By Matthew Gordon and Kim Maguire-Wright,
Today, payers and other stakeholders are demanding more (and more robust) real-world evidence (RWE) of a drug’s effectiveness and benefits. It’s understood that randomized clinical trials (RCTs), designed for regulatory approval, don’t provide a true picture of what happens in the real world. The Catch-22 is that payers would like RWE before they place a product on a formulary, or incorporate it into guidelines, but such evidence is difficult to collect unless and until a product is widely available and utilized. Consequently, companies all too often don’t have adequate RWE at the time their drug is approved, and must scramble, post-approval, to fill evidentiary gaps.
Sometimes, they can scramble for years. This clearly is inefficient, and costs companies valuable time in the market, leading to lost revenue that can never be recovered.
The RWE landscape is complicated. The volume and sophistication of secondary data from healthcare data assets (HDAs) – including national or disease-specific patient registries, electronic health records and electronic medical records (EHRs and EMRs), biobanks, longitudinal health insurance claims data, national surveys, and hospital utilization data – has increased dramatically over the last decade. However, successfully integrating healthcare data assets into your evidence generation plan can reduce your scrambling costs, and improve your case for payers and other stakeholders.
So why doesn’t everybody do it?…
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