The cost and burden of eye diseases and preventable blindness Deloitte Access Economics Italy Copyright 2013 by Deloitte Consulting CVBA. All rights reserved. This document is intended to provide general information on a particular subject or subjects and is not an exhaustive treatment of such subject(s). Accordingly, the information in this document is not intended to constitute accounting, tax, legal, investment, consulting or other professional advice or services. Before making any decision or taking any action that might affect your personal finances or business, you should consult a qualified professional adviser. This document and the information contained herein is provided "as is," and Deloitte Consulting CVBA makes no express or implied representations or warranties regarding this document or the information. Without limiting the foregoing, Deloitte Consulting CVBA does not warrant that the document or information will be error-free or will meet any particular criteria of performance or quality. Deloitte Consulting CVBA expressly disclaims all implied warranties, including, without limitation, warranties of merchantability, title, fitness for a particular purpose, non-infringement, compatibility, security, and accuracy. Your use of this document and information is at your own risk. You assume full responsibility and risk of loss resulting from the use of this document or information. None of Deloitte Consulting CVBA, or any Deloitte Entities will be liable for any special, indirect, incidental, consequential, or punitive damages or any other damages whatsoever, whether in an action of contract, statute, tort (including, without limitation, negligence), or otherwise, relating to the use of this document or information.

Executive Summary Vision loss affects a large and growing number of individuals. These individuals are impacted by reduced wellbeing and quality of life. Leading to a loss in productivity and a large economic burden to society. By investing in cost-effective interventions, vision loss will be avoided. Resulting in a healthier, happier and more productive population. As the U.S. population ages and changes demographically, the impact of vision loss and visual disability will grow substantially in the future. loss of vision leads to disability, morbidity, and loss of productivity

This study quantified the economic impact of blindness and vision loss Four eye diseases Glaucoma Diabetic retinopathy Cataract Wet age-related macular degeneration Seven countries Phase I – Italy and Germany Phase II – France, UK, Spain and Slovakia Phase III – Poland Study Completion – end of November Definition of blindness For Italy, best corrected visual acuity of less than 3/60 (WHO) Three outcomes Burden of disease Economic costs of disease Cost effectiveness of interventions that can prevent or delay progression to blindness

Number of blind individuals in 2013 The economic impact was estimated by using the prevalence approach to costing Number of blind individuals in 2013 Related financial and non-financial costs Total costs Costs included Type Definition Direct Healthcare All costs within the healthcare system paid by government or other payers (incl. patients) Indirect Productivity Income losses due to blindness for individuals of working age (15-64 years) Informal care Opportunity costs due to time spent on the provision of care for next of kin

Vision loss affects a large and growing number of individuals Italy has a population of 60.7 million, and out of this population 218,513 individuals are considered blind according to the WHO definition (BCVA <3/60) (prevalence rate of 0.36%). Many people in Italy suffer from cataract, diabetic retinopathy (DR), glaucoma, or wet age-related macular degeneration (AMD). As the working population ages, more individuals will be affected by vision loss leading to productivity losses. Prevalence of blindness and eye disease (number of people affected) Population Blindness Cataract Diabetic retinopathy Glaucoma Wet AMD 60,700,000 218,513 4,018,527 419,246 984,223 545,184

Estimated loss of wellbeing from eye diseases, DALYs in 2013 Individuals with eye diseases have a significantly reduced quality of life A DALY represent one lost year of "healthy" life. The sum of these DALYs across the population, or the burden of disease, quantifies the gap between current health status and an ideal health situation. Each individual eye disease leads to a significant reduction in DALYs. Within eye diseases, wet AMD leads to the largest loss in quality of life. The total loss in wellbeing is equivalent to 0.75% of the workforce in 2013. Estimated loss of wellbeing from eye diseases, DALYs in 2013 * DALYs = Disability-adjusted life years, which represent one lost year of "healthy" life. DR = Diabetic retinopathy, AMD = Age-related macular degeneration

These eye diseases also induce a large amount of healthcare costs The direct healthcare costs of blindness are €336.8 million (€1,541 per blind person) in Italy. Most of these costs (73.8%) are related to wet AMD Proportion of healthcare costs for blindness by disease (€336.8 million) This study estimated the combined economic impact of AMD, cataracts, diabetic retinopathy, glaucoma, and refractive error among Americans aged 40 years and older. The study estimated a total financial burden of major visual disorders of $35.4 billion comprised of $16.2 billion in direct medical costs, $11.1 billion in other direct costs, and $8 billion in productivity losses, in 2004. Annually, the federal government and state Medicaid agencies pay at least $13.7 billion of these costs. *Indirect costs are financial impacts on society that are more broadly, outside the health care system. DR = Diabetic retinopathy, AMD = Age-related macular degeneration

As well as a loss in productivity leading to a large economic burden Blindness results in annual economic costs (direct and indirect*) of just over €2.0 billion in Italy (€9,309 per blind person) Bulk of these costs are estimated to be due to informal care provision for blind people (68%) Annual costs of blindness by type of costs €2.0 billion This study estimated the combined economic impact of AMD, cataracts, diabetic retinopathy, glaucoma, and refractive error among Americans aged 40 years and older. The study estimated a total financial burden of major visual disorders of $35.4 billion comprised of $16.2 billion in direct medical costs, $11.1 billion in other direct costs, and $8 billion in productivity losses, in 2004. Annually, the federal government and state Medicaid agencies pay at least $13.7 billion of these costs. *Indirect costs are financial impacts on society that are more broadly, outside the health care system.

The economic impact of interventions was measured by cost-effectiveness analysis Economic evaluation is the comparative analysis of alternative interventions in terms of both their costs and consequences in order to assist policy decisions. The cost effectiveness of interventions are assessed using incremental cost effectiveness ratios (ICER), specifically the cost per DALY averted. The WHO uses GDP as a readily available indicator to define three categories to assess whether interventions are worth their investment: highly cost effective: cost per DALY averted less than GDP per capita; cost effective: cost per DALY averted between one and three times GDP per capita; and not cost effective: cost per DALY averted more than three times GDP per capita. Incremental Cost Effectiveness Ratio = Costs new intervention – Costs current intervention Benefit new intervention – Benefit current intervention

The costs per outcome were extracted for four interventions and adjusted per country ICER estimation and extrapolation methods ICERs extracted from studies Screening for cataracts (+ subsequent treatment) Screening for Diabetic Retinopathy (+ subsequent treatment) Glaucoma Eye Examination (+ subsequent treatment) Anti-VEGF treatment for wet AMD Max and Min estimated ICERs Convert to Euros using PPP Inflate to 2013 price using CPI GDP per capita adjustment Estimated ICERs for countries with C/E studies Extrapolated ICERs for countries without C/E studies ICER = Incremental cost-effectiveness ratio PPP = Purchasing power parity (An economic theory that estimates the amount of adjustment needed on the exchange rate between countries) CPI = Consumer price index, C/E = Cost-effectiveness GDP = Gross domestic product DR = Diabetic retinopathy, AMD = Age-related macular degeneration Assessed against WHO thresholds for cost-effectiveness 1 x GDP = Highly cost effective 3 x GDP = cost effective

Three out of four interventions were considered worth their investment Highly cost effective: Dilated eye evaluation to detect and treat cataracts (AMD, glaucoma and uncorrected refractive errors) Cost effective: Anti-VEGF treatment for wet AMD May not be cost effective: Technician-led glaucoma screening program for individuals aged >40 years if the prevalence is <4% Glaucoma screening Screening for diabetic retinopathy Cataract screening Anti-VEGF for AMD treatment Interventions worth their investment DR = Diabetic retinopathy, AMD = Age-related macular degeneration

Blind years and DALYs avoided per intervention Screening for glaucoma Investing in cost-effective interventions has a big impact on reducing disease burden Implementing DR screening (and subsequent treatment), screening for glaucoma (and subsequent treatment), and anti-VEGF treatment will result in prevention of up to 50,694 – 63,800 blind years per intervention This will avert up to 3,760 – 28,829 DALYs per intervention Blind years and DALYs avoided per intervention DR screening Screening for glaucoma Anti-VEGF treatment Blind years DALYs Lower limit Upper limit 24,127 51,855 1,066 3,760 50,694 3,723 15,330 19,732 63,800 3,765 28,829 DR = Diabetic retinopathy

These interventions will offset a significant amount of economic costs to society Each intervention can offset economic costs of €222m – €1.2bn Cataract screening Insufficient published information to estimate cost offsets due to blindness prevention

Vision loss can be avoided, resulting in a healthier and more productive population Blindness and vision loss lead to reduced quality of life and increased economic burden to society. In Italy, 218,513 individuals are considered blind. Vision loss among the workforce due to aging leads to decreased productivity. Eye diseases lead to a significant reduction of 16,989 – 96,901 DALYs. Economic burden of blindness to society is €2.0 billion. Cost-effective interventions offset economic costs of €222m – €1.2bn. Investing in cost-effective interventions will lead to a healthier population, resulting in: Reduced healthcare expenditure and more sustainable healthcare budget; Increased tax-paying workforce that has increased productivity and has a longer working life; Decreased costs and burden to informal care givers; and Improved wellbeing and costs to patients. Inclusion of screening, early diagnosis and adequate treatment of vision loss should be a health policy priority.