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NHS England Considers Reimbursment for Bionic Eye

NHS England to consider reimbursing “bionic eye” treatment for blindness caused by retinitis pigmentosa

September 2013

NHS’s Advisory Group (PSSAG) to meet on 17 September to consider offering Argus® II Retinal Prosthesis System to blind patients treated within the NHS

Second Sight Medical Products Inc’s Argus II Retinal Prosthesis, the world’s first approved device intended to restore some functional vision for people suffering from blindness due to outer retinal degenerations, is to be assessed next week by a group advising NHS England.

The Argus II System works by converting video images captured by a miniature camera housed in the patient’s glasses into a series of small electrical pulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. These pulses are intended to stimulate the retina’s remaining cells resulting in the corresponding perception of patterns of light in the brain. The patient then learns to interpret these visual patterns thereby regaining some visual function. Second Sight gained European approval (CE Mark) for the system in 2011 and FDA approval in 2013. It is the first approved retinal prosthesis anywhere in the world, and the only such device approved in the USA.

The majority of blind subjects fitted with the Argus II consistently identify letters and words using the retinal implant, according to a study published in the British Journal of Ophthalmology (BJO), indicating reproducible spatial resolution. This, in combination with the proven, stable, long-term function of the device, represents significant progress in the evolution of artificial sight.

According to another study published in Ophthalmology2, two types of real-world orientation and mobility (O&M) tests were performed: a door test where subjects were asked to find a door across a room and a line test where subjects were asked to follow a white line on the floor. Subjects performed statistically better with the Argus II system on versus off in the visual tasks:

• 96% of subjects improved in object localization
• 57% of subjects improved in motion discrimination
• 23% of subjects improved in the discrimination of oriented gratings

In addition, significant improvements in the O&M tasks were noted and the safety profile of
Argus II was found to be comparable to other ophthalmic devices and procedures. Although
There are several research efforts in retinal prostheses worldwide, none has demonstrated the
reliability and efficacy of such a device in a multicenter, long-term, controlled clinical trial
involving 30 subjects, as was demonstrated by the Argus II in this study.

Lyndon da Cruz, MD PhD Consultant Retinal Surgeon at Moorfields Eye Hospital in London , UK “ The fact that nearly all patients had a stable, safe and functioning system and that a majority of patients could recognize large letters, locate the position of objects and the best could read short words impressed us beyond our most optimistic expectations"

“This ‘artificial retina’ brings hope to thousands of people with advanced retinal diseases” added David Head, Chief Executive of the British Retinitis Pigmentosa Society. “The restoration of an element of vision may bring with it the restoration of independence and mobility that would greatly improve a patient’s quality of life.

The NHS’s Prescribed Specialised Services Advisory Group (PSSAG) considers whether to include treatments which are intended for fewer than 500 cases per year in England within the definition of specialised services. PSSAG will be considering Argus II at its meeting on 17 September.  As a result of the meeting, PSSAG will make a recommendation to Ministers. Ministers will consider the recommendations and consult on them with NHS England.

If the treatment is included in the specialised services definition, it will be commissioned by NHS England rather than individual Clinical Commissioning Groups (CCGs). In this case, NHS England will develop a service specification and agree on a process for selecting providers. The detail of this will be discussed at the first meeting of the Rare Diseases Advisory Group (RDAG) on 15 October.

NHS England will be considering a number of proposals for new services and these will be prioritised at a meeting of NHS England’s Clinical Priorities Advisory Group (CPAG) later this year.

Robert Greenberg, MD PhD, President and Chief Executive Officer at Second Sight, says: "We very much hope that patients in England will soon be able to experience the life changing benefits from our prosthesis already enjoyed by RP patients elsewhere in Europe and in the USA. The UK has been instrumental in the clinical research of the Argus II.”

“The Argus II has been available and reimbursed for patients in Germany and Italy for the past two years, and has just become reimbursed for patients in the USA. The reimbursement approval for Argus II proves how important this technology is for the patients affected with blindness from the untreatable orphan disease - retinitis pigmentosa.”

Robert Greenberg adds:

 “Physicians and patients are eagerly awaiting decisions later this year about how Argus will be funded by the NHS in England.”

Second Sight announced last week that the company has been selected as a 2014 Technology Pioneer by the World Economic Forum. Previous Technology Pioneers include worldwide leading companies such as Google (2001), Wikimedia (2008), Twitter (2010) and Dropbox (2012). 

 “We are honored and humbled to be named alongside such prominent, world-class innovators as a 2014 Technology Pioneer,” says Robert Greenberg.  “At Second Sight, this recognition by the World Economic Forum has validated our commitment to providing state-of-the-art technology to patients suffering from retinitis pigmentosa and other forms of vision loss.”

 
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