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TiGenix (NYSE EURONEXT: TIG) announces the reimbursement approval of ChondroCelect in Belgium by the Minister of Social Affairs within a convention and provides a reimbursement update for other European countries.
TiGenix introduced an application for the reimbursement of ChondroCelect to the Belgian reimbursement authority (RIZIV/INAMI) in April 2010. Today the company has received the notification by the Minister of Social Affairs of the approval of a convention agreement (Art 81) between the RIZIV/INAMI and TiGenix for the reimbursement of ChondroCelect for wellindicated patients in specialised treatment centers. This convention covers a period of three years, and defines the specific treatment criteria and follow-up measures the company has to conduct.
With the signing of this reimbursement convention, ChondroCelect is not only the first cellbased product to have obtained centralised European marketing authorisation, it is also the first Advanced Therapy Medicinal Product (ATMP) to obtain a national reimbursement.
Also in other countries, progress is being made towards making the ChondroCelect product available to patients.
In France, where the transparency commission of the “Haute Autorité de Santé” (HAS) had in October 2010 declared that they were not able to evaluate the therapeutic benefit of the product and had not recommended ChondroCelect to be put on the list of reimbursable products, a positive advice has now been issued by the ‘Haut Collège’ of the HAS recommending the conditional reimbursement of the combination of cultured autologous chondrocytes, membrane and surgical procedure under a special reimbursement scheme (“Remboursement dérogatoire” Art. 165-1-1). Since ChondroCelect is the only approved medicinal product for autologous chondrocyte transplantation in France, this decision opens the perspective to obtain controlled access to the French market.
In the Netherlands, the procedure for reimbursement of ChondroCelect under a special reimbursement scheme for innovative new medicines (“Beleidsregel Dure Geneesmiddelen”) is still ongoing. A decision is now expected in the second quarter of 2011.
In the United Kingdom, two primary care trusts (PCT) of the National Health Care System (NHS) as well as five of the largest health insurance funds are reimbursing ChondroCelect treatments for well-indicated patients. Reimbursement discussions with additional public and private health insurance funds are ongoing.
In Germany, thirty-six German hospitals filed for NUB approval at the end of 2010. These hospitals were recently informed by InEK that the product obtained this year NUB Status 4 (“Neue Untersuchungs und Behandlungsmethode”). Contrary to Status 2 and 3, products with a Status 4 are eligible for reimbursement (on a case by case basis).
In Spain, the reimbursement application for this first ATMP has been submitted in November 2010. A decision on the national level is expected in the second quarter of 2011. Discussions at the regional level will follow and are currently being prepared.
Based in Leuven, Belgium, TiGenix NV (NYSE Euronext Brussels: TIG) is a biomedical company that focuses on ‘Regenerating Motion’. The company is exploiting the power of Regenerative Medicine to develop innovative local treatments for damaged and diseased skeletal tissues. The lead indication among these is cartilage damage, which is a debilitating affliction affecting the mobility and functioning of patients. Western societies are characterised by ageing populations that place an increasing emphasis on high quality of life and life-long mobility, and, as such, cartilage problems represent a large and growing unmet medical need. Current therapies do not provide satisfying, long-term durable repair and TiGenix therefore believes there is a need for more effective treatments for cartilage damage.
ChondroCelect®, the company’s lead product for cartilage regeneration in the knee, is the first cellbased product that successfully completed the entire development track from research, over clinical development to central European registration as a medicinal product. ChondroCelect consists of characterised cultured chondrocytes derived from the patient’s own cartilage and is used for autologous chondrocyte implantation (ACI), a surgical procedure to treat cartilage defects. Cartilage defects of the knee are very common, and the spontaneous healing capacity of cartilage is limited. On October 5, 2009 ChondroCelect received European marketing authorisation as the first Advanced Therapy Medicinal Product, indicated for repair of single symptomatic cartilage defects of the femoral condyle of the knee (International Cartilage Repair Society [ICRS] grade III or IV) in adults.
ChondroMimetic is a porous, resorbable implant which is designed to support the regenerative repair of damaged joint surfaces and bony defects caused by trauma or disease. ChondroMimetic contains three readily-absorbed, non-synthetic biomaterials: collagen, glycosaminoglycan and calcium phosphate in a dual-layer porous implant. The product allows pre-hydration with sterile fluids and autologous blood products and provides optimum environmental conditions for cell infiltration and tissue regeneration via its unique materials composition and scaffold architecture. The product is supplied sterile and ready to use, and is compatible with open and minimally invasive implantation methods. The product received CE-mark approval for the treatment of chondral and subchondral lesions.
Source: TiGenix
Tags: legal
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