Chlormethine HydrochlorideLEDAGA

7.1 The PBAC recommended the Section 85, Authority Required listing of chlormethine hydrochloride gel (hereafter chlormethine gel) for the topical treatment of mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in adult patients who have no more than 25% of their body surface area (BSA) involved. The PBAC acknowledged the clinical need for additional treatment options for patients with MF-CTCL.PSD · Nov 2023

7.2 The PBAC noted the input from a health care professional and Rare Cancers Australia, and recalled consumer comments from the March 2023 submission. The PBAC reaffirmed its March 2023 advice that there was a clinical need for a range of treatment options in this chronic disease (para 7.2, chlormethine gel, PSD, March 2023 PBAC meeting).PSD · Nov 2023

The use of a CUA was not supported by clinical evidence (para 7.7, Addressed, a CMA was provided. chlormethine gel, PSD, March 2023 PBAC meeting). A CMA against phototherapy should be provided in any resubmission (para 7.10, chlormethine gel, PSD, March 2023 PBAC meeting).PSD · Nov 2023

Utilisation and financial impact The utilisation and financial estimate were based on a complex Partially addressed, a prevalence approach was approach, a prevalence approach should be applied (para 6.61, utilised, however the evaluation considered the chlormethine gel, PSD, March 2023 PBAC meeting) estimates remained subject to considerable uncertainty with regard to the estimated number of patients and the extent of use.PSD · Nov 2023

6.19 The resubmission's clinical claim was that chlormethine gel is non-inferior in effectiveness and has similar safety to phototherapy. This differed from the claim in the March 2023 submission, which asserted non-inferiority in terms of effectiveness based on rmDOCR and superiority in terms of HRQoL compared to phototherapy.PSD · Nov 2023

6.20 In March 2023, the PBAC considered that there were issues of transitivity affecting the comparability of the studies included in the unanchored ITC due to differences in: the definition of response, prior treatments, sample sizes, time and location at which the studies were conducted, and the duration of the studies being compared.PSD · Nov 2023

6.2 The PBAC noted and welcomed the input from a health care professional (1) and an organisation (1) via the Consumer Comments facility on the PBS website. The comments from the health care professional described the impact of MF-CTCL on patients’ quality of life noting it can be highly visible and uncomfortable.PSD · Nov 2023

6.47 The resubmission did not provide a Risk Sharing Arrangement. For more detail on PBAC’s view, see section 7 PBAC outcome.PSD · Nov 2023