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New HTA Decisions in England
August 2021
Drug name
LEDAGA® (chlormethine gel)
Company
Recordati Rare Diseases and Helsinn Healthcare
Decision date
15/07/2021
Therapeutic area
Blood and immune system conditions
Therapeutic sub area
Blood and bone marrow cancers
Decision
Recommended
Indication
Chlormethine gel is indicated for treating early stage (stage 1A, 1B, and 2A) mycosis fungoides-type cutaneous T‑cell lymphoma (MF‑CTCL) in adults.
Decision Detail
It is only recommended if the company provides chlormethine gel according to the commercial arrangement (simple discount patient access scheme).
Summary
The main clinical evidence for chlormethine gel comes from Study 201, which was a non-inferiority trial comparing chlormethine gel with chlormethine ointment in 260 people with early stage MF CTCL (stage 1A to 2A). Results from Study 201 show that chlormethine gel improves the skin symptoms of early stage MF-CTCL. However, because the comparator ointment is no longer used in clinical practice, the committee concluded that Study 201 does not show how effective chlormethine gel is compared with current alternative treatments. There was no evidence in the company's submission directly comparing chlormethine gel with phototherapy, and no connected network for an indirect comparison could be formed. Therefore, the company did an unadjusted naive comparison. However, most of the studies available to provide estimates of phototherapy's effectiveness are of low quality and there was considerable debate about the most appropriate source to use. The committee concluded that the true clinical effectiveness of chlormethine gel compared with phototherapy is not known, given the high uncertainty associated with the unadjusted naive comparison. There are updated patient access schemes for chlormethine gel and a patient access scheme for the subsequent treatment, bexarotene. Therefore all costs and incremental cost-effectiveness ratios (ICERS) are confidential and are not reported. However, the cost-effectiveness estimates for chlormethine gel in early stage disease, using the preferred assumptions and the company's updated patient access scheme, are below what NICE normally considers an acceptable use of NHS resources. The committee was aware of the uncertainty associated with the effectiveness estimates of phototherapy, which was used as a comparator in the model, and the average amount of chlormethine gel used per day. However, it agreed that the most plausible ICER is unlikely to be above what NICE normally considers an acceptable use of NHS resources. It therefore recommended chlormethine gel as an option for treating adults with early stage (stage 1A, 1B, and 2A) MF CTCL.