Jetrea (Ocriplasmin) - JE Part B

Jetrea® (Ocriplasmin) is approved for the treatment of specific ocular conditions with the intent to prevent the need for surgery. Noridian has reviewed the proper use of this agent with the specialty societies and researchers that have experience with it. Based upon their professional feedback, we have adopted the following coverage criteria.

A single intravitreal injection of Ocriplasmin is considered medically necessary for treatment of an eye* with symptomatic vitreomacular adhesion (VMA) when all of the following criteria are met:

1. Individual's age is equal to or greater than 18 years;
2. 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).
3. Individual has best-corrected visual acuity of 20/25 or less in the eye to be treated with ocriplasmin;
4. Individual does not have any of the following:
   • proliferative diabetic retinopathy;
   • neovascular age-related macular degeneration;
   • retinal vascular occlusion;
   • aphakia;
   • high myopia (more than -8 diopters);
   • macular hole greater than 400 µm in diameter;
   • vitreous opacification;
   • lenticular or zonular instability;
   • history of retinal detachment in either eye;
   • prior vitrectomy in the affected eye;
   • prior laser photocoagulation of the macula in the affected eye.
   • lprior treatment with ocular surgery, intravitreal injection or retinal laser photocoagulation in the previous 3 months;
   • patients with uncontrolled glaucoma.

*Note: For treatment of bilateral VMA, a waiting period of at least seven (7) days is recommended before treatment of the contralateral eye.

Coding Guidelines

Sources

Peer Reviewed Publications

1. Benz MS, Packo KH, Gonzalez V, et al. A placebo-controlled trial of microplasmin intravitreous injection to facilitate posterior vitreous detachment before vitrectomy. Ophthalmology. 2010; 117(4):791-797.
2. Sebag, J. Treatment of vitreomacular adhesion: present status, future prospects. Retina Today. 2012; 55-58.
3. Stalmans P, Benz MS, Gandorfer A, et al.; MIVI-TRUST Study Group. Enzymatic vitreolysis with ocriplasmin for vitreomacular traction and macular holes. N Engl J Med. 2012; 367(7):606-615.
4. Stalmans P, Delaey C, de Smet MD, et al. Intravitreal injection of microplasmin for treatment of vitreomacular adhesion: results of a prospective, randomized, sham-controlled phase II trial (the MIVI-IIT trial). Retina. 2010; 30(7):1122-1127.

Government Agency, Medical Society and Other Authoritative Publications

1. American Hospital Formulary Service® (AHFS®). AHFS Drug Information 2012®. Bethesda, MD: American Society of Health-System Pharmacists, 2012.