68611-0190-XX ILUVIEN 0.19MG Implant ( (ALIMERA SCIENCES)
Fluocinolone is a corticosteroid. Corticosteroids generally inhibit inflammatory response to a variety of conditions including edema. Diabetic macular edema is was one form of edema that has had historical difficulty in treatment until an intravitreal form of corticosteroidal implant in a time released formula was developed.
Fluocinolone intravitreal implant for the treatment of diabetic macular edema is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Fluocinolone intravitreal implant for the treatment of other conditions/diseases is considered investigational.
Fluocinolone intravitreal implant is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of Diabetic Macular Edema
Individual is 18 years of age or older
Prior treatment with a course of corticosteroids without clinically significant rise in intraocular pressure
Absence of ocular and periocular infections
BCBST requirement: Must not be used in combination with other sustained-release intravitreal corticosteroids (e.g., dexamethasone implant)
Absence of glaucoma with cup to disc ratio of greater than 0.8
Individual does not have a torn or ruptured posterior lens capsule
Individual’s best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment
Individual’s intraocular pressure is measured at baseline and periodically throughout therapy
Fluocinolone intravitreal implant is considered medically appropriate for renewal every 36 months (one implant per eye) if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Response to treatment as indicated by stabilization of visual acuity or improvement in BCVA score when compared to baseline
Absence of unacceptable toxicity from the implant. Examples of unacceptable toxicities include: endophthalmitis and retinal detachments, increase in intraocular pressure, ocular inflammation, posterior subcapsular cataracts, glaucoma, etc.)
DOSAGE & ADMINISTRATION
Diabetic macular edema
Administer0.19 mg fluocinolone acetonide intravitreal implant into the affected eye(s), in a non-bioerodible intravitreal implant drug delivery system, once every 36 months
LENGTH OF AUTHORIZATION
Coverage will be provided for 1 implant per eye every 36 months and may be renewed.
Refer to DOSAGE LIMITS below
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).
BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2018). Intravitreal Corticosteroid Implants (9.03.23). Retrieved January 3, 2019 from BlueWeb.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, December). Fluocinolone. Retrieved June 16, 2020 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2017, March). Center for Drug Evaluation and Research. ILUVIEN® (fluocinolone acetonide intravitreal implant). Retrieved June 16, 2020 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/201923s000lbl.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 10/31/2020
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