Reason for request

First listing

Summary of opinion

Favourable opinion for reimbursement in the maintenance treatment of schizophrenia in adult patients stabilized with aripiprazole.

No clinical added value of the new forms, ABILIFY MAINTENA 720 mg and ABILIFY MAINTENA 960 mg (prolonged-release aripiprazole) prolonged-release suspension for injection in pre-filled syringe as a two-monthly injection, compared to the forms, ABILIFY MAINTENA 300 mg and ABILIFY MAINTENA 400 mg (prolonged-release aripiprazole as a monthly injection), already available.


Clinical Benefit

Substantial

The Committee deems that the clinical benefit of the proprietary medicinal products ABILIFY MAINTENA 720 mg and ABILIFY MAINTENA 960 mg (prolonged-release aripiprazole) prolonged-release suspension for injection in pre-filled syringe as a two-monthly injection is substantial in the MA indication.


Clinical Added Value

no clinical added value

Considering:

  • pharmacokinetic data having reported similar mean plasma aripiprazole concentrations and areas under the time-concentration curve between prolonged-release aripiprazole 960 mg as a two-monthly injection after the 4th dose and prolonged-release aripiprazole 400 mg as a monthly injection after the 7th or 8th doses in a comparative study for which several limitations were identified (off-label clinical indication (bipolar disorder type I) in 30% of cases, prior aripiprazole treatment for only a third of patients, data only available for the 960 mg strength, high attrition rates, transposability),
  • the absence of efficacy data versus an active comparator enabling to position the medicinal product in the care pathway, in a context in which the other prolonged-release therapeutic alternatives that can be administered in adults stabilized with aripiprazole (i.e., prolonged-release aripiprazole monthly injection or prolonged-release risperidone two-monthly injection) have demonstrated their non-inferiority versus an active comparator,
  • the absence of data supporting an improvement in patient compliance, safety and/or quality of life compared to monthly injections, in particular,

but taking into account

  • the known efficacy profile of aripiprazole as monthly injections currently available,
  • the safety data having reported a similar safety profile between two-monthly injections and monthly injections, although with more injection site reactions (18.2% versus 9.0%, respectively) and weight gain (22.7% versus 20.9%, respectively),
  • the benefit of having dosage forms enabling a different administration schedule, without, however, a formally demonstrated improvement in terms of quality of life or acceptability,

the Committee deems that the proprietary medicinal products ABILIFY MAINTENA 720 mg and ABILIFY MAINTENA 960 mg (prolonged-release aripiprazole) prolonged-release suspension for injection in pre-filled syringe as a two-monthly injection are range supplements that do not provide any clinical added value (CAV V) compared to the ABILIFY MAINTENA 300 mg and ABILIFY MAINTENA 400 mg (prolonged-release aripiprazole as a monthly injection) forms already listed.


Contact Us

Évaluation des médicaments