France's Transparency Commission Issues Positive Opinion for Reimbursement of JETREA®
Assessment highlights JETREA® as particularly suited for treatment of earlier-stage patients suffering from vitreomacular traction including macular hole
Leuven, Belgium – 16 January, 2014 - ThromboGenics NV (Euronext Brussels: THR), an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announces today that the Transparency Commission (“Commission de la Transparence” or CT) of the French National Health Authority (“Haute Autorité de Santé” or HAS) has issued a positive opinion for the reimbursement and hospital listing of JETREA® by the French National Health Insurance.
The CT recommends JETREA® for the treatment of adult patients with vitreomacular traction, including when associated with macular hole of diameter less than or equal to 400 microns, for whom symptomatology does not require immediately a vitrectomy at the earlier stage of this disease. Those patients represent the vast majority (85%) of the total patient population covered by the approved label from EMA in March 2013.
The CT assessment recognizes the medical benefit (“Service Médical Rendu” or SMR) of JETREA®, indicating that JETREA® becomes eligible for reimbursement in France. The assessment underlines the absence of clinically relevant alternatives to JETREA®, in the proposed reimbursed indication. The CT assessment further highlights the importance of treating VMT early, from the diagnosis and/or when the patient first experiences metamorphopsia or other symptoms.
Pricing and reimbursement negotiations will now begin with the Economic Committee of Healthcare Products (“Comité Economique des Produits de Santé” or CEPS) in France.
ThromboGenics signed a strategic partnership in 2012 with Alcon, the eye care division of Novartis, for the commercialization of JETREA® outside of the United States.
Dr Patrik De Haes, CEO of ThromboGenics, said, “Today’s news from France underwrites that the benefits of JETREA® for patients with VMT are clearly recognised by one of Europe’s leading regulatory agencies. The French Transparency Commission’s assessment also highlights JETREA® as a drug particularly suited for the treatment of earlier-stage VMT patients. This positive initial review of JETREA® in France adds to the earlier positive decisions in Germany and the UK.”