Cogience Insights
Insights
Research and perspective on healthcare, technology, and market access - published when there's something worth saying.
UX111 under MHRA review: Sanfilippo gene therapy meets NICE HST
The MHRA has accepted Ultragenyx's Sanfilippo type A gene therapy for review, with NICE aligning its HST evaluation. A single-arm evidence package and a $3.95 million US price make it a test case.
Camizestrant JCA report: what the EU assessment inherits
The Commission has published the joint clinical assessment report on camizestrant. We look at the SERENA-6 evidence behind it and what market access teams should plan for in national submissions.
NICE's SMART pilot: a shorter first appraisal for new medicines
NICE and NHS England are piloting a shorter first assessment for promising medicines, followed by managed access and a full evaluation. The evidence plan now matters before the first decision.
G-BA's first JCA-informed AMNOG decision: what Ojemda shows
Germany has closed its first AMNOG assessment built on an EU joint clinical assessment report. Ojemda shows the JCA adds to national work rather than replacing it, and why single-arm and orphan programmes need to plan for PICO scoping now.