Update: National Institute for Health and Care Excellence (“NICE”)

In this post I’ll go over some relevant discussion in NICE’s March 2024 Integrated Performance Report as related to guidance timelines.

The Report

“In 2022/23, NICE reduced the time taken to deliver guidance on medicines following GB marketing authorisation (MA) by 17%. In 2023/24, we aim to reduce the time by a further 15%.”

NICE characterizes topics as “optimal” or “divergent”.

One characteristic of an “optimal” topic is:

“NICE is notified of topic >16 months ahead of GB marketing authorisation.”

NWBO notified NICE in December of ’22. Sixteen months from then is May of ’24.

The days between a GB marketing authorisation and final TA/HST guidance for an optimal topic in the ’22/’23 period is:

✅55 days (Mean)
✅62 days (Median)

What does this mean?

With the goal of an additional 15% improvement in timelines for ’23/’24, we can reasonably hope for a <2 month timeline from approval to final NICE guidance.