1.1 Cenegermin is not recommended, within its marketing authorisation, for treating moderate or severe neurotrophic keratitis in adults.
1.2 This recommendation is not intended to affect treatment with cenegermin that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
There is no standard care pathway for neurotrophic keratitis in the NHS. Treatment options include artificial tears and serum-derived eye drops, as well as surgery such as eyelid closure (tarsorrhaphy).
Evidence suggests that when used for 8 weeks, cenegermin is an effective treatment compared with vehicle in terms of corneal healing. But the longer-term effects are not known because there are no data about this.
Any estimate of cost-effectiveness is very uncertain. Because of errors in costs, implausible assumptions and uncertainty in utility values, the modelled benefits for cenegermin are therefore likely to be overestimated. This, plus the unknown longer-term corneal healing effects, mean it is not possible to identify a robust cost-effectiveness estimate for cenegermin compared with artificial tears. However, based on the evidence presented, the most likely cost-effectiveness estimate would be higher than the range that NICE normally considers to be an acceptable use of NHS resources. Because of this, cenegermin cannot be recommended.