Approximately 34.2 million people had diabetes in 2018, and more than two in five Americans with diabetes have diabetic retinopathy, the most common diabetic eye disease. The prevalence of vision-threatening diabetic retinopathy in the United States is 4.4% and is the leading cause of blindness in American adults aged 20 to 74 years. Over time, about half of patients with diabetic retinopathy will develop diabetic macular edema (DME). Poor blood glucose control and comorbidities increase the risk of blindness from DME.
During a presentation at the Asembia 2020 Summit, Joshua Mali, MD, vitreoretinal surgeon at The Eye Associates, founder and CEO of Mali Enterprises, and medical director of the Macular Degeneration Association in Sarasota, FL, and Cari W. Pao, PharmD, MSHCM, MBA, senior clinical director of health outcomes at Walgreens in Fairfax, VA, discussed the treatment and management of diabetic retinopathy and DME.
Three risk factors for diabetic retinopathy and DME include blood sugar, blood pressure, and cholesterol. Other factors include duration of diabetes, hyperglycemia, hypertension, hyperlipidemia, nephropathy, smoking, and obesity (including a sedentary and inactive lifestyle).
Early cases of diabetic retinopathy have no symptoms, so it is important for patients with diabetes to get routine eye exams. The first signs of this condition include “floaters,” spots from bleeding, and abnormal retinal blood vessels. Only 60% of patients with diabetes are screened annually.
“Luckily, we have a vast variety of treatment options for these patients,” said Dr. Mali. The goal of treatment for these conditions is to reverse vision loss and prevent additional vision loss and progression to DME. Treatment goals should also consist of maintaining adherence and minimizing adverse events. Treatment options include anti-vascular endothelial growth factor (VEGF) drugs, corticosteroid injections, laser photocoagulation, and vitrectomy.
Anti-VEGF treatments include ranibizumab and aflibercept, which are approved for the treatment of diabetic retinopathy and DME, as well as bevacizumab, which is often used off label to treat these conditions. However, more than 40% of patients do not sufficiently respond to anti-VEGF therapy and require rescue therapy. Patients with DME also have difficulty adhering to the demanding treatment schedule. In a 2018 study published in Retina, 46% of patients with DME had at least one break-off from therapy, and the number of break-offs were significantly associated with change in visual acuity (P=0.017). Emerging therapies in this space include faricimab, brolucizumab, and ranibizumab port delivery system.
“This is a growing market in the United States,” said Dr. Pao, noting that the market is projected to cost more than $4.1 billion by 2027. Before 2012, use of intravitreal injections was less common, but by 2016, more than 70% of patients with DME were using intravitreal injections and implants. In a 2008 retrospective study published in Current Medical Research and Opinion, employees with DME had a mean 75% higher annual direct and indirect costs compared with those who had diabetic retinopathy but did not have DME ($28,606 vs. $16,363).
Costs are increasing because more patients are diagnosed with diabetes and there are better therapies, coverage, and access. The 2019 Magellan Medical Pharmacy Trends Report showed that ophthalmic injections are the second highest drug category spend for Medicare, and the spend is expected to increase by 38% by 2023. Treatments for these conditions have been revolutionary, she said, but can cost up to $11,204 per year. Treatment coverage is also a big concern for patients.
DME can impact patient quality of life, as some patients experience pain upon injection and there is a concern for infection, with the risk being about one in 5,000. Treatment should be personalized to optimize outcomes in each patient. An intensive injection regimen and requirement for multiple hospital and clinic visits can be a burden on patients, and 53% of working patients report needing to take off at least one day per appointment, according to a 2016 study published in Clinical Ophthalmology. In addition, 75% of patients reported having anxiety about their treatment appointment, including 54% who were anxious for two days prior to the injection. The first year of treatment is important to achieve therapy goals, but nine or 10 injections per year can be unrealistic, said Dr. Pao. Patients want fewer injections and appointments to achieve the same visual results.
Specialty pharmacists play an important role in helping patients with diabetes prevent vision loss. Pharmacists can reduce gaps in care and reinforce messaging. “Health literacy is really critical in this disease, because for many of these patients, this is rather abstract,” said Dr. Pao. “They don’t think about how managing their diabetes actually impacts their eyes long-term. It’s important to make sure you help with that and ask them to know their numbers (blood pressure, lipids, hemoglobin A1C).”
Encourage annual screenings and lifestyle changes to reduce the progression of diabetic retinopathy and DME. Ophthalmologists may want to integrate primary care practitioners, internists, pharmacists, diabetes educators, nutritionists, and others to improve access, encourage self-management, and improve outcomes in patients with diabetes. Pharmacists are an integral part of patient education and training, adherence to therapy, and patient assistance programs. “We can provide value when asking and reminding patients to monitor the risk factors and maintain a healthy lifestyle,” said Dr. Pao. “These little nudges from pharmacists are important, and they do work. Patients do better when they feel someone is there on a monthly basis reminding them.”
Presentation: Diabetic Retinopathy and Macular Edema: Treatment and Management Updates. Asembia 2020 Specialty Pharmacy Summit Virtual Experience, May 12, 2020.