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CMS grants permanent J-Code for ThromboGenics’ Jetrea

Leuven, BelgiumWednesday, December 4, 2013, 15:00 Hrs  [IST]

ThromboGenics NV, an integrated biopharmaceutical company focused on developing and commercializing innovative ophthalmic medicines, has announced that CMS (Center for Medicare and Medicaid Services) has published the permanent HCPCS (Healthcare Common Procedure Coding System) code for Jetrea (ocriplasmin) J7316. The permanent J-Code for Jetrea will become effective January 1, 2014.

The absence of a HCPCS code for Jetrea has meant that US physicians have had to manually submit Jetrea claims to payers following their use of this novel treatment for symptomatic VMA (vitreomacular adhesion). This has led to delays in reimbursement, and certain inefficiencies in use of financial working capital at a retina practice management level. The permanent J-Code will streamline the reimbursement process for retina practices and instil higher reimbursement confidence. Recent market research conducted by ThromboGenics has highlighted that the lack of a permanent J-Code is having an adverse impact on the uptake of Jetrea.

Dr Patrik De Haes, CEO of ThromboGenics said, “We are extremely pleased that the CMS has granted a permanent J-Code for Jetrea. We are confident that the automation of the reimbursement process will be an important facilitator in this novel product’s uptake as US physicians will now be reimbursed for Jetrea in a timelier and more efficient manner.”

Jetrea (ocriplasmin) is a truncated form of human plasmin. In the US, Jetrea is indicated for the treatment of symptomatic VMA. In Europe, Jetrea is indicated for the treatment of vitreomacular traction (VMT), including when associated with macular hole of diameter = 400 microns. Jetrea is a selective proteolytic enzyme that cleaves fibronectin, laminin and collagen, three major components of the vitreoretinal interface that play an important role in vitreomacular adhesion.

Jetrea has been evaluated in two multi-center, randomized, double-masked phase III trials conducted in the US and Europe involving 652 patients with vitreomacular adhesion. Both studies met the primary endpoint of resolution of VMA at day 28.

Jetrea’s phase III programme found that 26.5% of patients treated with ocriplasmin saw resolution of VMA, compared with 10.1% of patients receiving placebo (p<0.01). The phase III programme also showed that Jetrea was generally well tolerated with most adverse events being transient and mild in severity.

 
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