Mirikizumab

The PBAC recommended the Section 100 (Highly Specialised Drugs Program) and General Schedule listings of mirikizumab (MIRI) for the treatment of moderate to severe ulcerative colitis (MSUC). The Section 100 recommendation was for listing the vial for intravenous (IV) infusion for initial treatment, and the General Schedule listing was for the pre-filled pen for subcutaneous (SC) injection for maintenance therapy.PSD · Jul 2023

The PBAC’s recommendation for listing was based on, among other matters, its assessment the cost effectiveness of MIRI would be acceptable if it were cost minimised to the least costly alternative therapy of adalimumab (ADA), golimumab (GOL), infliximab (IFX), ozanimod (OZA), tofacitinib (TOF), ustekinumab (UST), upadacitinib (UPA) and vedolizumab (VDZ).PSD · Jul 2023

The submission presented a cost-minimisation approach comparing MIRI with VDZ (IV formulation only), assuming equivalent total costs over the first two years (104 weeks), and accounting for IV infusion administration costs. Given VDZ is subject to a Special Pricing Arrangement and the effective AEMP was unknown to the sponsor, the results presented in the submission used the published AEMP.PSD · Jul 2023

The proposed equi-effective doses were based on the recommended doses:PSD · Jul 2023

Near market comparator: MIRI is clinically non-inferior in terms of efficacy and comparable in terms of safety versus UST. Source: Table 1, p31 of the submission.PSD · Jul 2023

ADA=adalimumab, IV=Intravenous, MIRI=mirikizumab, MSUC=moderate to severe ulcerative colitis, SC=Subcutaneous, UST=ustekinumab, VDZ=vedolizumab. * The submission nominated VDZ IV as the main comparator, but patients can switch to VDZ 108 mg SC injection every 2 weeks from Week 6 after the first two IV infusions (Week 0 and 2). ^ UST IV 260 mg for weight ≤ 55 kg; UST IV 390 mg for weight > 55 kg to ≤ 85 kg; UST IV 520 mg for weight > 85 kg.PSD · Jul 2023