WALTHAM, Mass.--(BUSINESS WIRE)--Avedro, Inc., a leading commercial-stage ophthalmic medical technology company and a global leader in corneal remodeling, today announced that Anthem, the largest member of the Blue Cross Blue Shield Association, has issued a positive coverage policy for Avedro’s FDA-approved corneal cross-linking procedure bringing the total number of commercial plans covering the Photrexa® drug formulations and the KXL® System to 60. The addition of the nation’s second largest commercial plan affects 31 million beneficiaries, or 10 percent of the United States population.
Avedro has now secured positive coverage from America’s largest national commercial payers, United Healthcare, Anthem Blue Cross Blue Shield, Aetna, Cigna, Humana and HealthNet, facilitating access to more than 90 percent of commercially covered lives. This positive momentum underscores payer confidence in the safety, efficacy and cost-effectiveness of corneal cross-linking.
This news follows the recent decision by the Centers for Medicare and Medicaid Services (CMS) to issue a product-specific J code for Photrexa® Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and Photrexa® (riboflavin 5’-phosphate ophthalmic solution). The new J code, J2787, will become effective on January 1, 2019.
“Over the past year and in collaboration with the American Academy of Ophthalmology, the American Society of Cataract and Refractive Surgery, the Cornea Society, doctors and the National Keratoconus Foundation, we have made great strides in increasing market access to medically necessary, FDA-approved corneal cross-linking,” said Reza Zadno, PhD, Chief Executive Officer of Avedro. "In the past month alone, our Photrexa drug formulations were issued a permanent J code from CMS, and we added an additional 40 million lives who can access cross-linking. Our goal is to ensure cross-linking is accessible to every patient struggling with progressive keratoconus. Reaching these milestones brings us increasingly closer to this goal.”
“This news is certainly encouraging to patients who are struggling with this sight-threatening disease, and it is wonderful to see that our combined efforts are having a significant impact on market access,” said Mary Prudden, Director of the National Keratoconus Foundation. “Increasingly, we are hearing from patients that they are now able to obtain coverage for their treatment. I am very hopeful that this trend will continue.”
Patients can find the list of private payer insurance companies providing coverage for corneal cross-linking at LivingwithKeratoconus.com.
Avedro is a leading commercial-stage ophthalmic medical technology company focused on treating corneal ectatic disorders and improving vision to reduce dependency on eyeglasses or contact lenses. Avedro’s proprietary Avedro Corneal Remodeling Platform strengthens, stabilizes and reshapes the cornea utilizing corneal cross-linking in minimally invasive and non-invasive outpatient procedures to treat corneal ectatic disorders and correct refractive conditions. The Avedro Corneal Remodeling Platform is comprised of Avedro’s KXL and Mosaic systems, each of which delivers ultraviolet A light, and a suite of proprietary single-use riboflavin drug formulations, which, when applied together to the cornea, induce a biochemical reaction called corneal collagen cross-linking.
IMPORTANT SAFETY INFORMATION
INDICATIONS
Photrexa®
Viscous (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) and
Photrexa® (riboflavin 5’-phosphate ophthalmic solution) are
indicated for use with the KXL System in corneal collagen cross-linking
(CXL) for the treatment of progressive keratoconus and corneal ectasia
following refractive surgery.
LIMITATIONS OF USE
The safety and
effectiveness of CXL 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. For more information, see Prescribing Information.
You may report an adverse event to Avedro by calling 1-844-528-3376, Option 1 or you may contact the U.S. Food and Drug Administration (FDA) directly at 1-800-FDA-1088.
