Reason for request

First assessment

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 data in respect of the non-inferiority of BYANNLI 700 mg and 1000 mg (six-monthly injection) compared to TREVICTA 350 mg and 525 mg (three-monthly injection), in terms of preventing relapses in paucisymptomatic patients, over a treatment period limited to 12 months,
  • the lack of data supporting improved patient compliance, safety and/or quality of life,
  • the medical need partially met by the antipsychotics already available,
  • the lack of comparative data versus XEPLION 100 mg and 150 mg (monthly injection)
  • the lack of suitable doses for patients treated with XEPLION 25 mg, 50 mg and 75 mg or with TREVICTA 175 mg and 263 mg,

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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