![]() ![]() This strategic document incorporates comprehensive insights on the product’s added value and differentiation from existing products, disease burden, unmet need, clinical characteristics and economic value. The GVD is a critical component for implementation of such a global market access strategy. To guarantee sufficient return of investment, it is important for the marketing authorisation holder to have a strong market access strategy, which requires clinical evidence obtained from the clinical development program, to enable the product to be reimbursed by healthcare systems at a price that reflects it value to both the payer and the company. ![]() Having well-defined value drivers and value messages allows pharmaceutical and biotech companies to build the compelling value story.Īlthough obtaining a marketing authorisation is often the goal of clinical development, pharmaceutical companies need to think one step ahead and plan how to ensure patient access. It then elaborates on the drug’s capacity to address this unmet need by defining, often with concise value messages, the clinical and economic evidence base to effectively communicate the product’s value, from a payer’s perspective. By identifying what the unmet need in a given disease area is, the GVD establishes what the value drivers will be for the product. The GVD plays a key role both in external communication of the product’s value to payers and internal alignment among local affiliates of pharmaceutical and biotech companies. ![]() It is a strategic tool that captures all clinical, safety, and economic information about a new drug. The global value dossier (GVD) is a core document, which may be considered the “heart” of the pharmaceutical product’s payer communication strategy. Why is that the case? Today it all comes down to demonstrating value of the product. Having robust efficacy and safety data documented in thoroughly planned and strictly conducted clinical studies may not suffice to guarantee patient access to innovative drugs and medical devices. The pharmaceutical industry has evolved significantly over the last couple of decades when it comes to bringing new drugs to the market and ensuring patients’ access to them. ![]()
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