Creating a Successful Global Value Dossier Webinar Q & A

Thank you for attending our webinar! Below are the answers to a few questions that we didn't address during our presentation. If you would like to speak with us about how we can help you with your specific Global Value Dossier needs, please contact our team using the form to the right.

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Q. If a GVD is to support a value story, wouldn't it introduce a lot of bias? I.e. leaving info behind that refute the value message.

A. A GVD is an internal document that does aim to present a product in good light. Nonetheless, it also needs to be balanced, and for example, present all safety data and a thorough review of the clinical evidence. However, the value messages will focus on the positive aspects of the product. Where clients prefer, we also prepare global reimbursement dossiers—which are less commercial, not message-driven and follow a more typical HTA format—as an alternative to the GVD. This may be useful where the preference is for a dossier that does not build the story and can more easily be cut-and-pasted in its entirety. However, many organisations prefer a GVD—which provides guidance to affiliates on the attributes of a product and how best to demonstrate these by building the story in terms of burden and unmet need, allowing them to use this guidance in the development of their own local submissions. This can also be more useful in terms of the development of tools required for launch, such as slide sets and leave behinds which are more commercial.

Q. Are there any unique features to preparing a GVD for an orphan indication?

A. When developing a GVD for an orphan indication, you need to be mindful of different HTA requirements and ensure that the GVD is tailored towards those for orphan products. Both the amount of evidence and the level of evidence that is available may be different (e.g. non-comparative studies with low patient numbers are more acceptable) compared with non-orphan products. The majority of HTA organizations accept this but it is important to explain the trial design and limitations of the data, along with interpretation of the results.

Q. Can you please give few tips to adapt GVD to recent EUnetHTA Core template?

A. GVDs are designed as internal documents to communicate the value of a product to affiliates, enabling them to use the information to develop their own dossiers. While some elements can be cut-and-pasted, a degree of adaptation is required. The EUnetHTA Core template is more akin to a global reimbursement dossier and may be used as a template to develop a dossier for direct use by several markets. The format of the EUnetHTA template is quite different to the standard HTA templates, with various assessment elements, domains, and issues. Therefore if you decide you’d like a global reimbursement dossier to use the EUnetHTA format it would be more efficient to develop this from the bottom-up – either alongside or instead of a GVD. We are currently watching to see how the EUnetHTA format is used by European HTA organizations.

Q. Can you expand more on seeking input from key affiliates—are you getting specific HTA advice/consultation?

A. When developing GVDs, we find it useful to seek specific external advice—from national, regional or local payers—during the value message development phase of the project. For markets of interest, we would suggest either advisory boards in key regions, telephone interviews with key stakeholders or targeted web surveys, to ensure that unmet needs are identified correctly, that the interpretation of the clinical data is both robust and impactful and that any local issues are identified early in the process.

Subsequently, when developing the GVD itself we consider the information from the early payer testing and generally only seek additional input from the company’s team in specific countries. These may be from health economics, market access, marketing or medical—depending on local arrangements and resources. The local team are usually familiar with their country’s requirements and landscape and can thus advise on what they need from a GVD. Where appropriate, we may also identify HTA experts in key markets to review the GVD as it near completion although this is more common with reimbursement dossiers.

Q. How to best use payer feedback such as payer research, scientific advice, HTA submissions results, etc. to inform, guide the GVD Development and revision.

A. Feedback from payer research is helpful to test the resonance of each value message in different markets, and to determine the evidence that will be required to underpin the messages. The wording and prioritization of value messages should be altered if needed, in line with the stakeholder feedback. The feedback from the scientific advice process helps to shape the product reimbursement strategy and would, therefore be embedded in the content of the GVD. Results from HTA submissions of competitor products can be used to guide the local reimbursement strategy for the product of interest, indicating what has worked well, and highlighting where issues need to be addressed or defended. Experiences from earlier HTA submissions of the product of interest should be shared with affiliates later in the launch sequence to build on previous learnings.