Economic Considerations When Selecting First-line Treatment for Wet AMD

When selecting treatment for patients newly diagnosed with wet AMD, a practitioner will ideally want to focus on the factors that are unique to that patient. No specialist wants to have a medical decision hinge upon a practical concern such as cost. However, in the current healthcare environment, cost is an unavoidable consideration. Indeed, it often must be a preliminary consideration when discussing treatment options with a patient.

“I think it’s important to know before you even walk into the room with a new wet AMD patient what treatments that patient will be eligible to receive with his insurance,” says John Kitchens, MD. “For some patients who require a low-cost option — for those who would otherwise fall through the cracks — we are fortunate that we have bevacizumab (Avastin, Genetech). Bevacizumab also can be a good option for some Medicare patients who are motivated to seek low-cost options. Of course, we also can be grateful that there are patient assistance and co-payment programs; with these, most patients in our practice have a variety of options. But I never want to go into a room with a patient who is only able to get one medicine and talk to that patient about all the different options available. If I know that someone is eligible for all of the treatments, which is ideal, I can begin to discuss treatment in light of the nuances of that patient’s disease,” says Dr. Kitchens.

Philip J. Rosenfeld, MD, PhD, faces similar issues when selecting treatment. “Unlike most retina specialists,” he says, “I practice in two different settings — in a hospital-based practice, and in a private, or provider-based setting. Most retina specialists do not practice in a hospital, and in that setting, Medicare only fully reimburses for treatment with ranibizumab (Lucentis, Genentech) or aflibercept (Eylea, Regeneron). So, in a hospital-based practice, where I’m only reimbursed for these two drugs, I choose aflibercept for first-line treatment. In a provider-based setting, I start with bevacizumab, because most insurance companies cover it and, in the majority of cases, it’s an effective treatment. This decision also gives me time to sign the patient up with the Chronic Disease Fund. They assess whether the patient’s insurance will cover ranibizumab or aflibercept. While that’s going on, I use bevacizumab. Depending how the patient responds and whether his insurance covers aflibercept, I can decide whether to stay on bevacizumab or switch to aflibercept.”

Dr. Kitchens also stresses that it’s important to avoid delaying treatment.

“I think we’re finding more often we have to get pre-authorizations from insurance companies to give patients medications on the day they are diagnosed. I hate to turn away patients with vision loss from AMD, and have them come back in a week and a half to receive treatment. So if there is one option that allows patients to receive treatment on the day of diagnosis, then I want to know about it and I want my patient to know about it, because in my experience, most patients will opt to begin treatment right away.”

FOCUSING ON INDIVIDUAL PATIENT NEEDS

“When eligibility for a particular drug is not an issue,” says Dr. Kitchens, “I can determine whether a patient has any characteristics that may respond better to one medication over another. Primarily what I’m looking for is a pigment epithelial detachment (PED) component in patients with wet AMD. A sub-analysis of the VIEW 1 and VIEW 2 studies showed that patients with PED are more likely to respond when given aflibercept compared with ranibizumab.¹ In our practice, we did see evidence that patients with PEDs were responding better with aflibercept, but we didn’t know for sure; it was only after we had the data from the VIEW studies that our clinical impressions were confirmed.”

Dr. Kitchens notes that for patients in whom PED is not a critical factor, studies have shown that the three options are roughly equivalent in terms of efficacy.

“I also consider three factors to determine whether a patient has a high-risk lesion. First, if the patient is monocular, it may not necessarily change what I recommend, but it makes me more inclined to talk to the patient about more aggressive treatment, or about treating more often. If someone presents with hemorrhage, then once again, we’ll talk with the patient about the fact that he or she will need more injections. And in some instances, when I see a retinal angiomatous proliferation (RAP) lesion, I will want to follow the patient more frequently. Those are really the three things that will lead me to paint the picture that there may be a need for more aggressive treatment.”

Dr. Rosenfeld also notes a rough equivalence among the three drugs in terms of efficacy. “We now know that based on several randomized prospective clinical trials that there is no difference between bevacizumab and ranibizumab,^2-5 with the exception of the compounding safety issue associated with bevacizumab. By now, I think those in our profession have been educated sufficiently to select an appropriate compounding pharmacy. Therefore, assuming that you obtain safe and properly prepared bevacizumab, there’s no difference between these drugs, so I will always choose bevacizumab over ranibizumab. However, with regard to choosing between ranibizumab and aflibercept, the clinical trial data suggested that aflibercept had a longer duration of effect.⁶ We just completed our own retrospective study here, looking at our most recalcitrant patients, and its unambiguously clear that in patients who had been on long-term bevacizumab and ranibizumab, with persistent or recurrent fluid, despite frequent treatment, demonstrated a superior response to aflibercept, particularly those patients with vascularized PEDs. For that reason, whenever I would have used ranibizumab as first-line therapy, I now use aflibercept as first-line therapy.”

WEIGHING COST ISSUES

“The emphasis on selecting a cost-effective treatment is a pressing issue not only in the United States, but also in many other countries, and we should pay attention to how other countries are wrestling with the problem,” says Peter K. Kaiser, MD. “At a recent meeting in Amsterdam, for example, I listened as a Dutch working group presented its country’s plan to treat patients with exudative AMD in the most cost-effective manner.”

According to the Dutch plan, patients will be treated with bevacizumab on an as-needed basis after a monthly loading phase, and be switched to another anti-VEGF agent only if they lose vision or do poorly on bevacizumab. While the plan seems to place an emphasis on cost, the working group is carefully monitoring outcomes before and after enactment of the plan to make sure patients have optimal visual gains. With limited healthcare resources, the Dutch are seeking a cost-effective solution, but are being careful not to sacrifice quality of care.

“This is eerily similar to what insurance companies and large hospital systems are starting to demand of retina physicians in the United States — bevacizumab first, before anything else,” says Dr. Kaiser.

But there is one important difference: In the United States, there doesn’t seem to be a focus on outcomes; instead, the focus is on the bottom line.

“One might argue that many people do well on bevacizumab,” says Kaiser, “and if patients are not started on this drug, there is no way of knowing if it would have worked. However, one could also argue that any loss of vision from selecting a less than optimal treatment regimen can never be regained.”

“Like many specialists, I start with bevacizumab in my patients without insurance, or with those who have insurance-related restrictions. However, I currently use aflibercept in most of my treatment-naïve patients, when their insurance permits it, because I think it is identical to ranibizumab in efficacy and better in terms of cost and duration of action.”

Dr. Kaiser says that as we prepare to come to terms with episodic care under the Affordable Care Act, we’ll have many difficult questions to consider, such as whether preventing vision loss in a few is worth the expense to society of on-label treatment for the many. He hopes new drugs or delivery systems on the horizon may help specialists make the best decision for each and every patient. ■

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