Summary

Excerpt

The studies reviewed and issues addressed in this supplement underscore the challenges facing patients with primary immunodeficiency disease (PI) and the physicians who treat them. The first article emphasizes the importance of individualized treatment driven by clinical outcomes for patients with PI and the fact that immunoglobulin G (IgG) products cannot be considered as generic. Different patients with PI may require very different dosing regimens to achieve protection against infections. Treatment based on trough IgG levels rather than clinical outcomes is contrary to current guidelines. Differences among products in IgA, sugar and sodium content, and osmolarity may have little or no effect on efficacy, but they may impact safety and tolerability in particular patient subsets. Problems faced by physicians and patients reviewed in the second article strongly support the belief that decisions made by insurers often ignore the clinical evidence that provides the basis for the use of intravenous or subcutaneous IgG. The failure of insurers to follow clinical guidance for the treatment of PI patients has resulted in problems with care that include delayed infusions, denial of reimbursements, cancelled treatment, changes in infusion site, switching to a less preferred or less well-tolerated product, and reduced dosages. …