What is burden of proof?
Burden of proof refers to the requirement to provide robust, evidence-based justification for a product’s approval, pricing, reimbursement, or adoption. It applies in regulatory review, payer evaluations, and health technology assessments (HTAs), where decisions are contingent on demonstrating clinical and economic value.
Why is burden of proof important in pharmaceutical strategy?
Meeting the burden of proof requires a well-planned evidence-generation program and strong alignment between Clinical, HEOR, and Market Access functions. The strength and relevance of the evidence submitted directly influence approval, pricing, and market access outcomes. Anticipating and addressing stakeholder requirements early is key to success.
