24856-0002-XX Jetrea 0.375 MG/0.3ML SOLN (THROMBOGENICS)
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.
Ocriplasmin for the treatment of vitreomacular adhesion (VMA) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Ocriplasmin for the treatment of other conditions/diseases is considered investigational.
Ocriplasmin is considered medically appropriate if ALL of the following:
Individual is 18 years of age or older
Diagnosis is vitreomacular adhesion (VMA) confirmed by optical coherence tomography (OCT) or dynamic B-scan ultrasound
Condition is symptomatic (e.g., metamorphopsia (distorted vision), floaters, micropsia (flashes of light), visual acuity changes, central microscotoma, etc.)
Ocriplasmin is NOT considered medically appropriate for renewal
DOSAGE & ADMINISTRATION
Vitreomacular adhesion (VMA)
0.125 mg (0.1 mL) 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
LENGTH OF AUTHORIZATION
Coverage will be provided for a single injection into each affected eye and may not be renewed.
Refer to DOSAGE LIMITS below
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). Ocriplasmin for symptomatic vitreomacular adhesion (9.03.30). Retrieved February 20, 2019 from BlueWeb.BGarcia-Layana, A., Garcia-Arumi, J., Ruiz-Morena, J. M, Arias-Barquet, L., Cabrera-Lopez, F. and Figueroa, M. S., (2015). A review of current management of vitreomacular traction and macular hole. Journal of Ophthalmology, 2015 (809640). Retrieved May 30, 2019 from https://dx.doi.org/10.1155/2015/809640.
Khan, M. A., & Haller, J. A. (2016). Ocriplasmin for Treatment of Vitreomacular Traction: An Update. Ophthalmology and therapy, 5(2), 147–159. Retrieved May 30, 2019 from https://doi:10.1007/s40123-016-0062-6
Lexicomp Online. (2019). AHFS DI. Ocriplasmin. Retrieved May 28, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2018, March). Ocriplasmin. Retrieved May 28, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2017, February). Center for Drug Evaluation and Research. JETREA® (ocriplasmin) injection, for intravitreal injection Retrieved May 28, 2019, from http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/125422s037lbl.pdf.
Vitreomacular Traction Syndrome. American Society of Retina Specialists. Retrieved May 30, 2019 from https://www.asrs.org/patients/retinal-diseases/12/vitreomacular-traction-syndrome
ORIGINAL EFFECTIVE DATE: 11/5/2012
MOST RECENT REVIEW DATE: 9/30/2019
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.
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Maximum billable units per dose and over time by indication as a Medical Benefit