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Real-World Data Strategies

August 22, 2017

Payers are more concerned with how drugs work in the real world than in controlled trial environments. Unfortunately, real-world data is expensive to collect. Fortunately, there are databases filled with real-world evidence that developers can use to support their value case in their submissions.

When it comes to approving a new drug, regulators are looking for evidence of efficacy (the drug’s desired effect) and safety (the drug’s undesirable effects, and how serious they may be). Payers, however, may have additional interests.

They are less concerned with how the drug works in a controlled trial environment than with how it will work in the real world, in real settings, with real patients living real lives. And, most assuredly, they are looking at the price the developer is proposing to charge for the drug. Often they will want to know whether it is cost-effective. That, too, largely depends upon how it performs—and the costs that attach to it—in the real world.

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