NICE Wants More Information on Santen’s Ikervis

The UK’s healthcare costs regulator is asking Santen Pharmaceutical to provide more information on its Ikervis eye drops following a preliminary recommendation denying its use for the treatment of severe keratitis in adults with dry eye disease that didn’t improve with tear substitutes.

In draft guidance, the National Institute for Health and Care Excellence says its independent appraisal committee wants to see an indirect comparison of the clinical effectiveness of Ikervis (ciclosporin) plus corticosteroids, if needed, and artificial tears, and corticosteroids alone, if needed, and artificial tears. The panel also wants Santen to provide a cost-effectiveness comparison of the two regimens.

Ikervis is administered once daily at bedtime, an advantage over other treatments, which need to be taken several times a day. The drug’s monthly cost is $113.

Comments are due by July 15. The appraisal committee will meet again on Aug. 18, and final guidance is expected to be published in September. Read the draft guidance at www.fdanews.com/6-15-NICE-Ciclosporin.pdf. — Jonathon Shacat