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NICE has yesterday published preliminary recommendations on ciclosporin (Ikervis, Santen Pharmaceutical) for treating severe keratitis(1) in adults with dry eye disease which has not improved despite treatment with artificial tears, and has asked for more information from the company.

Dry eye disease is chronic inflammation of the eyes caused by reduced tear production or excessive tear evaporation. It can be triggered by a number of factors, including dry or air-conditioned environments, auto-immune diseases (such as rheumatoid arthritis, and lupus), and the adverse effects of some medications. Symptoms include irritation and redness in the eyes, blurred vision, and a sensation of grittiness or a foreign body in the eye.

The independent Appraisal Committee noted that it had not been presented with evidence on the relative cost and clinical effectiveness of ciclosporin compared with established clinical practice. The Committee concluded that it needed additional evidence from the company to inform its decision-making, which should include:

• An indirect comparison of the clinical effectiveness of ciclosporin plus corticosteroids (if needed) and artificial tears, and that of corticosteroids (if needed) and artificial tears.
• An economic model comparing the cost effectiveness of ciclosporin plus corticosteroids (if needed) and artificial tears, with that of corticosteroids (if needed) and artificial tears.

Professor Carole Longson, Director of the Centre for Health Technology Evaluation at NICE said: "Severe dry eye disease can be painful and can have a significant negative effect on day-to-day life for people with the condition.  Unfortunately, because of gaps and uncertainties in the evidence submitted by the company, NICE's independent committee was minded not to recommend ciclosporin for this condition. The next step is for the company to submit further information requested by the Committee which will then be considered at its next meeting in August."

The preliminary draft guidance (appraisal consultation document / ACD) can be found at: /guidance/indevelopment/gid-tag466/documents

This draft guidance has now been issued for consultation; NICE has not yet published final guidance to the NHS. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its guidance on a technology it replaces local recommendations across the country.

Final guidance is expected to be published in September 2015. 

About the final draft guidance

1. Ciclosporin (Ikervis, Santen Pharmaceutical) is a sterile, positively charged, oil-in water, unpreserved ophthalmic emulsion that contains ciclosporin (CsA).  Its formulation contains an excipient, cetalkonium chloride, which acts as a cationic agent and is specifically designed to prolong the time each eye drop stays on the epithelial layer of the eye. Ciclosporin has an anti-inflammatory effect on the cornea and the lacrimal (tear) gland.  Following administration, ciclosporin blocks the expression of pro-inflammatory cytokines and subsequently enters corneal and conjunctival infiltrated T-cells, activating them. It has a marketing authorisation in the UK for treating ‘severe keratitis in adult patients with dry eye disease, which has not improved despite treatment with tear substitutes’.  Ciclosporin is administered as an eye drop of 1 mg/ml once daily at bedtime.

2. The acquisition cost of a monthly course of ciclosporin is £72 (excluding VAT). Costs may vary in different settings because of negotiated procurement discounts.

3. The Scottish Medicines Consortium has scheduled ciclosporin (Ikervis, Santen Pharmaceutical) for the treatment of severe keratitis in adult patients with dry eye disease which has not improved despite treatment with tear substitutes for assessment over the coming 2/3 months.  Further information can be found at:https://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/ciclosporin_Ikervis

References

• Keratitis is inflammation of the cornea, the front part of the eye.

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