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Clinical Policy Bulletin:
Suprachoroidal Injection of Pharmacologic Agents
Number: 0777


Policy

Aetna considers suprachoroidal injection of pharmacologic agents experimental and investigational for all indications because the effectiveness of this approach has not been established.



Background

Treatment of diseases of the posterior segment of the eye such as choroidal neovascularization presents a major challenge in ophthalmology.  The posterior segment of the eye, including the retina, macula, and optic nerve, is difficult to access due to the recessed location within the orbital cavity. 

Current drug delivery techniques to access the posterior segment of the eye include intra-vitreal injections, peri-ocular injections (i.e., subconjunctival, subtenon, or juxtascleral), and intra-vitreal implants.  Drug delivery by injection into the suprachoroidal space is another technique that has recently been proposed in the treatment of posterior segment disease.  The suprachoroidal space provides a potential route of access from the anterior region of the eye to the posterior region.

The iScience Surgical Ophthalmic Microcannula, or iTrack (iScience Surgical Corporation, Menlo Park, CA) is designed to access ocular structures such as schlemm's canal, subretinal space, vitreous cavity, and the suprachoroidal space.  The iTrack received 510(k) clearance from the U.S. Food and Drug Administration on June 22, 2004 as a flexible microcannual for atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics.  The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.

There is inadequate evidence regarding the clinical utility of supracoroidal injection of pharmacologic agents for the treatment of any ophthalmologic condition.  Clinical outcome studies published in the peer-reviewed medical literature are needed to determine the value of this drug delivery method in the management of patients with diseases of the posterior segment of the eye.
 
CPT Codes / HCPCS Codes / ICD-9 Codes
CPT codes not covered for indications listed in the CPB:
0186T


The above policy is based on the following references:
  1. Olsen T. Drug delivery to the suprachoroidal space shows promise. Retina Today. 2007;March/April:36-39.
  2. Olsen TW, Feng X, Wabner K, et al. Cannulation of the suprachoroidal space: A novel drug delivery methodology to the posterior segment. Am J Ophthalmol. 2006;142(5):777-787. 
  3. U.S. Food and Drug Administration (FDA). iScience surgical ophthalmic microcannula. 510(k) Summary. K041108. iScience Surgical Corporation, Redwood City, CA. Rockville, MD: FDA; June 22, 2004. Available at: http://www.fda.gov/cdrh/pdf4/k041108.pdf. Accessed January 8, 2008.
  4. iScience Interventional. iTrackTM Microcatheter. iScience InterventionalTM. Menlo Park, CA. Available at: http://www.iscienceinterventional.com/US/itrack.htm. Accessed January 8, 2008.
  5. Patel SR, Lin AS, Edelhauser HF, Prausnitz MR. Suprachoroidal drug delivery to the back of the eye using hollow microneedles. Pharm Res. 2011;28(1):166-176.


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Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.
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