85% of respondents stated that greater PMA input into clinical development would improve future launches. Conclusions: PMA teams face fewer internal launch challenges, but difficulties remain during payer negotiations due to insufficient clinical data. There is a need to better integrate PMA input early in the clinical development process to make the necessary evidence available at launch, and effectively manage senior leadership expectations around price potential and the associated evidence requirements, particularly in EU markets.

85% of respondents stated that greater PMA input into clinical development would improve future launches. Conclusions: PMA teams face fewer internal launch challenges, but difficulties remain during payer negotiations due to insufficient clinical data. There is a need to better integrate PMA input early in the clinical development process to make the necessary evidence available at launch, and effectively manage senior leadership expectations around price potential and the associated evidence requirements, particularly in EU markets.