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. "Adaptive pathways" 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.
Centre for Advancement for Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, United Kingdom.
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Faulkner
Price Waterhouse Cooper's Strategy&, London, United Kingdom.
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Lee
Price Waterhouse Cooper's Strategy&, London, United Kingdom.
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Qin
Centre for Advancement for Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, United Kingdom.
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Morrell
Italian Medicines Agency, Rome, Italy.
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Xoxi
Italian Medicines Agency, Rome, Italy.
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Sammarco
Italian Medicines Agency, Rome, Italy.
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Cammarata
Italian Medicines Agency, Rome, Italy.
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Russo
Italian Medicines Agency, Rome, Italy.
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Pani
Centre for Advancement for Sustainable Medical Innovation (CASMI), University of Oxford, Oxford, United Kingdom.
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Barker
D002017:Budgets; D003365:Costs and Cost Analysis; D003695:Delivery of Health Care / Q000191:economics / Q000458:organization & administration*; D004059:Diffusion of Innovation; D005062:European Union; D006297:Health Services Accessibility / Q000191:economics*; D006301:Health Services Needs and Demand; D006801:Humans; D012051:Reimbursement Mechanisms / Q000191:economics*; D013997:Time Factors; D014481:United States