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Dexycu receives transitional pass-through status and C-code
EyePoint Pharmaceuticals is planning the commercial launch of the drug in the first half of 2019.
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Dexycu for postoperative inflammation after eye surgery has been approved for transitional pass-through status and reimbursement through a C-code by the CMS.
“This is a great moment for us,” Thomas Hadley, vice president of marketing and sales for EyePoint Pharmaceuticals, told Ocular Surgery News. Dexycu (dexamethasone intraocular suspension) 9% is a sustained-release alternative therapy to steroid drops that is administered through a single intraocular dose behind the iris after ocular surgery.
“CMS has approved Dexycu for transitional pass-through status, which is the reimbursement through a C-code. The C-code for Dexycu is C9034 and [became] effective on Oct. 1, 2018,” he said. “Having this really helps support the commercialization launch of Dexycu and more importantly provides patients an alternative single injection steroid, other than steroid drops.”
Pathway to market
Drugs that are administered during cataract surgery can be covered under a CMS transitional pass-through payment, but drug applications must meet certain qualifications for inclusion. The status is temporary for 3 years, and products are reimbursed under a C-code, according to an EyePoint press release.
“Drug delivery is the way of the future in ophthalmology, and any new product that decreases the need for patient compliance will ensure better outcomes,” Lisa Nijm, MD, JD, founder and medical director of Warrenville EyeCare & LASIK, told OSN.
“CMS established pass-through status to encourage the development of innovative drugs, devices and biologics. A new innovation such as a drug can be reimbursed as part of the ‘facility fee package’ that the hospital or ASC would otherwise receive payment for or be granted time-limited ‘pass-through status’ such that it is reimbursed in addition to the facility fee,” Nijm said. “It is becoming more imperative for ophthalmologists to familiarize themselves and their operating facilities with how these codes work as more innovations come to market. Ophthalmology is driven by new technologies aimed at improving quality of care for patients and increasing efficiency. However, with this new technology comes a responsibility to understand the coding and reimbursement system to ensure we will be able to incorporate these new innovations for the benefit of our patients.”
Some ophthalmologists may initially be put off by the expense of a pass-through drug.
“In 2014, CMS confirmed that new drugs which function as ‘supplies in surgery’ must meet the cost requirement of the ‘policy packaged’ test to achieve pass-through status,” she said. “The complex formula, dictated by CMS, is used to determine if a drug meets this standard and comes from the requirement for CMS to maintain budget neutrality. Therefore, being granted pass-through status is no small feat.”
EyePoint is planning the commercial launch of Dexycu in the first half of 2019. The inflammation treatment has the potential to fill the unmet need of steroid drops, the current standard of care to treat inflammation after ocular surgery, by providing a long-acting alternative therapy, Hadley said.
“We are on track for the commercial launch. We have been building out a number of strategic initiatives for the commercial launch. There are four pillars to that. One is hiring a top-tier sales team, the second is building out a robust medical education plan, the third is gaining payer access, and finally initiating a superior marketing strategy. We are very excited about the potential for Dexycu to meet a high unmet need for preventing inflammation post-cataract surgery with the ease of a single steroid injection at the end of surgery,” Hadley said.
Evolution of EyePoint
EyePoint has more than 20 years of experience in the ophthalmology field. Starting as a research and development company called pSivida, EyePoint began to transition into a fully integrated commercial organization after the acquisition of Icon Biosciences and Dexycu, Hadley said.
“With the change from pSivida to EyePoint, we have increased our commitment to ophthalmology markets. That will be our sole focus going forward. Dexycu will be our first commercial product we’re able to bring to market during the first half of next year. We also have a Nov. 5, 2018, PDUFA date for Yutiq, which is our 3-year sustained-release implant for noninfectious posterior uveitis. This is the beginning of EyePoint Pharmaceuticals as a fully commercial organization, and I think we’re well on our way to helping patients with vision-threatening diseases,” Hadley said.
Dexycu was approved by the FDA on Feb. 9 and is the only FDA-approved single-dose intraocular product for the treatment of postoperative inflammation after ocular surgery. – by Robert Linnehan
- EyePoint Pharmaceuticals secures pass-through payment status and assignment of C-code for Dexycu. http://investors.psivida.com/news-releases/news-release-details/eyepoint-pharmaceuticals-secures-pass-through-payment-status-and. Published Sept. 5, 2018. Accessed Sept. 5, 2018.
- For more information:
- Thomas Hadley can be reached at EyePoint Pharmaceuticals, 480 Pleasant St., Suite B300, Watertown MA 02472; email: thadley@eyepointpharma.com.
- Lisa Nijm, MD, JD, can be reached at Warrenville EyeCare & LASIK, 2S631 State Route 59, Suite A, Warrenville, IL 60555; email: lmnijm@uic.edu.
Disclosures: Hadley reports he is the vice president of marketing and sales for EyePoint Pharmaceuticals. Nijm reports she is a consultant for EyePoint Pharmaceuticals.