Incorporating New Technologies Into Practice: The Big Picture
When it comes to managing patients with diabetic macular edema, embracing new treatments requires planning.
Evaluating a new technology or product primarily involves weighing risks and benefits, with cost as a secondary consideration. Unfortunately, insurers often dictate what we can and cannot use to manage and treat patients. In an effort to provide the best care to my patients, I ignore insurer factors as much as possible in my initial assessments. That is why it is important to stay ahead of the curve with advances in technology. This article explains how I try to do just that.
DO NOT GET LEFT BEHIND
The pace of innovation in the retina field is dramatic. Luckily, for physicians, learning continues in perpetuity. Remaining inquisitive and driven to understand newly available technologies is imperative to providing patients with optimum care. We can keep up to date on treatments and technologies on the way to market and newly available by attending conferences and reading published literature and literature reviews.
When we integrate new technologies into a practice, there is a balance between reasonable financial risk and potential revenue loss due to insurers denying coverage of your expenses. Your benefits manager and the person running your revenue cycle are important allies in determining the expenses your practice can manage while implementing new technologies.
Sometimes there is hesitancy to embrace the reimbursement assistance and support programs that pharmaceutical companies have available for physicians and patients. There may also be reluctance to let drug company representatives into the office to discuss new products; however, they can serve as valuable resources in determining which technologies and products can be integrated into your practice. For example, their insights into which payers cover certain products, how inventory control works, and how often you can expect to be paid can be beneficial to consider in determining the best course of implementation in your practice.
FILLING UNMET NEEDS
For a new product or technology to be successful, it must fill an unmet need. For example, consider the case of diabetic macular edema (DME), a disease affecting an estimated 746 000 Americans with diabetes.1 There has been a revolution in the past decade with the introduction of anti-VEGF medications, yet there has remained an unmet need for a therapy that can reduce the frequency of treatment. Anti-VEGF therapy works well, and many patients with DME have benefited from intravitreal injections of ranibizumab (Lucentis, Genentech), aflibercept (Eylea, Regeneron), and off-label compounded bevacizumab (Avastin, Genentech). However, use of these products comes at a cost. For example, it is not unusual for a patient to require up to 10 anti-VEGF injections in the first year of treatment, which presents a significant burden to the patient and his or her family, not to mention the retina practitioner. Additionally, some insurers cover only bevacizumab, or insist on tiered treatment decisions, despite the fact that ranibizumab or aflibercept may potentially be more efficacious in certain patients (especially in light of the recently published DRCR.net Protocol T results).2
The fluocinolone acetonide intravitreal implant 0.19 mg (Iluvien, Alimera Sciences) is an option that fulfills an unmet need in the current DME treatment paradigm. As a low-dose corticosteroid therapy that delivers 36 months of continuous treatment with a single injection, it provides both an alternative treatment mechanism and relief from the burden of frequent anti-VEGF injections (see “Fail-Proof Intravitreal Injection Technique” above). This corticosteroid implant can provide a substantial visual benefit in patients with DME (see “Case Studies” on the next page), although patients must first be treated with a course of corticosteroids to screen for any clinically significant rise in intraocular pressure (IOP).3,4 In the pivotal phase 3 clinical study of the implant, in the population that did not require IOP-lowering surgery, the benefit of treatment with the implant clearly outweighed the risk.
THE BUSINESS OF RETINA
Once the visual benefits and potential risks of a new drug or technology have been weighed, the more commercial—and less medical—aspects must be considered prior to bringing it into your practice.
Although most physicians (myself included) would prefer to analyze only the health risks and benefits of care for patients, our treatment decisions are often affected by economics. Retina practices are a small business. We do not solely care for our patients’ health; we must also conduct benefits investigations with insurance companies to ensure that any new drug will be paid for, and we must manage the mechanics of ordering drugs and maintaining inventory.
Insurers generally catch up with technology at some point, but there are times when insurers have yet to accept a product that is available, or they may mandate the use of an off-label product. That being said, many pharmaceutical companies provide programs to assist with patients’ out-of-pocket expenses if a prescribed or recommended product is not covered or, as is often the case, is insufficiently covered. Some income restrictions apply, but most patients qualify for assistance. In addition, most insurers have prior approval and appeal processes, whereby a noncovered treatment can be considered for payment.
Once the determination has been made that a patient is eligible to receive a particular drug or technology, the retina specialist can begin the process of acquiring that product. This includes carrying out a benefits investigation, potentially getting the patient on an assistance program, and performing an inventory management evaluation. Fortunately, most companies have made the process fairly straightforward and expeditious, and often a product will even ship to the practice overnight.
KEEP IT CURRENT
Deciding which new technologies to implement into a practice involves knowing which patient needs are going unmet by current treatment paradigms and which technologies will work best for a particular practice. Using all available resources to stay current on what the best new products are and how they can work for your practice is of utmost importance. Remember to weigh the risks and benefits against the costs, always with the underlying consideration of what is best for your patient. n
Szilárd Kiss, MD, is the director of clinical research and an associate professor of ophthalmology at Weill Cornell Medical College, and an associate attending physician at the New York Presbyterian Hospital. He is a member of the Retina Today editorial board and has consulting and speaker’s bureau relationships with Alimera, Allergan, Genentech/Roche, and Regeneron. Dr. Kiss may be reached at email@example.com.
1. Varma R, Bressler NM, Doan QV, et al. Prevalence of and risk factors for diabetic macular edema in the United States. JAMA Ophthalmol. 2014;132(11):1334-1340.
2. Wells JA, Glassman AR, Ayala AR, et al; Diabetic Retinopathy Clinical Research Network. Aflibercept, bevacizumab, or ranibizumab for diabetic macular edema. N Engl J Med. 2015;372(13):1193-1203.
3. Campochiaro PA, Brown DM, Pearson A, et al. Long-term benefit of sustained-delivery fluocinolone acetonide vitreous inserts for diabetic macular edema. Ophthalmology 2011;118:626-635.
4. Campochiaro PA, Brown DM, Pearson A, et al. Sustained delivery fluocinolone acetonide vitreous inserts provide benefit for at least 3 years in patients with diabetic macular edema. Ophthalmology 2012;119:2125-2132.