Immune Globulin Largely Prescribed Off-Label

A new analysis revealed that 1 in 20 Prime Therapeutics customers using immune globulin received the drug for an indication that was not FDA-approved or supported through extensive literature.

Since more than 80% of immune globulin use is billed through the medical benefit, it is difficult to assess trends without integrated medical and pharmacy data, according to the press release. This study highlights the need for integrated data to facilitate the analysis of drug trends, the authors noted.

Included in the study were integrated medical and pharmacy claims for immune globulin drugs among 1.5 million Prime members from January to June 2016. Findings from the study will presented at the Academy of Managed Care Pharmacy’s 2017 Annual Meeting.

The drugs are typically used to treat immunodeficiency, immune-related disorders, or blood disorders. According to WebMD, immune globulin drugs are thought to lower the risk of infection in patients with weakened immune systems by strengthening the immune system.

However, immune globulin drugs are sometimes prescribed off-label for indications that are neither FDA-approved nor supported by other studies. While some off-label uses have some evidence of benefit, it may only be supported by 1 study in certain cases, according to the release.

During the study, 724 Prime members had a pharmacy or medical claim for the drug. This spending accounted for $17.2 million in costs, which was approximately $1.95 per member per month. Of all claims for immune globulin during this time, 84% were submitted through the medical benefit, accounting for $14.3 million in costs, according to the press release.

Prime reported that more than 90% of spending on immune globulin drugs was for FDA-approved indications or for conditions where literature supported the drugs’ use. The authors also discovered that non-supported or approved indications accounted for 6% of total costs for immune globulin drugs.

This analysis suggests that physicians should use FDA indications and current, confirmed studies to determine if immune globulin use is appropriate for a certain patient.

“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.”