After the NICE draft no to Yescarta in DBLCL, NICE says draft no to Kymriah. The immediate question is: what is going on at NICE, are they going to deny access to CAR-Ts in DBLCL? The draft recommendation posted today provides NICE’s reasons for this no, and they are very similar to Yescarta’s:
- Lack of comparative evidence vs. standard of care
- Immature data, i.e. NICE’s experts would like to see longer follow-up data
- ICER above NICE threshold
The negative recommendations are only the first step in a process that will result in final decisions between December 2018 and January 2019.
What next? For Kymriah, we can expect some fine-tuning on the cost-effectiveness side. Certainly, there is no time for generating comparative data vs. standard of care and that will be challenging in any case. As NICE said, there is ‘no standard treatment for relapsed or refractory diffuse large B- cell lymphoma after 2 or more systemic therapies‘. Probably, Novartis will refine its work on indirect comparisons with chemotherapy. A few more months of follow up may also add to evidence that already looks strong to many experts.
Our expectations: despite the disappointing NICE Draft reccomendations, we are still positive on UK DBLCL patients’ chances to access CAR-Ts.