MMIT Reality Check on Macular Edema (1Q2023)
A review of market access for macular edema treatments shows that under the pharmacy benefit, about 30% of the lives under commercial formularies are covered with utilization management restrictions. Around 58% of the lives under Medicare formularies are not covered for at least one of the drugs.
Under the medical benefit, about 46% of the lives under commercial policies are covered with utilization management restrictions. Almost 68% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.
For about 91% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 7% require multiple steps. Around 63% of payer-controlled pharmacy benefit covered lives require prior authorization, with 9% of those lives covered by policies that are restrictive as compared with a product’s FDA-approved label.
FDA Approves Cimerli
In August 2022, the FDA approved Coherus BioSciences, Inc.’s Cimerli (ranibizumab-eqrn) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy (DR) and myopic choroidal neovascularization (mCNV). The therapy is the second biosimilar of Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab) but is the first that the FDA has deemed interchangeable with all of the reference drug’s indications. The vascular endothelial growth factor (VEGF) inhibitor was approved in both 0.3 mg and 0.5 mg dosages and has one year of interchangeability exclusivity. Dosing for wet AMD and macular edema following RVO is 0.5 mg via intravitreal injection once a month; for DME and DR, dosing is 0.3 mg once a month; and for mCNV, dosing is 0.5 mg once a month for up to three months with retreatments possible if needed.
U.S. Sees First Ophthalmologic Biosimilar Launch in Crowded, High-Cost Space
The U.S. market recently welcomed the first ophthalmologic biosimilar onto the market: Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna), which references Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab). While the agent is entering what is becoming a fairly crowded space, it will offer a cost-effective option for payers, say industry sources.
On Sept. 20, 2021, the FDA approved Byooviz for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). Under an agreement with Genentech, Samsung Bioepis and Biogen were not able to market the vascular endothelial growth factor (VEGF) inhibitor in the U.S. until June 2022. Biogen Inc. and Samsung Bioepis Co., Ltd. said on June 2 that they had launched Byooviz, and the medication became commercially available on July 1. The list price of the intravitreal injection is $1,130 per single use vial, which is 40% less than Lucentis’ list price.
FDA Gives Beovu Additional Approval
In May 2022, the FDA gave another approval to Novartis Pharmaceuticals Corp.’s Beovu (brolucizumab-dbll) for the treatment of diabetic macular edema. The agency first approved the drug on Oct. 7, 2019. The recommended dose of the intravitreal injection, which is available in a single-dose prefilled syringe and vial, is 6 mg every six weeks for the first five doses, followed by one 6 mg dose every eight to 12 weeks. Drugs.com lists the price of one 6 mg/0.05 mL solution as more than $1,957.
Market Events Drive Changes
In August 2022, the FDA approved Coherus BioSciences, Inc.’s Cimerli (ranibizumab-eqrn) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion, diabetic macular edema (DME), diabetic retinopathy and myopic choroidal neovascularization. In May 2022, the agency gave another approval to Novartis Pharmaceuticals Corp.’s Beovu (brolucizumab-dbll) for the treatment of DME. In January 2022, the FDA approved Roche Group member Genentech USA, Inc.’s Vabysmo (faricimab-svoa) for the treatment of wet, or neovascular, AMD and DME.
Competitive Market Landscape
The anti-vascular endothelial growth factor (VEGF) drugs all work in similar ways to block vessel formation and prevent leakage in the retina. Regeneron Pharmaceuticals’ Eylea (aflibercept), Genentech’s Lucentis (ranibizumab) and Susvimo (ranibizumab), Cimerli and Beovu are FDA approved for macular edema, and Genentech’s Avastin (bevacizumab) and its biosimilars are used off-label for treatment of the condition. Vabysmo is the first bispecific antibody approved for the eye, blocking angiopoietin-2 (Ang-2) and VEGF-A. Multiple drugs are in late-stage clinical trials for macular edema, including biosimilar versions of Lucentis and Eylea. Trials also are evaluating therapies that target different pathways and are effective for a longer duration than the current treatments.
Pharmacy, Medical Benefit Implications
A good number of payers have written policies for these products and approve on-label coverage of macular edema and off-label coverage for Avastin for macular edema. Coverage is under both the pharmacy and the medical benefit.
Key Players in Market: