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Supplements A Managed Care Review: Approaches to Mitigate Blindness Associated with Neovascular Age-Related Macular Degeneration
Review of Neovascular Age-Related Macular Degeneration Treatment Options
Nancy M. Holekamp, MD
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Managed Care Opportunities and Approaches to Supporting Appropriate Selection of Treatment for Sight Prevention
Eric Cannon, PharmD, FAMCP
Approaches to Mitigate Blindness Associated with Neovascular Age-Related Macular Degeneration

Managed Care Opportunities and Approaches to Supporting Appropriate Selection of Treatment for Sight Prevention

Eric Cannon, PharmD, FAMCP
When evaluating the impact of vision-destroying diseases, pharmacologic therapies represent a significant cost to patients, insurance providers, and society. Currently, up to 11 million people in the United States have some form of age-related macular degeneration (AMD), which is one of the leading causes of vision loss in older Americans. Ophthalmologists have administered more than 6 million intravitreal injections of aflibercept, bevacizumab, pegaptanib, and ranibizumab last year. Comprehensive assessment requires managed care administrators and clinicians to understand the direct and indirect costs of vision loss as well as the comparative safety and efficacy profiles for each agent. In AMD, it is critical to understand the established and emerging treatment patterns.
 
Am J Manag Care. 2019;25:-S0
Introduction
Visual impairment has a significant impact on many aspects of a patient’s life. Although many individuals with vision impairment live independently, caregivers and society typically assume the burden of caring for these patients. When evaluating the impact of diseases that affect vision, pharmacologic therapies represent a significant cost. Yet clinicians, policy makers, and managed care administrators must also consider the total disease burden, including indirect costs. This is particularly important as the number and kind of therapies for age-related macular degeneration (AMD) increase.

AMD leads to a loss of the sharp, fine-detail “straight ahead” vision required for activities such as reading, driving, recognizing faces, and seeing the world in color. As the disease progresses, patients lose more of their vision field. AMD is a leading cause of legal blindness and visual impairment in the United States and around the world.1,2 The risk of developing advanced AMD increases from 2% for people between 50 and 59 years of age to almost 30% in people older than 75 years. Currently, as many as 11 million people in the United States have some form of AMD, and it is the leading cause of vision loss in Americans aged 60 years and older. This number is expected to double to nearly 22 million by 2050.3,4 Currently, just 10% of patients experience neovascular (wet) AMD (nAMD) for which existing treatments are indicated.

Aflibercept, bevacizumab, pegaptanib (which has been largely replaced by the other agents because of their better efficacy),5 and ranibizumab have changed how AMD is treated. These treatments have only been approved for the treatment of nAMD. An indication of how quickly anti-vascular endothelial growth factor (VEGF) utilization has grown is underscored by Medicare payments for physician services associated with the administration of anti-angiogenic drugs. In 2000, physicians reported 3000 Medicare-covered intravitreal injections. In 2008, they reported 1 million, and, in 2013, Medicare paid for 2.5 million intravitreal injections at a cost of more than $300 million.6 The American Academy of Ophthalmology (AAO) estimated that more than 4 million intravitreal injections were administered in 2014, and experts estimate more than 6 million were given in 2016.7

The Ultimate Cost: Visual Impairment
Visual impairment affects individuals, caregivers, and society as a whole in a ripple effect. In a comparison of community-dwelling, older Americans with and without vision impairment, visually impaired individuals reported significantly more disability, even with simple daily activities, than those with acceptable vision. Vision loss can lead to loss of independence.

For example, people who reported vision problems were significantly more likely than others to report difficulty getting into or out of a chair or bed, accessing outside places, preparing meals, shopping for groceries, handling money, and managing medication. Visually impaired individuals also reported a negative impact when participating in activities such as meetings, talking on the phone with friends and relatives, and partaking in various social activities. Among patients who are older than 70 years, those with vision problems were twice as likely to report depression, recent falls, or a broken hip.8

The economic consequences of vision impairment are significant. A review of 22 interventional, noninterventional, and cost-of-illness studies quantified the direct costs, indirect costs, and intangible effects related to visual impairment and legal blindness.9 Hospitalization, use of medical services related to the visual impairment diagnosis, and treatment all contributed the most to direct medical costs. Assistive devices and aids, home modifications, and healthcare services, such as home-based nursing or nursing home placements, were the major contributors to direct nonmedical costs. As visual impairment worsened, costs for support services and assistive devices increased; these were coded as direct nonmedical. Time spent caring for or assisting visually impaired individuals correlated to the degree of visual impairment, with individuals with most severe visual impairment requiring the most assistance. The time spent by caregivers ranged from 5.8 hours per week for a person with a visual acuity of more than 20/32 to 94.1 hours per week for an individual with a visual acuity of 20/250 or worse.9

Indirect costs that were associated with visual impairment are also significant. These costs, which emanate from patient and caregiver impact, include productivity losses, employment changes, income loss, premature mortality, and dead-weight losses (the costs to society created by market inefficiency).9

Economic Implications of Age-Related Macular Degeneration
A number of studies have attempted to quantify the economic costs associated with visual impairment, but few separate the burden by underlying diagnosis. Most authors still rely on figures calculated by Rein et al in 2006. They estimated the total economic burden of major visual disorders in 2004 dollars at $35.4 billion, which included $16.2 billion in direct medical costs, $11.1 billion in indirect costs, and $8 billion in lost productivity. Annually, the federal government and state Medicaid agencies are responsible for at least $13.7 billion of these costs.10 These figures are 12 years old, but no recent studies with updated data have been located.

A cross-sectional, prevalence-based healthcare economic survey assessed the annual, incremental, and societal costs associated with nAMD. They included direct ophthalmic medical costs, direct nonophthalmic medical costs, direct nonmedical costs, and indirect medical costs that are associated with nAMD in 4 cohorts. Patients with nAMD (n = 200, designated “the study cohort”) were compared with a control cohort of patients with good (20/20–20/25) vision. Three other cohorts included patients with diminishing vision in their better-seeing eye. Patients in the control cohort incurred a mean of $6116 in expenses, whereas those with AMD incurred an average of $39,910. Individuals whose impairment had no light perception incurred $82,984. Direct ophthalmic medical costs decreased, and indirect costs also decreased as a percentage of the total societal costs as patients’ vision worsened. In the study cohort, direct costs represented 17.9% of the overall total. Among the controls, direct costs were 74.1% of total societal costs. In individuals with no light perception, direct costs were 10.4% of total societal cost, indicating considerable indirect costs.11

Age-Related Macular Degeneration Treatment Costs
Based on safety and efficacy evidence, clinicians currently use intravitreal bevacizumab, aflibercept, and ranibizumab injection.12 Although researchers have published several cost-effectiveness studies about nAMD therapies, many included older treatments, such as laser photocoagulation, photodynamic therapy, and the early anti-VEGF medication pegaptanib.13  The direct cost of nAMD treatment in 2004 dollars was estimated at $575 million, which is expected to increase as society ages and more costly treatments are introduced.3,10

Ophthalmologists and policy makers want to know specifics when they consider the costs of AMD. Safety and efficacy are always primary concerns, and sufficient data are available to confirm that these agents are safe and approximately equally effective.12 The primary treatment goal of AMD is to restore or maintain vision, which is critical to the patient’s overall quality of life (QOL). The anti-VEGF agents improve vision-related quality of life (VRQOL) for patients with nAMD. Patients whose vision is maintained have better VRQOL, irrespective of which eye is treated (better or worse seeing eye).14

Stakeholders regularly compare new options to old options; those studies generally precede head-to-head comparisons. As early as 2011, researchers working in pharmacoeconomics compared laser photocoagulation and photodynamic therapy with verteporfin and intravitreal bevacizumab, pegaptanib, and ranibizumab. Anti-VEGF therapies appeared to be highly cost-effective compared with old therapies. The researchers indicated that although the anti-VEGF treatments improved visual acuity compared with older therapies, their increased cost was troublesome. Researchers concluded that ranibizumab was consistently shown to be a cost-effective therapy for nAMD compared with all other approved options. The cost-effectiveness of pegaptanib was marginal, depending on the disease stage. Few published studies compared active treatments at that time, and the researchers did not find any acceptable studies that addressed the off-label use of bevacizumab.13

Next, clinicians wanted long-term data about cost-effectiveness for options; patients who have nAMD can live with the disease for 20 years or longer.5 US data for bevacizumab became available in 2012 when researchers with the Veterans Affairs San Diego Healthcare System and University of California San Diego analyzed the cost-effectiveness of monthly ranibizumab and bevacizumab.15 The researchers developed a Markov model with 3-month cycles in a hypothetical cohort of 65-year-old patients (N = 1000) with nAMD. The economic analysis included physician visits, drugs, and monitoring costs. The total direct cost for bevacizumab was $30,349 per patient with a mean average of 21.6 quality-adjusted life-years (QALYs) over 20 years compared with $220,649 for ranibizumab with a mean average of 18.1 QALYs. Compared with ranibizumab, treatment with bevacizumab resulted in an incremental cost-effectiveness ratio (ICER) of –$54,649 to gain 1 additional QALY. Based on a willingness-to-pay (WTP) of $50,000, the researchers predicted bevacizumab would be more cost-effective than ranibizumab 95% of the time.15 These findings were replicated in 2013.16

Confirmation studies are of interest, especially when new dosing strategies are being explored. A 2014 cost-effectiveness analysis examined a hypothetical cohort of 80-year-old patients with newly diagnosed neovascular macular degeneration.17 The study looked at monthly bevacizumab, as-needed bevacizumab, monthly ranibizumab, or as-needed ranibizumab over a period of 20 years. In addition to costs, the researchers examined the potential for differences in risks of serious adverse effects (AEs) and therapeutic effectiveness. They concluded that17:
  • ICERs for monthly bevacizumab and monthly ranibizumab for nAMD were $242,357/QALY and $10,708,377/QALY, respectively.
  • As-needed ranibizumab was more costly and less effective than bevacizumab, and bevacizumab along with as-needed dosing represented the best value.
  • When the researchers varied the model parameters (ie, the proportion of patients with serious systemic AEs, the number of injections administered, the cost per injection, and patient’s life expectancy), bevacizumab was preferred in nearly two-thirds of the simulations using WTP of $100,000/QALY.


 
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