BlueCross BlueShield of Tennessee Medical Policy Manual

Fluocinolone Acetonide Intravitreal Implant for the Treatment of Uveitis

NDC CODE(S)

Retisert 0.59 mg Implant - 24208-0416-xx (Bausch & Lomb)

DESCRIPTION

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

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

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 implant under the brand name Retisert® for the treatment of other conditions and 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. RETISERT®  (fluocinolone acetonide intravitreal implant). Retrieved August 9, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021737s019.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  2/27/2018

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 the Treatment of Uveitis (Retisert®)

  1. Does the individual have a diagnosis of uveitis?

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 with this agent?

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 0.59 mg fluocinolone acetonide intravitreal implant (one billable unit) to be inserted into affected eye(s) once per 30 months (one per eye)?

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 disease show response as indicated by improvement in uveitis and lack of recurrence within the preceding 30 months?

If yes, go to question #7

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

  1. Was there absence of unacceptable complications/toxicity to the previous implant, e.g., eye pain, ocular/conjunctival hyperemia, reduced visual acuity (long term), conjunctival hemorrhage, headache?

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 0.59 mg fluocinolone acetonide intravitreal implant (one billable unit) to be inserted into affected eye(s) once per 30 months (one per eye)?

If yes, this satisfies medical necessity and medical appropriateness criteria

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

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