Harrow, Inc. and Apexus, LLC have agreed to a new contract in which IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3% and other Harrow products will be accessible through the 340B Prime Vendor Program (PVP).
Let’s start with Apexus.
Headquartered in Irving, Texas, Apexus operates as the U.S. government’s designation prime vendor for the federal 340B Drug Pricing Program.
- Its purpose: To provide 40,000+ healthcare facilities serving vulnerable populations with access to discounted medications and education as well as compliance needs and manufacturer refund services.
About the federal program: This enables covered entities (such as 340B hospitals) to stretch limited federal resources.
- The intended goal: to potentially reduce the price of outpatient pharmaceuticals for eligible patients and expand to more comprehensive health services (more on this below).
Zero in on this 340B PVP.
Managed by Apexus, the contracted 340B Prime Vendor Program was granted by the U.S. Health Resources and Services Administration (HRSA)—which is also responsible for administering the 340B Drug Pricing Program.
What it is: The voluntary program was created to develop, maintain, and coordinate a program capable of distribution, facilitation, and other related activities in order to support the 340B Program.
Talk specifics on this support.
Specifically, the program offers three main services:
- Negotiating sub-340B pricing on pharmaceuticals
- Establishing national, regional, and specialty distribution solutions and networks for improving access to affordable medications
- Providing other value-added products and services
Gotcha. So how does Harrow come into play?
Through the 340B PVP, three of the company’s products will now be available:
- IHEEZO
- VIGAMOX
- ILEVRO
Note: In January 2023, Harrow acquired the exclusive U.S. rights to VIGAMOX and ILEVRO (as well as to other FDA-approved branded ophthalmic products) from Novartis.
Give me details on these products.
- First up: IHEEZO (chloroprocaine hydrochloride ophthalmic gel) 3%
- What it is: a sterile, single-use, physician-administered, preservative-free low-viscosity ophthalmic gel
- Regulatory status: FDA approved in September 2022
- U.S. commercial launch: May 2023
- Indication: ocular surface anesthesia
- Next: VIGAMOX (moxifloxacin hydrochloride ophthalmic solution) 0.5%
- What it is: a topical fluoroquinolone antibiotic eye drop
- Regulatory status: FDA approved in 1999
- U.S. commercial launch: August 2023
- Indication: for the treatment of bacterial conjunctivitis caused by susceptible strains of organisms such as Corynebacterium species, Micrococcus luteus, and Staphylococcus aureus, to name a few.
- Finally: ILEVRO (nepafenac ophthalmic suspension) 0.3%
- What it is: a nonsteroidal, anti-inflammatory (NSAID) topical eye drop
- Regulatory status: FDA approved in 2005
- U.S. commercial launch: May 2023
- Indication: for the treatment of pain and inflammation associated with cataract surgery.
What does this mean for patients?
On behalf of the company, Harrow Chairman and CEO Mark L. Baum stated that, ““We believe the value this agreement provides to eligible participants will open access to IHEEZO (plus VIGAMOX and ILEVRO) for the U.S. hospital market.”A key fact: An estimated 2.4 million annual emergency room visits in U.S. hospitals are due to eye-related issues, according to the Centers for Disease Control and Prevention (CDC).
Baum noted: “Consistent with our commitment to ensure access and affordability to our products, with around 44% of U.S. hospitals participating in the Apexus 340B Prime Vendor Program, we are thrilled about the potential benefits we see from our new relationship, especially for vulnerable populations.”
And when is this agreement effective?
As of July 1, 2024.