BlueCross BlueShield of Tennessee Medical Policy Manual

Dexamethasone Intravitreal Implant

NDC CODE(S)

00023-3348-XX Ozurdex 0.7 MG IMPL (ALLERGAN)

DESCRIPTION

Dexamethasone is a corticosteroid shown to suppress inflammation.  In this application, the dexamethasone is loaded into a rod-shaped implant which is injected directed into the vitreous of the eye.  The implant itself is composed of a PLGA matrix without a preservative which slowly degrades to lactic acid and glycolic acid.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S) DOSAGE & ADMINISTRATION
All indications One ophthalmic intravitreal injection (containing 0.7 mg dexamethasone implant) into affected eye(s) per 4 to 6 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 dexamethasone intravitreal implant 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.

Mehta H, Gillies M, Fraser-Bell S. Perspective on the role of Ozurdex (dexamethasone intravitreal implant) in the management of diabetic macular oedema. Ther Adv Chronic Dis. 2015 Sep;6(5):234-45.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2017, August). Dexamethasone. Retrieved August 16, 2017 from MICROMEDEX Healthcare Series. 

U. S. Food and Drug Administration. (2014, September). Center for Drug Evaluation and Research. Ozurdex®(dexamethasone intravitreal implant) for intravitreal injection. Retrieved August 8. 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2014/022315s010lbl.pdf.

ORIGINAL EFFECTIVE DATE:  12/1/2016

MOST RECENT REVIEW DATE:  9/12/2017

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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

Dexamethasone Intravitreal Implant (Ozurdex®)

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

If yes, go to question #2

If no, go to question #5

  1. Does the individual have documented absence of ALL of the following?

If yes, go to question #3

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

  1. Does the individual have a diagnosis of ANY ONE 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 per affected eye containing 0.7 mg dexamethasone (7 billable units) for a period of 4 to 6 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 medical appropriateness criteria in questions #2 and 3?

If yes, go to question #6

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., development of cataract, increased intraocular pressure, endophthalmitis, or conjunctival hemorrhage?

If yes, go to question #7

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

  1. Is there disease response as indicated by ANY ONE of the following?

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 per eye containing 0.7 mg dexamethasone (7 billable units) for a period of 4 to 6 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.