What Should Biopharma Companies With Drugs Moving Into Phase 3 Clinical Trials Prioritize With Respect To Supporting Payer Access In The U.S.?

IT IS WISE FOR COMPANIES PREPARING TO ENTER PHASE 3 TRIALS — or even earlier in the development process — to consider how payers define value for a specific medicine. A Phase 3 clinical trial design should go beyond the baseline requirements for safety and regulatory approval to include endpoints or measurable outcomes that either create broader healthcare savings or point to payer requirements in support of a drug’s value proposition. If a drug developer waits until after regulatory approval to conduct real-world evidence studies, for example, it won’t help when payers are making initial decisions about coverage and reimbursement.

JEFF BERKOWITZ, CEO, Real Endpoints and board member, H. Lundbeck A/S.