Policyholder Services

What is OMIC’s position regarding use of intravitreal anti-VEGF (IVAV) agents for treatment of ROP?

Laser surgery remains the current standard treatment for ROP; however, other means of arresting ROP are sometimes needed. Some babies are too sick to tolerate the anesthesia needed during the surgery. In others, the abnormal vessels are in an area that the laser cannot safely reach, or the view is obstructed by blood or a persistent tunica vasculosis lentis. Some infants have disease that persists despite laser treatment.  In these situations, intravitreal injection of anti-VEGF agents (“IVAV”) may be indicated.

Adult patients with retinal conditions due at least in part to VEGF have been successfully treated for many years now with intravitreal injections of anti-VEGF agents such as Avastin^TM (bevacizumab), Macugen^TM (pegaptanib), Lucentis^TM (ranibizumab), and Eylea^TM (aflibercept). ROP is similar to certain retinal conditions in adults, prompting clinical trials on the use of IVAV in neonatal populations. Published reports of IVAV from both clinical trials and “off-label” use suggest  that it can be effective and does not—so far—appear to produce many serious short or long-term side effects. However, the efficacy, safety, and long-term consequences have not yet been definitely proven, and cases of late recurrence of ROP have been reported. Concerns about IVAV both as primary or salvage therapy have been addressed in the literature and at eye society meetings. In addition, many questions are currently being studied and debated, such as agent, dosage amount, volume, timing of injections, length of follow-up, and contraindications. Despite these uncertainties, when faced with aggressive or refractive ROP, ophthalmologists at times feel there is no other prudent choice but to treat ROP with IVAV.

Because off-label use of approved drugs and devices is a necessary and legal part of the practice of medicine and use of non-approved drugs and devices is also appropriate in certain situations, OMIC’s policy does not contain any provisions or exclusions that would prohibit coverage for such activities outside of clinical trials. Additionally, OMIC’s policy does not contain any exclusions regarding the treatment of ROP, either traditionally or with IVAV. However, given the potential liability concerns with this new treatment modality, OMIC carefully underwrites physicians who administer intravitreal anti-VEGF agents for the treatment of ROP and has adopted requirements regarding appropriate treatment indications and post-injection monitoring.

To further manage the potential liability concerns associated with the off-label use of IVAV for the treatment of ROP, OMIC has developed risk management recommendations and a sample consent form for anti-VEGF treatment of ROP. OMIC policyholders who administer anti-VEGF medications for ROP are strongly encouraged to call OMIC Risk Manager Anne M. Menke, RN, PhD at 1.800.562-6642, extension 651 to discuss this treatment modality. This is a confidential call.