Simulation contact lenses for AMD health state utility values in NICE appraisals: a different reality

BACKGROUND/AIMS The National Institute for Health and Care Excellence (NICE) has recommended the use of ranibizumab for neovascular age-related macular degeneration (AMD) and for diabetic macular oedema (DMO) as part of its health technology appraisal process. In the economic evaluations of both interventions, utility values were derived from members of the general public wearing contact lenses with a central opacity that was meant to simulate the blind spot experienced by many patients with advanced retinal disease. This paper tests the validity of the contact lens simulation, and finding it to be invalid, explores the impact on prior economic evaluations. METHODS Visual acuity, contrast sensitivity and visual fields were assessed with and without simulation lenses in five healthy subjects with normal vision. RESULTS We identified important differences between the contact lens simulation and vision loss experienced by patients with AMD. The contact lens simulator did not cause the central scotoma which is characteristic of late-stage AMD and which leads to severe difficulty with everyday activities such as reading or recognising faces and objects. The contact lens instead caused a reduction in retinal illumination experienced by the subjects as a general dimming across the retina. CONCLUSIONS A contact lens with a central opacity does not simulate a central scotoma. The clinical differences between simulated and actual AMD suggest there has been an underestimation of the severity of AMD health states. This brings into question the validity of the economic evaluations of treatments for AMD and DMO used by NICE.