Effective Dec. 1, 2011, Coventry Health Care in Pennsylvania, Missouri, and Illinois introduced a restrictive formulary, which affects patients with primary immunodeficiency diseases (PIDD) who use immunoglobulin (Ig) replacement therapy.
Coventry’s formulary curtails access to Ig products, mandating patients with PIDD be switched to use Coventry’s preferred product.
Health plans may change their formularies for admirable reasons.
Naturally, health plans want to try to hold down the cost of health care and health insurance by bargaining for the best possible prices and making the most efficient possible use of plan resources.
By the time you read this, maybe the concerns about the Coventry formulary change will be cleared up.
But this case points to the importance of understanding that there are significant reasons why physicians need to prescribe specific Ig products. A change in the list of approved Ig products is a patient safety issue that must be resolved.
Ig replacement therapy is not a life-enhancing therapy; it is lifesaving. Many patients with PIDD rely on a routine regimen of lifelong Ig replacement therapy in order to live normal, productive lives. Without Ig therapy, patients with PIDD would be prone to constant, sometimes life-threatening infections, multiple visits to ERs, hospital stays, nearly constant use of multiple antibiotics, and the development and treatment of serious co-morbidities.
What makes Ig therapy particularly different from many other medications is that it is a blood plasma-derived biologic therapy, not a pill. Ig therapy partly replaces what the body should be making. Ig therapy provides only temporary protection—it does not help the patient’s immune system make more. Most antibodies, whether produced by the patient’s own immune system or given in the form of Ig, are used up or “metabolized” by the body. Approximately half of the infused antibodies are metabolized over three weeks, so repeat doses are required at regular intervals.
It is the opinion of the Immune Deficiency Foundation (IDF), Towson, Md. — a national patient organization dedicated to improving the diagnosis, treatment and quality of life for persons with PIDD—that Ig therapy is not appropriate for an insurance formulary, as there are no generic Ig therapy products. Ig therapies are not interchangeable, and the FDA recognizes each product as unique. The medical evidence shows that patients with PIDD tolerate Ig products differently. Following the standards of care as outlined by the American Academy of Allergy, Asthma & Immunology (AAAAI) will result in optimal patient care and help avoid costly infections down the line.