BlueCross BlueShield of Tennessee Medical Policy Manual

Ocriplasmin

NDC CODE(S)

24856-0001-XX - Jetrea 0.5 mg Injection (ThromboGenics, Inc)

DESCRIPTION

Ocriplasmin is a recombinant form of the human enzyme plasmin.  Plasmin is a serine proteinase which degrades protein components such as laminin, fibronectin and collagen which are found within the eye.  These protein components may clump together to form a protein matrix in the vitreous body and vitreoretinal interface which causes symptomatic vitreomacular adhesion (VMA).  VMA can contribute to eye problems if the vitreous begins to move away from the macula causing damage to the macula due to pulling and tugging.

Ocriplasmin breaks down the protein components to dissolve the matrices and allow better separation between the vitreous and macula.  This reduces the risk of adhesion and damage to the macula.  The only previous treatment for symptomatic VMA was the surgical option of a vitrectomy.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

·       Ocriplasmin is considered medically appropriate if ALL of the following:

RENEWAL CRITERIA

·       Ocriplasmin is NOT considered medically appropriate for renewal

INDICATION(S)

DOSAGE & ADMINISTRATION

Vitreomacular adhesion (VMA)

0.125 mg administered by intravitreal injection to the affected eye once as a single dose. For treatment of bilateral VMA, a waiting period of at least seven (7) days is recommended before treatment of the contralateral eye

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 ocriplasmin for the treatment of other conditions or diseases.

SOURCES

BlueCross BlueShield Association. Medical Policy Reference Manual. (3:2016). Ocriplasmin for symptomatic vitreomacular adhesion (9.03.30). Retrieved November 14, 2016 from BlueWeb.

Lexicomp Online. (2016). AHFS DI. Ocriplasmin. Retrieved November 14, 2016 from Lexicomp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Evaluations. (2016, October). Ocriplasmin. Retrieved November 14, 2016 from MICROMEDEX Healthcare Series. 

U. S. Food and Drug Administration. (2016, March). Center for Drug Evaluation and Research. Jetrea® (ocriplasmin) intravitreal injection, 2.5mg/mL. Retrieved November 14, 2016 from http://www.accessdata.fda.gov/drugsatfda_docs/label/2016/125422s037lbl.pdf.

ORIGINAL EFFECTIVE DATE:  11/5/2012

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

Ocriplasmin (Jetrea ®)

 

1.     Is this the initial request for this agent (per eye, left or right)?

 

If yes, go to question # 2

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

 

2.     Does the individual have a diagnosis of symptomatic vitreomacular adhesion (VMA)?

 

If yes, go to question # 3

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

 

3.     Is the request for a single injection per eye as specified left or right?

 

If yes, go to question # 4

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

 

4.     Is the request for 4 billable units per eye x 1 for dosage of 0.125 mg by intravitreal injection per eye as a single dose with a recommended waiting period of at least 7 days before treatment of the contralateral eye?

 

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.