TRACLEER - TRACLEER - CT 6316 - English version

Has

Description

Introduction TRACLEER 62.5 mg, film-coated tablet B/56 (CIP code: 563 621-1) TRACLEER 125 mg, film-coated tablet B/56 (CIP code: 563 622-8) TRACLEER 32 mg, dispersible tablets B/56 (CIP code: 399 351-0) Posted on Jan 05 2011 Active substance (DCI) bosentan 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 C02KX01 Laboratory / Manufacturer ACTELION PHARMACEUTICALS FRANCE TRACLEER 62.5 mg, film-coated tablet B/56 (CIP code: 563 621-1) TRACLEER 125 mg, film-coated tablet B/56 (CIP code: 563 622-8) TRACLEER 32 mg, dispersible tablets B/56 (CIP code: 399 351-0) Posted on Jan 05 2011

Sujets

• Maladie génétique
• RARE

Informations

• Publié par: haute-autorite-sante-maladies-appareil-respiratoire
• Publié le: 05 janvier 2011
• Nombre de lectures: 13
• Licence : En savoir +
  Paternité, pas d'utilisation commerciale, partage des conditions initiales à l'identique
• Langue: English

Extrait

 

  The legally binding text is the original French version   TRANSPARENCY COMMITTEE

  OPINION   5 January 2011     TRACLEER 62.5 mg, film-coated tablet B/56 (CIP code: 563 621-1) TRACLEER 125 mg, film-coated tablet B/56 (CIP code: 563 622-8) TRACLEER 32 mg, dispersible tablets B/56 (CIP code: 399 351-0)     Applicant: ACTELION PHARMACEUTICALS FRANCE   bosentan ATC code: C02KX01   List I Medicine for hospital prescription only. Prescription restricted to specialists and/or hospital departments specialising in pneumology, cardiology, rheumatology, dermatology, or internal medicine. Medicine requiring special monitoring during treatment.   Date of initial Marketing Authorisation (centralised procedure): 15 May 2002 Orphan drug (initial date of designation for TRACLEER proprietary drugs: 14 February 2001)   Reason for examination: Reassessment of actual benefit and improvement in actual benefit under article R-163-21 of the Social Security Code.   Indications:   “Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in: - primary (idiopathic and familial) PAH - PAH secondary to scleroderma without associated significant interstitial pulmonary disease. - PAH associated with congenital systemic -to-pulmonary shunts and Eisenmenger’s syndrome.  Some improvements have also been shown in patients with PAH WHO functional class II.”   Dosage: see SPC   The Transparency Committee has reassessed all treatments for PAH. Distinctions have been drawn between the various proprietary drugs (see complete report attached). The Transparency Committee’s conclusions regarding TRACLEER were as follows:  

 

1/2

Actual benefit (AB) 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. Median survival under symptomatic treatment is around 2.5 years for patients with functional class III PAH and 4.8 years for those with functional class II PAH.   All treatments for PAH are in the symptomatic category. The efficacy/adverse effects ratio is moderate. This medicinal product is a first-line therapy.   No public health benefit is expected.   The actual benefit is moderate.   Improvement in actual benefit (IAB) In the light of the data available and clinical experience, the Transparency Committee considers that TRACLEER provides a moderate improvement in actual benefit (IAB III) in the management of idiopathic pulmonary arterial hypertension, or hypertension associated with connective tissue disease or congenital cardiopathy, for patients in functional class II or III.   The Transparency Committee will reassess TRACLEER proprietary drugs in the light of the findings of the European reassessment of the hepatotoxicity of endothelin antagonists.   The Transparency Committee expresses the wish, at the request of the Directorate General for Health, that proprietary drugs administered per os route be made available for delivery on retail pharmacies.                         Medical, Economic and Public Health Assessment Division

 

2/ 2