"Payers want value in the real world," says Merck & Co's Swapnil Rajpathak

Nobody is surprised now when pharma companies that are presenting data at scientific conferences choose to focus on real-world evidence (RWE) as much as, or more than, on their results from randomized control trials.

The growing importance of agreeing prices with payer organizations, as well as convincing clinicians and sometimes patients themselves that a drug provides benefit and value, means that a drugmaker’s efforts to establish a drug’s efficacy rarely end with regulatory approval.

Criticism of pharma’s development of ‘me too’ drugs, whether fair or not, creates a greater need to prove that the benefit is more than just an effect given off by a well-designed Phase III trial.