U.K. review proposes new accelerated review pathway

In its final report, the U.K.'s Accelerated Access Review recommended the creation of an Accelerated Access Pathway that would speed patient access to highly innovative products by up to four years. As part of the new pathway, five to 10 therapies or technologies each year would receive a "transformative designation" based on preclinical and early clinical data that suggest a significant benefit in either outcomes or cost.

The pathway is meant to work in parallel with other regulatory mechanisms, such as EMA's PRIME scheme, that accelerate development of certain drugs. A compound with transformative designation also would receive advice from regulators on market access and commercial arrangements. The report proposed that drug sponsors and NHS research bodies act in concert to gather clinical and real-world data to help assess drugs' value. ...