The long-anticipated regulatory approval of Beovu (brolucizumab, Novartis) gives retina specialists the first new anti-VEGF agent for age-related macular degeneration since the approval of Eylea (aflibercept, Regeneron Pharmaceuticals) eight years ago, and the first patients likely to get the new treatment are those with persistent fluid on optical coherence tomography after monthly treatment with the previously approved agents, an investigator of the Phase III trial tells Retina Specialist Magazine.
Beovu 6 mg is approved for every eight-to-12-week dosing after three monthly loading doses in neovascular AMD. At a wholesale cost of $1,850 per vial, which matches Eylea's per-vial price, the first year cost of Beovu would be $11,100 for 12-week treatment and $13,875 for eight-week treatment. For each year thereafter, cost would be $7,400 and $11,100 for 12- and eight-week regimens. In the HAWK and HARRIER trials, more than half of patients on Beovu were on the 12-week dosing interval after a year.1 By comparison, Eylea 2 mg is approved for every four-to-eight-week dosing in nAMD after three loading doses, which equates to a yearly cost of $22,200 to $13,875.
“We chose to price it comparably with other anti-VEGF drugs indicated for wet AMD,” says Patrick Mooney, vice president and head of Novartis’ U.S. ophthalmology franchise. “Our strategy is to remove nonclinical barriers for payers and for physicians, and we wanted the clinical profile of the drug to stand on its own.”
Arshad Khanani, MD, MA, of Reno, Nevada, a HAWK investigator, has treated multiple patients with Beovu post-approval. He says initially he used Beovu in patients with persistent subretinal or intraretinal fluid after monthly treatment with Eylea.
OCT results so far have been
encouraging, he says. “If there’s no subretinal fluid on OCT after a month, I’m going to try to extend the patient out to six weeks with the next Beovu injection,” he says. He notes that Beovu is also suitable for treatment-naïve patients.
“I think the majority of physicians who don’t have the experience with Beovu are likely to use it initially on previously treated patients with persistent subretinal or intraretinal fluid on four-to-five-week treatment with Eylea,” Dr. Khanani says.
He notes the HAWK and HARRIER trials reported that Beovu was more effective than Eylea at resolving subretinal and/or intraretinal fluid as well as subretinal pigment epithelium fluid. “Once they see the efficacy in terms of drying the retina and that they can actually increase the interval between treatments, then they’re going to start using Beovu more in treatment-naïve patients,” he says.
At first some physicians may have been reluctant to use Beovu because it doesn’t have a J-code, but Novartis does have support programs to deal with coverage lapses, Dr. Khanani says. A permanent J-code has already been assigned by the Centers for Medicare and Medicaid Services and it will go in effect in January 2020.
1. Dugel P, Koh A, Ogura Y, et al, for the HAWK and HARRIER study investigators. HAWK and HARRIER: Phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2019 April 12. [Epub ahead of print]
Study upends conventional thinking on retinal artery occlusion, stroke
Occlusion of the retinal artery has been thought to be a predictor of stroke, but an analysis of patients with diagnosed retinal artery occlusion at the Cleveland Clinic has found that their risk of stroke is about the same as the general population.
“Subsequent hemispheric stroke is rare with or following retinal artery occlusion,” says David Laczynski, MD, a vascular surgeon at the Cleveland Clinic. He reported the results at the annual meeting of the Midwestern Vascular Surgery Society in Chicago. “We do caution that large database studies may be overestimating the risk of stroke after RAO,” he says, citing studies that have reported stroke rates of up to 20 percent at one year.1
The study evaluated 221 patients whose RAO was confirmed with fluorescein angiography from 2004 to 2018 at the Cleveland Clinic Cole Eye Institute.2 The study population is the largest series in RAO ever reported, he says.
The impetus of the study was to use the eye center to evaluate the institution’s experience with RAO, Dr. Laczynski says. “We were specifically concerned with looking at confirmed, symptomatic RAO with the risk of subsequent stroke,” he says. The study’s hypothesis was that RAO isn't associated with an increased risk of stroke.
The average age of patients was 66 years. With a median follow-up of 2.2 years, the stroke rate was 2.3 percent (n=5), with four of the strokes occurring at the time of RAO and one at 1.2 years later. Only one stroke patient had greater than 50 percent stenosis of the carotid artery. The rate of stroke, death or myocardial infarction was 10 percent (n=22), Dr. Laczynski says. When concurrent ischemic events were excluded, the stroke rate was less than 1 percent.
“Sixty-three percent of patients (n=141) had carotid imaging, but only 14.2 percent (n=20) had more than 50 percent stenosis of the carotid artery,” Dr. Laczynski says. “Ten patients had carotid intervention.”
Among study limitations Dr. Laczynski points out were its single-center, retrospective nature and that not all patients had carotid artery imaging. “We cannot make any conclusion in regard to RAO and carotid artery disease,” Dr. Laczynski says. RS
1. Chang YS, Jan RL, Weng SF, et al Retinal artery occlusion and the 3-year risk of stroke in Taiwan: a nationwide population-based study. Am J Ophthalmol. 2012;154:645-652.
2. Laczynski DJ, Lyden SP, Gallop J, Bena J, Caputo FJ. Retinal artery occlusion does not portend an increased risk of stroke. Abstract presented at Midwestern Vascular 2019; Chicago, Ill.; September 13, 2019.