Bevacizumab (AVASTIN™) - Treatment of Neovascular (Wet) Macular Degeneration

This article was initially published in the July 2006 Newsline and was revised in the December 2006 Newsline. The entire article is being republished with an additional statement regarding drug compounding. This new requirement becomes effective immediately.

Cahaba GBA, LLC will consider claims for Bevacizumab (AVASTIN™) for neovascular ("wet") macular degeneration on an individual basis.

Neovascular Age-related Macular Degeneration (AMD), when untreated or refractory to usual therapies, almost always leads to permanent blindness. As such, additional therapeutic interventions have been pursued in order to try and salvage the vision of AMD patients who have failed to respond to the usual therapies.

One of these options is the use of bevacizumab. Bevacizumab is not FDA approved for the treatment of AMD. Bevacizumab works by blocking vascular endothelial growth factor, a potent angiogenic and permeability factor, and as such it is attracting much attention as a potential treatment option for neovascular age-related macular degeneration as well as for macular edema. The physician's decision to use bevacizumab is based on favorable, though not definitive, studies.

The USP DI includes the following "off-label" indication for Bevacizumab: Treatment of neovascular (wet) age-related macular degeneration in patients failing standard therapy.

The ophthalmology community is increasingly using intravitreal bevacizumab in the treatment of wet AMD that has not responded to other accepted therapies.

The use of bevacizumab is not to be taken lightly. The agent has many potential medical complications. Bevacizumab comes from the manufacturer in a concentration unsuitable for ocular use and, therefore, must be diluted before such use.

To use this agent, the ophthalmologist must have extensive experience in the treatment of wet AMD and be well versed with the latest guidelines on care before, during and after the administration of bevacizumab.

Required Medical Record Documentation
All of the following criteria should be clearly documented in the patient's medical record prior to the use of bevacizumab for the treatment of wet AMD.

Patient Selection

• Fluoroscein angiograms and OCT's should be performed to evaluate the lesion type, location and size, and the presence of subretinal fluid.



• In accordance with the prescribing information for bevacizumab, screen all patients for medical conditions that would contraindicate the use of bevacizumab. This screening should include but is not limited to gastrointestinal hemorrhage or perforations, wound healing complications, other hemorrhage, arterial thromboembolic events, hypertension, proteinuria and heart failure. Currently published data excluded patients with a history of myocardial infarction or uncontrolled hypertension.



• Consider a medical screening and clearance for patients with medical comorbidities. Medical clearance should also be obtained when the patient is scheduled for any major surgery and should include when to stop the use of bevacizumab preoperatively and when bevacizumab may reasonably be restarted after surgery.

Patient Consent

• The patient should be clearly aware of the real potential for complications associated with this drug. This includes not only ophthalmic complications (such as endophthalmitis, detached retina and complications of increased intraocular pressure) but also complications associated with the use of bevacizumab in the treatment of cancer.



• The use of bevacizumab for the treatment of wet AMD is "off-label" and not FDA approved.



• Entry in the medical record documenting that these items have been discussed and that the patient appears to understand the risks and benefits of the use of this drug in an off label setting. Formal consent and documentation should also follow specialty societies and risk management guidelines and may include added notes as recommended in these guidelines.

Drug Administration
The medical record must contain the actual dosage, site, the lot number of the vial, date and time of administration and any unusual reactions.

CPT/HCPCS Codes
J3590 should be used when bevacizumab injection is prepared in the physician's office or more often when a supplier or pharmacist compounds the drug and provides it to the physician to inject.

ICD-9 Codes that are Covered

Claim Information
Providers should maintain required documentation in case this data is needed to properly adjudicate the claim.

For J3590, include the drug's name and the actual dose given in item 19 of the HCFA-1500 form or claim equivalent. If the drug is compounded, a copy of the compounding invoice will be needed to properly adjudicate the claim.