MMIT Reality Check on Macular Edema

Payer Coverage:

A review of market access for macular edema treatments shows that under the pharmacy benefit, about 26% of the lives under commercial formularies are covered with utilization management restrictions. Around 57% of the lives under Medicare formularies are not covered for at least one of the drugs.

Under the medical benefit, about 44% of the lives under commercial policies are covered with utilization management restrictions. Almost 66% of the lives under Medicare Part B policies have access to at least one of the drugs without utilization management restrictions.

For about 90% of the covered lives, payer pharmacy benefit formularies do not require step therapy (ST). Of the lives that require ST, about 3% require multiple steps. Around 54% 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.

Trends:

FDA Approves Xipere

In October 2021, the FDA approved Bausch Health Companies Inc. eye health business Bausch + Lomb and Clearside Biomedical, Inc.’s Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. Xipere is the first — and currently only — therapy utilizing the suprachoroidal space to treat macular edema associated with uveitis.

FDA Approves Byooviz

In September 2021, the FDA approved Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). The biosimilar of Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab) is the first ophthalmology biosimilar that the agency has approved. Recommended dosing for wet AMD and RVO is every 28 days via an intravitreal injection, while dosing for mCNV is every 28 days for up to three months, with re-treatment if needed. Samsung Bioepis and Biogen will be able to market the therapy in the U.S. in June 2022.

FDA Approves Byooviz, First Ophthalmology Biosimilar in U.S.

The FDA approval of the first biosimilar for ocular use is poised to bring savings to a costly class, particularly in Medicare. However, ophthalmologists’ and retinologists’ lack of experience with biosimilars is a potential roadblock to these drugs’ uptake. Payers should focus on provider education and outreach ahead of these drugs’ launches in order to ease concerns about their use, say industry experts.

Key Findings:

Market Events Drive Changes

In October 2021, the FDA approved Bausch Health Companies Inc. eye health business Bausch + Lomb and Clearside Biomedical, Inc.’s Xipere (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of macular edema associated with uveitis. Xipere is the first — and currently only — therapy utilizing the suprachoroidal space to treat macular edema associated with uveitis. In September 2021, the FDA approved Samsung Bioepis Co., Ltd. and Biogen Inc.’s Byooviz (ranibizumab-nuna) for the treatment of neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO) and myopic choroidal neovascularization (mCNV). The biosimilar of Roche Group unit Genentech USA, Inc.’s Lucentis (ranibizumab) is the first ophthalmology biosimilar that the agency has approved.

Competitive Market Landscape

Multiple drugs are in late-stage clinical trials for macular edema, including biosimilar versions of Lucentis. 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 Genentech, Inc.’s Avastin (bevacizumab) for macular edema. Most payers do not cover Alimera Sciences, Inc.’s Iluvien (fluocinolone acetonide intravitreal implant) for this indication. Coverage is under both the pharmacy and the medical benefit.

Key Players in Market:

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