ThromboGenics NV has announced that JETREA® (ocriplasmin) has been selected to receive a Single Technology Appraisal (STA) from the UK’s National Institute for Health and Clinical Excellence (NICE).
The outcome of the STA, in the form of NICE guidance, is expected later in 2013, following the launch of JETREA® in the UK.
The JETREA® European Marketing Authorization Application is currently under review by the European Medicines Agency.
A decision on European approval is expected in the first half of 2013.
JETREA® was recently approved by the U.S. Food and Drugs Administration for the treatment of symptomatic Vitreomacular Adhesion (VMA).
In March 2012, ThromboGenics has signed a strategic partnership with Alcon (Novartis) for the commercialization of ocriplasmin outside the United States.
The NICE STA process is designed to provide recommendations on the use of new medicines in the National Health Service (NHS).
The STA is specifically designed to appraise a single product with a single indication, and enables NICE to produce guidance soon after the technology is introduced in the UK. During the appraisal process, NICE seeks evidence from several sources.
ThromboGenics and its partner Alcon, will submit the principal evidence for the JETREA® STA shortly. This submission will be assessed by an Evidence Review Group (ERG), an external independent academic organization, which will produce a review of the evidence submission.
The STA also relies on information and evidence from clinical consultants, and NHS commissioning authorities as well as patient groups.
Dr Patrik De Haes, CEO at ThromboGenics, said: "We are delighted that the UK Department of Health has asked NICE to appraise JETREA® (ocriplasmin) for the treatment of vitreomacular traction. We strongly believe that JETREA® has the potential to dramatically change the treatment paradigm in the UK for this progressive sight threatening condition".
We plan to submit, along with our partner Alcon, our dossier for the STA shortly and look forward to working with NICE and all parties involved in the appraisal process.”