mp-312 - mp-312 - Medical Policies
Suprachoroidal Delivery of Pharmacological Agents
Policy Number: MP-312
Last Review Date: January 2021
Policy Grade: Effective January 1, 2015: Active Policy but no longer scheduled for regular literature reviews and updates
Suprachoroidal delivery of a pharmacologic agent is considered investigational.
DESCRIPTION OF PROCEDURE OR SERVICE:
Delivery of pharmacological agents to the suprachoroidal space is being investigated for treatment of diseases of the retina and optic nerve. A microcannula system is used that combines a drug delivery channel with a fiberoptic light source for localization of the cannula tip. 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. This technique is being investigated for the treatment of subchoroidal neovascularization related to diseases of the retina.
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
- Subconjunctival injections
- Transscleral diffusion from controlled release systems
- Topical administration on the eye
- Intravenous infusion and injection
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.
An example of a device for suprachoroidal delivery of a pharmacologic agent includes the iTrack™ from iScience Interventional. All devices for suprachoroidal delivery of a pharmacologic agent are considered investigational regardless of the commercial name, the manufacturer or FDA approval status.
Literature review through January 2021.
SUMMARY OF EVIDENCE:
Controlled trials are needed to evaluate the safety and efficacy of suprachoroidal drug administration compared to the standard of care. Evidence to date consists of two small case series from the same group of investigators in Europe. Current evidence is insufficient to determine whether suprachoroidal delivery of pharmacologic agents improves the net health outcome. Thus, this procedure is considered investigational.
PRACTICE GUIDELINES AND POSITION STATEMENTS
No guidelines or statements were identified.
U.S. PREVENTIVE SERVICES TASK FORCE RECOMMENDATIONS
Suprachoroidal delivery system, iTrack™, suprachoroidal delivery of pharmacological agents
APPROVED BY GOVERNING BODIES:
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.”
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply
FEP contracts: FEP does not consider investigational if FDA approved and will be reviewed for medical necessity. Special benefit consideration may apply. Refer to member’s benefit plan.
|67299||Unlisted procedure, posterior segment|
Suprachoroidal injection of a pharmacologic agent (does not include supply of medication)
- Abarca EM, Salmon JH, Gilger BC. Effect of choroidal perfusion on ocular tissue distribution after intravitreal or suprachoroidal injection in an arterially perfused ex vivo pig eye model. J Ocul Pharmacol Ther. 2013;29(8):715-722.
- Chen M, Li X, Liu J, et al. Safety and pharmacodynamics of suprachoroidal injection of triamcinolone acetonide as a controlled ocular drug release model. J Control Release. 2015;203:109-117.
- Del Amo EM, Urtti A. Current and future ophthalmic drug delivery systems. A shift to the posterior segment. Drug Discov Today. 2008 Feb;13(3-4):135-43.
- Gilger BC, Mandal A, Shah S, et al. Episcleral, intrascleral, and suprachoroidal routes of ocular drug delivery -recent research advances and patents. Recent Pat Drug Deliv Formul. 2014;8(2):81-91.
- Goldstein DA, Do D, Noronha G, et al. Suprachoroidal corticosteroid administration: A novel route for local treatment of noninfectious uveitis. Transl Vis Sci Technol. 2016;5(6):14.
- Habot-Wilner Z, Noronha G, Wykoff CC, et al. Suprachoroidally injected pharmacological agents for the treatment of chorio-retinal diseases: A targeted approach. Acta Ophthalmol. 2019;97(5):460-472.
- Hartman RR, Kompella UB. Intravitreal, subretinal, and suprachoroidal injections: Evolution of microneedles for drug delivery. J Ocul Pharmacol Ther. 2018;34(1-2):141-153.
- iScience Interventional. iTrackTM Microcatheter [website]. Menlo Park, CA: iScience Interventional; 2008. Available at: http://www.iscienceinterventional.com/US/itrack.htm.
- Kadam RS, Williams J, Tyagi P, et al. Suprachoroidal delivery in a rabbit ex vivo eye model: Influence of drug properties, regional differences in delivery, and comparison with intravitreal and intracameral routes. Mol Vis. 2013;19:1198-1210.
- Olsen T. Drug delivery to the suprachoroidal space shows promise. Retina Today; March/April 2007. Available online at: www.retinatoday.com/Html%20Pages/0307/0307_feature_olsen.pdf.
- 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.
- 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.
- Pearce W, Hsu J, Yeh S. Advances in drug delivery to the posterior segment. Curr Opin Ophthalmol. 2015;26(3):233-239.
- Rai Udo J, Young SA, Thrimawithana TR, et al. The suprachoroidal pathway: A new drug delivery route to the back of the eye. Drug Discov Today. 2015;20(4):491-495.
- Rizzo S, Ebert FG, Bartolo ED et al. Suprachoroidal drug infusion for the treatment of severe subfoveal hard exudates. Retina 2012; 32(4):776-84.
- Rosenbaum, James. Uveitis: Treatment. In: UpToDate Post TW (Ed), UpToDate, Waltham, MA. Topic last updated: November 2019. Available at <http://www.uptodate.com> (Accessed January 2021).
- 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): 183-9.
- Venkatesh P, Takkar B. Suprachoroidal injection of biological agents may have a potential role in the prevention of progression and complications in high myopia. Med Hypotheses. 2017;107:90-91.
- Willoughby AS, Vuong VS, Cunefare D, et al. Choroidal changes after suprachoroidal injection of triamcinolone acetonide in eyes with macular edema secondary to retinal vein occlusion. Am J Ophthalmol. 2018;186:144-151.
- U.S. Food and Drug Administration. Center for Devices and Radiological Health. Summary of Safety and Effectiveness: iScience Surgical Ophthalmic Microcannula (iTRACK) - June 22, 2004. Available online at: www.accessdata.fda.gov/scripts/cdrh/devicesatfda/index.cfm?db=pmn&id=K041108.
Medical Policy Group, December 2007 (2)
Medical Policy Administration Committee, January 2008
Available for comment January 5-February 20, 2008
Medical Policy Group, December 2008 (1) Update to Key Points and References; no change to policy statement
Medical Policy Group, December 2009 (1)
Medical Policy Group, December 2010 (1): Description updated, reference list updated.
Medical Policy Group, October 2011 (1): Update to Description, Key Points and References; no change in policy statement
Medical Policy Panel, December 2012
Medical Policy Group, January 2013 (1): Update to Key Points and References, no change to policy statement
Medical Policy Group, December 2013 (1): 2014 Coding Update: added unlisted code 67299, effective for use 01/01/2014; moved deleted code 0186T to Previous Coding section, effective 01/01/2014
Medical Policy Panel, December 2013
Medical Policy Group, January 2014 (1): Update to References with current literature search; no change to policy statement
Medical Policy Panel, December 2014
Medical Policy Group, February 2015 (6): Update to Key Points, Approved by Governing Bodies and References; retiring policy; no change to policy statement.
Medical Policy Group, November 2019 (6): Updates to Description, Key Points, Governing Bodies, Current Coding (0465T) and References.
Medical Policy Group, January 2021 (6): Updates to Description, Key Points and References.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.