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Age-Related Macular Degeneration—Determining Appropriate Use of Treatments: A Stakeholder Summit

Age-Related Macular Degeneration—Determining Appropriate Use of Treatments: A Stakeholder Summit

In April 2017, in Washington, DC, AJMC® Peer Exchange® hosted a panel of ophthalmology and managed care decision makers and providers to define age-related macular degeneration (AMD) and to provide insight regarding its impact on patients and caregivers. Panelists included Peter Dehnel, MD, medical director of Integrated Health Management at Blue Cross Blue Shield of Minnesota; Jared Nielsen, MD, ophthalmologist specializing in vitreoretinal diseases and surgery at Wolfe Eye Clinic in West Des Moines, Iowa; Charles Wykoff, MD, PhD, director of Clinical Research for Retina Consultants of Houston, and deputy chair for Ophthalmology at Blanton Eye Institute—Houston Methodist Hospital in Houston, Texas; and Gary L. Johnson, MD, MS, MBA, practicing physician and regional medical director in Madison, Wisconsin. The moderator was Peter L. Salgo, MD, a professor of medicine and anesthesiology at Columbia University College of Physicians and Surgeons and an associate director of Surgical Intensive Care at New York-Presbyterian Hospital in New York.
Clinical Background of Wet Age-Related Macular Degeneration
The difference between dry and wet AMD can be confusing, Wykoff acknowledged. “Everybody with macular degeneration has dry macular degeneration. That’s sort of a baseline mild or intermediate form, and then if you develop the advanced form, you either develop wet macular degeneration with bleeding, or advanced dry. It’s unfortunate that the early and the advanced forms can both be called dry,” he said. One classification system used to characterize AMD is taken from the Age-related Eye Disease Study (AREDS), which classifies AMD stages as: 1) no AMD; 2) early AMD; 3) intermediate AMD; and 4) advanced AMD (Table 1).1

A second way to classify AMD is a more broad approach, dependent on abnormal neovascularization.2 Wet AMD refers to the presence of bleeding in the back of the eye, which ultimately destroys the central retina. The majority of cases of AMD are considered of the atrophic variety. However, the neovascular subtype, or wet AMD, while only affecting 10% to 20% of patients with AMD, is responsible for approximately 90% of AMD-related severe vision loss.3

In developed countries, age-related AMD is among the leading causes of severe and irreversible visual impairment.1,3-5 Often overshadowed by the impact of diabetes on vision loss in working-age individuals, AMD takes over as the leading cause of blindness after the age of 55 years.3,6 In fact, the prevalence skyrockets in people aged more than 80 years; it affects an estimated 1 in 10 individuals. Salgo noted that although AMD is “a massive problem…I’m not sure…that a lot of primary care docs are aware of it.” Nielsen agreed. “I think it does not have the same recognition outside of ophthalmology that certainly we see on a daily basis with our patients,” he said. “By 2050, there will be [an estimated] 80 million people worldwide affected by this disorder, and that’s staggering.”

The earliest symptom people usually notice of AMD is light/dark disassociation. That means problems, Wykoff explained, “if you go from a bright area outside, or a brightly lit room, into a darker room—the classic example is going [from outside] into a restaurant. People just won’t be able to adapt to darker settings as quickly as others. That’s the most common symptom if you look across all types of AMD,” he continued. “That mostly represents the early mild or intermediate forms of dry AMD. But then when you get into significant visual acuity loss, you’re talking about either bleeding in the back of the eye, which is wet macular degeneration, or geographic atrophy, which is death of the central macula.”

Given the size of the aging US population combined with improved longevity, the prospect of an increasing elderly population with blindness carries with it a severe economic burden, not only for the individuals affected, but society as a whole.4 “As you can imagine, patients who suffer with loss of central vision can’t drive, can’t do many of the things that they like to do, and it really affects their quality of life,” said Nielsen. “Unfortunately, the person who suffers from AMD isn’t the only victim of this disease. It affects caregivers and families who then have to step in and help somebody who’s lost their independence and ability to take care of themselves.”

In terms of overall cost to the healthcare system, visual disorders rank seventh among all diseases, placing it in front of stroke, diabetes, coronary heart disease, and depression in Australia.5 Unfortunately, similar data for the United States is lacking. In 2014, the economic burden of eye disorders among the US population was estimated to be $145 billion per year, and by 2050, the cost is expected to rise to $717 billion.7 Nielsen noted that the “economic burden of someone who’s visually impaired is staggering. And if we can [diagnose] somebody early and keep them productive, keep them working in the job that they want to continue to work in, that has a huge societal benefit.” With the drive toward better management of scarce healthcare resources and cost containment efforts, a further examination of AMD, along with its current and future treatment options, is warranted.

While 80% of AMD patients have atrophic, or dry, AMD, 90% of severe AMD-related loss of visual acuity is related to wet AMD, caused by neovascularization.1 Landmark advances involving trials of intravitreal injections of compounds that inhibit vascular endothelial growth factor (VEGF) have been shown to impact the pathophysiology of neovascularization.4 The results from these early treatments of wet AMD were remarkable, altering the course of a disease once believed incurable.4 Since that time, further advances in diagnostics, earlier detection, and monitoring have been made, and new drugs in varying stages of development have been steadily introduced into the pipeline. However, while the improvements in visual acuity that were achieved during clinical trials with anti-VEGF drugs were substantial, they have also been difficult to fully replicate in typical practice settings.4,8 “If we look at the results of these phase 3 trials, they’re spectacular,” Nielsen confirmed. “We have a cure for neovascular or wet AMD, but when we look at what happens in the real world, when we look at a very influential paper in our field that was published looking at what happened in Europe, patients just don’t have the outcomes [in the real world] that they do in these clinical trials. The main underlying reason is that they don’t get treated enough. It’s tough for family members [and] for patients to come on a regular basis, to have these treatments in the eyes.”

Indeed, studies have shown that the inability to achieve the outcomes seen in clinical trials can be attributed to the frequency of the treatment regimens, which often require monthly intravitreal injections for extended periods of time.9 Long-term follow-up studies have also identified the need for additional research and development, sparked by a large percentage of patients who lost the early gains they made in visual acuity.

 
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