Sacubitril/ValsartanARX-SACUBITRIL/VALSARTAN

The PBAC noted the submission lacked standard information expected in a major submission, including the literature search, clinical trial reports, economic analysis, clinical study reports (CSRs) and discussion of the applicability of trial data to PBS population. These deficiencies impeded the Committee’s ability to consider the submission. The Committee agreed any resubmission should include all standard information expected in a major submission.PSD · Nov 2020

With respect to the core propositions of the submission, the PBAC did not recommend amending the listing of sacubitril/valsartan to amend the ejection fraction threshold in the restriction to include patients with an LVEF between 41% - ≤50% (from the current ≤40%), nor to remove the requirements for prior treatment with an ACE 28PSD · Nov 2020

The submission did not present an economic evaluation, arguing that the magnitude of benefit is the same in patients with versus without prior exposure to an ACE- inhibitor or ARB, and there are no proposed changes to the price for sacubitril/valsartan. The current prices (published and effective, including Special Pricing Arrangement) for sacubitril/valsartan are to be applied to patients in the ACE- inhibitor/ARB-naïve population.PSD · Nov 2020

The PSCR argued the results of the PIONEER-HF trial demonstrated the magnitude of benefit in the current and requested sacubitril/valsartan PBS populations was the same, irrespective of prior ACE inhibitor/ARB therapy and that the magnitude of benefit for the whole trial population was consistent with that observed in the PARADIGM-HF trial. The ESC disagreed with the PSCR and considered the available information was uninformative for decision making.PSD · Nov 2020

The submission described sacubitril/valsartan as superior in terms of effectiveness compared to ACE-inhibitors (enalapril). ESC agreed with the evaluator that the therapeutic conclusion of superior efficacy was inadequately supported by the evidence presented in the submission, given the issues described above with regards to the applicability of PIONEER-HF population and subgroup analyses.PSD · Nov 2020

The submission further argued that patients in the PIONEER-HF trial would achieve a similar magnitude of benefit from treatment with sacubitril/valsartan as observed in the PARADIGM-HF trial, which was the primary evidence considered by the PBAC in the previous submissions for sacubitril/valsartan (March, July and August 2016).PSD · Nov 2020

Sacubitril/valsartan currently has a risk share arrangement, and the sponsor stated that any additional use should also be subject to this arrangement. Sacubitril/valsartan is listed with a Special Pricing Arrangement and subsidisation caps.PSD · Nov 2020

1 Ferreira J, et al. Heart failure in the outpatient versus inpatient setting: findings from the BIOSTAT‐CHF study. European Journal of Heart Failure. 2019;21(1):112-120 23PSD · Nov 2020