The National Institute for Health and Care Excellence (NICE) has recommended Recordati Rare Diseases and Helsinn Healthcare’s Ledaga for a type of lymphoma that affects the skin.
Ledaga (chlormethine gel) is recommended for use on the NHS to treat early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL). It is used as a topical ointment, applied as a thin layer once daily, to relieve symptoms of the disease.
MF-CTCL is a form of non-Hodgkin’s lymphoma that affects the skin, causing itchy and painful red patches or lesions.
In clinical trials, Ledaga has been shown to improve the condition of skin lesions caused by early-stage MF-CTCL – NICE added that it may be ‘especially beneficial’ for the treatment of lesions covering limited areas of the body and for patients who are unsuitable for the current standard treatment, phototherapy.
NICE previously chose not to recommend Ledaga for the general treatment of MF-CTCL, although the cost-effectiveness watchdog has since made the positive recommendation after the submitting company updated the economic model for the drug.
A new commercial agreement for Ledaga has now been agreed, meaning the topical ointment can be routinely used on the NHS.
In May, the Scottish Medicines Consortium (SMC) also accepted Ledaga for routine use on NHS Scotland for the treatment of MF-CTCL.
At the time, the SMC said the treatment offers an alternative option to phototherapy for these patients, which requires frequent hospital visits.