26 March 2020 - Additional insights from the second round of public summary documents (first time rejections and deferrals).

Siponimod hemifumarate (Mayzent)

The PBAC considered that, despite the high unmet clinical need, the appropriate place of siponimod hemifumarate in the treatment algorithm for MS was uncertain, and noted the proposed restriction did not specifically identify patients with secondary progressive multiple sclerosis (SPMS) or exclude patients with relapsing-remitting multiple sclerosis (RRMS).

The PBAC acknowledged a key reason for this uncertainty is that it can be clinically difficult to determine when patients transition from RRMS to SPMS. As such, the PBAC considered that it is likely some people currently treated with RRMS disease modifying therapies may meet the criteria for siponimod hemifumarate under the requested listing.

The submission did not provide a reliable basis to assess the cost-effectiveness of siponimod hemifumarate.

Talazoparib tosylate (Talzenna)

The PBAC noted there was a moderate benefit in terms of progression free survival however it was unclear whether talazoparib tosylate would lead to any gains in overall survival as the data provided were still immature.

The PBAC considered the modelled incremental overall survival benefit was optimistic and the ICER was unacceptably high, uncertain and potentially underestimated.

Neratinib maleate (Nerlynx)

The PBAC considered the clinical place of neratinib maleate was reduced to a limited and diminishing population given the changing landscape for treatment of HER2 positive early breast cancer.

The PBAC noted that the resubmission had provided limited or no evidence for some patient groups. For the remaining relevant patient groups where evidence was presented, the PBAC considered that the benefit of neratinib maleate was likely to be small, and the economic model had not provided a reliable basis for estimating the cost-effectiveness of neratinib maleate in these patients.

Dulaglutide (Trulicity)

The PBAC has requested a revision of the financial estimates as the PBAC considered the estimated financial impact of extending the current listing of dulaglutide to include use in combination with insulin was substantially underestimated due to underestimated patient numbers, market share and market growth.

The PBAC agreed with the view of the EASD and ADA in the 2018 consensus statement that the management for type 2 diabetes has become increasingly complex due to the vast number of diabetes medicines available and continuous change in guidelines overseas. The PBAC noted that the new Australian guidelines for the management of type 2 diabetes to be published in 2020 are likely to be similar to the ADA/EASD guidelines. The PBAC considered that it may be appropriate to review the listings of medicines for type 2 diabetes once the guidelines are updated.

Additional insights from the November 2019 PBAC meeting will be published in future issues of MAESTrO Daily.