Successful product development, regulatory approval, market access and launch requires pharmaceutical and biotech companies to identify and meet the needs of all stakeholders be they patients, healthcare professionals (HCPs), payers, regulators or policymakers.

The role of stakeholders is to essentially assess the clinical and economic value of the new product in question. The value that the product represents is usually viewed differently by each key stakeholder because of their diverse interests. Undertaking stakeholder analysis before, during and after product development to understand what value means to each key individual is therefore a crucial and complex part of any market access project. 

To ensure success, companies need to plan and integrate market access strategies into the product development process. Clinical trials should be designed to meet the needs of decision-makers and include clinical and economic end points as well as patient-reported outcomes. Disease registries pre-launch, or observational studies post-approval, enable data to be captured which provides information on the use of a product when it reaches the market. The need for this real-world data has gained significant traction more recently, and the ability to demonstrate the value of a new product in the real world is now essential for many stakeholders. Health economic data and budget impact data are other important challenges.

Early dialogue with key stakeholders is therefore of upmost importance, not only to understand everyone’s views on value, but also on how to best design the trials or registries that will collect the value data they require. Successful market access outcomes often rely on how well the clinical and economic value of the new product has been conveyed to stakeholders.

HCC views stakeholders as real collaborators and distinct from customers. We work directly with stakeholders throughout product development with the common aim of improving patient access to new technology. We encourage pharmaceutical and biotech companies to align product development with the unmet needs of all stakeholders so that new drugs and devices can meet increasing market access demands. By collaborating with stakeholders and holistically identifying their priorities, companies can produce the clinical and economic data to create a convincing and data-driven value story.

HCC is committed to ongoing dialogue with all stakeholders which doesn’t stop after product launch. Through advisory boards, virtual payer panels, Delphi research and face-to-face visits, we ensure that initial clinical trials and post approval activities meet the data needs of regulators and payers.


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