OctreotideOctreotide GH

7.1 The PBAC recommended the Authority Required (STREAMLINED) listing for octreotide on a cost minimisation basis with lanreotide for the treatment of patients with non- functional GEP-NET, in line with the current listing for lanreotide. The PBAC recommendation was made on the basis that octreotide should be available only under special arrangements under Section 100 (HSD Program).PSD · Jul 2019

7.2 The PBAC noted that the submission positioned octreotide as an alternative treatment to lanreotide in the first-line treatment of patients with metastatic or non-resectable (Grade 1 or 2) non-functional midgut NET (a sub-set of non-functional GEP-NET) based on the patient population in the key trial for octreotide, PROMID.PSD · Jul 2019

6.30 The equi-effective doses were estimated as octreotide 30 mg every 28 days and lanreotide 120 mg every 28 days, based on the doses of each medication used in the trials. While there was insufficient evidence to confirm equi-effectiveness of these dose strengths, for both medications they are the only dose strengths recommended for this indication.PSD · Jul 2019

6.31 The submission presented a cost-minimisation analysis of octreotide versus lanreotide based on a non-inferiority claim for clinical effectiveness and safety (see Table 9). The cost-minimisation analysis was based on drug costs only, with no differences assumed in the use of other health care resources.PSD · Jul 2019

6.27 The submission described octreotide as non-inferior in terms of effectiveness and non- inferior in terms of safety compared with lanreotide in the treatment of patients with metastatic non-functioning NETs of midgut or suspected midgut origin. The evaluation considered this claim was not adequately supported by the submission, as the included trials were not sufficiently similar to determine reliable estimates of comparative efficacy and safety.PSD · Jul 2019

6.28 The PSCR acknowledged the uncertainty in the indirect comparison with lanreotide but argued that the claim of non-inferiority is reasonable, noting that international guidelines, such as those published by the European Neuroendocrine Tumour Society (ENETS)1, suggest that when NETs of midgut or suspected midgut origin metastasise, there are two options: watch and wait, or first-line somatostatin analogues, i.e., octreotide or lanreotide.PSD · Jul 2019

6.41 The sponsor noted that a Risk Sharing Agreement (RSA) was proposed for lanreotide in the November 2017 resubmission, with the PBAC advising that an RSA with 100% rebate above the financial caps would be required to manage the risk of any use above what was expected (November 2017 lanreotide PSD). The submission indicated a willingness to work with the PBAC to determine the equivalent price and RSA terms for octreotide for non-functional midgut NETs.PSD · Jul 2019

6.42 The PBAC advised that it considered it would likely be appropriate, and it supported octreotide joining the existing RSA subsidisation cap for lanreotide for non-functional GEP-NETs as this would ensure no further financial costs, it was a matter for the Minister to determine if octreotide was eligible for a rebate based Deed under current policy.PSD · Jul 2019