MepolizumabNucala

5.1 The PBAC did not recommend amendments to the authority level for mepolizumab for the treatment of uncontrolled severe asthma. The PBAC considered that while the available data suggested that the growth of mepolizumab is gradually stabilising, the overall uncontrolled severe asthma market continues to grow.PSD · Mar 2024

5.2 The PBAC noted that the submission claimed that the annual initiations for the anti- IL5 biologic agents (i.e., mepolizumab and benralizumab) for the treatment of uncontrolled severe asthma have stabilised.PSD · Mar 2024

The resubmission presented a modelled economic evaluation based on the SYNAPSE trial. The type of economic evaluation presented was a cost-utility Markov model incorporating a cohort value expected analysis. The economic model presented remained structurally the same as the previous submission but differed based on certain key inputs (time-horizon; maintenance of response; source of utility values; 22PSD · Nov 2022

There were several translational issues which were not considered nor adjusted for by the resubmission that could affect the cost effectiveness of mepolizumab in the proposed PBS population. As discussed in paragraph 6.32, even though the requested restriction allowed access for patients who had a BEC ≥150 cells/µL but <300 cells/µL if they were treated with OCS in the last 12 months; who were deemed unsuitable for surgery; who were contraindicated or …PSD · Nov 2022

The resubmission described mepolizumab as superior in terms of effectiveness compared with SoC in patients with a baseline BEC ≥300 cells/µL (or BEC ≥150 cells/µL if they have had OCS in the previous 12 months). This was based on the consideration that the BEC ≥300 cells/µL subgroup results demonstrated treatment differences that were clinically meaningful to patients, including the secondary outcome of time to NP surgery.PSD · Nov 2022

The resubmission also stated the ITT population demonstrated clinically meaningful and statistically significant changes in the secondary endpoints of HRQoL (as measured by the SNOT-22) and systemic steroid use as well as in the exploratory analysis of the SF-36. The BEC ≥300 cells/µL subgroup were consistent with the ITT population for these outcomes.PSD · Nov 2022

4.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (4) and organisations (6) via the Consumer Comments facility on the PBS website. The comments described a range of benefits of the proposed amendments to mepolizumab for uncontrolled severe asthma, including reduced administrative burden and complexity for prescribers.PSD · Mar 2024

4.3 The input was also supportive of the removal of the OCS requirement from the clinical criteria. It stated that in order to enable access to mepolizumab, the current threshold may result in unintended exposure to higher doses of corticosteroids beyond what is clinically reasonable. This may lead to long term OCS-related side effects and reduced quality of life.PSD · Mar 2024