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Avedro Launches Comprehensive Effort to Secure Coverage and Facilitate Reimbursement of FDA-Approved Corneal Cross-Linking Treatment

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Avedro Launches Comprehensive Effort to Secure Coverage and Facilitate Reimbursement of FDA-Approved Corneal Cross-Linking Treatment May 2017

Multi-Faceted Initiative Is Designed to Improve Patient Access to Therapeutic Treatment for Sight-Threatening Orphan Diseases

Avedro Launches Comprehensive Effort to Secure Coverage and Facilitate Reimbursement of FDA-Approved Corneal Cross-Linking Treatment

Multi-Faceted Initiative Is Designed to Improve Patient Access to Therapeutic Treatment for Sight-Threatening Orphan Diseases

Avedro, Inc., an ophthalmic pharmaceutical and medical device company and the world leader in corneal remodeling, today announced a comprehensive effort to secure commercial coverage and support reimbursement of Photrexa Viscous (riboflavin 5’-phosphate in 20% dextran solution), Photrexa (riboflavin 5’-phosphate dextran solution) and the KXL System used in corneal cross-linking for the treatment of progressive keratoconus and corneal ectasia following refractive surgery. The company’s multi-faceted initiative will help improve patient access to medically necessary treatment for these sight-threatening orphan diseases.

“Avedro has heard from many patients and physicians that the current out-of-pocket payment structure is an impediment to patients getting treated with cross-linking,” said Reza Zadno, Chief Executive Officer of Avedro. “Avedro is committed to supporting patients who require cross-linking so that they have access to this procedure. We believe that insurance companies will recognize the benefits of cross-linking, and we look forward to working with patients and physician practices to navigate this process, while increasing access to care.”

The initiative encompasses several components, including the launch of the Avedro Reimbursement Customer Hub (ARCH) Program. Starting June 15th, the ARCH Program will offer:

1. A Reimbursement Support Service, including a hotline for questions and resources to assist with the commercial payer appeals process
2. A Patient Assistance Program that supports financially eligible, uninsured patients by providing Photrexa Viscous and Photrexa at no charge
3. A Prescription Assistance Program, which minimizes insured patients’ out-of-pocket expenses for Photrexa Viscous and Photrexa in cases of commercial insurance coverage denials

In addition, Avedro has established commercial pricing for Photrexa Viscous and Photrexa. The commercial pricing brings this one-time, medically necessary treatment to a level that is reflective of its significant clinical value.

“Keratoconus, when left untreated, can result in significant deterioration of vision, and may lead to multiple, costly corneal transplants, with the potential to adversely affect patients’ quality of life,” said Rajesh Rajpal, MD, Chief Medical Officer for Avedro. “We believe that working together with physicians, specialty societies and commercial payers, as well as with patients, will ultimately result in more patients having access to this medically necessary treatment.”

“Keratoconus patients face serious challenges with their disease, both clinically and financially,” said Mary Prudden, Program Director, National Keratoconus Foundation. “We know that the number one reason patients delay treatment is financial, often resulting from lack of insurance coverage. We are thrilled that Avedro is supporting the effort to drive insurance coverage for patients. The company’s advocacy and support programs will help reduce financial barriers to the treatment of keratoconus.”

What is Corneal Collagen Cross-Linking?

Corneal cross-linking is a minimally invasive outpatient procedure that combines the use of Photrexa Viscous®, Photrexa®, and the KXL® System for the treatment of progressive keratoconus and corneal ectasia following refractive surgery.

The safety and effectiveness of corneal cross-linking has not been established in pregnant women, women who are breastfeeding, patients who are less than 14 years of age and patients 65 years of age or older.

Photrexa Viscous and Photrexa should be used with the KXL System only.

Warnings and Precautions
Ulcerative keratitis can occur. Patients should be monitored for resolution of epithelial defects.

Adverse Reactions
In progressive keratoconus patients, the most common ocular adverse reactions in any CXL treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision. In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision.

These are not all of the side effects of Photrexa Viscous, Photrexa and the CXL treatment. Click here for full Prescribing Information or ask your healthcare provider.

You are encouraged to report negative side effects of prescription drugs to the FDA.  Visit http://www.fda.gov/medwatch or call 1-800-FDA-1088.

About Avedro, Inc.

Avedro is a privately held pharmaceutical and medical device company, the world leader in corneal remodeling for the treatment of keratoconus and refractive correction. Avedro’s Photrexa® Viscous (riboflavin 5-‘phosphate in 20% dextran ophthalmic solution), Photrexa® (riboflavin 5-‘phosphate ophthalmic solution) and KXL® System are approved for sale in the United States. Avedro’s products sold outside of the United States include capital equipment such as the UV-X devices, the KXL and Mosaic™ Systems, and related proprietary pharmaceuticals such as the VibeX® and MedioCROSS® formulations.

Contact

David Iannetta
Avedro, Inc.
Telephone: 1-844-528-3376
info@avedro.com

Media

Michele Gray
BioComm Network, Inc.
Telephone: 917-449-9250
michele_gray@me.com

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