DESCRIPTION
Delivery of pharmacologic agents to the suprachoroidal space is being investigated for treatment of posterior eye segment diseases. The structure of the eye is classified under two subheadings: (1) anterior segment, and (2) posterior segment. The anterior segment consists of the front one-third of the eye that includes; pupil, cornea, iris, ciliary body, aqueous humor, and lens; the posterior segment consists of the back two-thirds of the eye that includes vitreous humor, retina, choroid, macula, and optic nerve. Posterior segment ocular diseases (e.g., age-related macular degeneration, diabetic neuropathy) are the most prevalent causes of visual impairment. The following is a list of the various routes for ocular drug administration:
Invasive drug administration to intraocular cavities
Suprachoroidal injections
Intravitreal surgery
Intravitreal injections
Intracameral surgery
Subretinal injection
Intracameral injections
Invasive periocular and scleral modes of drug administration
Intrascleral surgery
Episcleral surgery
Periocular injections
Subconjuctival injections
Transscleral diffusion from controlled release systems
Noninvasive methods
Topical administration on the eye
Systemic administration
Intravenous infusion and injection
Oral
Many ocular diseases are treated with either topical or systemic medications. Topical application has remained the most preferred delivery route due to ease of administration. Topical application is useful in the treatment of disorders affecting the anterior segment of the eye. Although topical and systemic routes are convenient, lack of bioavailability and failure to deliver therapeutic levels of drugs to the retina has prompted vision scientists to continue to explore alternative routes of administration.
One potential advantage of suprachoroidal injection would be the ability to minimize systemic adverse effects while delivering higher local tissue levels of drugs. This proposed benefit assumes that high local levels lead to improved outcomes. Weighed against this potential benefit is the risk of localized tissue damage from the microcannula. A microcannula system combines a drug delivery channel with a fiberoptic light source for localization of the cannula tip. This technique is being investigated for the treatment of subchoroidal neovascularization related to diseases of the retina.
The iTrack™ (iScience Interventional), which is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye for infusion and aspiration of fluids during surgery, received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA). The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance. The microcannula “is indicated for fluid infusion and aspiration, as well as illumination, during surgery.”
POLICY
Suprachoroidal delivery of a pharmacologic agent is considered investigational.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
Evidence remains insufficient for the use of suprachoroidal delivery of pharmacologic agents to improve the net health outcome. Thus, this procedure is considered investigational.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (10:2010). Suprachoroidal delivery of pharmacologic agents (9.03.19). Retrieved December 29, 2010 from BlueWeb. (2 articles and / or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 4/4/2011
MOST RECENT REVIEW DATE: 4/4/2011
ID_EBA
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