AprepitantAprepitant Lupin

5.1 The PBAC recommended Section 100 (Efficient Funding of Chemotherapy – Related Benefits) listing and General Schedule Authority Required (STREAMLINED) listing of a new brand of aprepitant (Aprepitant Apotex) for the same indication as the currently listed brand, Emend® (PBS item codes: 2518M and 2550F).PSD · Jul 2019

5.2 The PBAC noted that the requested listing would be unlikely to result in a cost to the PBS as the sponsor has requested an AEMP lower than the currently listed brand of aprepitant, Emend®.PSD · Jul 2019

6.9 In the previous major submission considered by PBAC in November 2015, the submission did not present a formal economic evaluation. The PBAC considered that in the absence of an economic evaluation, the cost-effectiveness of aprepitant in the broader population requested could not be determined.PSD · Mar 2016

6.10 The re-submission proposed a new lower price for this listing consistent with the price of aprepitant when used with moderately emetogenic chemotherapy, re-weighted at '''''''% and ''''''% respectively across use in MEC and HEC regimens. The submission also applied a statutory 5% price reduction expected from 1 April 2016. 6PSD · Mar 2016

6.7 The clinical claim remains unchanged from the previous major submission considered in November 2015. As noted above, the previous submission claimed aprepitant plus standard antiemetic therapy was superior in terms of comparative effectiveness and similar in terms of comparative safety when compared with standard therapy alone.PSD · Mar 2016

6.8 The PBAC consideration of the clinical claim remained unchanged from its November 2015 meeting.PSD · Mar 2016

6.16 As noted above, the PBAC previously considered that the requested listing would make aprepitant available to a substantially broader population of patients and the financial implications of such an extension to listing were uncertain. The PBAC considered that if the listing was extended in the future, there should be a risk sharing mechanism to manage for potential use beyond the estimated patient numbers.PSD · Mar 2016

6.17 In accordance with the PBAC recommendation, the minor re-submission proposed RSA parameters which would be acceptable to the sponsor (Minor resubmission, pp. 9-10), including:  yearly caps (up to five years) based on the financial estimates provided in the re- submission; and  rebates for any incremental sales over the caps of '''''''%.PSD · Mar 2016