VBI Vaccines Inc. (NASDAQ: VBIV), the biopharmaceutical company, stated that AMA (American Medical Association) CPT panel issued a Current Procedural Terminology (CPT) code for a 3-antigen Hepatitis B vaccine.
New code to differentiate vaccine: VBI believes, the unique code issued by AMA CPT on 3-antigen HBV (Hepatitis B vaccine) candidate, will be recorded using new code, making it different from single – antigen HBV vaccine available in the market. The company’s 3-antigen HBV candidate is currently undergoing regulatory approval or review in the U.S or Europe for marketing. As per US FDA (The U.S. Food and Drug Administration), Prescription Drug User Fee Act (PDUFA) targeted action to date has been set as November 30, 2021.
As per the management, the new code for the HBV is critical achievement and a critical step for the potential approval for the launch of vaccines for adults in the U.S market. The company will continue to support the Food and Drug Administration for the review of the product.
Hepatitis B is a significant infectious disease, with approximately 290 million people got infected globally. Hepatitis B is a one of the vital reason of liver disease and with the treatment, this is available at the moment, is very difficult to cure, with patients with cancer. The new vaccine (3-antigen HBV) is commercially available in Israel. The new code helps the specialist (Doctor or a medical professional) with a common language and description, streamlines reporting, increases efficiency and accuracy. The CPT is common terminology in the medical field in the U.S market, and it helps the general public and privately managed health insurance programs for reimbursement purpose.
Approval of a new unique code for the vaccine will be critical for a patient to sail through the entire reimbursement process smoothly. It will also make life simpler for doctors or medical representatives to provide a detailed description.