SecukinumabCosentyx

5.1 The PBAC recommended the Authority Required listing of secukinumab (SEC) for the treatment of moderate to severe hidradenitis suppurativa (HS). The PBAC’s recommendation was based on, among other matters, its assessment the cost- effectiveness of SEC would be acceptable if it were cost minimised to adalimumab (ADA) (noting it was the only biologic disease modifying anti-rheumatic drug (bDMARD) currently PBS listed for HS).PSD · Nov 2023

• SEC 300 mg (which could be in the form of 2 x 150 mg doses or 1 x 300 mg doses) given at weeks 0, 1, 2, 3, 4, 8, 12 and 16 (initial phase), followed by SEC 300 mg given either once every two weeks or once every four weeks; andPSD · Nov 2023

4.3 At its July 2023 meeting, the PBAC considered, based on the CMA presented in that submission, that treatment with SEC was likely to be more costly than treatment with ADA as the submission did not account for any use of the Q2W maintenance dosing schedule or response being measured at a later timepoint than for ADA (paragraph 7.10).PSD · Nov 2023

4.4 Based on the survey results, the revised CMA in the re-submission included an assumption that 20% of patients would receive a Q2W maintenance regimen of SEC and presented a weighted CMA on that basis.PSD · Nov 2023

The submission described secukinumab as superior compared to placebo in terms of effectiveness, and non-inferior to adalimumab. This claim was not adequately supported by the available evidence, which suggested secukinumab may provide a modest benefit over placebo in the SUNRISE/SUNSHINE trial populations, noting that this benefit is uncertain in the proposed PBS population, and the Q4W arm of SUNSHINE failed to demonstrate a statistically significant …PSD · Jul 2023

A range of applicability and transitivity issues were identified between the key secukinumab trials and target PBS population, as the existing restrictions were based on the on the adalimumab PIONEER and M10-467 trial populations (discussed in paragraph 6.12).PSD · Jul 2023

The PBAC noted and welcomed the input from individuals (7), health care professionals (7) and organisations (2) via the Consumer Comments facility on the PBS website. The comments from healthcare professionals noted the need for additional treatment options, the loss of efficacy with alternative treatments and the impact of HS on patients’ quality of life.PSD · Jul 2023

The PBAC noted input from the Australasian College of Dermatologists supported the listing and highlighted the importance of an additional/alternative effective treatment for HS on the PBS.PSD · Jul 2023