FDA OKs Implantable Treatment for Diabetic Macular Edema
The FDA has approved a new implantable treatment for adults with diabetic macular edema (DME) after studies showed that it could help maintain vision with as few as two treatments per year.
Sold as Susvimo, it's the first device that slowly releases ranibizumab, a medicine that treats eye diseases, so patients don’t need frequent injections.
Ranibizumab helps reduce swelling in the macula by blocking a protein called VEGF-A, which causes harmful blood vessels to grow in the eye.
DME affects about 750,000 people in the United States and 29 million globally. High blood sugar can damage tiny blood vessels in the eyes, causing fluid leakage and swelling in the macula — the part of the eye responsible for clear vision. This swelling can lead to serious vision problems or blindness, and treatments often involve monthly injections, highlighting the need for more convenient options.
Actual size
Susvimo is a medicine to treat certain eye conditions involving unstable, leaky blood vessels in the eye, such as wet age-related macular degeneration and diabetic macular edema. You get this medicine from an implant that is placed in your eye and is refilled with medicine, usually about every six months. Common side effects include eye pain, eye redness, and bleeding in the eye. It is important to carefully follow all of the instructions given to you by your healthcare provider about Susvimo. Call your healthcare provider right away if you see flashing lights or a curtain or veil over part of your vision or get vision loss, light sensitivity, increased eye pain, eye discharge, eye watering, or a feeling that something is in your eye.
WebMD: Susvimo (ranibizumab) - Uses, Side Effects, and More
Certain eye conditions, such as diabetic macular edema and wet age-related macular degeneration, happen when the small blood vessels in the eyes become unstable. These unstable blood vessels leak fluid and blood into the eyes, which can cause changes in vision and vision loss.
Susvimo works by keeping active forms of vascular endothelial growth factor A (VEGF-A) from binding to cells. By blocking the activity of VEGF-A, Susvimo helps to stop leakage and growth of new, unstable blood vessels in the eye.
Managed Healthcare Executive: FDA Approves Susvimo for Diabetic Macular Edema
The price of the Susvimo implant and medicine is $16,950 the first year, and two Susvimo refills every six months in year two are priced at $16,000, a company spokesperson said last year.
Genentech offers a $0 copay assistance program for the medication portion for patients with commercial insurance, with a limit of $15,000 a year. The company also provides copay assistance for administration costs with a limit of $1,000 a year. The terms say that this assistance is for the benefit of patients, and Genentech may adjust or exclude assistance if plans adjust cost sharing programs.
Access and Reimbursement Guide
SUSVIMO is covered under Medicare Fee-for-Service[/Part B] and Medicare Advantage.
However, some Medicare Advantage plans may require step edits before covering
SUSVIMO. Please check the individual payer policies for more information.
