ASSESSMENT OF UTILITY LOSS FROM DIABETIC MACULAR EDEMA BASED ON RESTORE TRIAL
Author(s)
Knudsen MS1, Thomas S2, Gallagher M3, Mitchell P41IMS Health, London, United Kingdom, 2Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA, 3Novartis Pharma AG, Basel, Switzerland, 4University of Sydney, Westmead, Australia
OBJECTIVES: Evidence is limited on the extent to which health state utility decrements differ between changes in the better-seeing and worse-seeing eyes following treatment. This study presents estimates of the utility levels as a function of the visual acuity in the treated eye stratified by the condition of the fellow (untreated) eye in patients treated for visual impairment caused by diabetic macular edema (DME). METHODS: Data from RESTORE clinical trial with (12 months follow up of ranibizumab treatment for DME) were analyzed. 8 health states were defined by BCVA in the treated eye. Mean utility was estimated using multivariate regression (repeated measures analysis). The regression was tested for confounders including disease severity. The influence of BCVA in the fellow eye on the health index was explored by separating treated eyes into cohorts according to visual acuity of the fellow eye: better, equal or worse. Results were compared with other published studies. RESULTS: The utility ranged from 0.86 (SE=0.014) with BCVA 76-100 letters (Snellen score) to 0.55 (SE=0.083) with BCVA 0-25 letters (unadjusted model). Disease severity had a non-significant effect on this range (p>0.05). BCVA of the worse seeing eye had a significant impact on the utility (utility decrement -0.11 from 76-100 letters to 36-45 letters), with better seeing eyes demonstrating a utility decrement -0.14 from 76-100 letters to 36-45 letters. Results were inconclusive for health states below 35 letters due to small numbers. CONCLUSIONS: This explorative analysis reveals that visual acuity of a worse seeing eye has a significant impact on utility and may be comparable to the impact on the better seeing eye. Importantly, these findings are supported by improvements in quality of life observed using the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25) for DME patients treated with ranibizumab in the worse seeing eye in RESTORE.
Conference/Value in Health Info
2011-11, ISPOR Europe 2011, Madrid, Spain
Value in Health, Vol. 14, No. 7 (November 2011)
Code
PSS30
Topic
Patient-Centered Research
Topic Subcategory
Health State Utilities
Disease
Sensory System Disorders