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.

Based on medical literature, there is an increased risk of adverse events that occurs when patients switch Ig therapies or try a new product. From IDF survey data, we know that approximately one-third of all adverse reactions in patients with PIDD occur in the context of trying a new product. These adverse reactions can range from mild headaches, fevers, and aches to thrombosis, stroke, seizures, aseptic meningitis with debilitating long-lasting headaches, loss of consciousness,acute respiratory distress syndrome, and anaphylaxis which in rare cases can lead to death. 

Most insurance companies recognize that they do not have sufficient internal expertise on the best ways to diagnose and treat patients with uncommon complex diseases like PIDD. These insurance companies often turn to various outsideresources and experts for assistance. Unfortunately, some of these outside sources may be providing inaccurate or out of date information. In other cases, insurers elect to move forward without a comprehensive understanding of thecomplexity of these disorders. Often, the end result is the establishment of faulty internal guidelines for diagnostic criteria and therapeutic options without taking into consideration the most recent standard of care guidelines promoted by the professional societies concerned with the care of PIDD patients.

For more than 30 years, IDF has been providing accurate and timely information for the nearly quarter-million Americans who have been diagnosed with a primaryimmunodeficiency disease. Governed by a board of trustees—and supported by a medical advisory committee comprised of some of the world’s leading clinical immunologists, as well as hundreds of grassroots volunteers and a compassionate, professional staff—IDF has provided individuals and their families with vital knowledge.

Additionally, IDF has successfully worked with several insurers in the past to update andrevise their Ig guidelines in accordance with the standards set forth by the AAAAI. Examples include:

  • BlueCross BlueShield of Minnesota: After working with IDF and AAAAI, BlueCross BlueShield of Minnesota revised theirguidelines and is now appropriately covering this therapy.
  • Aetna: In another case, Aetna approached IDF to help develop their guidelines for coverage of Ig therapy.
  • Highmark BlueCross BlueShield in Pennsylvania: In 2011, Highmark BlueCross BlueShield in Pennsylvania instituted a fail-first formulary for Ig therapy that would restrict all patients to a single Ig therapy product. Highmark worked with IDF and made changes to their formulary, including allowing patients who were already stabilized to be “grandfathered” to stay on their existing therapies.

Unfortunately, the policy Coventry had in effect at the time I wrote this was impacting patient care. A physician in Pennsylvania was treating a patient with PIDD who was a Coventry member. The patient was stabilized on a different Ig product for two years with no issues. Following the implementation of this formulary, the patient was forced to switch to the new preferred product. Within an hour of the infusion, the patient experienced partial face paralysis and a respiratory issue.

Clearly, that kind of outcome is not in the best interest of patients, insurers or group plan sponsors.

IDF is eager to assist Coventry, and other insurers, in developing treatment guidelines that not only provide guidance for optimal treatment of PIDD, but also can assist in correctly identifying individual patients for whom Ig replacement therapy is not appropriate.