So reimbursement dossiers came into being about a decade ago, when technology manufacturers
realized that they needed to develop a reimbursement application that was a generic reimbursement
application that could be used globally. And that what they could do is share that information
with their regional affiliates and individual country affiliates around the world to satisfy
the requirements of local payers. And so, because medical technology manufacturers didn’t
have reimbursement staff in each individual country, then the reimbursement dossier format
grew to – to meet that need of translation of the – of the clinical
and economic evidence from the global level to local use to establish reimbursement. Over
time, people have moved away from the – the term, “reimbursement dossier,” and have
begun using what they refer to as a “global value dossier” format, in recognition that
a single document can often be used to summarize the key information and clinical data that’s
needed to satisfy regulatory approval, reimbursement, and also key marketing messages about the
value of the technology. And so, many technology manufacturers use this global value dossier
format to provide the clinical and the economic value messages that can be used for regulatory
approval, reimbursement, and marketing. And to ensure that everyone has the same information
and the same core messages about the value of the technology or the therapy. I’d have
to say that it’s very inconsistent as to when manufacturers choose to develop a global
value dossier for – for new products. It’s typically reserved for more breakthrough therapies,
and that it’s really a practical question of whether in day-to-day business, it turns
out to be efficient to – to have such a single document, or whether you want to – to
do it on a case-by-case basis. What I’ve found is that the commercial organization
usually wants what I refer to as a mini dossier or a tender support document that is a short,
three to five page document. A reimbursement dossier is often a 100 to 150-page document
that the commercial organization or even local reimbursement staff find to be very unwieldy
and unuseful. And so it’s very important to really get clearly in mind what format
you want, how long does it need to be, and if you’re gonna develop a reimbursement
dossier, know that you’re gonna use it to fulfill reimbursement requirements in a particular
region or – or set of regions, so that for example, if your initial use of the document
is to get reimbursement in Germany, France, Italy, and the UK, that you know what those
requirements are, and that you’re not developing a document that doesn’t fulfill those key
questions that the payer needs to answer.