FLOLAN - FLOLAN - CT 6424 - English version

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Introduction FLOLAN 0.5 mg, powder and solvent for solution for injection 50-ml vial (CIP code: 561 400-8) FLOLAN 1.5 mg, powder and solvent for solution for injection 50-ml vial (CIP code: 561 398-3) Posted on Jan 05 2011 Active substance (DCI) epoprostenol sodium Pneumologie - Mise au point Progrès thérapeutique : – important pour FLOLAN ; – modéré pour TRACLEER ; – mineur pour ADCIRCA, REMODULIN, REVATIO, VENTAVIS et VOLIBRIS Les médicaments de l’hypertension artérielle pulmonaire (HTAP) n'apportent qu'un bénéfice symptomatique, et celui-ci est modeste. FLOLAN (époprosténol) est le seul ayant montré une augmentation de la survie. Son rapport efficacité/effets indésirables est donc important ; il est modéré pour les autres médicaments. Il s’agit de médicaments de première intention, excepté REMODULIN et VENTAVIS, qui sont utilisés en deuxième intention. N.B. – THELIN a été retiré du marché en raison de son risque d'atteinte hépatique sévère. Pour en savoir plus télécharger la synthèse ou l'avis complet ci-dessous ATC Code B01AC09 Laboratory / Manufacturer GLAXOSMITHKLINE FLOLAN 0.5 mg, powder and solvent for solution for injection 50-ml vial (CIP code: 561 400-8) FLOLAN 1.5 mg, powder and solvent for solution for injection 50-ml vial (CIP code: 561 398-3) Posted on Jan 05 2011

Informations

• Publié par: haute-autorite-sante-maladies-appareil-respiratoire
• Publié le: 05 janvier 2011
• Nombre de lectures: 10
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

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    The legally binding text is the original French version   TRANSPARENCY COMMITTEE

  OPINION   5 January 2011     FLOLAN 0.5 mg, powder and solvent for solution for injection 50-ml vial (CIP code: 561 400-8) FLOLAN 1.5 mg, powder and solvent for solution for injection 50-ml vial (CIP code: 561 398-3)     Applicant: GLAXOSMITHKLINE   epoprostenol sodium ATC code: B01AC09   List I Medicine for hospital prescription only, restricted to specialists and/or departments specialising in pneumology or cardiology   Date of Marketing Authorisation (national procedure): 6 March 1998, revised on 13 December 2004   Reason for examination: Reassessment of actual benefit and improvement in actual benefit under article R-163-21 of the Social Security Code.   Indications:   “FLOLAN is indicated for long-term treatment of pulmonary arterial hypertension (PAH), administered via continuous drip:   - idiopathic pulmonary arterial hypertension - familial or sporadic,   - pulmonary arterial hypertension associated with systemic collagenosis.   For patients in clinical functional stage III or IV (on the New York Heart Association severity scale).”   Dosage: see SPC   The Transparency Committee has reassessed all treatments for PAH. Distinctions have been drawn between the various drugs (see complete report attached). The Transparency Committee’s conclusions regarding FLOLAN were as follows:            

 

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Actual benefit PAH is a rare pulmonary condition that affects life expectancy. It is characterised by gradual blocking of the small pulmonary arteries, leading to a gradual increase in pulmonary arterial pressure and right cardiac insufficiency. PAH is defined by an increase in mean pulmonary arterial pressure (mPAP) measured by right cardiac catheterisation which is equal to or greater than 25 mmHg at rest, with no increase in pulmonary capillary pressure. Asthenia, dyspnoea, chest pain and loss of consciousness are the most frequent clinical signs. The median survival time for patients with PAH in functional class III receiving symptomatic treatment is around 2.5 years.   All treatments for PAH are in the symptomatic category. The efficacy/adverse effects ratio is high. In practice, prostacyclins are used as second-line treatment, with the exception of the proprietary drug FLOLAN, which is a first-line treatment for patients suffering from functional class IV PAH as it is the only treatment indicated for these severely ill patients for whom no other alternative medicinal products exist. In the current state of knowledge, it is expected that FLOLAN proprietary drugs will benefit public health. This benefit is slight.   The actual benefit is substantial.   Improvement in actual benefit (IAB) In view of the known and proven effect on survival, and its therapeutic use, particularly for patients with functional class IV PAH, the Transparency Committee considers that FLOLAN provides an important improvement in actual benefit (IAB II) in the management of patients suffering from idiopathic PAH or PAH associated with connective tissue disease who are in functional class III or IV.                       Medical, Economic and Public Health Assessment Division

 

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