Back to School analyzes the issues surrounding last stage of the pathway, the decision either to grant full approval or withdraw a drug, on Thursday.
In a pair of articles, Washington Editor Steve Usdin provides a comprehensive analysis of the forces surrounding market access, finding both regulators and payers are limited by the binary options available to them. The stretch vision would see regulators endowed with regulatory “rheostats” that allow them to tailor access to the drugs to the right patients, and payers deploy value-based payment models to couple reimbursement to the level of certainty of the evidence.
Hansen adds analysis of the relatively new pathways in China and Japan in one article, and the very new process in the U.K. in another, all of which take steps along the path to the stretch vision.
To view Thursday's Back to School content, click on the links below:
Regulatory rheostats key to meeting promise of expedited approvals
Better mechanisms are needed to dial in appropriate access based on postmarket evidence
MHRA seizes opportunity to reshape expedited approval
Newly independent, MHRA leapfrogs FDA, EMA pathways by integrating regulatory, reimbursement throughout the process
Pricing the uncertainty in expedited therapies
How new ideas about pay for performance aim to temper uncertainties, and controversies, about accelerated approvals
China and Japan raise the bar on expedited approvals, adding time limits
Iterating of FDA, EMA expedited approvals with stricter requirements for postmarket data submissions
Modifying access for accelerated approvals: a BioCentury Back to School podcast
Regulators, payers need more tools to ensure the right patients get the right drugs