ABILIFY MAINTENA (aripiprazole) - traitement d'entretien de la schizophrénie
Reason for request
Favourable opinion for reimbursement in the maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
What therapeutic improvement?
A therapeutic improvement over XEPLION (paliperidone palmitate) in the maintenance treatment of schizophrenia.
Role in the care pathway?
Antipsychotics are the standard pharmacological treatment for schizophrenia. They are used in the treatment of the acute phase and as maintenance therapy in the prevention of relapses.
The choice of antipsychotic takes into account response to previous treatments, the safety profile of antipsychotics and the patient’s individual susceptibility to adverse reactions. Second-generation antipsychotics are recommended as first-line treatment since they have a better tolerance than first-generation antipsychotics. Antipsychotic monotherapy should be favoured.
A multidimensional approach is necessary for patients with schizophrenia. Medicinal treatments should be combined with individual or group psychotherapy sessions, institutional or family care and social interventions.
The prescription of a long-acting injectable form may be considered when the patient expresses a preference for this type of treatment and/or when a patient adequately stabilised by oral treatment during the initial treatment phase has difficulty maintaining compliance with their treatment.
In its 2015 opinion on inclusion renewal2, the Committee had maintained the role of ABILIFY MAINTENA (aripiprazole LP) administered as a monthly intramuscular injection as a therapeutic alternative to the other long-acting injectable antipsychotics in the maintenance treatment of schizophrenia in patients stabilised with oral aripiprazole.
Role of the medicinal product in the care pathway
- data from the initial inclusion having demonstrated the non-inferiority of ABILIFY MAINTENA (prolonged-release aripiprazole) as a monthly injection versus oral aripiprazole in terms of efficacy on the exacerbation of psychotic symptoms in patients stabilised with oral aripiprazole and its superiority versus placebo on the time to relapse,
- new comparative quality of life data from a single-blind study (primary endpoint assessed under blind conditions by the investigator) having demonstrated the non-inferiority and superiority of the maintenance treatment strategy under ABILIFY MAINTENA (prolonged-release aripiprazole) as monthly injections versus paliperidone palmitate as monthly injections (XEPLION) with a modest effect size over a short treatment duration of 28 weeks (difference of 4.7 points on a 126-point scale; CI95% [0.32; 9.02]; p=0.036),
- new data from indirect comparisons (Ostuzzi et al. network meta-analysis, 2021) having reported a superiority in terms of acceptability (defined as the percentage of treatment discontinuations for all causes) of prolonged-release aripiprazole compared to five prolonged-release injectable antipsychotics, including monthly paliperidone palmitate,
- and its known safety profile,
the Committee considers that ABILIFY MAINTENA (prolonged-release aripiprazole) as monthly injections is a preferential alternative to XEPLION (paliperidone palmitate) as monthly injections in terms of acceptability and quality of life in the maintenance treatment strategy of patients having been initially stabilised under oral antipsychotics in accordance with their respective MAs. However, it highlights the fact that the superiority in terms of efficacy compared to other second-generation long-acting injectable antipsychotics has not been demonstrated.
Taking into account the MA for ABILIFY MAINTENA restricting its use to patients stabilised patients stabilised with oral aripiprazole, the Committee raises the question of whether it might be appropriate to revise the prescription conditions defined in the MA and to restrict prescription to psychiatric specialists and departments, in line with several other second-generation injectable antipsychotics also indicated in the same clinical situation: ZYPADHERA (olanzapine pamoate monohydrate), XEPLION and TREVICTA (paliperidone palmitate).
The Committee deems that the clinical benefit of ABILIFY MAINTENA (aripiprazole) is substantial in the MA indication.
Clinical Added Value
Abilify Maintena (aripiprazole), within the framework of the strategy of stabilizing the patient with the same oral molecule beforehand, provides a minor clinical added value (CAV IV) compared to paliperidone palmitate in monthly injection (XEPLION) in the maintenance treatment strategy of schizophrenia in of patients who were initially stabilised on oral antipsychotics in accordance with their respective MAs.