Keeping an Eye on the Drug Pipeline

New treatments for ophthalmic disorders increase options for patients
BRIEFING
October 20, 2022
Vice President & Head of PBM & Specialty Product Innovation
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Specialty Pharmacy Pipeline: Drugs to Watch

Anticipated Launches | Q4 2022 – Q1 2023

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The robust drug development pipeline features potentially disruptive treatments for ophthalmic disorders. The total economic burden of eye disorders and vision loss in the United States has been estimated at $139B, which includes $65B in annual medical costs and $48B in lost productivity.https://www.norc.org/Research/Projects/Pages/the-economic-burden-of-vision-loss-and-eye-disorders-in-the-united-states.aspx These new drugs could provide new options for patients and increase price competition in the marketplace.

$65B in annual medical costs

Ophthalmic disorders and prevalence

Age-related macular degeneration (AMD) is an eye disorder associated with aging. The macula is the central part of the retina that allows the eye to see fine details.https://www.cdc.gov/visionhealth/basics/ced/index.html AMD affects 11 to 15 million Americans – 2.1 percent of those ages 50 and over.https://www.brightfocus.org/macular/article/age-related-macular-facts-figureshttp://www.visionproblemsus.org/amd/amd-map.html There are two kinds of AMD, wet and dry; 90 percent of AMD patients have the dry type.https://www.brightfocus.org/macular/article/age-related-macular-facts-figures Drugs approved to treat wet AMD include Eylea (aflibercept) and Lucentis (ranibizumab).

Geographic atrophy is an advanced form of dry AMD that affects approximately 1 million people in the United States. It is a leading cause of blindness; currently there are no treatments that have been approved by the U.S. Food and Drug Administration (FDA).https://pubmed.ncbi.nlm.nih.gov/33630787/

Macular edema is swelling in part of the retina, caused by blood vessels leaking into the macula. Diabetic macular edema is caused by diabetic retinopathy and affects an estimated 3.8 percent of the U.S. population.https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/macular-edema#:~:text=Macular%20edema%20is%20swelling%20in,swelling%20and%20prevent%20vision%20loss.

Diabetic retinopathy occurs when high levels of glucose damage the blood vessels in the retina over time.https://www.ajmc.com/view/overview-of-diabetic-macular-edema This disease affects one in three people with diabetes, and disproportionately affects Latinx and African American populations.https://www.cdc.gov/visionhealth/pdf/factsheet.pdfIbid.

New market entries to treat ophthalmic disorders

Many of the therapies for ophthalmic disorders are reference brand biologics. Biosimilars can help to increase competition in the marketplace and thus lower drug costs for plan sponsors and patients. A biosimilar is highly analogous to the reference product but may not be approved for all indications of the reference drug.

Interchangeable biosimilars may be substituted for the reference product at the pharmacy without a prescriber or member request.* To be considered interchangeable, a biosimilar must meet additional conditions during the FDA approval process. If a biosimilar is not interchangeable, a new prescription will be needed for the biosimilar. On our formularies, CVS Health preferences the lowest net cost option.

Vabysmo (faricimab-svoa, Genentech), launched in February 2022, is approved for the treatment of both neovascular (wet) age-related macular degeneration and diabetic macular edema. Its dosing schedule of up to every 4 months, versus competitors’ more frequent dosing requirements, may improve patient adherence and convenience.

An FDA-approved biosimilar to Lucentis (Genentech/Roche) launched in June 2022. Byooviz (ranibizumab-nuna), produced by Biogen/Samsung Bioepis, is a vascular endothelial growth factor (VEGF) inhibitor that is administered monthly by intravitreal injection.

Cimerli (ranibizumab-eqrn, Coherus BioSciences) was approved as an interchangeable biosimilar to Lucentis in August 2022 and launched earlier this month. It is a monthly intravitreal injection.

Notable drugs in the pipeline

The first biosimilar to Eylea is pending approval by the FDA and is expected to launch in late 2023. Produced by Johnson & Johnson/Viatris/Momenta Pharmaceuticals, the new drug is a VEGF inhibitor. Eylea is used to treat neovascular (wet) AMD, macular edema following retinal vein occlusion, diabetic macular edema, and diabetic retinopathy.

Pegcetacoplan is a new formulation of an existing drug, Empaveli, that is being developed to treat geographic atrophy; currently, it is the only pipeline agent for the treatment of dry AMD. Administered as a subcutaneous infusion via an infusion pump, pegcetacoplan is expected to be approved in December.

Lytenava (bevacizumab-vikg, Outlook Therapeutics) is anticipated to enter the market in the third quarter of 2023. An intravitreal injection, it would be the first commercially formulated replacement for compounded bevacizumab that has been used to treat wet AMD.

Manage costs with forward-thinking strategies

Most therapies for ophthalmic disorders are intravitreal injections administered in a clinic, rather than self-administered. They are commonly covered under the medical benefit, which should be managed with the same tools as the pharmacy benefit, such as utilization management, lower cost preferred drug designs, and plan design, but should also employ site-of-care optimization and additional pricing strategies to eliminate waste.

Our proprietary technology platform, Novologix®, provides visibility across pharmacy and medical benefits and enables payors to efficiently manage spend in either one. The platform offers real-time, online access to an automated PA process across both benefits with a single front-end system. This enables precision across both benefits for maximum savings.

Want to know more about how to best manage the treatment pipeline for ophthalmic disorders? Ask Us
BRIEFING
October 20, 2022
Vice President & Head of PBM & Specialty Product Innovation

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This article contains references to brand-name prescription drugs that are trademarks or registered trademarks of pharmaceutical manufacturers not affiliated with CVS Health.

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