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 decision to use bevacizumab is based on favorable anecdotal reports and on the fact that its related compound, ranibizumab, has shown promising early results as a therapy for "wet" AMD.

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

The following criteria are a minimum that should be clearly documented in the patient's medical record prior to the use of bevacizumab for the treatment of wet AMD.

1. PATIENT SELECTION
   1. The selected patient must have failed to improve or stabilize using other currently accepted ophthalmic therapies. This therapy may include Visudyne and/or Macugen.
   2. Given that the use of bevacizumab should only be attempted after other treatment failure(s), at least two fluoroscein angiograms and OCT's should be performed, the first to evaluate the lesion type, location and size and the presence of subretinal fluid and the second or subsequent to document failure of the initial therapy(ies).
   3. 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.
   4. 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.
2. PATIENT CONSENT
   1. 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.
   2. The use of bevacizumab for the treatment of wet AMD is "off-label" and not FDA or compendium approved.
   3. 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 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.

J3590 may 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.

CLAIMS Information

1. Provider should maintain required documentation is case this data is needed to properly adjudicate the claim.
2. For J9035 indicate the actual dose given in either Box 19 or the notepad.
3. For J3590 include the drug's name and the actual dose given in Box 19 or the notepad.
4. For compounded bevacizumab we will pay the actual invoice price with line itemization.