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Overview of Age-Related Ocular Conditions
Esen K. Akpek, MD; and Roderick A. Smith, MS
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Managed Care Implications of Age-Related Ocular Conditions
William J. Cardarelli, PharmD; and Roderick A. Smith, MS
Addressing the Clinical and Managed Care Challenges in Treating Diseases of the Aging Eye

Managed Care Implications of Age-Related Ocular Conditions

William J. Cardarelli, PharmD; and Roderick A. Smith, MS
The economic costs of age-related ocular diseases and vision loss are increasing rapidly as our society ages. In addition to the direct costs of treating age-related eye diseases, elderly persons with vision loss are at significantly increased risk for falls and fractures, experiencing social isolation, and suffering from an array of comorbid medical conditions compared with individuals with normal vision. Recent studies estimate the total economic burden (direct and indirect costs) of adult vision impairment in the United States at $51.4 billion. This figure is expected to increase as the baby boomer generation continues to age. While a number of highly effective new therapies have caused a paradigm shift in the management of several major age-related ocular diseases in recent years, these treatments come at a substantial cost. This article reviews the economic burdens and treatment-related costs of 4 major ocular diseases of aging—glaucoma, age-related macular degeneration, diabetic retinopathy, and dry eye disease—and the implications for managed care.

(Am J Manag Care. 2013;18:S85-S91)
EDITOR'S NOTE: A clarification has been made within the supplement entitled: Addressing the Clinical and Managed Care Challenges in Treating Diseases of the Aging Eye. Within the section entitled “Managed Care Implications of Age-Related Ocular Conditions,” a statement on page s89 has been corrected to state the following: “Topical cyclosporine comprised 68% of dry eye medication prescriptions in 2003 to 2004, increasing to 84% of prescriptions in 2005 to 2006.”The original statement referred to topical cyclosporine as comprising 68% of glaucoma medication prescriptions.

Economic Burden of Vision Loss in the United States

Visual impairment and blindness has a profound impact on individuals, caregivers, and society as a whole. Older adults with impaired vision are at least twice as likely as those with normal vision to report difficulty walking or getting into or out of bed, and at least 3 times as likely to have difficulty going outside, preparing meals, grocery shopping, and managing medications.1 Visually impaired older adults are also significantly more likely to have 1 or more major comorbidities.2 Of the estimated 5.7 million people with vision loss in the United States, 3.3 million are at risk for mild to moderate depression, 350,000 are at risk for severe depression, 1.2 million have diabetes, and 3 million have impaired hearing.2 Older adults who have vision loss and a major age-related comorbidity (eg, breathing problems, heart disease, diabetes, joint/back pain) report substantially greater degrees of physical and social impairment, difficulty with shopping, and an increased likelihood of poor overall health.2

The economic costs of age-related ocular diseases and vision loss are increasing rapidly as our society ages. A 1981 economic analysis of vision loss conducted by researchers at Penn State University reported a total cost from vision problems of $14.1 billion; updates to this analysis conducted in 1991 and 2003 by researchers at the National Eye Institute put the inflation-adjusted costs at $38.4 billion and $67.6 billion for those 2 years, respectively.3 In a widely cited paper, Rein et al estimated the total economic burden of major visual disorders in 2004 dollars at $35.4 billion—$16.2 billion in direct medical costs, $11.1 billion in indirect costs, and $8 billion in lost productivity.4 Outpatient health services and pharmaceutical costs comprised the majority of direct medical costs.

A second study by Frick et al used data from the Medical Expenditure Panel Survey (1996-2002) to examine the financial costs of vision impairment for individuals and caregivers.5 They reported a total cost of $5.5 billion in direct medical expenditures, informal care, and health utility, which amounted to almost $1400 per year for each of the 3.7 million visually impaired or blind adults in the United States. Utilization of home healthcare services, the single greatest medical expenditure, was significantly increased in visually impaired individuals. Compared with persons without vision impairment who used home health agencies, visually impaired individuals spent an extra $4900 in home health services per year. The researchers also projected that visually impaired individuals lost a total of more than 209,000 quality-adjusted life-years (QALYs) each year, adding another $10 billion or more to the annual economic impact, and bringing the total cost to nearly $16 billion.

The healthcare-related cost of visually impaired individuals is projected to increase as the society ages and newer, more costly treatments for ocular diseases are developed.4 In their 2006 paper, Rein et al projected that the cost of treatment for age-related macular degeneration (AMD) would increase from $575 million to $845 million over the following 15 years due to the aging of the population alone. Similar trends are expected for glaucoma, diabetic retinopathy (DR), and other age-related ocular diseases. The introduction of new medications, such as intravitreal anti-vascular endothelial growth factor (VEGF) agents for wet AMD and diabetic macular edema (DME), and prostaglandins and topical cyclosporine for glaucoma and dry eye disease, respectively, has accelerated this trend. Moreover, enactment of the Medicare Part D prescription drug program in 2006 was expected to result in greater use of prescription medications in patients at least 65 years of age with glaucoma, and this may apply to other eye diseases.

The following sections review the economic burden of the 4 major age-related eye diseases discussed in this supplement—glaucoma, wet AMD, DR/DME, and dry eye disease—and implications for managed care, including reimbursement issues and comparative efficacy.

Open-Angle Glaucoma

Open-angle glaucoma (OAG) affected an estimated 2.2 million US residents 40 years and older according to 2004 data, and that figure is projected to increase by 50% to 3.36 million Americans in 2020.6,7 As glaucoma is often asymptomatic in its early stages, much of the medical resource use for this disease has historically occurred during the later stages, at which point aggressive treatment is indicated to preserve vision.8 It should be noted that, with greater awareness, improved diagnostic instruments, and greater access to care, OAG is now diagnosed at reasonably early stages and pharmaceutical treatment is far more common than surgical intervention. A retrospective study of medical records of 151 individuals found that the average direct cost of glaucoma treatment increased from $623 per patient per year for those with suspected or early-stage glaucoma (stage 0-1) to $2511 per patient per year for patients with endstage disease (stage 5; blindness).8 Medications comprised the largest proportion of total direct costs for all glaucoma stages; using real-world compliance estimates, medication use accounted for 38% of total costs for patients with stage 5 glaucoma, and at least 44% for those with stage 1 to 3 glaucoma. One potential mitigating factor in these costs is the introduction of generic latanoprost in 2011.7 In another retrospective analysis of Medicare beneficiaries with glaucoma, patients with vision loss were significantly more likely to be placed in a nursing home (odds ratio [OR] = 2.18; 95% confidence interval [CI], 2.06-2.31) and develop depression (OR = 1.63; 95% CI, 1.54-1.73) than those with no vision loss.9 Additionally, patients with vision loss were 67.4% more likely to fracture a femur (OR = 1.67; 95% CI, 1.53-1.83) and 58.6% more likely to experience a fall or accident (OR = 1.59; 95% CI, 1.50-1.68) versus the reference group (Figure).9 The mean total and component annual healthcare costs increased incrementally with increasing severity of vision loss, ranging from $8157 for no vision loss to $18,670 for blindness.

The most comprehensive analysis of glaucoma medication expenditures comes from the 2001 to 2006 Medical Expenditure Panel Survey, which compiled data on glaucoma medication from interviews and pharmacy prescribing records for 1404 participants at least 18 years of age.7 Mean glaucoma medication expenditure increased from $445 in 2001 to $557 in 2006 (slope = 20.8; P <.001). Significant increases in expenditures were found for women (P = .02), Caucasians (P =.02), middle-aged participants (45-64 years; P = .001), older age participants (≥65 years; P = 0.02), and those with less than a high school education (slope = 55.1; P = .008).

In terms of specific medications, expenditures increased significantly for prostaglandin analogues (from $168 in 2001 to $271 in 2006) but decreased for b-blockers (from $167 in 2001 to $69 in 2006).7 The majority of patients took only 1 medication class per year (range, 61%-68% for 2001- 2006). While only 130 of the study participants enrolled in the Medicare Part D prescription drug plan in 2006, these patients demonstrated a significant increase in glaucoma medication expenditures relative to participants with private insurance ($772 vs $440; P <.001), but not versus participants with public insurance without Part D coverage ($613; P = .12).

A limitation of the study is that it did not account for medication compliance, which is a major problem in patients with glaucoma. It is possible that poor compliance with medications could keep costs down initially, but increase costs later on as patients undergo more expensive procedures for late-stage disease.7 On the other hand, newer treatments that improve compliance (ie, require less frequent dosing) or those that more effectively lower intraocular pressure may reduce the number of patients who progress to more severe stages of vision impairment.

Wet AMD

The direct cost of treatment of wet AMD in 2004 dollars was estimated at $575 million, which is expected to increase as the society ages and as more costly treatments are introduced.4,10 While there are a substantial number of published cost-effectiveness studies of wet AMD therapies, many of these looked at older treatments, such as laser photocoagulation, photodynamic therapy (PDT), and pegaptanib sodium, a first-generation intravitreal anti-VEGF agent.11 A 2009 review of 44 cost-effectiveness studies in AMD found that, overall, older treatments (eg, PDT) were more cost-effective compared with best supportive care or no treatment, while newer therapies (eg, ranibizumab) were more cost-effective than older treatments.11 Across the studies analyzed, a treatment time horizon of at least 5 years was generally needed to demonstrate cost-effectiveness for the newer, more clinically efficacious AMD therapies at standard willingness-topay (WTP) thresholds compared with older, less-effective therapies.

Following publication of the CATT (Comparison of Agerelated macular degeneration Treatment Trials)12 and IVAN (Inhibit VEGF in Age-related choroidal Neovascularisation)13 studies demonstrating clinical equivalence of ranibizumab and bevacizumab for wet AMD, much of the cost discussions have focused on these 2 agents. A 2011 survey of retina specialists (Patterns and Trends Survey) found that bevacizumab was chosen over ranibizumab 70% of the time to treat wet AMD based on its lower cost.14 The per unit dose cost of ranibizumab (approximately $2000) is as much as 50 times that of bevacizumab (around $50), the latter of which is typically split up into 1.25-mg single injections from the original 100-mg vial licensed for cancer treatment.15,16

As bevacizumab is not licensed to treat wet AMD, there are few published studies on the cost-effectiveness of this agent for this condition. However, a British study published in 2007 found that bevacizumab would need to be approximately 40% as effective as ranibizumab for the treatment of predominately classic AMD for the latter to achieve £30,000 per QALY, a standard cost-effectiveness threshold.17 (It should be noted that the 2010 Patient Protection and Affordable Care Act prohibits the use of QALYs for making reimbursement decisions in the United States, but QALYs are widely used outside the United States to measure costeffectiveness.)18

 
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