BYANNLI (palmitate de palipéridone) - Schizophrénie
Reason for request
Key points
Approval for reimbursement for the maintenance treatment of schizophrenia in clinically stable adult patients treated with paliperidone palmitate injections given every month or every three months.
Therapeutic improvement?
No therapeutic improvement in relation to TREVICTA 350 mg and 525 mg in the treatment of schizophrenia patients.
Role in therapeutic strategy?
“Conventional” (first-generation) antipsychotics and “atypical” antipsychotics have been shown to be effective in the treatment of schizophrenia, in particular on positive symptoms, and are considered as the conventional drug-based treatment. Atypical antipsychotics (risperidone, olanzapine, aripiprazole, paliperidone, quetiapine) are recommended as a first-line approach especially for adolescents, on account of their superior safety profile.
Antipsychotic monotherapy is preferable, if possible in oral form. The minimum effective dose should always be sought.
The therapeutic strategy for these patients is not solely based on optimising the antipsychotic treatment, but also includes psychosocial rehabilitation interventions and treatment of any comorbidities (psychiatric and somatic).
Role of the medicinal product
BYANNLI (injected every six months) is a treatment option for patients treated with TREVICTA (injected every three months) at 350 mg or 525 mg doses, or with XEPLION (injected every month) at 100 mg or 150 mg doses, not requiring dose adjustments, provided that spacing out injections does not adversely affect the patient’s medical follow-up, especially when initiating treatment. The doses in which BYANNLI is available are not suitable for patients receiving injections of XEPLION 25 mg, 50 mg and 75 mg once a month, or injections of TREVICTA 175 mg and 263 mg once every three months.
Clinical Benefit
Substantial |
The Committee deems that the actual clinical benefit of BYANNLI is significant in the marketing authorisation indication. |
Clinical Added Value
no clinical added value |
Considering:
the Committee deems that BYANNLI provides no clinical added value (CAV level V) compared to TREVICTA 350 mg and 525 mg in the treatment of schizophrenia patients.
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