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Do your global value dossiers contain these 5 common omissions?

11/20/2023

In the health technology assessment (HTA) process, effective communication of global strategy and product value to affiliate teams is crucial.

In this market access update, we explore how you can better support your affiliates by creating a high-quality global value dossier that avoids 5 common omissions.

Up to 30% of global HTA template requirements may not be met by your global value dossier.

A recent mapping exercise evaluated how many requirements from current HTA templates could be met by a typical global value dossier (GVD). The study found that up to 30% of requirements that were expected to be addressed by the global data package (ie, not local data or country-specific requirements) were not met.

 

Do your global value dossiers contain these 5 common omissions?

 

1. Inadequate justification

HTA agencies require robust justification for all submission parameters. A lack of clear rationale in global documents may not provide local teams with the strategic guidance or depth of information required for their submissions. Key parameters requiring justification may include (but are not limited to):

  • Appropriate comparator
  • Patient-relevance and validity of endpoints
  • Generalizability of the data
  • Economic model inputs

 

2. Insufficient trial and analysis information

HTA agencies require comprehensive trial and analysis information; this is commonly included in the GVD summaries but the detail is often insufficient. For global teams to provide local markets with the correct data cuts and the detailed information required, additional information should be provided in appendices, or through clear links to signpost affiliates to the data they need.

 

3. Poor consideration of humanistic burden

Several HTA agencies assesses patient-reported outcomes as part of health-related quality of life and patient-relevant morbidity outcomes. However, a clear narrative between demonstrating the humanistic burden of the disease and current treatments, and the benefits of the proposed product, is often missing in GVDs.

 

4. Economic impact

Although many HTA agencies do not formally assess cost-effectiveness, information on investment and tools required to use the proposed product versus the current standard of care should be included in GVDs, to meet HTA requirements. For example, changes to treatment setting and service organization.

 

5. Evidence summaries

One size does not fit all when it comes to GVDs and HTA templates; therefore, evidence summaries should be reported alongside the detail, to address different levels of information requirements in local submissions.

 

The often-missing key consideration of global value dossier dissemination

A GVD is an internal document designed to be used as a global source material for local market access teams, to establish the product value proposition with decision-makers who will be responsible for adoption, access, reimbursement, and funding. Therefore, GVDs should be structured with worldwide submission templates, requirements, and guidelines in mind, allowing efficient population of local submissions, while maintaining the integrity of the global value story.

 

Want to learn more about supporting your affiliates in the generation of simultaneous, high-quality HTA submissions?

This analysis was enabled by PRMA Navigator® technology. This technology drives continuous HTA submission improvements, in part by:

  • Ensuring the changing local HTA requirements are captured
  • Identifying gaps in global source material
  • Driving more targeted affiliate-focused deliverables

The PRMA Navigator® is a digital application that improves the quality of multiple HTA submissions, through the delivery of auto-populated draft submissions that are up to 80% complete and aligned with the global strategy for the product. Auto-populated draft submissions based on global and local source documents are delivered in as little as 2 weeks, so that affiliates can utilize their time to generate local data, engage with key stakeholders, and craft the value story and strategy.

Alongside the PRMA Navigator®, we have developed the PRMA Navigator® GVD template, a framework based on core content requirements that are consistent across current HTA templates, capturing the breadth of clinical, economic, and humanistic evidence necessary to meet the multifaceted criteria of HTA agencies. These content requirements have been mapped from our review of worldwide HTA templates, agency requirements/guidelines, and extensive project experience, including working closely with clients to develop HTA templates for those countries without publicly available or official templates.

The PRMA Navigator® GVD template can be used as a standalone template, or within the PRMA Navigator® application. Partnered with the PRMA Navigator®, a robust, fit-for-purpose GVD can maximize quality and efficiency gains when supporting your affiliates with their local submissions.

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