is sitting at a desk, working on a computer. She is looking intently at the screen. She has braided hair and is wearing a black top and a red and black scarf. On the desk, to the right, there is a notepad, writing utensils and a telephone. Behind the woman is a window. The facade of the building opposite can be seen through the window.

Two screens, each with at least three open windows, showing tables and text from dossiers, statistical calculations, diagrams, etc.

Week 2: Documentation specialist Annette examines the documents submitted in the dossier. The manufacturer refers to 2 studies. We have to check more closely whether both are basically suitable for our benefit assessment. #IQWiGfotostory

A man is sitting at a desk, working on a computer. He is smiling and looking intently at the screen. He has brown curly hair, and is wearing glasses and a grey sweatshirt. There are two folders of documents on the table. In the background are windows. Through them, you can see the facade of the building opposite.

Screen with a table documenting the search terms for the search for the cough medicine “HustenWeg” in scientific literature databases.

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

Two women stand facing each other. They look intently at a flipchart standing between them. On it is the PICO scheme: Population, Intervention, Control and Outcome for the studies on the cough medicine "HustenWeg". The woman on the right has long hair and is wearing a striped top. The woman on the left has short hair, and is wearing glasses and a white top.

Printout of the draft of the dossier assessment where the exact research question and the appropriate comparator therapy are specified.

Printout of the draft of the dossier assessment where the two clinical studies cited by the manufacturer are described in a table.

Discussion with supervisor Katrin: In both studies, "HustenWeg" was compared with the correct standard therapy. But according to its approval status, it may only be used after pre-treatment. We have to consider this when checking the relevance of the studies. #IQWiGfotostory

A group of people are sitting around an oval table, looking intently at a large screen with information about the data. To the left is a flip chart.

A woman is standing at a flipchart giving a presentation. People are seated around an oval table, intently following the presentation. To the left of the flipchart there is a large screen. On the table are a laptop, documents, notepads, a cup and a bottle of water.

A group of people are sitting around an oval table, intently following a presentation. A woman in the group has a laptop in front of her and is giving the presentation. Behind her is a flipchart. There is a large screen in the middle and further back.

Week 3: kick-off of the project group. The patients received different pre-treatments in the studies. We have questions as to whether the respective pre-treatment was clinically appropriate. We will clarify these questions with the external expert. #IQWiGfotostory

A woman is sitting comfortably at her desk, smiling into the camera. She has long hair, and is wearing glasses and a pink top. In front of her on the desk are two screens, a computer keyboard, a laptop, a telephone and documents. In the background to the right are windows.

A woman is sitting at her desk, working. She has a computer keyboard in front of her and is looking intently at two screens. She has long hair and is wearing a purple top. To the left of the screens is a telephone. In the background, on the right, the office door is open, facing a green corridor wall.

A man is sitting at a desk, looking at the camera. He has short hair, and is wearing glasses and a grey jacket with a light blue shirt underneath. There are documents in front of him. He is holding a pen in his right hand. On the table are books, pamphlets, a computer keyboard, a screen and a telephone. There are windows in the background to the right.

Statistician Mandy checks whether the data were correctly analysed. Health economist Min checks the case numbers and cost information in the dossier. And an expert gets in touch; IQWiG (Director Jürgen Windeler) signs a contract with her. #IQWiGfotostory

Two women are standing next to each other, discussing a document. The woman on the right has long hair and is wearing a checked shirt. She is holding the document. The woman on the left has chin-length hair, and is wearing glasses, a grey cardigan with a black sweater underneath, and a yellow scarf. There is a plant in front of each of the women and in the background.

Desk with three sheets of paper: two from the questionnaire completed by the external experts and one from the draft of the dossier assessment describing the treatment in the two clinical studies.

Checked sheet with a simple sketch showing the intersection of the pre-treatments of the patients in the two clinical studies.

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

A woman is sitting at her desk, working on her computer. She is looking intently at the screen and has her hair in a braid. She is wearing glasses and a light blue top. In front of her on the desk are two screens, a computer keyboard and a computer mouse. There are writing utensils on the left side of the desk. There are also two cups, a flask and an apple.

Flipchart sheet with six green and red bar graphs showing that the response rates to the quality-of-life surveys in one of the two studies are very low.

Table from the draft of the dossier assessment listing the relevant endpoints that were recorded in both studies - from all-cause mortality to diarrhoea.

Two screens in an office. On the left one, the table of endpoints. On the right one, an Excel spreadsheet showing the decreasing response rates over the course of the first study.

Week 5: Is quality of life better with "HustenWeg" than with standard therapy? If too much study data is missing, the answer to this important question remains uncertain. Statistician Mandy estimates how great this risk of bias is. #IQWiGfotostory

A group of people are sitting around an oval table listening to a presentation and smiling. In front of them, to the right, a woman is standing next to a flipchart with writing on it. She is giving the presentation. She has her hair in a braid and is wearing glasses, a blue top with white dots, and blue jeans. She is holding a pen in her right hand.

Again, the table describing the two clinical studies. You can see that, for example, the study design and the study populations are the same.

Week 6: Team meeting. The evaluation of the two studies showed: Both are relevant to the assessment. They are also so similar that we can combine them in a meta-analysis. That's good; two studies are more meaningful than one. #IQWiGfotostory

Two women are talking in an office with large windows in the background. The woman on the right is sitting at a desk. There are two screens, a laptop, writing utensils and a telephone. She has her hair in a braid and is wearing a white top and a red and black scarf. She is looking at the other woman in an attentive and friendly way. The woman on the left is standing to the right of the desk and looking at her colleague. She has long hair and is wearing a beige cardigan over a white shirt, blue jeans and black shoes. She is holding a notepad and pen in her right hand.

A woman is sitting at a table, reading a document that she is holding in her hands. She has long hair and is wearing a white shirt.

Two sheets from a completed patient questionnaire and a table of endpoints from the draft of the dossier assessment are displayed on a desk.

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

People are sitting around an oval table. They are facing the front of the room, listening attentively to a presentation. There are writing utensils, water bottles, drinking glasses and a laptop on the table. To the right of the table, a woman with brown, medium-length hair is giving the presentation. She is wearing glasses, a black top and blue jeans. To her left is a flipchart with writing on it. To the left of the flipchart is a large screen.

A woman is sitting at her desk, absorbed in her work on the computer. She has medium-length brown hair, and is wearing glasses and a black top. On the desk in front of her is a computer keyboard and screen. To the left, there is an open laptop and a water bottle. There is a window in the background on the left.

A table from the draft of the dossier assessment listing severe side effects according to younger and older patients.

Week 8: There is a subgroup effect: older people have more side effects with the new drug than with standard therapy. We do not see a difference in younger people. We have to determine the added benefit for older and younger people separately. #IQWiGfotostory

A long-haired woman is standing in front of a large window, with her arms outstretched. The palms of her hands are pointing upwards imitating a scale pan. She is wearing a black top and a checked skirt. To her right is a flipchart. Two scales are drawn on it. Through the window, you can see the Cologne Cathedral in the background.

Printed full-page table on the extent of the added benefit of the cough medicine “HustenWeg”. The lower part of the table shows that older people have more severe side effects than younger people do.

Continuation of the table on the extent of the added benefit of “HustenWeg”, here on the side effect “diarrhoea”, which again occurred more frequently in older people.

Printed overview of the positive and negative effects of the drug. For the negative effects, a distinction is made between people under 65 years of age and people over 65 years of age. This is followed by a summary of the results of the dossier assessment.

We consider the pros and cons of the new drug. It yields better results than standard therapy. But stronger side effects in older people limit its added benefit. Due to sparse data, it is hardly possible to draw a conclusion on quality of life. #IQWiGfotostory

A woman is standing in an office. She has long hair in a braid, and is wearing a dark top, blue jeans and white shoes. She is talking to another woman who is sitting at a desk in the middle of the office. She has braided hair and is wearing a black sweatshirt over a turquoise top. She has a key chain around her neck. In the office, on the left, there is a filing cabinet and a shelf. There is a window in the background. Through it, you can see the facade of the building opposite.

Two women are looking at a computer screen on a desk, with a look of surprise. The woman in the foreground is sitting in a chair, using a computer mouse with her right hand. She has her hair in a braid and is wearing a black top. To her right is the other woman. She leans forward with her upper body towards the computer screen and leans on the table with her right hand. She has her hair in a braid and is wearing a black top and blue jeans. There is a water bottle, a second screen and a telephone on the desk. The computer keyboard is in front of the seated woman.

A woman is sitting at her desk, looking intently at the computer screen in front of her. She has her hair in a braid and is wearing a black top and blue jeans. Her right hand is controlling the computer mouse. Her left hand is typing on the computer keyboard. There are writing utensils and a telephone on the desk. In the background, there are plants and a window.

A woman is standing at a counter next to a coffee pot, filling her cup with coffee. The woman has her hair in a braid, and is wearing a black top and necklace. The pot is on a counter. On the left side of the counter is a small porcelain dinosaur with a coin slot. There is a grey cupboard in the background and a glass door on the left.

Week 10: Project manager Vanessa continues to write the draft report at full speed. In between, she consults with Min from the Health Economics Unit, to ensure that, for example, the abbreviations are identical in all chapters. #IQWiGfotostory

A woman with short hair, who is wearing glasses and a black top, is sitting at her desk, looking at a report. She is wearing a watch on her left wrist. She is leafing through the report with her left hand. Her right hand is controlling the computer mouse. In front of her on the desk are a computer keyboard, two screens and a telephone. To the right of the telephone there are more writing utensils and a water bottle. Behind the woman is a shelf with several bound reports and books. In the background, the cathedral can be seen through a window.

Screen with an open Word document in the “track changes” mode: the subchapter "Loudness of coughing" has just been heavily revised; there is a lot of red and crossed-out text.

A man and a woman are sitting at a round table looking at a document. The woman has short hair, and is wearing glasses and a black sweatshirt. The man has short hair, and is wearing glasses and a blue shirt. There is another pile of documents on the table and a coffee cup.

Week 11: Supervisor Katrin and Gregor from the Quality Assurance Unit check the report for content errors. Highly focussed, each word of the report is scrutinized again. #IQWiGfotostory

A man is sitting at his desk, pointing with his left index finger at the screen in front of him with a look of surprise. On the desk in front of him are a computer keyboard, two screens and a laptop. On the wall in front of him are two posters, a table, a picture and a calendar.

Screen with the summary of product characteristics (SmPC) of the standard therapy, where the dosage for adolescents and adults appears to have been changed. This information is circled.

A long-haired woman in a grey jumper is sitting at a desk. Next to her is a short-haired woman in a corduroy jacket. She has both palms facing up, as a gesture of confusion. Both are looking at a flat screen. In the background are windows and plants.

We look over the shoulders of two women at a screen displaying a summary of product characteristics (SmPC). They are discussing the new information.

Week 12: Jürgen from the Information Management Unit discovers an updated Summary of Product Characteristics on standard therapy for the disease. Now we have to quickly check: Will we have to make changes to our assessment? #IQWiGfotostory

Two printouts on one table: the new summary of product characteristics (SmPC) and the section of the dossier assessment describing the standard therapy. Here, additional information has been inserted in blue letters.

Two women are standing in front of a white wall with a light green vertical stripe. The woman on the right is holding two large documents and a pen. They are discussing a problem and seem relieved to have solved it.

Project manager Vanessa and her team compare the old and new Summary of Product Characteristics: How much do we have to change in our assessment in the last week? Fortunately, only one item needs to be slightly adjusted. #IQWiGfotostory

A man with short dark hair, who is wearing glasses and a black T-shirt, is sitting at a desk and smiling at the camera. MS Word files can be seen on the two screens in front of him. In the background is a window, through which the building opposite can be seen.

Screen with a document containing numerous formatting changes and deletions that, according to the comments column, were made by Jochen.

A woman with dark hair in a bun and wearing a black top is sitting at a desk, working on a text. In front of her is a leaflet with a medical illustration and a red notepad. On the wall behind the computer screen are photos. In the background, there are several plants and a telephone.

Three men in blue shirts and a woman in a top with large coloured dots are sitting around a round light-brown table and are discussing a text that is printed out in front of them. Through the window, you can see Cologne Cathedral in the distance.

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

Early benefit assessment of medications

At the front left, a man with short hair and a beard, wearing a black pullover, is sitting in a chair, turning his head towards the camera. There are two screens on the desk. As it is not possible to see exactly what is in the email on the left screen, the text has been enlarged and placed in front of it. It reads: "Upload protocol of your submission".

A man with short black hair and a woman with long blonde hair, both wearing dark jumpers, are sitting at a desk talking about what they are seeing on the screens. The woman is moving the computer mouse. To the right are two plants, and through the window you can see a lake and houses reflected in the water.

Screen with the project page for the cough medicine “HustenWeg” on www.iqwig.de. The project page does not exist in reality, as the photo story is about a fictitious commission.

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