Subject:
Ocriplasmin (Jetrea®)
Description:
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IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
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Ocriplasmin is a recombinant form of human plasmin. Ocriplasmin has proteolytic activity against protein components of the vitreous body and the vitreoretinal interface (VRI), thereby dissolving the protein matrix responsible for the vitreomacular adhesion (VMA).1
Ocriplasmin is indicated for the treatment of symptomatic vitreomacular adhesion. This indication is based on two multicenter, randomized, double masked, vehicle-controlled, 6 month studies in patients with symptomatic vitreomacular adhesion (VMA). A total of 652 patients (ocriplasmin, 464; vehicle, 188) were randomized in these 2 studies. Patients were treated with a single injection of ocriplasmin or vehicle. In both of the studies, the proportion of patients who achieved VMA resolution at Day 28 was significantly higher in the ocriplasmin group (26.5%) compared with the vehicle group (10.1%) through Month 6 (P<0.001). Ocular adverse events were self-reported and occurred in 68.4% of ocriplasmin-injected eyes and in 53.5% of placebo-injected eyes (P<0.001), and the incidence of serious ocular adverse events was similar in the two groups (P=0.26). The most common adverse events (2%-<5%) included: macular edema, increased intraocular pressure, anterior chamber cell, photophobia, vitreous detachment, ocular discomfort, iritis, cataract, dry eye, metamorphopsia, conjunctival hyperemia, and retinal degeneration.1
Vitreomacular adhesion is observed after partial posterior vitreous detachment, when a portion of the posterior vitreous remains attached to the macula. When traction increases in response to anteroposterior forces, tangential forces, or both, the adhesion may cause vitreomacular traction and become symptomatic. Symptoms typically include metamorphopsia and blurring of visual acuity with central visual-field defects. Vitreomacular traction can lead to macular distortion and edema and to the formation of macular holes. Vitrectomy is the only treatment for vitreomacular traction and macular holes, and because it poses certain risks (infection, retinal detachment, hemorrhage, and cataract), it is usually withheld until loss of vision has become clinically significant.2
Ocriplasmin is marketed as Jetrea by ThromboGenics, Inc. in Iselin, New Jersey. Jetrea was approved by the U.S. Food and Drug Administration (FDA) on October 17, 2012.3
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance)
1. Jetrea (ocriplasmin) is considered medically necessary for the treatment of symptomatic vitreomacular adhesion in adults (≥18 years of age) when all of the following criteria are met:
a. Posterior segment optical coherence tomography (OCT) demonstrates all of the following:
- There is vitreous adhesion within 6-mm of the fovea (center of macula); AND
- There is elevation of the posterior vitreous cortex (outer layer of the vitreous); AND
b. Member has best-corrected visual acuity of 20/25 or less in the affected eye
c. Member does NOT have any of the following:
- Proliferative diabetic retinopathy; OR
- Neovascular age-related macular degeneration; OR
- Retinal vascular occlusion; OR
- Aphakia (absence of the lens of the eye); OR
- High myopia (more than −8 diopters); OR
- Uncontrolled glaucoma; OR
- Macular hole greater than 400 ìm in diameter; OR
- Vitreous opacification; OR
- Lenticular or zonular instability; OR
- History of retinal detachment in either eye; OR
- Prior vitrectomy in the affected eye; OR
- Prior laser photocoagulation of the macula in the affected eye; OR
- Prior treatment with ocular surgery, intravitreal injection or retinal laser photocoagulation in the previous 3 months.
d. The prescriber is a specialist in the area of the patient's diagnosis (e.g. ophthalmologist) or has consulted with a specialist in the area of the patient's diagnosis.
[INFORMATIONAL NOTE: As per the FDA approved package insert, the use of Jetrea in pediatric patients is not recommended. A single center, randomized, placebo controlled, double masked clinical study to investigate the safety and efficacy of a single intravitreal infection of 0.175mg ocriplasmin in pediatric subjects as an adjunct to vitrectomy was conducted in 24 hours of 22 patients. There were no statistical or clinical differences between groups for the injection of total macular PVD, any of the secondary endpoints or adverse events.]
2. Jetrea (ocriplasmin) is medically necessary for one time administration at the following FDA approved dose:
a. 0.125 mg (0.1 mL of the solution) administered by intravitreal injection to the affected eye(s) once as a single dose.
3. Repeated injections to the eyes is not considered medically necessary due to lack of safety and efficacy data based on the FDA package insert.
[INFORMATIONAL NOTE: Each vial should only be used to provide a single injection for the treatment of a single eye. If the contralateral eye requires treatment, a new vial should be used and the sterile field, syringe, gloves, drapes, eyelid speculum, and injection needles should be changed before JETREA is administered to the other eye, however, treatment with JETREA in the other eye is not recommended within 7 days of the initial injection in order to monitor the post-injection course including the potential for decreased vision in the injected eye.]
4. The use of Jetrea (ocriplasmin) in other conditions are considered investigational, including but not limited to the following conditions:
a. Proliferative diabetic retinopathy
b. Neovascular age-related macular degeneration
c. Retinal vascular occlusion
d. Aphakia
e. High myopia (more than -8 diopters)
f. Uncontrolled glaucoma
g. Macular hole greater than 400 µm in diameter
h. Vitreous opacification
i. Lenticular or zonular instability
j. History of retinal detachment in either eye
k. Prior vitrectomy, laser photocoagulation of the macula, treatment with ocular surgery, intravitreal injection, or retinal laser photocoagulation in the previous 3 months
l. Diabetic macular edema
m. Uveitis
n. Catheter-related thrombosis
o. Coronary artery thrombosis
p. Peripheral arterial occlusion
q. Stroke
Medicare Coverage
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage will follow the Horizon Policy.
Medicaid Coverage
For Horizon NJ Health members, please follow this link for the corresponding HNJH drug policy https://services3.horizon-bcbsnj.com/ddn/NJhealthWeb.nsf
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Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
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Index:
Ocriplasmin (Jetrea)
Jetrea (Ocriplasmin)
References:
1. Jetrea (ocriplasmin). [Prescribing Information]. ThromboGenics, Inc. Iselin, NJ 08830. February 2017.
2. Stalmans P, Benz MS, Gandorfer A, et al. Enzymatic Vitreolysis with Ocriplasmin for Vitreomacular Traction and Macular Holes. The New England Journal of Medicine 2012:367:606-15.
3. FDA News Release – FDA approves Jetrea for symptomatic vitreomacular adhesion in the eyes. FDA News & Events. October 18, 2012. Available at: www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm324369.htm
4. Jetrea (ocriplasmin). Micromedex Health Series. Thomson Gateway. Available at: http://www.micromedexsolutions.com/micromedex2/librarian/ND_T/evidencexpert/ND_PR/evidencexpert/CS/553136/ND_AppProduct/evidencexpert/DUPLICATIONSHIELDSYNC/21C152/ND_PG/evidencexpert/ND_B/evidencexpert/ND_P/evidencexpert/PFActionId/evidencexpert.DisplayDrugpointDocument?docId=930370&contentSetId=100&title=Ocriplasmin&servicesTitle=Ocriplasmin&topicId=dosingAndIndicationsSection&subtopicId=fdaSection
5. Jetrea (ocriplasmin). Clinical Pharmacology. 2016. Available at: http://clinicalpharmacology.com/Forms/Monograph/monograph.aspx?cpnum=3786&sec=monindi&t=0
6. Verhamme P, Jerome M, Goossems G, et al. A pilot trial of microplasmin in patients with long-term venous access catheter thrombosis. J Thromb Thrombolysis. 2009; 28(4):477-481.
7. Thijs VN, Peeters A, Vosko M, et al. Randomized, placebo-controlled, dose-ranging clinical trial of intravenous microplasmin in patients with acute ischemic stroke. Stroke. 2009;40(12):3789-3795.
8. Chambers W, Harris J. BLA 125422 – Jetrea (ocriplasmin) intravitreal injection. FDA Dermatologic and Ophthalmic Drugs Advisory Committee. July 2012. Accessed April 20, 2015. Available at: http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/DermatologicandOphthalmicDrugsAdvisoryCommittee/UCM314198.pdf
9. Verhamme P, Jerome M, Goossems G, et al. A pilot trial of microplasmin in patients with long-term venous access catheter thrombosis. J Thromb Thrombolysis. 2009; 28(4):477-481.
10. Dommke C, Turschner O, Stassen JM, et al. Thrombolytic efficacy of recombinant human microplasmin in a canine model of copper coil-induced coronary artery thrombosis. J Thromb Thrombolysis. 2010;30(1):46-54.
11. Verhamme P, Heye S, Peerlinck K, et al. Catheter-directed thrombolysis with microplasmin for acute peripheral arterial occlusion (PAO): An exploratory study. Int Angiol. 2012;31(3):289-96.
12. National Institutes of Health Clinical Center (CC); National Eye Institute (NEI). Microplamin intravitreal administration in participants with uvetic macular edema (MIME). Available from: http://clinicaltrials.gov/show/NCT01194674. NLM identifier: NCT01194674. Accessed April 21, 2015.
13. ClinicalTrials.gov accessed April 27, 2020 at https://clinicaltrials.gov/ct2/results?term= ocriplasmin=Search
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
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Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
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