HTA Quarterly | Fall 2019

By Xcenda |

In this issue, our editors examine cost-effectiveness assessments for innovative but high-cost treatments, market access for cell and gene therapies in key European countries, and the newest joint HTA assessment agency, FINOSE.

Heard on the Street

“Understand the ideas, concerns, and expectations of whoever you are talking to. You have to recognize that around the world, there are some really good people who want to make a difference.”

– Sir David Haslam’s advice to the new Chair at NICE as he prepares to step down after 6 years in the role.
Looking Back at NICE: Sir David Haslam

HTA by the Numbers

3 or 3:1 or 3 in 1
The number of agencies concurrently approving combination Keytruda plus Lenvima for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability high (MSI-H) or mismatch repair deficient (dMMR) and who have disease progression following prior systemic therapy but are not candidates for curative surgery or radiation. The approvals from the US FDA, the Australian Therapeutic Goods Administration, and Health Canada mark the first collaboration between the agencies under Project Orbis. The collaboration aims to reduce the burden and delays associated with regulatory reviews of cancer therapies and identify regulatory divergence across review teams.

Source: Simultaneous review decisions for pembrolizumab plus lenvatinib in Australia, Canada and US