Mini-Global Value Dossiers (GVDs)

Smaller Can Be Better!

Mini-Global Value Dossiers (GVDs)

FALL 2021, THE EVIDENCE FORUM, WHITE PAPER


Donald Smith, PhD
Senior Scientific Director
Evidence Synthesis, Modeling & Communication
Evidera, a PPD business
Naomi Stapleton
Naomi Stapleton, BS
Associate Director
Evidence Synthesis, Modeling & Communication
Evidera, a PPD business
Leslee Masten
Leslee Masten, BA
Principal Market Access Writer
Evidence Synthesis, Modeling & Communication
Evidera, a PPD business

The use of streamlined, pharmaceutical product global value dossiers (called “mini-GVDs”) has increased in the last two years. Mini-GVDs come in a variety of formats, can be useful in a number of different situations, and can be created prior to, near, or after product launch. This article will describe mini-GVDs, some of their potential uses, and also several benefits that they can provide to our clients and their affiliates.

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    What is a Mini-GVD and What Does It Look Like?

    A GVD is a document that contains information on a particular pharmaceutical product and the disease area/indication in which the product is used. The dossier also includes value messages that highlight the clinical, humanistic, and economic value of a product in a particular patient population. This document is used as a source of information by affiliates in the pharmaceutical and biotechnology industries to create reimbursement dossiers for local and regional submissions. GVDs help prepare these affiliates for discussions with public and private payers about their product and the value that it provides.

    A standard full-length GVD covering disease burden, current treatments, unmet needs, and product value can often be 200 pages or more. In addition, traditional GVDs are often arranged by topic (e.g., epidemiology, economic value), rather than by value message, with the sections varying widely in terms of length and often exceeding 10 pages each.

    In contrast, a mini-GVD is a streamlined document presenting typical GVD content in a more concise, digestible, navigable, and accessible format in approximately 50 pages. Furthermore, the content of a mini-GVD is typically organized by value message and color-coded by section for ease of use. The key supporting evidence for each value message in a mini-GVD is usually summarized in only one or two pages using a combination of text, tables, figures, and bulleted lists. Often, there is an emphasis on supporting visuals since these can be more engaging for the reader and help bring the product value story to life. Figure 1 shows an example of one approach to developing a streamlined version of a mini-GVD.

    Figure 1. Example Mini-GVD Page*

    Example Mini-GVD Page

    *Content is for example purposes only.
    GVD = global value dossier

    In addition, a mini-GVD often contains a contents/index page that gives the reader an overview of the dossier, the value messages, and the supporting content. This index page frequently has hyperlinks so that the reader can easily navigate directly to any value message and/or supporting content that they wish. Appendices with tables and figures may also be included if there is a desire to include additional information on some of the most important studies. An example of an appendix table from a mini-GVD is
    shown in Figure 2.

    Figure 2. Example Appendix Table from a Mini-GVD*

    Example Mini-GVD Page

    *Content is for example purposes only.
    GVD = global value dossier

      Why Develop a Mini-GVD?

      During the past couple years, there has been an increase in demand for GVDs that are comprehensive, but also streamlined. The more concise format of a mini-GVD provides some benefits over a traditional GVD. For example, the brevity of the mini-GVD allows the dossier to focus on the most important content, thus becoming less of a data repository and more of a story-telling tool. Our clients have found that this concise format is particularly useful for affiliates that do not require as much detail as a traditional GVD provides, including affiliates representing countries with less rigid health technology assessment (HTA) requirements, as well as affiliates that are responsible for multiple products in their region and have less time to review large dossiers for individual products.

      Furthermore, the typical mini-GVD can be developed in 3 to 6 months in contrast to a standard GVD that usually takes 6 to 15 months to complete, which can be beneficial if development timelines are condensed. Another advantage of a mini-GVD is its flexible structure and format that can be adjusted to best meet the needs of the users based on the available data, the product strategy, and the needs of the client. Finally, a mini-GVD can be more cost effective than a traditional GVD due to its smaller size and shorter development timeframe.

        When Should a Mini-GVD be Developed?

        Standard full-length GVDs are typically developed as Phase III trial results start to become available, with the dossier content being finalized in time for product launch and potentially updated as additional developments occur (e.g., new indications, availability of real-world data). Mini-GVDs offer flexibility in that they may be developed prior to, simultaneously with, instead of, soon after, or long after a full-length GVD.

          Developing a Mini-GVD Prior to a Traditional GVD

          Mini-GVDs can be developed before the Phase III, or even Phase II, trials of a product have commenced. A mini-GVD produced early in clinical development provides a good starting point for a full-length GVD and can also plant the seeds for the development of the corresponding value story. A mini-GVD that is developed early in the product lifecycle may be useful if:

          • The users are unfamiliar with a particular disease area and/or the current treatment landscape
          • A dossier would help address internal needs, but it is too early to start work on a full GVD to support a product launch
          • There is an interest in defining the key evidence gaps and understanding how the available literature supports an early value story
          • There are plans to use the product in multiple indications or disease populations and getting an early start on a dossier would facilitate other pre-launch activities

          Mini-GVDs that are developed prior to a traditional GVD often contain fairly complete sections on disease burden and unmet need and well-supported value messages related to those topics. Depending on how early on in development the mini-GVD is generated, the disease burden and unmet need sections may be able to inform the design of Phase II and/or Phase III trials.

          On the other hand, mini-GVDs that are developed prior to a full-length GVD may lack information related to product labeling, clinical trials, and/or economic models. Therefore, the sections on product information, clinical value, and economic value may be incomplete. However, these relatively brief sections can still be useful. For example, the clinical value section may contain information on the design of each main study along with a list of aspirational value messages related to the key endpoints.

            Developing a Mini-GVD Simultaneously with a Traditional GVD

            While developing a mini-GVD simultaneously with a traditional GVD is uncommon in our experience, it may appeal to those who feel that a mini-GVD might be a better companion piece to a full-length GVD than a GVD slide deck. Based on conversations with our partners and their operating companies, a mini-GVD may be preferable to a GVD slide deck in certain cases since a mini-GVD provides more information and detail than a GVD slide deck while still presenting the information of interest in a more visual and streamlined manner than a traditional GVD.

              Developing a Mini-GVD Instead of a Traditional GVD

              A mini-GVD may be preferred over a traditional GVD because it provides a fresh approach, giving affiliates the value story and key supporting evidence in a direct, impactful way. For example, a client expressed concern that its GVDs had been frequently growing in length and complexity, becoming more of a data repository than a compelling story-telling tool to facilitate market access. For their new product in development for a rare disease with no approved treatments, they wanted a streamlined GVD that presented the disease background, unmet need, and clinical evidence in a concise, digestible format. Our client also needed a way to ensure access to more detailed data and comprehensive reports when required by an affiliate. The mini-GVD for this product summarized the most important and compelling information in the body of the dossier, highlighting and illustrating key points with tables and figures. Links were provided to study details and additional data in the appendix. Instructions were provided so that external full reports and publications could be accessed for more in-depth information. Each section opened with key value message tables that included cross-references to supporting evidence either in the text or the appendix. The mini-GVD thus provided an easy to use resource for product value evidence to support global payer communications.

                Developing a Mini-GVD Soon after a Traditional GVD

                A mini-GVD may still be beneficial even if a traditional GVD has been developed recently. One example was a product whose GVD had recently been updated to reflect changes in current disease management, as well as to cover the product’s multiple indications in different lines of therapy and age groups. The updated GVD had grown to a large size (nearly 300 pages) to accommodate descriptions of multiple pivotal trials and the competitive treatment landscape. Users of the GVD therefore had a potentially overwhelming amount of information available to them, and some affiliates found that the GVD was too long to read and too cumbersome to quickly find key information. While the increased level of detail in the full-length GVD was required for creating submission dossiers, a more concise presentation of the key information and overall narrative was also needed. The mini-GVD was developed as a resource that presented the evidence-based value story and key messages for the product in a clear, succinct, and accessible manner.

                Tailoring the mini-GVD to the needs of the users and making it more digestible and navigable encouraged broad use of the dossier by the affiliates as a “go to” source for information. The more concise format was also positively received in its use as a companion to the full-length GVD for negotiations with payers in multiple countries.In particular, the brevity of the dossier was found to be most useful in Latin American, Middle Eastern, and African markets, where HTA submissions may require less detail than European country submissions, or affiliates may be responsible for multiple products and have less time to review each GVD.

                  Developing a Mini-GVD Long after a Traditional GVD

                  Mini-GVDs can also be developed long after a full-length traditional GVD. One example where a mini-GVD proved beneficial involved a product that received initial approval in the US and EU approximately a decade ago. The next step in development was to prepare to support the launch of the product in several new countries and its re-launch in other countries. Since the original full-length GVD had not been updated since the initial approval of the product, there was a discussion with the client team about whether to update the existing GVD or generate a completely new one. Since there was also a desire to update the evidence base to include a series of publications about recent realworld evidence that supported the clinical, humanistic, and economic value of the product as a treatment of choice in the disease area, we suggested developing a clear and concise mini-GVD that could highlight the latest data, the current value narrative, and be more easily accessible to the affiliates.

                    Conclusions

                    As mentioned earlier, the use of mini-GVDs has been on the rise in recent years, and there are a variety of reasons for their increasing use. Many companies have found that mini-GVDs are useful as either a companion piece to a full-length GVD or as a stand-alone piece that provides all of the pertinent information in a streamlined and accessible format. Their popularity is also affected by the ability to develop them prior to, simultaneously with, instead of, soon after, or long after a full-length traditional GVD. The adaptable format of mini-GVDs means that they can be designed for the unique needs of the users and the specific characteristics of the product, allowing companies flexibility in creating the right communication vehicle for the right audience at the right time. In addition, they can be developed more quickly than standard GVDs and at a lower cost, which may be a more attractive option in certain situations. As competition increases and time becomes even more critical in getting products to market, mini- GVDs are one growing option providing companies the ability to plan and execute their evidence strategies and dissemination plans in the most effective way possible.