Availability of comparative trials for the assessment of new medicines in the European Union at the moment of market authorization

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Pricing and reimbursement experiences and insights in the European Union and the United States: Lessons learned to approach adaptive payer pathways

Earlier patient access to beneficial therapeutics that addresses unmet need is one of the main requirements of innovation in global healthcare systems already burdened by unsustainable budgets. \u201cAdaptive pathways\u201d encompass earlier cross-stakeholder engagement, regulatory tools, and iterative evidence generation through the life cycle of the medicinal product. A key enabler of earlier patient access is through more flexible and adaptive payer approaches to pricing and reimbursement that reflect the emerging evidence generated