71879-0136-XX Yutiq 0.18 mg IMPL (EYEPOINT PHARMACEUTICALS US)
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 acetate intravitreal implant (Yutiq™) for the treatment of chronic non-infectious uveitis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Fluocinolone acetate intravitreal implant for the treatment of other conditions/diseases is considered investigational.
Fluocinolone acetate intravitreal implant (Yutiq™) is considered medically appropriate if ALL of the following criteria are met:
Individual is 18 years of age or older
Absence of ocular and periocular infections
Diagnosis of chronic (one year or greater history) non-infectious uveitis affecting the posterior segment of the eye(s)
Other causes of uveitis have been ruled out (e.g., infection, malignancy, etc.)
BCBST requirement: Must not be used in combination with other sustained-release intravitreal corticosteroids (e.g., dexamethasone implant)
Individual does not have a torn or ruptured posterior lens capsule
Individuals best corrected visual acuity (BCVA) is measured at baseline and periodically during treatment
Individuals intraocular pressure is measured at baseline and periodically throughout therapy
Fluocinolone acetate intravitreal implant is considered medically appropriate for renewal if ALL of the following criteria are met:
Individual continues to meet initial approval criteria
Absence of unacceptable toxicity from the drug. Examples of unacceptable toxicity include the following: cataract formation, endophthalmitis, increased intra-ocular pressure, etc
Disease response as indicated by ANY ONE of the following:
Stabilization of visual acuity or improvement in BCVA score when compared to baseline
Improvement in vitreous haze score (decrease in inflammation
DOSAGE & ADMINISTRATION
Chronic posterior non-infectious uveitis
Administer 0.18 mg fluocinolone acetonide intravitreal implant inserted, into affected eye(s), in a non-bioerodible intravitreal implant drug delivery system, once per 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).
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, March). Fluocinolone. Retrieved May 26, 2020 from MICROMEDEX Healthcare Series.
Eyepoint Pharmaceuticals. (2018, October). Package Insert YUTIQ® (fluocinolone acetonide intravitreal implant). Retrieved June 1, 2020 from https://eyepointpharma.com/wp-content/uploads/2018/10/YUTIQ-USPI-20181013.pdf
Testi, I., Pavesio, C. (2019) Preliminary Evaluation of YUTIQ™ (Fluocinolone Acetonide Intravitreal Implant 0.18 Mg) in Posterior Uveitis Therapeutic Delivery. 10 (10):621-625. doi: 10.4155/tde-2019-0051. Epub 2019 Oct 30.
ORIGINAL EFFECTIVE DATE: 3/2/2019
MOST RECENT REVIEW DATE: 9/30/2020
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 1 billable unit = 0.01 mg