RisankizumabSkyrizi

The PBAC recommended the Authority Required (in writing) listing of two new forms of risankizumab (RIS, 150 mg pre-filled syringe (PFS) and 150 mg pre-filled pen (PFP)) for the treatment of severe chronic plaque psoriasis (CPP). The Committee noted it had previously recommended the listing of these forms of RIS for CPP in November 2021 and advised the basis of this recommendation differed to that of the previous outcome.PSD · Nov 2023

The PBAC recalled that RIS 150 mg PFP and PFS were recommended at the November 2021 meeting on a cost minimisation basis ‘to the lowest cost biological agent available for severe CPP, noting that any of the current PBS listed bDMARDs for severe CPP could be an alternative therapy to risankizumab’ (paragraph 6.3, risankizumab PSD, November 2021). The PBAC also recalled it had originally recommended the 75 mg form of RIS on a similar basis.PSD · Nov 2023

Consistent with the November 2021 submission, the sponsor requested the same published and effective prices for the 150 mg PFP and 150 mg PFS as the PBS-listed 75 mg PFS (two pack). The submission presented a cost-minimisation approach comparing risankizumab 150 mg PFP and 150 mg PFS with risankizumab 75 mg PFS, assuming the 150 mg presentations are equi-effective with two doses of the 75 mg PFS at the same recommended dosing schedule.PSD · Nov 2023

At its November 2021 meeting, the PBAC considered that risankizumab 150 mg PFP and 150 mg PFS are equivalent in efficacy and safety to two doses of risankizumab 75 mg PFS, but recommended listing on a cost-minimisation basis to the lowest cost biologic agent available for severe CPP under Section 101(3B) of the Act (paragraphs 6.2 and 6.3, risankizumab PSD, November 2021).PSD · Nov 2023

The submission stated that a random effects model was used for meta-analysis across trials with common interventions (e.g. prior to conducting the ITC), in-line with recommendations in the PBAC guidelines. The results presented in the submission, however, actually corresponded to meta-analysis assuming a fixed effects model.PSD · Nov 2023

Table 4: Summary of PASI 75 and PASI 90 response in the short-term (12-16 weeks) based on the direct randomised trials and indirect treatment comparisons presented by the submission for risankizumab versus other biologics.PSD · Nov 2023

The PBAC noted the advice received from the Australasian College of Dermatologists, which supported the listing and noted the availability of a single 150 mg injection to replace the 2 x 75 mg form reduces injection burden and will likely improve patient compliance to treatment.PSD · Nov 2023