Protecting access to immunoglobulin therapy

Why does access to immunoglobulin (Ig) replacement therapy matter?

Many people with PI rely on lifelong immunoglobulin (Ig) replacement therapy to protect them from life-threatening infections because they were born without a properly functioning immune system. Ig is a biologic—that is, a medication made from a biological rather than chemical source—derived from blood plasma and is administered intravenously (IVIG) or subcutaneously (SCIG).

According to IDF's 2018 Treatment Survey, 39% of people with PI who require Ig treatment receive IVIG, while 61% receive SCIG. The decision to use IVIG versus SCIG is individually determined by the patient and their physician. It involves considerations including vein access, dosing schedules, adverse reactions, and convenience of use based on the patient's lifestyle. As a biologic, Ig therapy is not interchangeable. Access to the product that works best for each patient is essential to avoid side effects and tolerability issues. 

Access to immunoglobulin (Ig) therapies through public and private payers tops IDF's advocacy priorities:

• Work to address barriers that prevent skilled nursing facilities (SNF) from administering Ig therapy, resulting in rejection of patients who need Ig therapy, or patients skipping needed Ig treatments while in a facility. 
• Ensure coverage for the formulation that works best for each patient through private and public payers.
• Enact a permanent Medicare benefit for home access to intravenous immunoglobulin (IVIG) treatments that covers all necessary supplies and services, as well as the medication itself. This priority was accomplished on December 23, 2022.

Why is coverage for all Ig formulations necessary?

IDF advocates with private and public insurance payers to ensure that patients with PI who need Ig therapy have access to the specific formulation they require using the mode of administration (i.e., SCIG or IVIG) and site of care (e.g., home, infusion suite) that they and their doctor have determined they need.

Ig therapy is not interchangeable and access to the product that works best for each patient is essential because of side effects and varying tolerability levels. In July 2021, the IDF Medical Advisory Committee (MAC) approved the Model Coverage Policy for Immunoglobulin Replacement Therapy for Primary and Secondary Immunodeficiency Diseases with Impaired Antibody Response, which states: 

“...the choice of product and route of administration, e.g., intravenous or subcutaneous, should be determined by the prescribing physician in consultation with the patient, based on his/her individual needs.” 

This document was developed to support proactive advocacy so that payers adopt medically appropriate policies around Ig therapy for the treatment of PI.

Payers not covering 16.5% or 20% immunoglobulin formulations 

Recently, IDF has become aware of both private and public health insurance plans that have removed 16.5% and/or 20% immunoglobulin formulations from their formulary lists entirely. Individuals covered by these plans are essentially being denied the option to infuse subcutaneously because the high-concentration formulations preferred for SCIG are not covered by their insurance plans. 

While three 10% Ig formulations are approved for SCIG in the U.S., these lower-concentration products require greater infusion volume. Large infusion volumes are not tolerable for many SCIG users, as they require more infusion sites and are not compatible with a biweekly SCIG regimen. IDF's 2018 Treatment Survey found that only 13% of PI patients using SCIG used 10% formulations. 

There is no medical justification for dropping coverage of 16.5% and/or 20% Ig formulations. SCIG is an important option for patients when IVIG is not well tolerated, when there is poor venous access (as in the elderly or in small children), or when the patient’s lifestyle is not compatible with IVIG. When 16.5% and/or 20% Ig formulations are not covered, patients may be forced to switch to lower-concentration SCIG or to IVIG, increasing their risk of adverse events and negatively affecting their quality of life.