Retinal Prosthesis System for Advanced Retinitis Pigmentosa: A Health Technology Assessment Update.

Abstract

Background: Retinitis pigmentosa is a group of inherited disorders characterized by the degeneration of the photoreceptors in the retina, resulting in progressive vision loss. The Argus II system is designed to restore partial functional vision in patients with profound vision loss from advanced retinitis pigmentosa. At present, it is the only treatment option approved by Health Canada for this patient population. In June 2016, Health Quality Ontario published a health technology assessment of the Argus II retinal prosthesis system for patients with advanced retinitis pigmentosa. Based on that assessment, the Ontario Health Technology Advisory Committee recommended against publicly funding the Argus II system for this population. It also recommended that Health Quality Ontario re-evaluate the evidence in 1 year. The objective of this report was to examine new evidence published since the 2016 health technology assessment.

Methods: We completed a health technology assessment, which included an evaluation of clinical benefits and harms, value for money, and patient preferences related to the Argus II system. We performed a systematic literature search for studies published since the 2016 Argus II health technology assessment. We developed a Markov decision-analytic model to assess the cost-effectiveness of the Argus II system compared with standard care, and we calculated incremental cost-effectiveness ratios over a 20-year time horizon. We also conducted a five-year budget impact analysis. Finally, we interviewed people with retinitis pigmentosa about their lived experience with vision loss, and with the Argus II system.

Results: Four publications from one multicentre international study were included in the clinical review. Patients showed significant improvements in visual function and functional outcomes with the Argus II system, and these outcomes were sustained up to a 5-year follow-up (moderate quality of evidence). The safety profile was generally acceptable.In the base case economic analysis, the Argus II system was cost-effective compared with standard care if the willingness to pay was more than $97,429 per quality-adjusted life-year. We estimated that funding the Argus II system would cost the province $0.71 to $0.78 million per year over 5 years, assuming 4 implants per year.People with lived experience spoke about the challenges of retinitis pigmentosa, including the gradual but persistent progression of the disease; its impact on their quality of life and their families; and the accessibility challenges they faced. Those who used the Argus II system spoke about its positive impact on their quality of life.

Conclusions: Based on evidence of moderate quality, the Argus II retinal prosthesis system improved visual function, real-life functional outcomes, and quality of life in patients with advanced retinitis pigmentosa. The Argus II system is expensive, but the cost to publicly fund it would be low, because of the small number of eligible patients. The Argus II system can only enable perception of light/dark and shapes/objects, but these advancements represent important gains for people with retinitis pigmentosa in terms of mobility and quality of life.