ThromboGenics NV, a biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, announced that the UK’s National Institute for Health and Care Excellence (NICE) has provisionally recommended Jetrea (ocriplasmin) for reimbursement within the National Health Service (NHS). The NICE Appraisal Consultation Document (ACD) initially recommends Jetrea as an option for treating vitreomacular traction (VMT) in adults, including when associated with a macular hole of less than or equal to 400 microns, when patients have severe symptoms and an epiretinal membrane is not present.
Jetrea is the first pharmacological treatment indicated for use in patients diagnosed with VMT and macular hole of diameter less than or equal to 400 microns and was approved in the European Union by the European Commission in March 2013. Partner Alcon launched the drug in the UK, its first market in Europe, in April, resulting in ThromboGenics receiving €90 million in milestone payments. Alcon, a division of Novartis, acquired the rights to commercialize Jetrea outside the United States in March 2012.
The NICE appraisal committee considers evidence submitted by the manufacturer and makes a judgment on whether or not the technology should be recommended as a clinically and cost-effective use of NHS resources, or whether it should only be recommended for specific subgroups of patients. This process also takes into account testimony from clinical experts, patient groups and carers.
After publication of the ACD, NICE invites formal consultees, commentators and the general public to comment on the ACD. After considering these comments, the Committee then finalizes its recommendations and submits them to NICE in the form of a Final Appraisal Determination (FAD). The final NICE guidance on Jetrea is expected in the third quarter of 2013.
Dr Patrik De Haes, CEO of ThromboGenics, said: “We are delighted by the preliminary NICE recommendation for Jetrea, the first and only pharmacological treatment licensed for VMT and macular hole. The Institute has concluded that treatment with Jetrea early in the course of the disease represents a step-change in how patients with VMT are currently managed, preserving visual function and quality of life for patients with this distressing, sight-threatening condition. We particularly welcome NICE’s endorsement that Jetrea is a cost-effective use of finite NHS resources, and represents good value for money in the patients in whom it is recommended.”
“People affected by VMT and macular hole can suffer significant vision distortion that can make it difficult for them to read, watch TV and drive. The draft NICE recommendation published today is important in improving their treatment options. For suitable patients it offers a simple treatment that may avoid the need for eye surgery, and means patients unsuited to surgery can now be treated, often before their condition deteriorates,” said Tim Jackson, Consultant Retinal Surgeon at King's College Hospital.
Jetrea contains the active substance ocriplasmin. It is administered through a single intravitreal injection to treat adults with vitreomacular traction (VMT).
VMT is a progressive, sight-threatening condition. It is caused by the vitreous humour having an abnormally strong attachment to the macula, the central part of the retina (the light sensitive membrane at the back of the eye). The macula provides central vision that is needed for everyday tasks such as driving, reading and recognizing faces.
When the vitreous humour shrinks, the strong attachment results in a pulling force on the retina, which may lead to visual distortion, decreased visual acuity and central blindness. When the disease progresses the traction may eventually result in the formation of a hole in the macula (called a macular hole).
Jetrea breaks down the protein fibers which cause the abnormal traction between the vitreous and the macula that causes VMT. By dissolving these proteins, Jetrea releases the traction, and helps to complete the detachment of the vitreous from the macula.
Jetrea can also be used when VMT has progressed and caused a small hole in the macula (central part of the light sensitive layer at the back of the eye).
It is estimated that 250,000 to 300,000 patients in Europe alone suffer from this condition.
The current approach in the EU is ‘observation’, ‘watchful waiting’ or ‘watch and wait’ until a patient becomes a candidate for surgical treatment, usually at a late stage of the disease. A patient would then receive a surgical procedure and repair of the retina. However, for many patients this is not a suitable option, as irreversible damage to the retina may have already occurred.
ThromboGenics is continuing to work closely with Alcon to ensure patients across Europe and rest of the world can access this innovative medicine and receive Jetrea as soon as it becomes available in the respective countries.
Jetrea (ocriplasmin) is a truncated form of human plasmin. In the US, Jetrea is indicated for the treatment of symptomatic VMA. In Europe, Jetrea is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter = 400 microns. Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.