Patients in England and Wales with the serious eye condition vitreomacular traction will from this week have routine access to the first and only approved medicine for the condition, following the all-clear from cost regulators.
In final guidance published this morning, the National Institute for Health and Clinical Excellence has recommended Novartis-unit Alcon's Jetrea (ocriplasmin) injection as an option for patients with the disease, deeming it both clinically and cost effective.
But the Institute has stipulated that Jetrea should only be considered if an epiretinal membrane is not present, and patients have a stage II macular hole (full thickness with a diameter of 400 micrometres or less) and/or severe symptoms.
Vitreomacular traction occurs when the vitreous, the gel-like substance in the eye, pulls abnormally on the retina, the light-sensitive layer of tissue at the back of the inner eye, which is responsible for processing visual images. The pulling of the gel disturbs the retina, causing swelling and distorted vision, and sometimes a hole in the macular area. It can occur as a result of ageing.
Jetrea was approved in March 2013 by the EU Commission for the treatment of vitreomacular traction, in adults, after clinical trials showed that, within 28 days, a single injection successfully resolved adhesion in around one out of four patients, and that over 40% had achieved closure of a macular hole.
The treatment offers an important alternative to the current standard approach of ‘watch and wait’, where patients undergo a period of observation before they become eligible for eye surgery due to worsening of their condition, so the availability of Jetrea means that those unsuited to a surgical procedure will now have the opportunity for treatment before their condition deteriorates.
The drug costs £2,500 per injection (just one of which is needed for treatment), and NICE concluded that the cost per QALY gained for patients with a stage II macular hole was likely to be under £30,500, and therefore a cost effective use of NHS resources.
Tim Jackson, Retinal Surgeon at King’s College Hospital, has welcomed the guidance.
"Ocriplasmin will be particularly helpful for patients who previously had a macular hole in one eye and are now developing an impending macular hole in the other – surgery may not yet be justified but equally we don’t want to wait until it is necessary. In this setting ocriplasmin may help avoid further loss of vision,” he told PharmaTimes World News.
But again highlighting the stark postcode lottery of care that persists in the UK, NICE' s sister body, the Scottish Medicines Consortium, has not recommended Jetrea for use within NHS Scotland.