Madhur Garg, Real World Evidence and Market Access, Sciformix, a Covance Company04.05.19
The emergence of value based payments (VBP) has highlighted the importance and relevance of real world evidence (RWE). RWE is used to assess a product’s safety, efficacy to effectiveness translation, cost effectiveness and product differentiation,1,2 thus helping payers and manufacturers to implement ‘performance-based risk-sharing agreements’ and patients to manage budgets and estimate risk benefit of interventions. Manufacturers can leverage RWE to obtain accelerated market access and it can facilitate payers in substantiating drug pricing and reimbursement. Real World Data (RWD) can help with regulatory approval of label expansion or new indications for marketed drugs.
However, the approach to collecting, evaluating and using RWD around the globe is very inconsistent. There is an increasing desire among a wide range of stakeholders—including industry, regulators, payers, providers and patients—to harmonize its use and impact for the overall benef
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