Revance Receives Permanent J-Code for DAXXIFY and Announces Publication of DAXXIFY Pivotal Study (ASPEN-1) Results in Neurology

Revance Therapeutics, Inc. (RVNC) today announced that the U.S. Centers for Medicare & Medicaid Services (CMS) has assigned a permanent J-code (J0589) for DAXXIFY, indicated for the treatment of cervical dystonia in adults. J-Codes are product-specific reimbursement codes used by commercial insurance plans, Medicare, and other government payers and are intended to simplify reimbursement for providers and expand access for patients.

The company also announced today the publication of results from the ASPEN-1 Pivotal Phase 3 study in Neurology, the medical journal of the American Academy of Neurology. The study, authored by Cynthia L. Comella, M.D., evaluated the safety, duration of response, and efficacy of two doses of DAXXIFY for the treatment of cervical dystonia (CD), and served as the foundation for Food and Drug Administration (FDA) approval of DAXXIFY for the treatment of cervical dystonia in August 2023.

“We are very pleased to receive our permanent J-Code for DAXXIFY as we continue to make great progress with our cervical dystonia PrevU program and prepare for launch,” said Mark J. Foley, Chief Executive Officer. “Thanks to the hard work of our therapeutics team, we have received our reimbursement code, secured coverage for over 100 million commercial lives from top payers across the country and are on track to commercialize DAXXIFY in the therapeutics market mid-year. Further, our confidence in DAXXIFY’s ability to deliver a favorable duration and safety profile in real-world cervical dystonia patients continues to grow based on positive feedback from our PrevU physicians and the over 250 patients that have been treated to date in the PrevU program. Based on DAXXIFY’s unique clinical profile, our early clinical experience and advances in our reimbursement and coverage efforts, we look forward to providing patients suffering from cervical dystonia with a compelling alternative to their conventional treatment options.”

“As an investigator in all stages of the ASPEN program and a participating physician in the DAXXIFY CD PrevU program, I’m happy to see publication of the pivotal study results in a peer-reviewed journal for the neurology community,” said Atul Patel, M.D., MHSA. “Importantly, the real-world clinical results of DAXXIFY from the patients I have injected so far in PrevU, including safety, efficacy and duration, are in-line with those seen in the ASPEN-1 study. By offering a long duration of treatment effect, DAXXIFY can help reduce symptom reoccurrence between injections, which is experienced by most patients being treated with conventional botulinum toxins. This would represent a significant advancement in the treatment of cervical dystonia, something we have not seen in decades.”