BlueCross BlueShield of Tennessee Medical Policy Manual

Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema

NDC CODE(S)

Iluvien 0.9mg Implant - 68611-0190-xx (Alimera Sciences)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
Diabetic macular edema 0.19 mg fluocinolone acetonide, in a non-bioerodible intravitreal implant drug delivery system, designed to release fluocinolone acetonide at an initial rate of 0.25 μg/day and lasting 36 months

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.

IMPORTANT REMINDER

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.

ADDITIONAL INFORMATION 

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).

No controlled studies were found in the published literature that validate the use of fluocinolone intravitreal implants under the brand name Iluvien®  for the treatment of other conditions or diseases

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2016). Intravitreal Corticosteroid Implants (9.03.23). Retrieved August 8, 2016 from BlueWeb.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, May). Fluocinolone. Retrieved August 9, 2016 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2014, September). Center for Drug Evaluation and Research. ILUVIEN® (fluocinolone acetonide intravitreal implant). Retrieved August 9, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/201923s000lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  12/1/2016

ID_MRx

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.

Pharmaceutical Decision Support Tree

Fluocinolone Acetonide Intravitreal Implant for Diabetic Macular Edema (Iluvien®)

  1. Does the individual have a diagnosis of diabetic macular edema?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is this the initial request for treatment for this individual?

If yes, go to question #3

If no, go to question #5

  1. Does the individual show evidence of ALL of the following?

If yes, go to question #4

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for one implant, 0.19 mg fluocinolone acetonide in a non-bioerodible intravitreal implant drug delivery system, or 19 billable units, per eye for a period of 36 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual continue to meet the approval criteria in question #3?

If yes, go to question #6

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Does the individual show response to treatment as indicated by stabilization of visual acuity or improvement in BCVA score when compared to baseline?

If yes, go to question #7

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is there absence of unacceptable toxicity from the implant (e.g., endophthalmitis and retinal detachments, increase in intraocular pressure, ocular inflammation, posterior subcapsular cataracts or glaucoma)?

If yes, go to question #8

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for one implant, 0.19 mg fluocinolone acetonide in a non-bioerodible intravitreal implant drug delivery system, or 19 billable units, per eye, for a period of 36 months?

If yes, this satisfies medical necessity and medical appropriateness criteria

If no, this does not meet medical necessity and/or medical appropriateness criteria

This document has been classified as public information.