24208-0416-XX Retisert 0.59 MG IMPL (VALEANT)
Fluocinolone acetate is a synthetic corticosteroid used to inhibit the inflammatory response. This intravitreal implant form of the agent is a tablet designed to release the agent slowly over 30 months for the treatment of uveitis. After depletion of the tablet it may be replaced if necessary.
Fluocinolone acetate intravitreal implant for the treatment of uveitis is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Fluocinolone acetate intravitreal implant (Retisert 0.59 mg Implant) for the treatment of other conditions/diseases is considered investigational.
Fluocinolone acetate intravitreal implant is considered medically appropriate if ALL of the following criteria are met:
Diagnosis of chronic (one year or greater history) non-infectious uveitis affecting the posterior segment of the eye(s)
Individual is 12 years of age or older
Absence of ocular and periocular infections
Fluocinolone acetate intravitreal implant is considered medically appropriate for renewal therapy if ALL of the following criteria are met:
Initial criteria for approval is still met
Absence of unacceptable complications/toxicity to implant, e.g.,cataract formation, endophthalmitis, increased intra-ocular pressure, etc;
Disease response as indicated by:
Posterior Segment Uveitis and 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)
|INDICATION(S)||DOSAGE & ADMINISTRATION|
|Chronic posterior non-infectious uveitis||0.59 mg fluocinolone acetonide intravitreal implant inserted into affected eye(s) once per 30 months|
LENGTH OF AUTHORIZATION
Coverage will be provided for 1 implant per eye every 30 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 May 3, 2018 from BlueWeb.
Lexi-Comp Online. (2018). AHFS DI. Fluocinolone Acetonide Intravitreal Implant. Retrieved May 3, 2018 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, April). Fluocinolone. Retrieved May 3, 2018 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2011, June). Center for Drug Evaluation and Research. RETISERT® (fluocinolone acetonide intravitreal implant). Retrieved May 3, 2018 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf.
ORIGINAL EFFECTIVE DATE: 12/1/2016
MOST RECENT REVIEW DATE: 8/14/2018
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.
This document has been classified as public information.
Maximum billable units per dose and over time by indication as a Medical Benefit 1 implant = 1 billable unit