COPAXONE - COPAXONE - CT 5615 - English version

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2010

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Introduction COPAXONE 20 mg/mL, solution for injection Prefilled syringe, B/28 (CIP code: 363 840-1) Posted on Jul 06 2012 Active substance (DCI) glatiramer acetate Neurologie - Mise au point Progrès thérapeutique modéré dans la sclérose en plaques Deux interférons bêta-1a (AVONEX et REBIF), un interféron bêta-1b (BETAFÉRON, EXTAVIA) et l’acétate de glatiramère (COPAXONE) sont indiqués dans le traitement de fond de la sclérose en plaques (SEP).Ces spécialités ont une efficacité modeste sur la fréquence des poussées, qui est réduite de 30 % à court terme. Leur efficacité sur l’évolution à long terme du handicap n’est pas démontrée. Ces médicaments représentent un progrès thérapeutique modéré.Les interférons bêta ou l’acétate de glatiramère (notamment en cas d’intolérance aux interférons) restent le traitement de fond de première intention de la SEP.Pour en savoir plus, téléchargez la synthèse ou l'avis complet ci-dessous ATC Code L03AX13 Laboratory / Manufacturer SANOFI-AVENTIS FRANCE COPAXONE 20 mg/mL, solution for injection Prefilled syringe, B/28 (CIP code: 363 840-1) Posted on Jul 06 2012

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haute-autorite-sante-maladies-systeme-nerveux

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Maladie auto-immune

The legally binding text is the original French version

TRANSPARENCY COMMITTEE OPINION 2 June 2010 Reassessment of the proprietary drug included on the list of reimbursable products for a period of 5 years starting from 27 August 2009 COPAXONE 20 mg/mL, solution for injection Prefilled syringe, B/28 (CIP code: 363 840-1) Applicant: SANOFI-AVENTIS FRANCE Glatiramer acetate List I Exception drug status Initial prescription and renewal by neurology specialists only Medicine requiring special monitoring during treatment ATC code: L03AX13 Date of MA and variations of MA: 26 March 2004 Reason for the request: Renewal of inclusion on the list of medicinal products reimbursed by National Health Insurance and reassessment of the improvement in actual benefit of beta interferons and glatiramer acetate indicated in multiple sclerosis. Therapeutic indications: "Glatiramer acetate is indicated for the reduction in frequency of relapses in ambulatory patients (i.e. who can walk unaided) with relapsing-remitting multiple sclerosis (MS) characterised by at least two attacks of neurological dysfunction over the preceding two-year period. No beneficial effect on progression of disability has been demonstrated by glatiramer acetate. Glatiramer acetate is not indicated for the treatment of primary or secondary progressive MS." Dosage: see SPC

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The Transparency Committee has reassessed beta interferons and glatiramer acetate in multiple sclerosis. According to the enclosed report, the Committee concluded: Actual benefit Multiple sclerosis is an incapacitating, progressive, chronic neurological disorder. It involves selective, chronic inflammation and demyelination of the central nervous system. It causes multiple deficits which vary according to the progression of the disease and the individual, including motor, sensory, bladder and sphincter, sexual, cognitive function and mood disorders. These disorders may considerably reduce patients’ autonomy and impair their quality of life. The disease varies considerably in severity, with benign forms which cause disability and severe forms which lead to major disability within a few years. COPAXONE is a medicinal product intended to prevent acute exacerbations and progression of disability. The efficacy of the product is relatively modest: the frequency of acute exacerbations is decreased by 30%. Efficacy against long-term progression of disability remains unclear and no criteria for discontinuing treatment have been established, but its safety profile is acceptable. It has a high efficacy/adverse effects ratio. Alternative medicinal products exist. Public health benefit: The public health burden of MS is moderate. Improvement in the treatment of MS is a public health need which is an established priority (French 2004 Law on Public Health). In view of the available data, the medicinal product COPAXONE has an impact on morbidity (frequency of acute exacerbations). This impact is low. The product therefore provides a partial response to an identified public health need. The public health benefit contributed by COPAXONE in MS is therefore low. The actual benefit of this medicinal product remains substantial. Improvement in actual benefit: In view of the absence of demonstrated long-term efficacy against disability provided by the medicinal product COPAXONE, the improvement in actual benefit is level III in the treatment of patients with multiple sclerosis. The Transparency Committee recommends maintaining inclusion on the list of medicines reimbursed by French National Health Insurance in the indications and at the dosages given in the MA. Packaging: appropriate for the prescription conditions. Reimbursement level: 65% Medical, Economic and Public Health Assessment Division

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