There is a critical nationwide shortage of Avastin, which is one of the treatment options for patients with sight threatening eye diseases such as wet macular degeneration, macular edema, neovascular glaucoma, and others. Macular edema can be caused by diabetic retinopathy or retinal vascular occlusions. Neovascular glaucoma is a complication of poor blood circulation in the retina.
The shortage has affected both access to and the price of the drug. The shortage is caused by an FDA pharmacopeia compliance standard that specifies a limit on particulate matter in ophthalmic injections and solutions.
Particulate matter in injections is extraneous particles that are unintentionally present in the drug. Particulate contaminants can come from various sources such as the packaging materials and undissolved formulation ingredients.
Particulate matter can be harmful when introduced into the bloodstream and that is the reason the United States Pharmacopeia (USP) places limits on the amount of sub-visible particles that are allowed in both ophthalmic injections and solutions.
There are required tests that must be done to ensure that ophthalmic injections and solutions pass the particulate matter requirement before they can be shipped to doctors and hospitals for use on patients.
New Syringe Needed
Facilities that package Avastin have had to switch to a different type of syringe that can meet the new stringent USP particle count standard, but many facilities are still having trouble with failure rates and so are not able to ship the drug.
In addition, repackaging Avastin with FDA-particulate compliant syringes requires more of the drug than was previously used in the older type of syringe.
Facilities that package Avastin have cited this as the reason for the increased price of Avastin. For example, 50 syringes could be prepared using a 100mg/4mL vial of Avastin, but with the new syringe type, only 20 syringes can be filled with the drug.
The American Academy of Ophthalmology (AAO) informed the FDA at a public meeting on May 21 of the shortage and subsequent price increase. The AAO has also asked the Centers for Medicare & Medicaid Service (CMS) to modify the reimbursement rates to reflect the increased price.
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