Calcipotriol + Betamethasone DipropionateActobet 50/500

6.27 The PBAC recommended the Restricted Benefit listing of calcipotriol + betamethasone gel (for the 30g strength), and the Authority Required (Streamlined) listing of calcipotriol + betamethasone gel (for the 60g strength) both for the treatment of chronic stable plaque type psoriasis vulgaris in a patient who is not adequately controlled with either a vitamin D analogue or potent topical corticosteroid monotherapy on a cost-minimisation basis against …PSD · Nov 2015

6.28 The PBAC noted that calcipotriol + betamethasone 60g gel for the treatment of the scalp became an Authority (streamlined) listing on 1 October 2015 from Authority Required. The PBAC considered that the Authority (streamlined) listing remained appropriate for extension to treatment of the whole body, rather than a Restricted Benefit listing as proposed by the Sponsor.PSD · Nov 2015

6.18 The submission requested the same price as the current listed calcipotriol + betamethasone gel and ointment, as confirmed in the PSCR (p4). The ESC considered this proposal was reasonable, given the likely similar clinical outcomes between the gel and ointment. The assumed equi-effective dose in the situation would be 1 g gel to 1 g ointment.PSD · Nov 2015

6.19 The submission presented a cost minimisation to derive a ‘supported’ price of the gel.PSD · Nov 2015

6.16 The submission claimed calcipotriol + betamethasone gel has equivalent efficacy and similar safety compared to calcipotriol + betamethasone ointment. This claim was based on the evidence provided by the PLQ-001 trial and the PRO-long study, and supported by the results of the indirect comparison assessing 3 gel trials and 4 ointment trials.PSD · Nov 2015

Assessment points varied across the trials. The time point chosen by the submission for analysis, 4 weeks, is of limited relevance to prolonged use as would be required for psoriasis.PSD · Nov 2015