Effective December 1, 2011, Coventry Health Care, HealthAmerica in Pennsylvania, introduced a restrictive formulary affects patients with primary immunodeficiency diseases (PIDD) who use immunoglobulin replacement (Ig) therapy. Coventry Group Health Plan in Missouri and Illinois are expected to soon follow. A formulary, by definition, will curtail access to Ig product selection, mandating patients be switched to use Coventry’s one preferred product. This is a patient safety issue that must be resolved.
The Immune Deficiency Foundation (IDF) is opposed to Coventry Health Care’s policy for the following reasons:
- This policy interferes with a physician’s ability to select the most appropriate IVIG therapy for each patient and further requires that a patient risk experiencing an adverse infusion reaction while switching, based on an insurance formulary rather than on a valid medical reason.
- This mandate will disrupt patient care by making an individual switch to a new therapy, even when their current therapy is successful. The results of this change could affect patient safety—causing some patients to experience adverse side effects ranging from mild headache, fevers, and aches to anaphylaxis, thrombosis, stroke, seizures, aseptic meningitis with debilitating long-lasting headaches, loss of consciousness, severe breathing problems or even the remote possibly of death.
- Immunoglobulin therapies are not generic or interchangeable. Each product is identified by the FDA as its own unique therapy and switching products is associated with an increased risk of adverse events like the ones listed above. As the FDA package insert for Gammaplex states “If the patient (a) has not received Gammaplex or another IgG product, (b) is switched from an alternative IGIV product or (c) has had a long interval since the previous infusion, prolong the observation time for adverse reactions after Gammaplex infusion.”
This is the Coventry HealthAmerica policy as the Immune Deficiency Foundation understands it based on information available to providers in Pennsylvania, the Coventry Immunoglobulin Therapy Policy, and conversations with policymakers at Coventry Health Care. We hope our efforts will focus their attention on patient safety.
InsurersAreNotDoctors.com will serve as a resource to bring updated information about this policy, and other policies, and share the stories of the patients with PIDD that will be affected. Please continue to check back for news and updates related to this harmful formulary. Learn More
