The PBS will subsidise brentuximab vedotin (Adcetris) for treatment of cutaneous T-cell lymphomas (CTCL) from 1 April.
The listing is expected to benefit about 60 patients per year who would otherwise pay up to $300,000 a year for this treatment.
The subsidy was recommended by the Pharmaceutical Benefits Advisory Committee (PBAC), which concluded in November 2018 that “brentuximab vedotin provides, for some patients with the mycosis fungoides (MF), Sézary syndrome (SS) and primary cutaneous anaplastic large cell lymphoma (pcALCL) subtypes of CTCL, a significant improvement in efficacy over methotrexate.”
In its assessment the PBAC noted “there is a need for additional therapies for patients with CTCL who have failed prior systemic therapies. The PBAC considered that a high unmet clinical need was particularly evident for patients with the MF, SS and pcALCL subtypes of CTCL.”
When it first reviewed the application in July 2018 the committee said there was a risk of use of brentuximab vedotin outside the PBS restriction as a first line systemic therapy, in retreatment of patients and in combination treatment with other CTCL therapies.
A resubmission therefore proposed the addition of the clinical criterion ‘The treatment must be the sole PBS-subsidised systemic anti-cancer therapy for this condition’ to address the concerns regarding use in combination treatment with other CTCL therapies.