1.1 Chlormethine gel is recommended as an option for treating early stage (stage 1A, 1B, and 2A) mycosis fungoides-type cutaneous T‑cell lymphoma (MF‑CTCL) in adults, only if the company provides chlormethine gel according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with chlormethine gel that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Most treatments for early stage MF‑CTCL aim to relieve the skin symptoms. Options depend on the extent of the skin affected, but include treatments applied to the skin, such as topical steroids, phototherapy (light therapy) and radiotherapy. Systemic treatment that targets the whole body, such as oral bexarotene, can also be used to relieve skin symptoms if those treatments do not work, no longer work, or become unsuitable.
Clinical evidence shows that chlormethine gel improves skin disease. It may particularly benefit people who have skin disease over a limited area of the body or for whom whole body phototherapy is unsuitable. However, there is no robust evidence for its effectiveness compared with other treatments or showing if it is more effective for people with limited skin disease.
Some things are still uncertain, including the true effectiveness of phototherapy, which was used as a comparator in the model, and the average amount of chlormethine gel used per day.
But the cost-effectiveness estimates for chlormethine gel in early stage disease, using the preferred assumptions and the company's updated patient access scheme, are within the range NICE considers cost effective. Therefore, chlormethine gel is recommended in early stage disease.