Revisiting the Familiar: Time to Re-evaluate the GVD?
By Xcenda |
HTA QUARTERLY | SPRING 2017
Revisiting the Familiar: Time to Re-evaluate the GVD?
By Ryan Clark, PharmD, MBA, MS and Evelyn Sarnes, PharmD, MPH
Same Document, New Environment: a Look at the Current GVD
*23 of 42 respondents received a GVD prior to their HTA submission.
The most common characteristic of the GVD that survey respondents found to impact its utility at the local level is that, while comprehensive, the content of the GVD isn’t relevant to their specific country (or HTA agency). For example, the relative value of quality of life or the acceptance of surrogate outcome measures can be very different by region; so it is critical that local experts provide feedback on the most important outcome measures in their country. Manufacturers may encounter problems if the GVD is developed without input from those who will ultimately be using the GVD for their HTA submission and/or if the GVD does not align closely with local HTA frameworks. Local input is especially important for those sections where HTA agencies often require country-specific data, like epidemiology, treatment patterns, economic burden, and cost-effectiveness/budget impact. When these local data are absent in the GVD, it forces affiliates to conduct their own literature reviews to identify and develop these sections for their local submission. Tailoring the content for HTA is also critical for sections such as economic modeling and the summary of clinical data. Because of intricacies and nuances of local HTA requirements, it is critical that local teams familiar with those processes be intimately involved in the creation of this section and the supporting materials. For example, when considering a product’s budget impact/cost-effectiveness, it would be important that representatives from France (along with other markets of interest) weigh in on the development of the economic model and ensure the major requirements of a Haute Autorité de santé (HAS) submission are met (in the case of France, by emphasizing the budget impact of the technology vs the quality-adjusted life year [QALY]-based cost-effectiveness that is required by NICE in the UK).
Another commonly cited issue with the GVD is that it may not clearly communicate a core value proposition or it is not transparent in how the value proposition is supported. When designed well, the GVD can very effectively deliver a robust starting point that provides a cohesive value story for local affiliates to use alongside other tools and resources. Unfortunately, it is not always clear in the GVD what level of evidence is present to support value statements made in the dossier. It is important to note this does not suggest affiliates want more data inserted into the GVD simply for the sake of having more data; rather, they are interested in a comprehensive value story with the complete suite of evidence available in support.
Strategic Actions to Maximize GVD Impact and Usefulness
So how can the GVD be made more useful for local affiliates and provide a more unified message to the numerous HTA agencies represented? Involving local affiliates (or those familiar with a given market’s HTA processes/requirements and/or who will be drafting the HTA submission) is critical to the GVD being more widely utilized. It is important to develop a feedback process in which affiliates can at least provide relevant input and data from their local market to proactively address the issue of relevancy. Another aspect to consider in creating a successful GVD is taking into account the language of the end user. Inadvertently, headquarters may take for granted the common use of the English language; local affiliates who must take the GVD and adapt for their own local HTA submissions may find the translation to be a very significant barrier to the timely use of the GVD . Local discussion on the language used in the GVD is important to understand which markets may require or request translation.
With several local affiliates all providing input on the GVD, the process and timelines can get complex, which may result in missing the critical window when the GVD is needed for local HTA submissions. In the survey described above, 36% of local affiliates who were involved in an HTA submission did not have a GVD prior to finalizing the submission dossier—though it is unknown if this was intentional or not. When asked about GVD timing, most affiliates preferred to have the GVD approximately 1 year prior to regulatory approval, which implies the GVD development process must begin well before the preparation for an HTA submission.
While they can be significant, these challenges are not insurmountable. The decision to develop a GVD should be elevated from a “checklist” item for global market access to careful consideration by the various stakeholders involved in order to fully recognize the potential such a global value document can provide to an organization. It is imperative to have in-house expertise or a strategic partner that not only understands how the document is used by local affiliates for HTA submissions but also can appropriately leverage the product’s clinical and economic value proposition . The GVD is a very valuable tool and certainly will remain as a core component of an organization’s global market access strategy; through innovative solutions, the GVD can thrive and be more willingly and efficiently used by local affiliates.
The article should be referenced as follows:
Clark R, Sarnes E. Revisiting the familiar: Time to re-evaluate the GVD? HTA Quarterly. Spring 2017. April 10, 2017.
- Sarnes E. Global Value Dossiers (GVDs): How to Ensure the Value Isn’t Lost in Translation. Presented at: ISPOR 19th Annual European Congress; 29 October – 2 November 2016.