Advocacy for Personalized IgG Therapy Choices

The Clinical Immunology Society (CIS) Advocacy for Personalized IgG Therapy Choices 


The Clinical Immunology Society (CIS) stands firmly in support of the autonomy inherent in the physician-patient relationship, essential for personalized decision-making in the selection of immunoglobulin (IgG) therapy for patients with primary immunodeficiency (PI). We believe that selecting an IgG product should consider a comprehensive array of factors, including the patient’s detailed medical history, existing comorbid conditions, and specific therapeutic needs. The CIS asserts that IgG product selection must be tailored to the individual, based on shared decision-making between the patient and their immunologist. We express deep concern over recent actions by some commercial health insurers, which propose switching patients’ IgG products due to changes in formulary. Such policies potentially overlook the nuanced considerations essential to IgG therapy: 


  • The Unique Nature of IgG Products: IgG therapies are not interchangeable, as each product has a unique composition that affects a patient’s response and tolerability. Therefore, any alterations in therapy must be underpinned by medical reasoning rather than adjustments to insurance formularies.
  • Risks of Non-medically Justified Changes: Switching IgG products without a solid medical basis can endanger patient health, leading to increased healthcare costs and a decline in quality of life due to potential adverse reactions, the need for additional treatments, and increased hospital visits.
  • Considerations for Comorbid Conditions: The selection of an IgG therapy is particularly critical for patients with comorbid conditions like diabetes or cardiac issues. The glucose content and sodium concentration in specific formulations can significantly impact the management of these conditions, highlighting the importance of appropriate IgG therapy selection to effectively manage the primary disorder while minimizing effects on other conditions. 


The requirement for IgG therapy in patients with PI to be precisely matched with their specific disease state, comorbidities, and lifestyle necessitates a collaborative decision- making process between the patient and their immunologist. Policies that compel changes in IgG products based solely on formulary changes compromise this vital process and potentially undermine the standard of care for these uniquely vulnerable patients. The CIS urges insurers and other stakeholders to recognize the critical need for individualized care in the management of primary immunodeficiency. We advocate for policies that facilitate the continued use of current, effective IgG therapies as determined by healthcare professionals, rather than being dictated by formulary adjustments.