following a full submission under the orphan medicine process:
chlormethine hydrochloride (Ledaga®) is accepted for use within NHSScotland.
Indication under review: for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
In a single-blind, randomised, phase II study, chlormethine gel was non-inferior to a compounded chlormethine ointment based on ≥50% improvement in Composite Assessment of Index Lesion Severity (CAILS) score confirmed after 4 weeks.
This advice applies only in the context of an approved NHSScotland Patient Access Scheme (PAS) arrangement delivering the cost-effectiveness results upon which the decision was based, or a PAS / list price that is equivalent or lower.
This advice takes account of the views from a Patient and Clinician Engagement (PACE) meeting.
Medicine details
- Medicine name:
- chlormethine hydrochloride (Ledaga)
- SMC ID:
- SMC2318
- Indication:
Topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-type CTCL) in adult patients.
- Pharmaceutical company
- Recordati Pharmaceuticals
- BNF chapter
- Skin
- Submission type
- Full
- Status
- Accepted
- Date advice published
- 10 May 2021