Prime Therapeutics Study Finds 1 In 20 Members May Be Using Immune Globulin For A Non-FDA Approved Or Non-Supported Indication

ST. PAUL, Minn.--(BUSINESS WIRE)--One in 20 immune globulin users did not appear to have a U.S. Food and Drug Administration (FDA) approved or literature supported indication in their medical claims history, according to an analysis presented next week at the Academy of Managed Care Pharmacy’s 2017 Annual Meeting by Prime Therapeutics LLC (Prime), a pharmacy benefit manager (PBM) serving nearly 20 million members nationally. With more than 80 percent of immune globulin utilization and spend billed under the medical benefit, it is difficult to accurately report trends without access to integrated medical and pharmacy data.

“Furthermore, off-label or unsupported use of immune globulin could lead to unnecessary exposure and increased risk of side effects.”

For the study, Prime researchers reviewed integrated immune globulin medical and pharmacy claims from January 2016 through June 2016 among 1.5 million commercially insured members. Immune globulin drugs, used to treat immunodeficiency and immune-mediated disorders, are frequently prescribed for uses other than what the FDA has approved or literature supports. Some of these “off-label” or unsupported uses may have some evidence, however for some diagnoses it might only be in one case report.

During the study period, 724 members had a pharmacy or medical claim for an immune globulin drug, and $17.2 million in total spend ($1.95 per member per month). 609 members’ (84 percent) claims accounting for $14.3 million in spend were processed through the medical benefit. More than 90 percent of spend was for FDA approved or literature supported uses, however, around 6 percent of spend among one in 20 members was for immune globulin use without evidence of an FDA approved indication or literature supporting use in their medical claims history.

“It is essential to have access to integrated medical and pharmacy data to accurately report utilization and spend for immune globulins,” said Cathy Starner, PharmD, principal health outcomes researcher at Prime. “Furthermore, off-label or unsupported use of immune globulin could lead to unnecessary exposure and increased risk of side effects.”

About Prime Therapeutics
Prime Therapeutics LLC (Prime) helps people get the medicine they need to feel better and live well. Prime manages pharmacy benefits for health plans, employers, and government programs including Medicare and Medicaid. The company processes claims and delivers medicine to members, offering clinical services for people with complex medical conditions. Prime serves nearly 20 million people. It is collectively owned by 14 Blue Cross and Blue Shield Plans, subsidiaries or affiliates of those plans.

For more information, visit www.primetherapeutics.com or follow @Prime_PBM on Twitter.