Several HTA agencies assesses patient-reported outcomes (PROs) as part of health-related quality of life (HRQL) and patient-relevant morbidity outcomes.Ī clear narrative between demonstrating the humanistic burden of the disease and current treatments, and the benefits of the proposed product, should therefore be demonstrated in a GVD. HTAs require comprehensive trial and analysis information this is often included in the GVD summaries but the detail is often insufficient.įor 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. ![]() ![]() Sufficient trial and analysis information patient-relevance and validity of endpointsĢ.Key parameters requiring justification may include (but are not limited to): Clear rationale in global documents will provide local teams with the strategic guidance or depth of information required for their submissions. HTA agencies require robust justification for all submission parameters. What should be included in a high-quality GVD?Ī GVD aims to meet the requirements of health technology assessment (HTA) templates but up to 30% of global HTA template requirements may not be met by a traditional GVD.Ī high-quality GVD should include the following elements. Source: How to build an optimized GVD to populate local HTA/payer templates ![]() The aim of a great GVD should be to cover as many ‘global payer requirements’ as possible, with coherent and robust value story A GVD helps to establish the product value proposition with decision-makers who will be responsible for adoption, access, reimbursement, and funding.Ī GVD 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. A global value dossier (GVD) is an internal document designed to be used as a global source material for local market access teams in pharmaceutical and biotechnology companies.
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