Cost-Effectiveness of the Argus II Retinal Prosthesis
Cost-Effectiveness of the Argus II Retinal Prosthesis
Retinitis Pigmentosa (RP) is a leading cause of blindness resulting in incurable visual impairment. It is a hereditary genetic disease causing bilateral retinal degeneration. It predominantly affects the photoreceptors of the retina and causes progressive loss of vision eventually leading to blindness. The prevalence of RP is estimated to be about one in 4000 affecting over one million individuals worldwide. RP is usually diagnosed in young adulthood, although it can present any time from infancy to the mid-30s to 50s. Most people who have RP are legally blind by the age of 40.
Visual deficiency results in a significant economic and social disadvantage in affected individuals, their families, and society in general. Patients with a visual deficiency have more frequent medical visits, and many need assistance to perform daily life activities. RP results in a drastic reduction of the quality of life in affected individuals. In patients who have lost their sight: admission to nursing homes occurs three years earlier; the probability of falling is two times higher, the incidence of depression is three times higher; hip fractures are four times more common and the likelihood of death is twice as compared to the general population of the same age.
According to an estimate of the Age related Macular Degeneration (AMD) International Alliance, blindness and visual impairment cost the world economy nearly 2.3 trillion euros in 2010. This estimate considers the direct medical expenses for the 733 million blind or severely visually impaired people all over the world, but also the value of the time dedicated to caring for them and the loss of productivity, resulting in a loss of tax revenues that sustain the healthcare systems. That means nearly 6 billion euros for the 1, 75 million affected by RP.
There is no treatment that can restore the functional vision or ensure regression or prevention of visual loss. Education, awareness of the disease, genetic advice and rehabilitation are used in regular practice to cope with the social and psychological impact of RP. Advanced RP is associated with blindness and these patients are given independent living rehabilitation and vocational rehabilitation to promote independence and to prevent injury. Care for these patients also include formal and informal nursing care.
A retinal prosthesis placed on the retinal surface has been investigated for several years. The healthy ganglion cell layer of the retina can be stimulated by using retinal prosthesis and these implants in animal models have long-term stability. Humayun et al. demonstrated the use of retinal prosthesis in human subjects. Currently these retinal prostheses represent the basis for further studies towards improvement of the future devices resolution.
Second Sight Medical Products Inc. developed Argus II, a retinal prosthesis system for treating RP. Argus II is the world's first ever-commercial implant intended to restore some vision in the blind patients. Argus II is an implantable device that works by converting video images captured from a miniature camera, housed in the patient's glasses, into a series of small electrical impulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. It has improved the visual function of patients, from minimal light perception to at least the perception of hand motions, even counting fingers. Patients can locate and recognize simple objects, see people in front of them, and follow their movement. It is the world's first and only device that has received both CE-mark and FDA approval intended to restore some functional vision for people suffering from blindness. Argus II is approved for use in the European Economic Area (CE Mark) and USA (FDA Approval).
We sought to conduct an economic evaluation of the Argus II device to inform reimbursement policy decisions and its implementation in usual practice. The aim of this study was to assess the cost-effectiveness of Argus II compared to usual care for the treatment of RP in Eurozone countries.
Background
Retinitis Pigmentosa (RP) is a leading cause of blindness resulting in incurable visual impairment. It is a hereditary genetic disease causing bilateral retinal degeneration. It predominantly affects the photoreceptors of the retina and causes progressive loss of vision eventually leading to blindness. The prevalence of RP is estimated to be about one in 4000 affecting over one million individuals worldwide. RP is usually diagnosed in young adulthood, although it can present any time from infancy to the mid-30s to 50s. Most people who have RP are legally blind by the age of 40.
Visual deficiency results in a significant economic and social disadvantage in affected individuals, their families, and society in general. Patients with a visual deficiency have more frequent medical visits, and many need assistance to perform daily life activities. RP results in a drastic reduction of the quality of life in affected individuals. In patients who have lost their sight: admission to nursing homes occurs three years earlier; the probability of falling is two times higher, the incidence of depression is three times higher; hip fractures are four times more common and the likelihood of death is twice as compared to the general population of the same age.
According to an estimate of the Age related Macular Degeneration (AMD) International Alliance, blindness and visual impairment cost the world economy nearly 2.3 trillion euros in 2010. This estimate considers the direct medical expenses for the 733 million blind or severely visually impaired people all over the world, but also the value of the time dedicated to caring for them and the loss of productivity, resulting in a loss of tax revenues that sustain the healthcare systems. That means nearly 6 billion euros for the 1, 75 million affected by RP.
There is no treatment that can restore the functional vision or ensure regression or prevention of visual loss. Education, awareness of the disease, genetic advice and rehabilitation are used in regular practice to cope with the social and psychological impact of RP. Advanced RP is associated with blindness and these patients are given independent living rehabilitation and vocational rehabilitation to promote independence and to prevent injury. Care for these patients also include formal and informal nursing care.
A retinal prosthesis placed on the retinal surface has been investigated for several years. The healthy ganglion cell layer of the retina can be stimulated by using retinal prosthesis and these implants in animal models have long-term stability. Humayun et al. demonstrated the use of retinal prosthesis in human subjects. Currently these retinal prostheses represent the basis for further studies towards improvement of the future devices resolution.
Second Sight Medical Products Inc. developed Argus II, a retinal prosthesis system for treating RP. Argus II is the world's first ever-commercial implant intended to restore some vision in the blind patients. Argus II is an implantable device that works by converting video images captured from a miniature camera, housed in the patient's glasses, into a series of small electrical impulses that are transmitted wirelessly to an array of electrodes on the surface of the retina. It has improved the visual function of patients, from minimal light perception to at least the perception of hand motions, even counting fingers. Patients can locate and recognize simple objects, see people in front of them, and follow their movement. It is the world's first and only device that has received both CE-mark and FDA approval intended to restore some functional vision for people suffering from blindness. Argus II is approved for use in the European Economic Area (CE Mark) and USA (FDA Approval).
We sought to conduct an economic evaluation of the Argus II device to inform reimbursement policy decisions and its implementation in usual practice. The aim of this study was to assess the cost-effectiveness of Argus II compared to usual care for the treatment of RP in Eurozone countries.
