A well-written global value dossier (GVD) can save time and resources for pharmaceutical market access teams and help accelerate patient access to new drugs and medical devices. One of the key success factors for creating a great GVD, is to consider the balance between the global value story and local payer requirements.
What is a GVD?
A GVD is an internal document of global source material for market access and HEOR teams involved in applying for reimbursement for a new pharmaceutical product.
A well-written GVD helps communicate the value of the product, its value proposition, with decision-makers in markets around the world. These decision-makers are stakeholders involved in the health technology assessment (HTA) process for the product, and are responsible for adoption, access, reimbursement, and funding of the product in their local market.
What is the objective of a well-written GVD?
To meet the assessment needs of international payers, GVDs should be structured with worldwide HTA submission templates, requirements, and guidelines in mind. However, a single GVD cannot meet all payer needs across all markets given the very specific payer requirements of some markets.
There is a need to find the right balance between level of detail and a clear value story, to support the efficient development of high-quality local HTA submissions that meet affiliate needs and local payer requirements.
Non-optimized global evidence packages can result in wasted time and resources, and ultimately a delay to return on investment and patient access.
Therefore, the objective of a well-written GVD is to:
- Ensure that the payer requirements, which are consistently requested across multiple countries and HTA agencies, are covered
- Enable local teams to focus their time on local strategy and data generation
- Optimize time to patient access and a return in investment
A great GVD balances a clear global value story with local payer requirements
You can think of payer requirements in two “buckets.” There are payer requirements that are consistently requested across multiple countries and HTA agencies. I refer to these as “global requirements.” Then there are country-specific payer requirements, which I call “local requirements.” Here are some examples:
Global payer requirements
- Describe the treatment setting and service organization for the proposed product, and if this differs from current clinical practice
- Provide rationale for any surrogate measures used
- Describe how the proposed product may be considered innovative, with rationale and justification
Local payer requirements
- Provide details of the expected market share of the drug for the budget impact analysis (local data)
- Provide details of any relevant NICE (National Institute for Health and Care Excellence) guidance, pathways or commissioning guides related to the condition for which the technology is being used (UK)
- Specify the benefit of the medicinal product to the public health system (France)
A great GVD will address as many global payer requirements as possible, with a coherent and robust value story, to directly inform local payer submissions, leaving affiliates time to focus on local strategy, while at the same time keeping the GVD length manageable and easy to navigate.
This on-demand webinar offers more recommendations to help you find the right balance between level of detail and a clear value story and build an optimized GVD to populate local HTA/payer templates. It also explains the 5 common omissions that could be met with global data to make your GVD most useful to local affiliates.
If you have any questions about how to write a great GVD, or want some support from our GVD services, we would be happy to help.