Biopharmaceutical company decision making on drug development is often hampered by a lack of focus on payer evidence needs next to FDA/EMA requirements, thus often resulting in poor access and/or poor pricing.
US and European payers are mentioning the following four typical evidence gaps as a reason for rejection or poor pricing:
1. Trial primary end point is not an accepted gold standard
2. Inappropriate trial comparator selection
3. Trial design not accepted
4. Length of trial insufficient
Drug pricing is a complex decision with many business/economic and social considerations. Understanding payer needs is critical.
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