CariprazineReagila

The PBAC recommended the Authority Required (STREAMLINED) listing of cariprazine (Reagila®) for the treatment of schizophrenia. The PBAC considered that the claims of non-inferior effectiveness and safety to aripiprazole and brexpiprazole were reasonable. The PBAC considered for the purposes of Section 101(3B) of the National Health Act 1953, additional alternative therapies include paliperidone, ziprasidone and lurasidone.PSD · Nov 2020

The PBAC considered that there was a low to moderate clinical need for cariprazine, noting that there are a number of alternative antipsychotics available on the PBS.PSD · Nov 2020

The submission presented a CMA comparing cariprazine to aripiprazole and brexpiprazole. The PBAC has previously considered the group of medicines that were listed on a cost-minimisation basis compared to olanzapine (paliperidone, ziprasidone, aripiprazole and lurasidone), as relevant comparators for brexpiprazole on the basis that, on balance, brexpiprazole has shown to be non-inferior to lurasidone.PSD · Nov 2020

To estimate the equi-effective doses the submission considered that the most relevant comparison between cariprazine and the nominated comparators, aripiprazole and brexpiprazole, is at their steady state doses, as the intended use of these drugs is as indefinite chronic treatment. The PBAC considered that this was appropriate and in line with the PBAC Guidelines v5.0.PSD · Nov 2020

On the basis of post-hoc direct comparison of cariprazine and aripiprazole (RGH-MD- 04 trial) and the ITC of cariprazine with aripiprazole and brexpiprazole via common placebo arm, the submission claimed that cariprazine was non-inferior in terms of effectiveness and safety compared to aripiprazole and brexpiprazole.PSD · Nov 2020

The PBAC considered that the claim of non-inferior comparative effectiveness was reasonable.PSD · Nov 2020