OzanimodZeposia

The PBAC amended its March 2022 recommendation for the General Schedule, Authority Required (in writing) listing of ozanimod (OZA) for the treatment of moderate to severe ulcerative colitis (MSUC). In considering the additional evidence presented in the current submission, the PBAC’s revised recommendation for listing 26PSD · Nov 2022

The PBAC reaffirmed its view (from March 2022) the equi-effective doses of OZA and alternative therapies could be derived with reference to the Therapeutic Relativity Sheets and relevant Product Information documents, noting the OZA equi-effective dose component should account for the titration period in be based on an OZA dose of 0.23 mg on Days 1 to 4, 0.46 mg on Days 5 to 7, then 0.92 mg orally once daily in both induction and maintenance therapy.PSD · Nov 2022

The submission did not present a revised economic analysis or request a change to the methodology of the cost minimisation approach (CMA) from the previous submission; however, the main request in the submission relates to which therapies should (or should not) be considered alternatives for the purposes of the cost minimisation approach. Relevant detail from the March 2022 economic analysis section are presented below.PSD · Nov 2022

The March 2022 submission presented a CMA of OZA compared with IFX IV, consistent with the claim of non-inferiority. The proposed equi-effective doses were based on the recommended doses: 24PSD · Nov 2022

The March 2022 submission described OZA as non-inferior in terms of effectiveness and safety compared to IFX. The PBAC considered, at that time, whilst there were numerous uncertainties with the indirect comparisons due to differences in the trial designs and recruited populations, taking into account the totality of the available evidence, that the claim of non-inferior comparative effectiveness to the primary comparator, IFX, was adequately supported.PSD · Nov 2022

The submission described OZA as having a reduced risk of some adverse events (specifically the risk of infection) compared to ADA. While this specific claim may be supported (based on the MAIC), the ESC considered the individual safety profiles of OZA and ADA also required consideration and considered, on balance, that a claim of different but not worse safety was reasonable.PSD · Nov 2022

Consumer comments were provided from Crohn’s and Colitis Australia (CCA), and the Gastroenterological Society of Australia (GESA). CCA emphasised the flexibility associated with oral therapy that does not require infusion in a medical facility, thereby avoiding absences from work and reducing travel requirements. Similarly, GESA noted that there are access issues with infusion centres that will be ameliorated with an oral therapy.PSD · Mar 2022

The comments from health care professionals described the effectiveness of OZA in the treatment of MSUC and highlighted the need for additional therapeutic options for the management of the condition, especially for those with a new mechanism of action for use in patients who have failed existing biological therapies.PSD · Mar 2022