SomatropinGenotropin and Genotropin Miniquick

6.1 The PBAC recommended the listing of somatropin solution for injection 6 mg (18 i.u.) in 1.03 mL and 12 mg (36 i.u.) in 1.5 mL (Saizen) for the treatment of severe late onset GHD, on the basis that it should be available only under special arrangements under Section 100 (Growth Hormone Program), and under the same circumstances as somatropin products currently PBS-listed for this indication.PSD · Sep 2023

6.2 In making its recommendation, the PBAC recalled its previous recommendation in July 2017 to list somatropin for the treatment of severe late onset GHD and noted that three brands of somatropin are currently PBS-listed as a result of this recommendation. The PBAC further noted that its July 2017 recommendation in relation to the forms of somatropin where a listing for severe late onset GHD had not been implemented has now been rescinded.PSD · Sep 2023

5.4 The submission noted that, since the July 2017 recommendation and listing of somatropin products for adult patients with severe GHD, the approved ex- manufacturer price (AEMP) of somatropin products has decreased by 24.79% due to a catch-up statutory price reduction on 1 April 2023. 5PSD · Sep 2023

5.5 The submission proposed an AEMP for Saizen 6 mg and 12 mg to match those of Norditropin FlexPro, NutropinAq and Genotropin GoQuick on a per milligram basis, that would apply to both paediatric and adult indications. The submission stated this was a 3.1% reduction in the current AEMP of Saizen 6 mg and 12 mg (see Table 1).PSD · Sep 2023

6.11 The November 2016 resubmission claimed that somatropin is superior in terms of comparative effectiveness with respect to QoL and noninferior in terms of comparative safety over standard care. In the absence of comparative data, the PBAC considered that the comparative effectiveness over standard care, in terms of QoL improvement, was difficult to quantify and was likely overestimated.PSD · Jul 2017

6.12 The minor resubmission claimed superior comparative effectiveness of somatropin compared with BSC. Specifically, it claimed that, “GH replacement improves body composition, cardiorespiratory function, metabolic status and QoL in adult patients with severe GHD.PSD · Jul 2017

6.2 The PBAC noted that no consumer comments were received for this item. However, the PBAC recalled that for its November 2016 consideration of somatropin for adults with GHD it received substantial input from individuals (68), health care professionals (2) and organisations (2) via the Consumer Comments facility on the PBS website.PSD · Jul 2017

6.59 The resubmission did not propose any Risk Sharing Arrangement, although the PBAC noted that such proposals would likely be beyond the scope of a submission not lodged by a sponsor.PSD · Nov 2016