The Patient, the Physician, and the Payor: A Multiperspective Look at the Challenges of Treating Primary Immunodeficiency

Patients with primary immunodeficiency disease (PI) requiring immunoglobulin (IgG) treatment pose a challenge to clinicians that has been further complicated by restrictions imposed by third-party payors. A symposium at the Clinical Immunology Society (CIS) Second Annual Meeting addressed the issues facing clinicians who manage patients with PI and the best practices for effectively dealing with them. This supplement summarizes the proceedings of that symposium, which was attended by an international group of clinical immunologists, researchers, and industry professionals. The information included in these articles may be particularly important for payors and insurers as well as physicians, and it is hoped this discussion will facilitate a dialogue aimed at achieving optimal patient outcomes. The first article, “Dosing and Therapy Utilization: A Discussion of Updates on PI Treatment Guidelines,” by Mark Ballow, MD, reviews key properties of IgG preparations and considerations for their use that should guide the clinical decision making by payors about these medications. These include properties and current indications for IgG, appropriate dosing for these products, intravenous (IGIV) versus subcutaneous (IGSC) administration, and whether or not it is appropriate to consider all currently available agents as equivalent. All of these considerations have the potential to influence treatment efficacy and safety for patients and should influence formulary and other reimbursement decisions. For example, decisions regarding the route of therapy should be individualized based on factors that include a patient’s history of tolerability, adherence with therapy, and lifestyle. Dosing with IgG preparations should also be based on clinical outcomes (e.g., protection from infection) rather than exclusively on trough IgG levels. This article also discusses the common practice of switching stable patients from one product to another and the potential for increased adverse events when this is done. In the second article, “Payor Issues From the Standpoint of the Physician and Patient,” Ralph S. Shapiro, MD, and Marcia Boyle review recent decisions by government and private insurers affecting both patients who require administration of IgG and the physicians who care for them. Issues addressed include barriers to initiation of treatment for patients with PI, misguided and potentially dangerous attempts to treat patients to progressively lower trough IgG levels and possibly “wean” them completely from treatment, limitations in products available on formularies, and the requirement for patients to change to and then fail a preferred product before they are returned to previously effective and well-tolerated therapy. The article also discusses the need for better-informed policies to ensure that the use of IgG leads to optimal outcomes in patients with PI. The third article, “Local and National Advocacy Support,” by Ralph S. Shapiro, MD, Marcia Boyle, and Elena E. Perez, MD, PhD, addresses local and national advocacy efforts for patients with PI who face payor-mandated A Proceedings Supplement of a Symposium Presented at the 2011 Annual Meeting of the Clinical Immunology Society.