Ranolazine

7.1 The PBAC recommended the Section 85 listing of ranolazine. The Committee is satisfied that ranolazine provides, for some patients, a significant improvement in efficacy over placebo. The PBAC also acknowledged the unmet clinical need in patients with stable angina whose symptoms are not controlled satisfactorily by the maximum tolerated doses of a beta-blocker or a calcium channel blocker, where revascularisation is not an option and haemodynamic …PSD · Mar 2018

7.2 The PBAC considered that given the sponsor was only seeking PBS listing of the 60 tablet pack size, although a 15 tablet pack size is also TGA registered, there may be wastage of tablets during the dose titration period. The PBAC advised that the proposed Authority Required (Telephone) listing is appropriate, given that ranolazine is positioned to be used as a later-line/add-on symptomatic treatment.PSD · Mar 2018

6.8 The major submission considered by the PBAC in March 2017 presented a cost-utility analysis against placebo. The minor resubmission did not present a revised model.PSD · Mar 2018

The March 2017 submission estimated that ranolazine would result in an incremental cost of less than $15,000 per quality-adjusted life year gained.PSD · Mar 2018

6.29 The submission described ranolazine as superior in terms of comparative effectiveness and slightly inferior in terms of comparative safety over placebo. 12PSD · Mar 2017

6.30 The claim of superior efficacy of ranolazine compared with placebo was not well supported for the requested PBS population, as the population in the pivotal trial (CARISA) was different to the requested PBS restriction.PSD · Mar 2017

6.3 The minor resubmission did not present any new clinical data. However, the minor resubmission presented:  discussion of clinical need and limitations of current treatments;  rationale for the proposed restriction;  discussion of mechanism of action of the anti-anginal medicines;  epidemiology of coronary artery disease and revascularisation rates; and  results of a survey of 50 cardiologists to help identify patients suitable for ranolazine under …PSD · Mar 2018

6.4 At its March 2017 meeting, the PBAC noted that ranolazine has a number of pharmacokinetic and pharmacodynamic concerns including variable bioavailability, affected by hepatic and renal impairment and it is a CYP3A4 inhibitor with multiple drug interactions (paragraph 7.2, ranolazine March 2017 PBAC Public Summary Document). The minor resubmission did not address the PBAC’s concerns.PSD · Mar 2018