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. 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. Why is that the case? Today it all comes down to demonstrating value of the product.
The global value dossier (GVD) is a core document, which may be considered the “heart” of the pharmaceutical product’s payer communication strategy. It is a strategic tool that captures all clinical, safety, and economic information about a new drug. 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. By identifying what the unmet need in a given disease area is, the GVD establishes what the value drivers will be for the product. 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. Having well-defined value drivers and value messages allows pharmaceutical and biotech companies to build the compelling value story.
Although 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. 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. The GVD is a critical component for implementation of such a global market access strategy. 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. Moreover, it contains a payer objection handler, which describes which are the main payer uncertainties and other anticipated market access challenges that the product has to overcome.
Market access and reimbursement is becoming a progressively complex multifactorial process which requires substantial efforts from different business departments, such as Medical, Marketing, Market Access and Regulatory teams. They should all work in close collaboration with each other to disseminate the value of their product successfully across local affiliates and HTA institutions. The GVD represents is an invaluable tool which is positioned in the core of these activities and that is why, it should be very structured, compile all the necessary information for the end user and have good value communication. This would allow all stakeholders to delve into its content easily and find everything they need. The GVD is the most practical way of disseminating the added value of a product to patients and healthcare systems and how it differentiates from the current treatment options. That is why, many, if not all, pharmaceutical and biotech companies have identified the GVD as a great tool that is worth investing in, which will facilitate patients’ access to their products and subsequently increase their profit.
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