NICE asks for more evidence from dry eye treatment maker
pharmafile | June 24, 2015 | News story | Research and Development, Sales and Marketing | Ikervis, NHS, NICE, ciclosporin, santen pharma
A NICE appraisal committee has asked for more information on a treatment for chronic dry eye syndrome, after failing to determine if it can be provided on the NHS.
In its preliminary recommendations the committee concluded that it ‘was minded not to recommend’ Ikervis (ciclosporin) due to a lack of evidence of its clinical and cost-effectiveness.
It asked Santen, a Japanese pharma firm that specialises in ophthalmology and rheumatology medicines which manufactures Ikervis (ciclosporin), for additional evidence that it needs to inform its decision-making.
NICE says this should include an indirect clinical comparison and an economic model comparing the cost-effectiveness of ciclosporin plus corticosteroids and treatment with artificial tears, and that of corticosteroids and artificial tears.
Dry eye disease is chronic inflammation of the eyes caused by a lack of, or excessive drying, of moisture in the eyes. It can be triggered by things including air-conditioning auto-immune diseases and the adverse effects of some medications. Symptoms include irritation and redness in the eyes, blurred vision, and a feeling of grittiness or a foreign body in the eye.
Professor Carole Longson, director of the Centre for Health Technology Evaluation at NICE says: “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 The draft guidance has now been issued for consultation; final guidance is expected to be published in September.
Lilian Anekwe
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