EyePoint Pharmaceuticals announced that the Centers for Medicare and Medicaid Services (CMS) has approved transitional pass-through status and reimbursement through a C-code for Dexycu (dexamethasone intraocular suspension) 9%. Dexycu is the company’s FDA approved product for the treatment of postoperative inflammation that is administered as a single intraocular dose at the end of ocular surgery. The code, C9034, will become effective on October 1, 2018.
“The receipt of pass-through status and the assignment of a C-code from CMS marks another important step forward in our commercialization preparation for Dexycu,” Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals, said in a company news release. “Our team continues to make progress on our commercialization strategy, hiring and scale-up initiatives in support of our planned commercial launch expected in the first half of 2019. We believe Dexycu has the potential to address the unmet need and limitations of steroid drops, the current standard of care available for patients to treat inflammation following eye surgery, by providing Dexycu as a convenient and long-acting single injection alternative therapy.”
Approximately 40% of patients who undergo cataract surgery are covered by Medicare Part B. Drugs that are administered as part of the cataract surgery procedure can be covered under a CMS administered transitional-pass-through payment. The pass-through payment was established by the U.S. government to help foster innovative drug development. Drug applications must meet certain qualifications for inclusion. The transitional pass-through status is temporary for 3 years and products are reimbursed under a C-code, which are issued quarterly by CMS.