Accelerated approval is intended to get needed drugs to patients, but there are sometimes distortions and complications in the process that should be addressed.
accelerated approval
Biopharmaceutical companies, insurers, pharmacy benefit managers and the government can and must work together to keep each other accountable and embrace value-based or outcomes-based reimbursement. The guiding principle being that “IF” the new innovative medicine delivers the outcomes and value promised to patients and the U.S. economy, the therapy will be rewarded.