ニュース
Sequana Medical granted US CPT® III reimbursement codes for alfapump® system
Sequana Medical granted US CPT® III reimbursement codes for alfapump® system
PRESS RELEASE
Strengthens US reimbursement position
Builds upon PMA application submitted to the US FDA on 27 December 2023
Ghent, Belgium – 03 January 2024 – Sequana Medical NV (Euronext Brussels: SEQUA) (the "Company" or "Sequana Medical"), a pioneer in the treatment of fluid overload in liver disease, heart failure and cancer, today announces that the American Medical Association (AMA) has issued six new Category III Current Procedural Terminology (CPT III) codes for the alfapump system, an important step in facilitating reimbursement for the Company’s innovative medical device for the treatment of recurrent or refractory ascites due to liver cirrhosis.
The Premarket Approval (PMA) application for the alfapump system was submitted to the US Food and Drug Administration (FDA) on 27 December 2023, based on the successful execution of Sequana Medical’s pivotal POSEIDON study.
Martijn Blom, Chief Commercial Officer at Sequana Medical, commented: “We are delighted with the issuance of six new Category III CPT codes by the American Medical Association for our alfapump system, which is a further important step in our US commercialization strategy and augments the existing ICD-10 procedure codes. Upon FDA approval, healthcare professionals will be able to submit claims for the alfapump system, paving the way for broader adoption and supporting our commercial roll-out in the US.”
Ian Crosbie, Chief Executive Officer of Sequana Medical, added: “Today's announcement marks another important milestone in our US commercial strategy for the alfapump and follows the recent submission of our PMA application. We are stepping up preparations for the US commercial launch of this breakthrough therapy for the treatment of recurrent or refractory ascites due to liver cirrhoisis, a significant patient population that is growing at 6-7% annually due to NASH / MASH. We believe that the alfapump will transform the treatment options for these patients, virtually eliminating the need for needle paracentesis, improving quality of life and delivering benefits to payors and healthcare systems.”
Six new CPT III codes for the alfapump system
In the US, CPT codes are used by public and private health insurance programs and offer doctors and health care professionals a method to identify medical services and procedures for reimbursement. Category III CPT codes are temporary codes assigned to new and developing technologies, procedures and services. The six CPT III reimbursement codes will be available for use by healthcare professionals and payors as of July 1st, 2024 for procedures related to the alfapump system, including implantation, revision, removal and programming of the pump system, replacement of the pump and the catheters.