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Insurers block immunoglobulin access using multiple tactics

May 01, 2024

Carrie DeSpain developed the purple-colored bruise on her breast in December 2022. A primary care doctor referred her to an oncologist who performed a biopsy. The specialist didn’t find cancer—but she did discover a rare autoimmune condition called granulomatous mastitis. In July 2023, an immunologist pinpointed the cause for what has become a chronic breast infection—common variable immunodeficiency (CVID).

Familiar with primary immunodeficiency (PI), the immunologist prescribed immunoglobulin (Ig) replacement therapy. DeSpain prepared herself for a visit to an infusion center. Even though other health problems like asthma, chronic sinusitis, irritable bowel syndrome, fatigue, depression, migraines, and leg weakness confined her to home for months, she was eager to start feeling better.

Then Premera Blue Cross, her insurance company, refused to cover her Ig therapy. Time after time, she and her immunologist worked to appeal the decision. Each time, the company had a different reason why it wouldn’t pay.

First, it inaccurately claimed she wasn’t taking prophylactic antibiotics. Then Premera Blue Cross said DeSpain needed to produce low antibodies to the pneumococcal vaccine, which she did—twice, an indicator of PI and part of the diagnostic criteria for CVID.

In the most recent denial, Premera Blue Cross claims that DeSpain’s immunoglobulin G (IgG) levels aren’t low enough to warrant Ig therapy. Premera Blue Cross told DeSpain that her IgG levels must be below 400 mg/dL before it approves Ig therapy. DeSpain’s IgG levels measure 423 mg/dL. The total IgG normal range for adults is 767-1590 mg/dL, according to Mayo Clinic laboratory guidelines.

DeSpain said she’s been denied 13 times by Premera Blue Cross since June 2023 in her efforts to get her Ig therapy treatment covered. Her doctor even met with a Premera Blue Cross medical provider for a peer-to-peer consultation, which yielded no results.

When contacted, a Premera Blue Cross representative did not address the required IgG level of 400 mg/dL and only said that Premera Blue Cross “has a robust appeals process.”

“I don't understand how they can set standards for the numbers when I have a diagnosis. How can they deny medical treatment when it’s needed? I wouldn’t wish this on anyone because it’s caused a lot of turmoil in my life,” said DeSpain, 53, who lost her job due to illness and is now applying for disability benefits.

Premera Blue Cross’ requirement that patients have an IgG level of less than 400 mg/dL is just one of the many maneuvers on the part of health insurance companies and other payers to block patient access to Ig therapy. Ig therapy is a specialty drug and is expensive. As health insurance companies look for ways to save money and increase their profits, delaying or denying patient care with Ig therapy is becoming more common. The goal is to discourage patients from using these high-cost drugs.

In addition to setting an IgG requirement, health insurance companies use other tactics to dodge coverage of Ig therapy or delay treatment with Ig. Companies may:

Patient Cindy Wilson (a pseudonym), diagnosed with hypogammaglobulinemia and IgG subclass deficiency in January 2024, is also being denied Ig therapy by her insurance company, Blue Cross of Idaho.

The first two times Blue Cross of Idaho refused to pay for Wilson’s treatment, the company deemed it not medically necessary because, like DeSpain, her IgG levels didn’t fall below 400 mg/dL.

The company denied two more subsequent appeals, claiming that Cuvitru, the prescribed Ig replacement therapy drug, is investigational; in those denials, the company mentioned nothing about requiring an IgG of less than 400 mg/dL. Cuvitru is approved by the Food and Drug Administration (FDA) to treat PI and other conditions.

Wilson’s PI has caused her to develop repeated lung infections and resulted in multiple COVID-19 infections. She suffers from extreme exhaustion, chest pains, trouble breathing, and headaches.

“You already feel beaten down being sick all the time, and then the people who are supposed to ‘help’ by giving you access to infusions to fight infections look the other way. The company follows its policy without looking outside the box and knowing that PI is not just a cookie-cutter illness,” said Wilson.

Immune Deficiency Foundation (IDF) Medical Advisory Committee (MAC) member Dr. Ramsay Fuleihan, an immunologist and PI specialist who practices at New York-Presbyterian/Columbia University Irving Medical Center and is clinical director of the Division of Pediatric Allergy, Immunology, and Rheumatology at Columbia University, said that if a patient has an IgG level on the low end of normal, and fails to produce antibodies to the pneumococcal vaccine, then Ig replacement therapy administration should be considered.

“It’s not reasonable to limit immunoglobulin to only patients who have IgG less than 400,” said Fuleihan.

According to the Model Coverage Policy for Ig Replacement Therapy prepared by IDF’s MAC in conjunction with the American Academy of Allergy, Asthma and Immunology (AAAAI):

“Although diagnostic and therapeutic guidelines.. are critically important in assuring that all but the most unusual cases of PI will receive appropriate therapy with parenteral immunoglobulin, it is impossible to prepare guidelines that will cover every situation. It is important to remember that in the relatively brief time since the human genome project was completed, the known number of recognized primary immunodeficiency diseases (inborn errors of immunity) has more than doubled.

“Therefore, it is essential that the insurance industry retain some flexibility so that those individuals with documented serious or recurrent infections who do not necessarily match the guidance outlined here can still gain access to at least a trial period of six months of immunoglobulin replacement therapy to determine if their increased susceptibility to infection can be controlled with treatment.”

In addition, the AAAAI’s Eight Guiding Principles for Effective Use of IVIG for Patients with Primary Immunodeficiency states, “There are a large number of PI diagnoses for which IVIG is indicated and recommended. Many have low levels of IgG, but some have a normal level with documented specific antibody disease.”

Because health insurance companies’ understanding of PI diagnosis and treatment is lacking and profits are important, patients like DeSpain continue to use what little energy they have to make appeals and fight for the treatment they need—and deserve.

“Just when you think things can’t get any worse, they’re getting worse,” said DeSpain. “I’m just falling apart—and desperate for help.”