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Writing reimbursement submissions

Level:
Advanced
Area:
Drug Development
Code:
DDA25
Duration:
03:30:00
Workshop profile:
The workshop will not assume any previous experience in writing health technology assessment (HTA)/reimbursement submissions, but those with some experience will also benefit. Knowledge of the principles of HTA is not essential. Those wanting an introduction to health economics should take the workshop of that name (PTF20).
Objective:
To enable participants to begin writing HTA/reimbursement submissions, and to provide a forum for those with some experience to discuss any difficulties and exchange ideas. The focus will be on the UK and Ireland submission templates; an overview of other European systems will be given and many of the topics will be generalisable, but the leaders have limited experience of submissions to non-UK/Ireland authorities.
Content:
Topic covered are: what is HTA; overview of European HTA systems; overview of the UK and Ireland systems and templates; and writing the different components of the submission (executive summary, product description, clinical background and place in therapy, clinical effectiveness of product and comparators, systematic literature review, evidence synthesis, economic section). We will discuss what assessors are looking for in terms of evidence presentation, and the importance of telling a strong value story. We will look at the project lifecycle of submissions and the role of the medical writer in the project team. The focus throughout is on writing and data presentation; we will not discuss submission strategy.