Step therapy requirements drive up time, costs in DME patients | ASRS 2026

Step therapy requirements for Vabysmo (faricimab) to treat patients with diabetic macular edema were associated with treatment delays and burdens for patients and providers, according to a modeled analysis presented at the American Society of Retina Specialists Annual Scientific Meeting, held July 15 through July 18, 2026, in Montreal.

“Step therapy is a barrier and a burden for patients financially and time-wise for the clinic as well. Additionally, we find that step therapy requirements are very variable in the [Medicare Advantage] plan environment. Elimination of step therapy may improve efficiencies in treating this DME [diabetic macular edema] population,” said Sabin Dang, M.D., an ophthalmologist at The Retina Institute, which has offices in Missouri and Illinois.

Developed by Genentech, Vabysmo is approved to treat wet age-related macular degeneration, DME and macular edema following retinal vein occlusion. Vabysmo is the first bispecific antibody that targets Ang-2 and VEGF-A simultaneously to reduce vascular leakage and inflammation. Since its approval, more than 11 million doses have been distributed to more than 100 countries.

DME is a serious eye condition that affects people with diabetes. DME results from the damaged blood vessels leaking fluid and causing swelling, which blurs vision and can lead to severe vision loss and even blindness when left untreated.

Dang and his colleagues created a mathematical model to assess the burden of step therapy requirements within their own practice over one year. They compared practice efficiency for patients with DME receiving first-line treatment with Vabysmo vs fourth-line Vabysmo, collecting data on provider and staff time required before, during and after patient visits. They also assessed the probability of same-day treatment and claim denial.

“The goal of this study was to quantify the economic and time impact that step therapy may have in a DME population through creation of a mathematical model,” Dang said during his presentation. “The model inputs were a comprehensive look at every step of the patient and clinic experience, starting from when the patient calls the office to schedule an appointment all the way to claim submission and reimbursement.”

They found that over one year, two additional step therapy requirements led to a staff burden of eight additional hours. For a clinic managing 1,000 patients with DME, this led to more than 8,000 additional hours for staff time and cost $380,000.

“In the worst-case scenario, if everyone had a double-step edit, the impact would be nearly half a billion dollars of increased retina overhead," Dang said. “We further stratified to differentiate Medicare Advantage, and we found increases in both time and money.”

Patients experienced an additional 7.8 hours of time burden, which included traveling distance and resulted in $284 in added costs. In an estimated 1,020 years of cumulative patient time burden, the mathematical model suggested it would lead to approximately $328 million in productivity losses. “We found that on the patient level, having a double-step edit created an additional eight hours of patient time that translated to an economic impact to the patient and their caregivers of $284,” he said.

Dang said his model creates hypothetical results for patients over time. If every patient with DME in the United States had a double-step edit, that would have a staggering $328 million economic impact on those patients and their families.