ZONDAR - ZONDAR - CT 12262 - Version anglaise

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Présentation ZONDAR 50 mg, gélule Boîte de 30 gélules- Code CIP : 3355301 Mis en ligne le 25 juil. 2013 Substance active (DCI) diacéréine Rhumatologie - Mise au point Avis défavorable au maintien du remboursement en raison d’un intérêt clinique insuffisant dans l’arthrose de la hanche et du genou Les AASAL ont une AMM dans le traitement symptomatique à effet différé de l'arthrose de la hanche et du genou.Leurs effets sur la douleur et la gêne fonctionnelle liées à l’arthrose sont minimes et de pertinence clinique discutable. Ils n’ont pas montré qu’ils réduisaient la consommation d’AINS.Ils n’ont donc pas d’intérêt clinique dans le traitement symptomatique de l’arthrose de la hanche et du genou. En conséquence, le service médical rendu par ZONDAR 50 mg, gélule est insuffisant pour une prise en charge par la solidarité nationale. Code ATC M01AX21 Laboratoire / fabricant PHARMA 2000 ZONDAR 50 mg, gélule Boîte de 30 gélules- Code CIP : 3355301 Mis en ligne le 25 juil. 2013

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Publié par

haute-autorite-sante-maladies-appareil-locomoteur

Publié le

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Médecine

The legally binding text is the original French version TRANSPARENCY COMMITTEE

OPINION

9 January 2013 The opinion adopted by the Transparency Committee on 4 July 2012 was given a hearing on 5 December 2012 and observations were examined on 9 January 2013 Examination of the dossier for a medicinal product included for a 5-year period starting on 20/11/2005 (Official Gazette) of 28/04/2006). ZONDAR 50 mg, hard capsule B/30 (CIP code: 335 530-01) Applicant: PHARMA 2000 Diacerein ATC code: M01AX21 Date of Marketing Authorisation: 12 August 1992, amended on 12 October 2007 (modification of the indication following re-assessment of the risk/benefit ratio of slow-action symptomatic anti-arthritic agents) Reasons for request: Renewal of inclusion on the list of medicines refundable by National Health Insurance. Re-assessment of the actual benefit following the Transparency Committee conclusions in its opinions of 26 November 2008 and reiterated in its opinion of 21 September 2011. Medical, Economic and Public Health Assessment Division

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Diacerein

1.1.

1.2.

Indication

“Symptomatic treatment with delayed effect for osteoarthritis of the hip or knee.

1.3. Dosage

“Two capsules per day, one taken in the morning and the other in the evening.

REMINDER OF THE COMMITTEE’S OPINIONS AND CONDITIONS OF INCLUSION

Committee Opinion of 16 December 1992 Request for inclusion in the indication “Symptomatic treatment of functional effects of osteoarthritis. Note: the action is delayed; the delay of 30 to 45 days necessary for development of the analgesic effect may require starting treatment with normal analgesics/ anti-inflammatories with an immediate action: “The problem is knowing how this medicinal product will be of therapeutic use for osteoarthritis. In the current state of the dossier, the therapeutic benefit is clear in the case where: - the product is initially co-prescribed with an immediate action symptomatic treatment, in patients whose condition requires permanent treatment with these therapies. And if, after one to two months, it is possible to gradually withdraw the NSAID to -avoid the drawbacks of these types of products. If the product is used according to the instructions stated, it is possible to consider that there is a modest, type III improvement in actual benefit, in terms of efficacy and safety of use. This is the first medicinal product that has demonstrated its efficacy in the authorised indication, with the possibility of a therapeutic window due to its residual action. The Committee could be called to re-assess the improvement in actual benefit in view of the therapeutic studies into the avoidance of long courses of NSAIDs and demonstrating the existence of a long-term chondroprotective effect. Reimbursement rate: 70% Committee Opinion of 15 December 1993 Re-assessment of the actual benefit following submission of new data: “The Committee notes the additional studies included in the dossier. It confirms that diacerein, in the class of anti-osteoarthritis treatments, is the first in the group of slow action symptomatic medicinal products with an original mechanism of action: inhibition of the effects of interleukin 1. Its benefit is in the substitution of NSAIDs, saving on their use and thus avoiding the complications linked to taking them. The Committee considers that this substitution is a consequence of the efficacy of diacerein and is its true therapeutic benefit. NSAIDs are not reference products for diacerein, which is in a new therapeutic category.

CHARACTERISTICS OF THE MEDICINAL PRODUCT

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Active ingredient

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