The National Institute for Health and Clinical Excellence has issued final guidance endorsing the use of Basilea’s Toctino (alitretinoin) on the National Health Service for hand eczema.
Doctors are now able to prescribe the treatment for adults with severe chronic hand eczema – as classed by a physician’s global assessment and a dermatology life quality index score of 15 or more – who have failed to respond to therapy with topical corticosteroids.
The drug’s approval is based on a cost analysis by the Institute which found that, taking into account its efficacy and price – £411.43 for a pack of 30 × 30mg capsules (excluding VAT) – the cost per QALY (quality per life year gained) falls well under its set limit, and so the therapy is considered to be a cost effective use of NHS resources.
However, the Institute has stipulated that treatment should stop as soon as the patient shows an adequate response, and, if the disease is still classed as severe after 12 weeks of therapy, or if there is no adequate response by 24 weeks, then treatment should also be stopped.
Hand eczema is a common inflammatory skin disease thought to affect up to 10% of the general population, of which around 5%-7% suffer from the more severe, chronic form, which can impair the use of hands and therefore the performance of many everyday activities.
Only other option
Toctino is currently the only other approved option for patients with the disease who are unresponsive to topical corticosteroids, and its regulatory clearance came on the back of impressive data from a multinational Phase III clinical trial programme, in which one study demonstrated that the agent induced clear or almost clear skin in almost 50% of patients taking the drug compared to 16.6% of those given a placebo.
According to Professor Peter Littlejohns, Clinical and Public Health Director at NICE, eczema can have “a huge impact on an individual…potentially impacting on work and social aspects of their lives” and the new guidance “will offer hope to adults whose severe chronic hand eczema hasn’t been helped by strong topical corticosteroids.”
