Step‑therapy requirements for the anti‑VEGF drug Vabysmo (faricimab) have been linked to treatment delays and added burdens for both patients and eye‑care providers, according to a modeled analysis presented at the American Society of Retina Specialists meeting in Montreal.
Study quantifies staff and patient costs
The Retina Institute team, led by ophthalmologist Dr. Sabin Dang, built a mathematical model to compare first‑line use of Vabysmo with fourth‑line use that involves two step‑therapy requirements. The model tracked staff time from the initial phone call through claim submission and examined the likelihood of same‑day treatment and claim denial.
For a practice handling roughly 1,000 diabetic macular edema (DME) patients, the model projected an extra 8,000 staff hours over a year, translating to about $380,000 in additional costs.
When each patient faced a double‑step edit, the analysis estimated an extra 7.8 hours of personal travel and appointment time, costing patients roughly $284 each. Patients feel the strain.
Aggregating these figures, the study suggested that the cumulative patient time burden could reach 1,020 years, with productivity losses approaching $328 million. In a worst‑case scenario where every DME patient encountered a double‑step requirement, the overhead for retina clinics could near $500 million.
Implications for Medicare Advantage plans
They noted that step‑therapy rules vary widely among Medicare Advantage plans, adding complexity for providers. “Elimination of step therapy may improve efficiencies in treating this DME population,” Dr. Dang said, emphasizing potential savings if insurers streamlined prior‑authorization processes.
Vabysmo, developed by Genentech, is approved for wet age‑related macular degeneration, DME, and macular edema after retinal vein occlusion. It is the first bispecific antibody targeting both Ang2 and VEGF‑A, aiming to reduce vascular leakage and inflammation. Since its approval, more than 11 million doses have been distributed worldwide.
Diabetic macular edema, a complication of diabetes, stems from damaged retinal vessels leaking fluid, leading to swelling, blurred vision, and risk of severe vision loss. The study shows how administrative hurdles can delay access to effective therapies, potentially worsening outcomes for a condition that already threatens sight.
Dr. Dang explained that the model incorporated every interaction point—from the moment a patient calls to schedule an appointment, through the in‑office evaluation, to the final step of claim processing—providing a full picture of the workflow impact. By quantifying both the staff effort required to manage additional authorization steps and the probability that a claim might be denied, the analysis highlighted how each extra layer of paperwork can cascade into longer wait times for treatment.
The variability of step‑therapy mandates across Medicare Advantage plans means that clinicians often must handle different prior‑authorization forms and criteria for each patient, creating a fragmented administrative setting. This inconsistency forces clinics to allocate additional resources to understand plan‑specific rules, train staff, and maintain up‑to‑date documentation, further inflating operational costs.
Beyond the direct financial implications, the model showed the hidden human cost of delayed therapy. Patients who travel longer distances for repeat visits not only incur out‑of‑pocket expenses but also lose valuable work hours, which can exacerbate socioeconomic disparities among those living with chronic diabetes. The cumulative effect of thousands of patients experiencing these delays translates into a measurable loss of productivity on a national scale.
By simulating a scenario in which every DME patient faced a double‑step edit, the researchers were able to illustrate the scale of potential inefficiencies within the retina specialty sector. This worst‑case projection serves as a benchmark for policymakers and insurers, suggesting that even modest reductions in step‑therapy requirements could generate substantial savings for both the healthcare system and the patients it serves.
