Suprachoroidal Delivery of Pharmacological Agents

POLICY NUMBER

L.9.03.402

DESCRIPTION

Delivery of pharmacological agents to the suprachoroidal space is being investigated for treatment of diseases 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 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 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.”

Other currently used and proposed treatments for CNV are addressed in Transpupillary Thermotherapy for Treatment of Choroidal Neovascular Conditions

POLICY

Suprachoroidal delivery of a pharmacologic agent is considered investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

1/11/2008: Policy added.

3/27/2008: Reviewed and approved by the Medical Policy Advisory Committee (MPAC).

04/19/2010: Policy description rewritten extensively regarding treatment approaches. Policy statement unchanged. FEP verbiage added to the Policy Exceptions section.

12/30/2010:  Policy reviewed; no changes.

12/01/2011:  Policy reviewed; no changes.

04/03/2013:  Policy reviewed; no changes.

03/13/2014:  Policy reviewed; no changes.

08/31/2015: Code Reference section revised for ICD-10. Removed deleted CPT code 0186T from the Code Reference section. Added CPT code 67299.

05/27/2016: Policy number L.9.03.402 added. Investigative definition updated in Policy Guidelines section.

12/30/2016: Code Reference section updated to add new 2017 CPT code 0465T.

05/29/2018: Medical policy link updated in policy description.

06/30/2023: Policy reviewed; no changes.

12/21/2023: Code Reference section updated to add new 2024 CPT code 67516, effective 01/01/2024.

06/24/2024: Policy reviewed; no changes.

SOURCE(S)

Blue Cross & Blue Shield Association Policy # 9.03.19

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

Investigational Codes

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