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ZYPREXA - ZYPREXA - CT 9128 - Version anglaise

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Présentation ZYPREXA VELOTAB 10 mg, comprimé orodispersible B/28 - Code CIP : 3545438 ZYPREXA VELOTAB 15 mg, comprimé orodispersible B/28 - Code CIP : 3545444 ZYPREXA VELOTAB 20 mg, comprimé orodispersible B/28 - Code CIP : 3545450 ZYPREXA VELOTAB 5 mg, comprimé orodispersible B/28 - Code CIP : 3545421 ZYPREXA 10 mg, comprimé enrobé B/28 - Code CIP : 3423801 B/56 - Code CIP : 3423818 ZYPREXA 5 mg, comprimé enrobé B/28 - Code CIP : 3423770 ZYPREXA 7,5 mg, comprimé enrobé B/28 - Code CIP : 3553716 B/56 - Code CIP : 3423787 Mis en ligne le 19 mars 2013 Substance active (DCI) olanzapine Progrès thérapeutique modéré dans le traitement de la schizophrénie Six antipsychotiques de seconde génération (ASG) ont l'AMM dans la schizophrénie : ABILIFY (aripiprazole), LEPONEX et génériques (clozapine), RISPERDAL et génériques (rispéridone), SOLIAN et génériques (amisulpride), XEROQUEL (quétiapine) et ZYPREXA et génériques (olanzapine).Les ASG constituent une classe hétérogène en termes d’efficacité et de tolérance. Cependant, les données ne permettent pas de privilégier un ASG plutôt qu’un autre. Code ATC N05AH03 Laboratoire / fabricant Laboratoire LILLY FRANCE ZYPREXA VELOTAB 10 mg, comprimé orodispersible B/28 - Code CIP : 3545438 ZYPREXA VELOTAB 15 mg, comprimé orodispersible B/28 - Code CIP : 3545444 ZYPREXA VELOTAB 20 mg, comprimé orodispersible B/28 - Code CIP : 3545450 ZYPREXA VELOTAB 5 mg, comprimé orodispersible B/28 - Code CIP : 3545421 ZYPREXA 10 mg, comprimé enrobé B/28 - Code CIP : 3423801 B/56 - Code CIP : 3423818 ZYPREXA 5 mg, comprimé enrobé B/28 - Code CIP : 3423770 ZYPREXA 7,5 mg, comprimé enrobé B/28 - Code CIP : 3553716 B/56 - Code CIP : 3423787 Mis en ligne le 19 mars 2013

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Published 30 November 2011
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The legally binding text is the original French version

TRANSPARENCY COMMITTEE

OPINION

30 November 2011


ZYPREXA 5 mg, coated tablet
B/28 (CIP code: 342 377-0)
ZYPREXA 7.5 mg, coated tablet
B/28 (CIP code: 355 371-6), B/56 (CIP code: 342 378-7)
ZYPREXA 10 mg, coated tablet
B/28 CIP code: 342 380-1), B/56 (CIP code: 342 381-8)
ZYPREXA VELOTAB 5 mg, orodispersible tablet
B/28 (CIP code: 354 542-1)
ZYPREXA VELOTAB 10 mg, orodispersible tablet
B/28 (CIP code: 354 543-8)
ZYPREXA VELOTAB 15 mg, orodispersible tablet
B/28 (CIP code: 354 544-4)
ZYPREXA VELOTAB 20 mg, orodispersible tablet
B/28 (CIP code: 354 545-0)

Applicant: LILLY FRANCE

Olanzapine
ATC Code: N05AH03

List I

Dates of Marketing Authorisations (MA):
ZYPREXA 5 mg, 7.5 mg, 10 mg, coated tablets: 27/09/1996
ZYPREXA VELOTAB 5 mg, 10 mg, 15 mg, 20 mg, orodispersible tablets: 03/02/2000

Reason for request: Re-assessment of the Actual Benefit and Improvement in Actual Benefit
in accordance with article R-163-21 of the Social Security Code.

Therapeutic indications:
Adults
"Olanzapine is indicated for the treatment of schizophrenia.
Olanzapine is effective in maintaining the clinical improvement during continuation therapy in
patients who have shown an initial treatment response.
Olanzapine is indicated for the treatment of moderate to severe manic episodes.
In patients whose manic episodes have responded to olanzapine treatment, olanzapine is
indicated for the prevention of recurrence in patients with bipolar disorder."

The transparency Commission has re-assessed the second generation oral antipsychotics in
the treatment of adult schizophrenia (c.f. report attached).
The conclusions were as follows:
1/3 Actual benefit

The key feature of schizophrenia is the presence of a set of signs and symptoms said to be
positive (delusional ideas, hallucinations, disorganised speech, grossly disorganised or
catatonic behaviour) or negative (dulled emotions, alogia, loss of motivation) associated with
clear social or activity-related dysfunction.
The course of schizophrenia varies, with some patients experiencing exacerbations and
remissions, while others are chronically affected. Some patients seem to show a relatively
stable course, while others experience progressive worsening associated with severe
disability.
Amisulpride in oral form is intended as symptomatic treatment in acute episodes and as long-
term preventative treatment of relapse.
The efficacy/safety ratio for these medicinal products in the treatment of schizophrenia is
high.
The alternatives are other antipsychotics indicated in the treatment of schizophrenia.
Whether first or second generation, antipsychotics are a heterogeneous class of drugs in
terms of efficacy and safety. In the light of recent publications, it would appear that there is
no data that allows one antipsychotic to be recommended over another. The choice of
therapy in the treatment of schizophrenia is a multifactorial and multidisciplinary decision. It is
based particularly on the expected benefits and safety profiles of the different antipsychotics,
experience of previous treatments, risk factors and patient preference.

Public health benefit of second-generation antipsychotics (SGA) in schizophrenia
The public health burden represented by schizophrenic psychoses, in view of their frequency
and severity, is substantial.
Improvement in their management is a public health need that falls within established
priorities (Public Health Act 20041 GTNDO2).
In light of the available data (meta-analyses of trials, pragmatic trials and observational
studies) demonstrating, in general, a difference in terms of efficacy favouring second-
generation antipsychotics (SGAs) over first-generation antipsychotics (FGAs), but whose
clinical relevance remains poorly established, fewer extrapyramidal symptoms with SGAs
than with FGAs and a higher rate of weight gain and metabolic disorders with some SGAs, it
may be considered that SGAs (as a class) have a low impact in terms of morbidity and
quality of life compared with FGAs [although patient compliance with SGA is also very low].
Within the SGA class, it seems difficult to distinguish individual antipsychotics in terms of
their impact on morbidity and quality of life. Furthermore, it should be reiterated that, due to
its less satisfactory safety profile, clozapine is a second-line treatment.
Given the available data, it is difficult to quantify the impact SGAs might have on healthcare
organisation compared with FGAs.
SGAs provide an additional solution to the identified public health need.
Consequently, in the current state of knowledge, ZYPREXA and ZYPREXA VELOTAB are of
benefit to public health in the indication for schizophrenia. This benefit is low.

The Actual Benefit of ZYPREXA and ZYPREXA VELOTAB in the treatment of schizophrenia
remains substantial.







1
Public Health Act 2004-806 of 9 August 2004: Objective concerning neuropsychiatric disorders
2
GTNDO. Groupe Technique National de Définitions des Objectifs (DGS - 2003) [National technical group for defining
objectives]
2/3 Improvement in actual benefit (IAB)

ZYPREXA and ZYPREXA VELOTAB, as with all other anti-psychotics (including first
generation anti-psychotics), provide a moderate Improvement in Actual Benefit (IAB III) in the
treatment of schizophrenia.

The transparency Committee recommends continued inclusion on the list of medicines
refundable by National Health Insurance in the indications and at the dosages given in the
Marketing Authorisation.

Packaging: appropriate for the prescription conditions.

Reimbursement rate: 65%





Medical, Economic and Public Health Assessment Division

3/3