New European Research: Is the Argus II (the "Bionic Eye") Cost-Effective?

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the Argus 2 system

A group of European researchers has undertaken an economic analysis of the Argus II Retinal Prosthesis System (also called the "artificial retina" or "bionic eye") to assess the cost-effectiveness of the Argus II compared to standard care for the treatment of retinitis pigmentosa (RP) in Eurozone countries.

To date, they have determined that the Argus II is cost-effective and provides quality-of-life health gains, based upon the projected life span of the Argus II, expected to be the lifetime of the user.

[Editor's note: The European Union (EU) is a political union, while the Eurozone consists of 17 EU member states (out of a total of 28) that use the Euro as official currency.]

The research, entitled The cost-effectiveness of the Argus II retinal prosthesis in retinitis pigmentosa patients, was published on April 14, 2014 in BMC Ophthalmology. BMC Ophthalmology is an open-access journal that publishes original peer-reviewed research in all aspects of the prevention, diagnosis, and management of eye disorders, as well as public health research and genetics.

The authors are Anil Vaidya, Elio Borgonovi, Rod S. Taylor, José-Alain Sahel, Stanislao Rizzo, Paulo Eduardo Stanga, Amit Kukreja, and Peter Walter, who represent the following EU-based institutions: Maastricht University, The Netherlands; Bocconi University, Milan, Italy; University of Exeter Medical School, Exeter, UK; Centre Hospitalier National d’Ophtalmologie, Paris, France; Santa Chiara Hospital, Pisa, Italy; Manchester Royal Eye Hospital and University of Manchester, Manchester, UK; Second Sight Medical Products, Lausanne, Switzerland; and RWTH Aachen University, Aachen, Germany.

About the Argus II Device

The Argus II, developed by Second Sight Medical Products, Inc., of Lausanne, Switzerland and Sylmar, California, has been approved to treat adults with severe to profound retinitis pigmentosa (RP). RP is a rare, inherited degenerative disease that damages light-sensitive cells in the retina, resulting in decreased vision at night or in low light; loss of side (peripheral) vision; and loss of central vision as the disease progresses. At present, there is no cure for RP.

The retina is the light-sensitive tissue that lines the inside surface of the eye. Cells in the retinal tissue convert incoming light into electrical impulses. These electrical impulses are carried by the optic nerve to the brain, which finally interprets them as visual images.

The Argus II is not a cure for RP; instead, it is intended to replace the function of the light-sensing cells that have been damaged and/or degraded by the disease.

The Argus II device consists of the following components:

  • a small video camera
  • a transmitter mounted on a pair of eyeglasses
  • a video processing unit (VPU)
  • an artificial retina (the implanted retinal prosthesis, which is an array of electrodes)

The video camera images are transformed into electronic data by the VPU that sends signals to a wireless receiver implanted in the eye (the retinal prosthesis electrodes). The electrodes allow the electronic signals to bypass the damaged retina and transmit directly to the brain, where they are interpreted as visual images.

The cost of the Argus II is approximately $150,000; additional fees include the implantation surgery and training to use the device. The Second Site website provides an illustrated system overview, including a video animation.

Some Background: Argus II Development in the United States

On February 14, 2013, Second Sight received approval from the U.S. Food and Drug Administration (FDA) for the Argus II.

In July 2013, Second Sight announced that the Argus II would be offered in 12 initial consultation and implantation centers in the United States: Ann Arbor, MI; Atlanta, GA; Baltimore, MD; Chicago, IL; Cleveland, OH; Dallas, TX; Durham, NC; Los Angeles, CA; Miami, FL; Nashville, TN; Philadelphia, PA; and San Francisco, CA.

On August 15, 2013, Second Sight announced that the Argus II was approved by the Centers for Medicare and Medicaid Services (CMS), beginning October 1, 2013.

Who Is Eligible for the Argus II?

The Argus II is implanted in a single eye, typically the worse-seeing eye. It is indicated for persons with severe to profound RP who meet the following criteria:

  • Age 25 or older
  • Have bare light or no light perception in both eyes: Bare light perception is the ability to perceive light, but not the direction from which the light is coming. If the person has no residual light perception, then evidence of intact inner layer retina function must be confirmed.
  • A previous history of useful form vision
  • Be aphakic or pseudophakic: Aphakic means that the eye is lacking its natural lens. Pseudophakic means that the eye has been fitted with an artificial lens implant (as in cataract surgery) to replace the missing or surgically removed natural lens.
  • If the person is phakic (i.e., has a natural lens or an artificial lens implant) prior to the Argus II implant surgery, the lens will be removed during the implant procedure.
  • Be willing and able to receive the recommended post-implant clinical follow-up, device fitting, and visual rehabilitation.

Argus II Clinical Trial Information

The Argus II clinical trial study group includes 11 locations throughout Europe, the United States, and Mexico. A two-patient pilot study was initiated in Mexico in 2006, followed by a 30-patient trial in Europe and the United States. Two ongoing clinical trials include the Argus® I Clinical Trial and the Argus® II Clinical Trial.

The following everyday activities were evaluated during clinical trials:

  • detecting the direction of motion
  • recognizing large letters, words, or sentences
  • detecting and identifying street curbs
  • walking on a sidewalk without stepping off
  • matching black, gray, and white socks
  • locating and touching a square on a white background
  • Results indicate that most participants were able to perform these activities better with the device than without it.

You can read more about the Argus II in real life at The Argus II: Fact or Science Fiction? A "Bionic Eye" Pioneer Tells Her Story at the VisionAware website.

More about the European/Eurozone Argus II Study

From The cost-effectiveness of the Argus II retinal prosthesis in retinitis pigmentosa patients, with the full text available as an open-source article:

Background: Argus II is the world's first ever-commercial implant intended to restore some vision in blind patients. The objective of this study was to assess the cost-effectiveness of the Argus® II Retinal Prosthesis System (Argus II) in retinitis pigmentosa (RP) patients.

Method: [A model] was developed to determine the cost-effectiveness of Argus II versus usual care in RP from the perspective of healthcare payer. A hypothetical cohort of 1,000 RP patients aged 46 years followed up over a (lifetime) 25-year time horizon. Health outcomes were expressed as quality adjusted life years (QALYs) and direct healthcare costs expressed in 2012 euros.

Results and Conclusion: This economic evaluation shows that Argus II is a cost-effective intervention compared to usual care of the RP patients.

Limitations: This study shares the general limitations of economic modeling. The analysis presented in this paper was based on the data from only 30 Argus II fitted patients followed up for 24 months. Data from increased numbers of Argus II fitted patients with longer follow-up in the coming years provides an opportunity to re-consolidate the results of our analysis.

Future research should estimate costs and elicit RP patients' preferences to determine the utility values in these patients at various visual acuity levels.

[Editor's note: "Utility value" refers to the user's assessment of the value of an investment (in this case, the Argus II), based on its anticipated performance.]

VisionAware will continue to report on Argus II developments as they become available.


Topic:
Retinitis Pigmentosa

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