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MP 9.03.19 Suprachoroidal Delivery of Pharmacological Agents

Medical Policy
Section
Other 		 Original Policy Date
12:2007		 Last Review Status/Date
Created with literature review/10:2009
Issue
10:2009		 Return to Medical Policy Index

Disclaimer
Our medical policies are designed for informational purposes only and are not an authorization, or an explanation of benefits, or a contract.  Receipt of benefits is subject to satisfaction of all terms and conditions of the coverage.  Medical technology is constantly changing, and we reserve the right to review and update our policies periodically.

Description

Delivery of pharmacological 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 while 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:
Classification of the 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
    • Transcleral diffusion from controlled release systems
  • Non-invasive 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. Though 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 for alternative routes of administration.

One potential advantage of suprachoroidal injection would be the ability to minimize systemic side 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 is used that 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) 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 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.

Policy Guidelines

Beginning January 1, 2008, there is a category III CPT code specific to suprachoroidal delivery of pharmacologic agents:
0186T: Suprachoroidal delivery of pharmacologic agent (does not include supply of medication)

Benefit Application

BlueCard/National Account Issues

No applicable information.

Rationale

A search of the MEDLINE database to December 2007 did not identify any clinical studies. One review discussed tests of the suprachoroidal injection technique in pig eyes. (1) The industry-funded studies included pharmacokinetic analysis of triamcinolone (1% sodium hyaluronate in controls) in various tissues of the eye as well as anatomical, physiological, and short- and long-term histopathological effects. Triamcinolone (3 mg) was found to remain at detectable levels in the posterior tissues of the pig eye for up to 120 days. Adverse events included infection (2/94), scleral ectsia (4/94), choroidal blood flow abnormalities (4/94), and inflammation (6/94). The author reported that some cannula tip designs resulted in snag lesions in the pigment epithelium, and that the suprachoroidal space was found to separate from the sclera following injection of sodium hyaluronate, but returned to a normal position after 1 month. The author noted that these data have been used to demonstrate the “relative” safety of this methodology for humans, and that clinical trials are in progress to investigate the potential use of this technology for treatment of macular disease. This procedure is investigational.

2008-2009 Update

A search of the MEDLINE database was performed for the period January 2008 through August 2009.
The literature search identified no clinical trial for suprachoroidal delivery of pharmacological agents.

A review article by Del Amo et al. (2) discusses the emerging methods of ocular drug delivery which include: polymeric-controlled release injections and implants; nanoparticulates; microencapsulated cells; iontophoresis; and gene therapy. The authors note the biggest drug delivery challenge is to develop effective methods for posterior segment therapies that would also be applicable for the out-patient use.

Summary

The evidence remains insufficient for the use of suprachoroidal delivery of pharmacological agents to improve net health outcome. Thus, the policy statement regarding this technique is unchanged.

Medicare National Coverage
No national coverage determination

References:

  1. Olsen T. Drug delivery to the suprachoroidal space shows promise. Retina Today; March/April 2007; available at: http://www.retinatoday.com/Html%20Pages/0307/0307_feature_olsen.pdf Last viewed December 2007.
  2. Del Amo EM, Urtti A. Current and future ophthalmic drug delivery systems. A shift to the posterior segment. Drug Discov Today 2008; 13(3-4):135-43.

 

Codes

Number

Description
CPT  0186T  Suprachoroidal delivery of pharmacologic agent (does not include supply of medication) (new code effective 1/1/08)
ICD-9 Procedure 
ICD-9 Diagnosis  Investigational for all codes 
HCPCS J2503 Injection, pegaptanib sodium, 0.3 mg
  J2778 Injection, ranibizumab, 0.1 mg (new code effective 1/1/08)
Type of Service  Vision 
Place of Service  Physician's Office

Index

Suprachoroidal delivery
Choroidal neovascularization
Macular degeneration

Policy History

Date Action Reason
12/13/07 Add policy to Other section, Vision subsection New policy
10/06/09 Replace policy Policy updated with literature search for the period January 2008 through August 2009; reference number 2 added; no change in policy statement.

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