Medical Policy

 

Subject: Suprachoroidal Injection of a Pharmacologic Agent
Document #: SURG.00101 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

This document addresses the use of an injection of a pharmacologic agent into the suprachoroidal space.

Position Statement

Investigational and Not Medically Necessary:

Suprachoroidal injection of a pharmacologic agent is considered investigational and not medically necessary for all indications.

Rationale

Injection into the suprachoroidal space has been proposed as a method to effectively deliver pharmacologic agents to the posterior segment of the eye. The posterior segment of the eye, including the retina, macula and optic nerve, is difficult to access due to the recessed position within the orbital cavity. Local delivery of pharmacologic agents to the posterior segment of the eye is essential in the management of diseases or degenerations of the retina and optic nerve. Current local drug delivery techniques to access the posterior segment are intravitreal injections, periocular injections and intravitreal implants.

At this time, published, peer-reviewed literature is limited. In a 2012 retrospective analysis by Tetz and colleagues, the authors reported on the safety and feasibility of delivering bevacizumab in combination with triamcinolone acetonide via a microcatheter to the suprachoroidal space of individuals with age-related macular degeneration unresponsive to conventional therapy. Conventional therapy included intravitreal injections of bevacizumab and/or ranibizumab, pegaptanib, and photodynamic therapy. A total of 21 participants were included in the review. The average best-corrected visual acuity was 0.98 logMAR which is characteristic of advanced macular degeneration. At the 1-month visit, the mean best-corrected visual acuity was 0.92 logMAR; at 3 months the mean best-corrected visual acuity was 0.96 logMAR, and at 6 months it was 0.93 logMAR. Central subfield foveal thickness showed an initial decrease at 1 month, then trended to preoperative levels at 6 months following insertion. Following the insertion of the microcatheter, 1 participant experienced an elevated intraocular pressure at the 3-month visit which returned to the preoperative level at 6 months following temporary glaucoma medication therapy. The authors conclude that further studies are necessary on larger participant groups to compare suprachoroidal injection to conventional intravitreal injections.

There is a need for additional studies to determine whether this technique is superior to other currently available treatment options for posterior segment disease.

Background/Overview

The suprachoroidal space is a potential space in the eye that is located between the choroid, and the sclera, the outer layer of the eye. The suprachoroidal space extends from the anterior portion of the eye near the ciliary body to the posterior end of the eye near the optic nerve. Normally the suprachoroidal space is not evident due to the close apposition of the choroid to the sclera from the intraocular pressure of the eye. Since there is no substantial attachment of the choroid to the sclera, the tissues separate to form the suprachoroidal space when fluid accumulation or other conditions occur. The suprachoroidal space provides a potential route of access from the anterior region of the eye to treat the posterior region.

Suprachoroidal injection of a pharmacologic agent has been proposed as an alternative to intravitreal and periocular injections. One example of a device that injects agents into the suprachoroidal space is the iScience Surgical Ophthalmic Microcannula or iTrack™ (iScience Interventional™, Menlo Park, CA). The iTrack received 510(k) clearance on June 22, 2004 as a flexible microcannula designed to allow 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.

Definitions

Choroid: The vascular layer of the eye that lies between the retina and the sclera. It provides nourishment to outer layers of the retina.

Sclera: The dense fibrous opaque white outer coat enclosing the eyeball.

Suprachoroidal: Of, relating to, or being the layer of loose connective tissue situated between the choroid and sclera.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When Services are Investigational and Not Medically Necessary:
When the code describes a procedure indicated in the Position Statement section as investigational and not medically necessary.

CPT

 

0465T

Suprachoroidal injection of a pharmacologic agent (does not include supply of medication)

 

 

ICD-10 Diagnosis

 

 

All diagnoses

References

Peer Reviewed Publications:

  1. Tetz M, Rizzo S, Augustin AJ. Safety of submacular suprachoroidal drug administration via a microcatheter: retrospective analysis of European treatment results. Ophthalmologica. 2012; 227(4):183-189.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. U.S. Food and Drug Administration 510(k) Premarket Notification Database. iScience Surgical Ophthalmic Microcannula. Summary of Safety and Effectiveness. No. K041108. Rockville, MD: FDA. June 22, 2004. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf4/k041108.pdf. Accessed on October 4, 2017.
Index

iTrack
Ophthalmic microcannula
Suprachoroidal Injection

The use of specific product names is illustrative only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.”

Reviewed

11/03/2016

MPTAC review. Updated Coding section with 01/01/2017 CPT changes; removed 67299 NOC code.

Reviewed

11/05/2015

MPTAC review. Updated Rationale. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review.

Reviewed

11/14/2013

MPTAC review. Updated Rationale and References. Updated Coding section with 01/01/2014 CPT changes; removed 0186T deleted 12/31/2013.

Reviewed

11/08/2012

MPTAC review. Updated Rationale.

Reviewed

11/17/2011

MPTAC review. Updated Index.

Reviewed

11/18/2010

MPTAC review.

Reviewed

11/19/2009

MPTAC review. Updated References.

Reviewed

11/20/2008

MPTAC review. Updated Coding and Background/Overview sections.

New

11/29/2007

MPTAC review. Initial document development.