VismodegibErivedge

5.1 The PBAC updated the advice that it provided in March 2016 when recommending an Authority Required listing of vismodegib for the treatment of metastatic or locally advanced BCC inappropriate for surgery and curative radiotherapy.PSD · Nov 2016

5.2 The PBAC confirmed its March 2016 advice that there was a continued unmet clinical need for vismodegib and that there was a likely benefit for a highly selected patient group.PSD · Nov 2016

 Updated data from the STEVIE study. This was used to justify the vismodegib overall response rate used in the economic evaluation.  Survey responses from two clinicians. This was used to justify the disfigurement rate with vismodegib.PSD · Nov 2016

4.5 Details of the studies presented in the resubmission are provided in Table 2.PSD · Nov 2016

6.18 Based on a naïve indirect comparison with no common comparator, the submission described vismodegib as equivalent in terms of comparative effectiveness and superior in terms of comparative safety over surgery. This claim was not adequately supported.  The evidence presented in the submission for vismodegib and surgery was not comparable.  The disfigurement rate associated with surgery was likely to be over- estimated.PSD · Mar 2016

The ESC noted that the use of Mohs surgery has greatly increased since the time of the data collection and consider this an area of uncertainty, increased use of Mohs surgery because it was better will favour vismodegib.  Using the available evidence, it was likely that surgery had superior efficacy in terms of response rate.PSD · Mar 2016

4.2 The PBAC noted and welcomed the input from individuals (1), health care professionals (3) and organisations (1) via the Consumer Comments facility on the PBS website. The comments described the clinical place for vismodegib, namely in patients with advanced BCC who are not eligible for surgery. One comment noted that treatment with vismodegib would be intermittent due to treatment-related side effects.PSD · Nov 2016

4.29 In its previous consideration, the March 2016 PBAC stated that “a total financial cap should be based on the submission’s estimated patient numbers, the estimated average cost per patient per course under the EOC, after taking into account PBAC’s requested price reduction. Beyond the financial cap a total rebate of '''''''''% of expenditure above the cap would be rebated to Government” (Paragraph 6.36).PSD · Nov 2016