American Regent’s injectafer assigned J Code by Centers for Medicare & Medicaid Services

Injectafer was approved by the U.S. Food and Drug Administration (FDA) on July 25, 2013 for the treatment of IDA in adult patients who have intolerance to oral iron or who have had an unsatisfactory response to oral iron, or in adult patients who have non-dialysis dependent chronic kidney disease.

The new J code, J1439, will become effective January 1, 2015, and will be universally accepted by all payers, permanently replacing the product’s temporary Q Code, Q9970. The Injectafer-permanent J code will further help streamline the billing and reimbursement process for healthcare providers who use Injectafer in patient care.

"We are extremely pleased that the CMS has granted a permanent J-Code for Injectafer, said Jackie Beltrani, Vice President, Commercial Operations, American Regent.

"We are confident that the automation of the reimbursement process will be an important facilitator in this novel product’s uptake as US physicians will now be reimbursed for Injectafer in a timelier and more efficient manner."

Injectafer can be administered as a single dose of up to 750 mg by IV push injection over 7.5 minutes or 15-minute infusion, and should be followed by a second dose 7 days later for a total cumulative dose of up to 1500 mg of iron per treatment course. The majority of patients (93 to 95 percent) in trials of Injectafer received the target dose of 1500 mg.

There are over 7.5 million people in the U.S. with iron deficiency anemia (IDA), a condition that occurs when body iron stores are inadequate for normal red blood cell production. Fatigue, difficulty concentrating, shortness of breath, and dizziness are common symptoms, significantly impacting patients’ quality of life.

IDA is a common complication of many diseases and conditions, including cancer, chronic kidney disease, gastrointestinal conditions, obstetric and gynecological conditions and congestive heart failure. It affects up to one-third of inflammatory bowel disease patients and nearly one-quarter of patients who have undergone gastric bypass surgery. IDA is prevalent in women, affecting over 3 million U.S. women of childbearing age due to conditions such as heavy uterine bleeding, postpartum anemia, and pregnancy.

Blood disease expert Lawrence Goodnough, MD, from Stanford University Medical Center and Lynell D’Sylva, RN, BSN, from American Regent recently discussed the importance of maintaining sufficient iron levels on Lifetime’s TV special, The Balancing Act.