00023-3348-XX Ozurdex 0.7 MG IMPL (ALLERGAN)
Dexamethasone is a corticosteroid shown to suppress inflammation. In this application, the dexamethasone is loaded into a rod-shaped implant which is injected directed into the vitreous of the eye. The implant itself is composed of a PLGA matrix without a preservative which slowly degrades to lactic acid and glycolic acid.
Dexamethasone intravitreal implant for the treatment of the following is considered medically necessary if the medical appropriateness criteria are met: (See Medical Appropriateness below.)
Dexamethasone intravitreal implant for the treatment of other conditions/diseases is considered investigational.
Dexamethasone intravitreal implant is considered medically appropriate if ALL of the following:
Absence of ALL of the following:
Ocular or periocular infection
Glaucoma with cup to disc ratio greater than 0.8
Torn or ruptured posterior lens capsule
BCBST requirement: Must not be used in combination with other sustained-release intravitreal corticosteroids
Used for the treatment of ANY ONE of the following:
Macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)
Diabetic macular edema
Non-infectious uveitis affecting the posterior segment of the eye
Dexamethasone intravitreal implant is considered medically appropriate for renewal therapy if ALL of the following:
Individual continues to meet medical appropriateness criteria for initial approval
Absence of unacceptable toxicity from the implant, e.g., development of cataract, increased intraocular pressure, endophthalmitis, conjunctival hemorrhage
Disease response as indicated by ANY ONE of the following:
Macular edema following retinal vein occlusion or diabetic macular edema with stabilization of visual acuity or improvement in best-corrected visual acuity (BCVA) score when compared to baseline
Posterior Segment Uveitis with stabilization of visual acuity or improvement in BCVA score when compared to baseline or improvement in vitreous haze score (decrease in inflammation)
DOSAGE & ADMINISTRATION
One ophthalmic intravitreal injection (containing 0.7 mg dexamethasone implant) into affected eye(s) per 4 to 6 months
LENGTH OF AUTHORIZATION
Coverage will be provided for 1 implant per affected eye every 4 to 6 months and may be renewed
Click here to view DOSAGE LIMITS
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).
Castro-Navarro, V., Cervera-Taulet, E., Navarri-Palop, C., Monferrer-Adsuara, C., Hernández-Bel, L., Montero-Hernández, J. (2019). Intravitreal dexamethasone implant Ozurdex® in naïve and refractory patients with different subtypes of diabetic macular edema. BMC Ophthalmology, (2019) 19(15).
Mehta, H., Gillies, M., Fraser-Bell, S. (2015). Perspective on the role of Ozurdex® (dexamethasone intravitreal implant) in the management of diabetic macular oedema. Therapies in Advanced Chronic Disease. 2015 Sep;6(5):234-45.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, April). Dexamethasone. Retrieved April 23, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, May). Center for Drug Evaluation and Research. Ozurdex®(dexamethasone intravitreal implant) for intravitreal injection. Retrieved April 23, 2019 from https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/022315s012lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 9/30/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
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Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 0.1 mg