Step therapy by Medicare Advantage plans was also associated with more injections, although that result fell short of meeting statistical significance standards.
CMS started allowing Medicare Advantage (MA) plans to implement step therapy for physician-administered Part B drugs in 2019. Health insurers' step therapy policies require patients with certain conditions to be treated with particular drugs before they “step up” to other drugs that are presumably more expensive for the insurer to cover. The anti-vascular endothelial growth factor (VEGF) injections used to treat retinal conditions, such as neovascular (wet) age-related macular degeneration and diabetic macular edema, have become prime targets of Medicare Advantage step therapy — and prior authorization — policies as their use and share of Part B spending have grown. A study published in JAMA Health Forum in 2023 identified Eylea (aflibercept) as the second most expensive drug by total spending for the Medicare Part B program in 2020, with more than $3 billion in annual costs, and Lucentis (ranibizumab) as the sixth most expensive drug by total spending, costing more than $1 billion. Both Eylea and Lucentis now have biosimilar competition.
Prithvi Reddy Bomdica, M.D., MBA
It's against this backdrop that Prithvi Reddy Bomdica, M.D., MBA, of The Retina Institute in St. Louis, presented results at the American Society of Retina Specialists today that show that step therapy was associated with more switching among anti-VEGF agents. His results also suggest that step therapy might be associated with more injections, although that finding did not reach the standards used to measure statistical significance.
Bomdica conducted his study of step therapy by doing a retrospective chart review of eyes diagnosed with neovascular (wet) age-related macular at The Retina Institute between January 2023 and September 2023. Eyes that had been previously treated were excluded, which narrowed the study to 1,794 eyes. He compared treatment covered by traditional Medicare, which does not step therapy, to treatment covered by a Medicare Advantage plan. Of the eyes in the study, treatment for 1,248 (almost 70%) was covered by traditional Medicare, 357 (almost 20%) by Medicare Advantage plans, and 189 (10.5%) by other types of insurance. Among the eye treatments covered by traditional Medicare, 31% were switched to a different anti-VEGF treatment within the first year of the diagnosis compared with 47% among those covered by Medicare Advantage plans that required step therapy.
Bomdica also compared the number of injections. The average number was 6.04 in the traditional Medicare patients compared with 6.49 in the Medicare Advantage patients, although he noted that the difference was not statistically significant.
Bomdica framed his findings as a matter of accuracy in picking the right treatment. “Retinal specialist-directed treatment selection for newly diagnosed [neovascular age-related macular degeneration] was significantly more accurate than treatments mandated under step-therapy requirements,” he concluded in the written abstract of his findings.
It is axiomatic that the findings of any study conducted at a single practice or center may not hold true when the research is expanded to include more practices or centers. And Bomdica noted in his conclusion that a larger study would “further clarify” the effects of step therapy on treatment burden — in this context that would mean the frequency of injections — and overall outcomes.
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